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2014 Annual Report www.agitg.org.au www.gicancer.org.au

2014 Annual Report - GI Cancer2 GI Cancer Institute and AGITG 2014 Annual Report Chair’s Message AGITG members share a commitment to making a significant difference to the lives

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Page 1: 2014 Annual Report - GI Cancer2 GI Cancer Institute and AGITG 2014 Annual Report Chair’s Message AGITG members share a commitment to making a significant difference to the lives

2014 Annual Reportwww.agitg.org.auwww.gicancer.org.au

Page 2: 2014 Annual Report - GI Cancer2 GI Cancer Institute and AGITG 2014 Annual Report Chair’s Message AGITG members share a commitment to making a significant difference to the lives

Contents GI Cancer - The facts and our objectives ____________________ 1

Chair’s Message _______________________________________ 2

Group Co-ordinator’s Report _____________________________ 3

Executive Officer’s Report _______________________________ 4

Our GI cancer heroes ___________________________________ 5

Investing in tomorrow’s researchers _____________________ 6–7

AGITG Annual Scientific Meeting ________________________ 8–9

Clinical trials _________________________________________ 10

Oesophageal cancer ___________________________________ 11

Stomach cancer, GIST and NETs __________________________ 12

Pancreatic cancer _____________________________________ 13

Liver cancer __________________________________________ 14

Gallbladder and biliary tract cancer _______________________ 15

Bowel, small intestine and anal cancer _________________ 16–17

Board of Directors _____________________________________ 18

Operations Executive Committee _________________________ 19

Scientific Advisory Committee ________________________ 20–21

Upper and Lower GI Working Parties ______________________ 22

Study Chairs _________________________________________ 23

Consumer Advisory Panel _______________________________ 24

Treasurer’s Report ____________________________________ 25

Income Statement _____________________________________ 26

Balance Sheet ________________________________________ 27

Grants Awarded ______________________________________ 28

Support our work _____________________________________ 29

Participating centres ________________________________ 30–31

Donate or leave a bequest ______________________________ 32

GI Cancer Institute sponsors ____________________________ 33 Cover Image: Tom & Sarah McGoram. For their story, see page 10

Page 3: 2014 Annual Report - GI Cancer2 GI Cancer Institute and AGITG 2014 Annual Report Chair’s Message AGITG members share a commitment to making a significant difference to the lives

FACTS YOU SHOULD KNOW

GI Cancer Institute and AGITG 2014 Annual Report 1

GI Cancer - The Facts

Our Objectives

Every day, 33 people die from gastro-intestinal (GI) cancer and every year, 24,600 more Australians are diagnosed with the disease – that’s three new diagnoses every hour.

These cancers attack the digestive system, including the oesophagus, stomach, liver, gallbladder, pancreas, bowel and anus. Five-year survival rates for GI cancers remain unacceptably low at 49% – ranging from 67% for bowel cancer to just 6% for pancreatic cancer. Since 1991 we have been conducting ground-breaking research that has changed the way GI cancer is treated.

Three Australians are diagnosed with

GI cancer every hour of every day

24,600 people are affected by GI cancer

each year

15,151 new bowel cancer diagnoses - one of the highest rates worldwide

In 2014 we conducted 18 clinical

trials

Bowel cancer (7), Oesophagus/Stomach/ GIST/NETs (7), Pancreatic (2), Bile Duct, Anal (1 each)33 Australians die

as a result of GI cancer every day

of the year

33

The GI Cancer Institute, which is part of the Australasian Gastro-Intestinal Trials Group (AGITG), is the only Australian charity dedicated to finding better ways to treat GI cancer. Our aim is to develop new standards of care for all GI cancers, to improve survival rates and to reduce suffering as much as possible. By conducting research in Australia, cancer patients receive new treatments many years earlier than if the research was to take place overseas.

Our objectives

• To use clinical trials to develop and evaluate new treatments for people with gastro-intestinal cancer.

• To encourage the medical and scientific community to participate in developing, conducting, evaluating and promoting clinical trials for GI cancer research.

• To publish and promote the results of trials to improve clinical practices.

• To raise funds for vital clinical trials for GI cancer.

Our research is crucial

• There are more questions than funds. Four out of five research proposals do not get enough funding. With more funds, we can provide the answers.

• Treatment is expensive and not always readily available.

• By conducting research in Australia, cancer patients receive new treatments many years earlier than if the research was to take place overseas.

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GI Cancer Institute and AGITG 2014 Annual Report2

Chair’s Message

AGITG members share a commitment to making a significant difference to the lives of people with GI cancers – to saving and extending their lives and improving their quality of life.

In May 2014 I was honoured to become Chair of the AGITG, an organisation dedicated to finding better treatments for this widespread and devastating group of cancers.

I have a tough act to follow: my predecessor, Professor John Zalcberg OAM, served with great distinction for eighteen years as Chairman since co-founding the AGITG. He remains actively involved in the group, chairing our International Development Committee and serving on our Scientific Advisory Committee and Increasing Trial Recruitment Working Group.

Professor Zalcberg has received many awards, and we have honoured his legacy by establishing the John Zalcberg OAM Award for Excellence in AGITG Clinical Trials Research. The first award will be presented at our 2015 Annual Scientific Meeting.

Continuing our record of investing in our researchers, we also announced the launch of our new annual grant of up to $100,000 per year for AGITG pilot studies and translational research. This grant has been made possible by the generosity of our donors. This is an exciting new initiative which further enhances the group’s ability to facilitate and encourage our members to take leadership in the design and conduct of investigator-initiated clinical trials and translational research.

Also making a hefty contribution to fostering our research talent has been the AGITG Preceptorship Program for junior consultants and senior trainees. This is a two-day intensive course led by Associate Professor Eva Segelov and based on learning about best practice treatments through the evolution of clinical trials.

The formation of our International Development Committee, led by Professor Zalcberg, will allow us to strengthen the collaboration between our own clinicians and researchers and their leading counterparts worldwide – a collaboration that has become one of our distinguishing features.

Our clinical trials continue apace. Our oesophago-gastric trial INTEGRATE has announced presentation of preliminary results and expects to present major findings in 2015; while ASCOLT, our landmark trial on aspirin in adjuvant

Associate Professor Tim Price Chair, AGITG

colorectal cancer treatment, was busily setting up sites across Australia; and our Gastro-Intestinal Stromal Tumour trial ALT-GIST was on the brink of opening its first site. Every one of our trials promises significant contribution.

All of this costs money. As well as the generous support of our corporate sponsors, public donations help to keep our research moving. Our community division, the GI Cancer Institute, continues to make progress in raising funds and awareness of GI cancers in the wider community.

To help us manage our finances most effectively, we need the best advice. We thank Mr Colin Sutton for providing sound guidance during his tenure on our Board of Directors, and on the Finance and Risk Management Committee, from 2009 to the end of 2014; and we are pleased to welcome a new Board member, Mr Michael Gordon, who will bring a wealth of financial expertise as a leader in Australian asset management and a thirty-year veteran of the financial services industry.

On the consumer side, we continue to draw invaluable advice from our Consumer Advisory Panel – people who provide us with priceless insights drawn from their own experience as patients, carers and survivors.

And we receive advice from many other quarters – clinicians, researchers and other professionals who give their time and energy for no financial reward to further the cause of GI cancer research. We are especially grateful to the NHMRC Clinical Trials Centre for their invaluable assistance.

We move into 2015 with a shared determination to continue and improve our world-leading clinical trials, to increase survival rates and ultimately to ensure that every GI cancer patient is a survivor.

Good luck and good health!

Associate Professor Tim Price MBBS DHthSc (Med) FRACP Chair, AGITG from May 2014

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GI Cancer Institute and AGITG 2014 Annual Report 3

Group Co-ordinator’s Report

Professor John Simes

Since the early 1990s, the AGITG has been helping to improve the care and outcomes for people with gastro-intestinal cancer by evaluating new treatments or approaches in combining treatments. We have published more than 80 journal articles and presented over 150 study findings at national and international conferences. Importantly, working in collaboration with the NHMRC Clinical Trials Centre (CTC), we continue to play a major role conducting and promoting clinical trials research and addressing key clinical questions.

2014 saw several new activities in terms of new concepts, trials starting up and in progress, as well as several trials completing recruitment. It is pleasing to see the successful completion of recruitment of INTEGRATE. The ALaCaRT trial of laparoscopic surgery for rectal cancer is on track to complete recruitment of 470 patients by the end of the year.

The ICECREAM study continues to recruit well for patients in colorectal cancer with a G13D tumour mutation. Patients have joined this study from Australia, Spain, Italy and the United Kingdom.

Publications and presentations

Results from AGITG trials have been published throughout 2014 with 14 journal articles in peer-reviewed journals.

A number of analyses are currently underway with the aim to present results at the American Society of Clinical Oncology (ASCO-GI) in January 2015 for both INTEGRATE and GAP. The primary results for TACTIC were presented at the

European Society for Medical Oncology (ESMO) and this trial remains in follow-up to capture longer term data on patients. The primary results for QUASAR2 were also presented at ESMO and a study manuscript is expected in early 2015. Further MAX publications and the final results from ATTAX3, PAN-1 and TACTIC are expected to be published early in 2015.

Ongoing clinical research

At the end of 2014 the AGITG had four studies in development, five open to patient participation, and nine in follow up.

Opening recruitment during the year was the ASCOLT study, an international trial led from Singapore to test the efficacy of aspirin in reducing the rate of recurrence from colorectal cancer in people who have already had surgery and adjuvant chemotherapy for their cancer. Aspirin is a relatively safe and inexpensive therapy and if shown to be effective would be a treatment that could be made widely available internationally. The potential role of aspirin to improve outcomes in colon cancer was one of the top priority questions identified from our consensus meeting in 2011 involving clinical researchers, funders and consumers.

Other trials open to recruitment included the IMPaCT trial (Individualised Molecular Pancreatic Cancer Therapy), in collaboration with Sydney Catalyst and the Australian Pancreatic Cancer Genome Initiative, which is testing novel strategies for assessing personalised therapy.

Trials in follow-up included the CO.23 study, run in collaboration with NCIC-CTG (Canada), to test a novel cancer stem cell inhibitor for people with advanced colorectal cancer no longer suitable for other therapies.

Trials planned to commence in 2015 include ALTGIST, an advanced gastrointestinal stromal tumour (GIST) study which is planned to open in Australia in February 2015 and internationally later in 2015. CONTROL NETS, a study for pancreatic and mid-gut neuroendocrine tumours, will open in

April 2015 supported by funding provided by the Unicorn Foundation.

Grant Funding

In late 2014 ALaCaRT was awarded a further five-year NHMRC Grant which will enable extended follow-up of the trial as well as planned combined analyses of recurrence and survival with the similar US trial. A Cancer Australia grant to support patient follow-up for the SCOT study was also confirmed in late 2014.

Towards the end of this year much work is in progress on grant applications to be submitted in early 2015. These include a Centre for Research Excellence (CRE) grant application on rare tumours from AGITG/ANZGOG/ CTC and several project grant applications including an NHMRC grant application for CONTROL NETS to support activities from 2016 onwards; a Cancer Australia grant application for ACTICCA - a trial for cholangiocarcinoma led by AIO in Germany in collaboration with the UK-based BILCAP group; DOCTOR, a second NHRMC grant for the follow-up phase of the trial; NABNEC, a neuroendocrine cancer trial concept which was awarded Best New Concept at the 2013 AGITG ASM; and SPAR, a trial to assess the effect of Simvastatin in rectal cancer.

I extend my sincere thanks to all those contributing to our clinical trials research effort: from staff and volunteers at the AGITG / GI Cancer Institute to staff at the CTC, to the many members and staff on each of our committees, to all the clinical investigators and study coordinators at each participating site, and especially to the patients and carers who have participated in the trials as well as supported the group – financially or through the benefit of their first-hand experience and sound advice.

Professor John Simes BSc MBBS FRACP MD SM

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GI Cancer Institute and AGITG 2014 Annual Report4

Executive Officer’s Report

Russell Conley

With 33 Australian deaths resulting from GI cancer every day, and funding levels not reflecting this impact, the need has never been greater for our world-leading clinical trials. In 2014 we broke new ground in our efforts to raise funding and community awareness – and in 2015 we’ll go even further, with the help of our dauntless and tireless supporters.

Strategic plans and partnerships

During 2014 the AGITG 2014-2018 Strategic Plan was developed. This was the culmination of two years of work involving the AGITG Board, Scientific Advisory Committee, Working Parties, membership, staff and key partners.

It has been a year of outstanding strategic partnerships – from the Unicorn Foundation’s grant of $200,000 to our CONTROL NETS trial, to the Felice brothers’ inspirational “Nina’s Quest for a Cure” raising a total of $76,000 for our research.

The GI Cancer Institute has enjoyed generous corporate sponsorship (led by our platinum and gold sponsors Bayer, Specialised Therapeutics Australia, Sanofi and Roche) and government support (from Cancer Australia) – as well as precious backing from all the many people who have donated, left bequests, made venues available, sponsored or coached our runners, provided access to media or promotion, volunteered in our office, or otherwise given their time and energy to help us raise funds and awareness. We are deeply grateful to

all of them and couldn’t do what we do without them.

Engage

Following the success of the Engage Community Forums pilot program in 2013, the program was awarded funding in 2014 by the Australian Government and is now a Cancer Australia Supporting people with cancer grant initiative.

Thanks to this support, in 2014 our Engage forums on GI Cancer reached far and wide across Australia – to Brisbane, Western Sydney, Perth and Canberra. Several hundred people heard presentations by leading medical oncologists and health professionals on the “Big Picture” of GI cancer and latest research developments; while people who had been through the experience of being treated, or had supported others, told of their experiences of survival.

The generous support of Cancer Australia, along with Clayton Utz and most recently the Royal Bank of Canada, allows us to take these valuable forums into regional Australia as well as capital cities in 2015 and 2016.

Gutsy Challenge

Our Gutsy Challenge mobilises thousands of people around Australia to enter fund-raising events – running, riding, walking, climbing – or to create their own healthy eating or other challenges to raise money for our research. This activity reached new levels in 2014, raising over $88,000. Our teams braved the rigours of half marathons, bridge walks, bike rides and more. And the Gutsy Challenge will reach

even greater heights in 2015 – with plans well advanced for an ambitious fund-raising assault on Africa’s highest peak, Mt Kilimanjaro.

Making a mark in many media

We were able to reach more and more Australians with our messages during the year – our stories appearing in major newspapers in Brisbane, Melbourne, Canberra and Perth, feature interviews on pay TV and regional TV, and much local media coverage of our clinical trials, Engage forums, Gutsy Challenges and survivorship stories. Our Community Service Announcements were played on TV networks and stations across Australia – with a new 15-second Community Service Announcement released in December.

Through our websites, newsletters and social media we have continued to provide a channel for GI cancer patients, survivors, family and friends, professionals and supporters, to exchange information, experiences and insights about GI cancers and our work.

Get involved!

There are many ways you can get involved and play a key role in clinical trial research. From taking part in a clinical trial, to donating, taking a Gutsy Challenge, providing pro bono services or leaving a bequest in your Will, your contributions all help us achieve our goal of beating GI cancer.

Russell Conley Executive Officer

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GI Cancer Institute and AGITG 2014 Annual Report 5

Our GI Cancer Heroes In 2014 we raised unprecedented funding for our research – thanks to the gutsy efforts of our wonderful supporters. They ran, walked and rode in a variety of challenges and held healthy eating events.

Our heartfelt thanks to our GI Cancer heroes – these are just a few examples.

Gutsy runners storm Harbour Bridge

Our Gutsy Challenge team of over thirty people ran and walked across the Sydney Harbour Bridge on September 22 to raise money for AGITG clinical trials - trained by expert trainer Cameron Paulinich who donated his services. The runners included Brad Jones, running a half marathon in the midst of chemotherapy after being diagnosed with bowel cancer four years earlier at the age of 24; and Alice Wood, running in memory of her father, one of more than 12,000 a year lost to bowel cancer.

Small morning tea for a big cause

Brisbane’s Badke family hosted a Gutsy Challenge Morning Tea on October 25 after Cindy Badke was diagnosed with bowel cancer at age 40. In August, Cindy and husband Shane attended our Engage Forum in Brisbane – and decided to pitch in for the cause. Cindy said they wanted to give something back to the “wonderful doctors and nurses” striving to improve research and treatment.

Couple rides to empower

Grant and Branka Baker, both in their early forties, were diagnosed with GI cancers within two weeks of each other - Branka with bowel cancer and Grant with oesophageal cancer. After enduring surgery and therapy, they rode in the Sydney Spring Cycle to raise money for AGITG research. Grant is also an advocate for empowering patients, and has assisted in an advisory role with our first national GI Cancer Awareness Week planned for 2015.

Tom’s gutsy party

Eight-year-old Tom Soutar (pictured at centre in dark shirt), of Albany Creek, Queensland, gave traditional party foods a shake-up by organising a healthy food party in a local park – replacing sugary and salty snacks with apple smiles, fruit smoothies, vegie sticks and chocolate beetroot slices. The event not only raised money for our research, but also satisfied the taste buds of all involved.

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GI Cancer Institute and AGITG 2014 Annual Report6

Investing in tomorrow’s GI Cancer Researchers AGITG Innovation Fund

In 2014, the AGITG launched a new annual discretionary grant of up to $100,000 a year for pilot studies and translational research.

The grant has been made possible by prudent investment of generous charitable donations through the GI Cancer Institute.

Said AGITG Chair, A/Prof Tim Price (pictured): “This is an exciting initiative which further enhances the group’s ability to facilitate and encourage our members to take

leadership in the design and conduct of investigator-initiated clinical trials and translational research.”

To be eligible, a pilot study (or sub-study arising from an existing trial) must be led by a registered clinical member or members of the AGITG.

Grants will be made according to scientific merit and contribution to the AGITG clinical trials program, scientific validity, high quality and with the potential to improve clinical practice.

John Zalcberg OAM Award

The AGITG also launched in 2014 a new research award in honour of its founding Chairman: the John Zalcberg OAM Award for Excellence in AGITG Clinical Trials Research.

Professor John Zalcberg OAM (pictured) was AGITG Chair for 18 years until May 2014.

On August 14, 2014, he received the 2014 Tom Reeve Award for Outstanding Contributions to Cancer Care from the Clinical Oncology Society of Australia.

The John Zalcberg OAM Award is presented annually to a member who has made a significant and outstanding leadership contribution to AGITG clinical trials research over a long period.

The award will be presented at the Annual Scientific Meeting of the AGITG in September 2015.

The Selection Committee consists of AGITG Chair A/Prof Tim Price, Ms Christine Bishop, Ms Christine Liddy AO, Prof David Watson and Prof Ian Olver.

The AGITG Kristian Anderson Award

The Kristian Anderson Award supports a clinician undertaking a higher degree (MD or Ph.D) researching an aspect of personalised medicine in the area of colorectal cancer.

The award provides one year of funding at an equivalent level to NHMRC support for a higher degree ($36,700). This would be the first year of a planned three-year project. The grant aims to allow the clinician to be more competitive for NHMRC or other funding agency support in later years, which the successful candidate would be responsible for securing funds to support.

Award recipient, Dr Danielle Ferraro presented to the 2014 AGITG Annual Scientific Meeting on her work towards a Ph.D at the University of Melbourne, developing a test to give clinicians more accurate information about which patients would benefit from the targeted agents cetuximab and panitumumab.

The Kristian Anderson Award is supported by an untied grant from Merck Serono Australia.

The AGITG is passionate about GI cancer research and is committed to supporting new researchers through awards, courses and grants.

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GI Cancer Institute and AGITG 2014 Annual Report 7

Second AGITG Preceptorship in Colorectal Cancer

Following the success of the first AGITG Preceptorship in Colorectal Cancer held in August 2013 in Melbourne, Associate Professor Eva Segelov (pictured) led the second two-day Preceptorship in CRC in Sydney in July 2014 with assistance from one of the 2013 Preceptorship attendees, Dr Yada Kanjanapan.

The Preceptorship is aimed at medical and radiation oncology registrars and junior consultants and is restricted to 40 participants, with five mentors who are key opinion leaders in CRC: Prof Peter Gibbs, A/Prof Chris Karapetis, A/Prof Jeremy Shapiro, A/Prof Niall Tebbutt and A/Prof Nick Pavlakis.

There is no cost to attend the two-day Preceptorship, which included presentations on clinical relevance of molecular characteristics of CRC, interactive research appraisals in adjuvant therapy and metastatic CRC.

Multidisciplinary cases were discussed by a panel consisting of the preceptors and a multidisciplinary team including Dr Kourosh Haghighi (Liver Surgeon), Professor Michael Solomon (Colorectal Surgeon), Dr Andrew Kneebone (Radiation Oncologist) and Dr Richard Maher (Interventional Radiologist).

A/Prof Segelov thanked Dr Kanjanapan for her huge effort and enthusiasm. Dr Kanjanapan was later selected to make an oral presentation at the COSA 2014 Annual Scientific Meeting on December 3 on “Learning through clinical trials: 2013 and 2014 Preceptorship in Colorectal Cancer (CRC) – an initiative of the Australasian Gastro-Intestinal Trials Group (AGITG)”.

The CRC Preceptorships have been supported by educational sponsorships from Roche Products Pty Ltd.

Best New Concepts and Best of Posters Awards

The New Concepts Symposium, sponsored by Specialised Therapeutics Australia, was once again a feature at the 2014 Annual Scientific Meeting.

Congratulations go to Dr Matthew Burge of Royal Brisbane Hospital for winning the Best of New Concepts Symposium Award, sponsored by Specialised Therapeutics Australia. (Dr Burge pictured right with Luke Garrick from Specialised Therapeutics on the left)

Dr Burge’s concept was entitled “A randomised Phase 2/3 study of Infusional FU/LV with panitumumab V FU/LV/capecitabine with bevacizumab as first line therapy for never resectable, RAS and RAF wild type metastatic colorectal cancer.”

Dr Burge also won the Best Poster Award sponsored by Ipsen. His poster was entitled: “A prospective, single institution study of the impact of Fluorodeoxyglucose (FDG) positron Emission Tomography with concurrent non-contract CT scanning (PET/CT) on the management of operable Pancreatic, Ampullary or Distal Bile Duct cancer.”

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GI Cancer Institute and AGITG 2014 Annual Report8

AGITG Annual Scientific MeetingsEach year, the AGITG scientific meeting brings together researchers and clinicians from Australia and New Zealand to present their recent research into GI cancers and to discuss current challenges and future directions for research and collaboration.

The meeting serves as a forum for the presentation of cutting-edge studies and overviews on the pathobiological and clinical aspects of GI cancer, and provides an opportunity for researchers and specialists to forge deeper understanding of current challenges in GI cancer and their possible solutions.

The 16th AGITG Annual Scientific Meeting was a resounding success. Held in Brisbane from August 20-22, the meeting featured presentations by world leaders in gastro-intestinal cancer research and presented updates on all current AGITG clinical trials in five sections: pancreas cancer and neuroendocrine tumours, rare gastro-intestinal cancers, advanced colorectal cancer, adjuvant colorectal cancer, and oesophago-gastric cancer.

There was also a translational research session, plenary sessions, radiation oncology breakfast symposium, “meet the Professor” breakfast and interactive workshop, and study co-ordinators’ forum.

The meeting began with a joint half day Pancreas Cancer Research Workshop held in conjunction with the Australasian Pancreatic Club (APC), which looked at new research concepts in pancreatic cancer. The workshop explored translational research and projects in the treatment and prevention of pancreatic ductal adenocarcinoma across a broad range of activities. This second annual workshop covered subjects ranging from basic science and clinical trials through to better outcomes for patients.

Seven new trials were proposed during the new concepts symposium – with awards presented for Best New Concepts (see page 7).

GOLD SPONSORS SILVER SPONSORPLATINUM SPONSOR BRONZE SPONSORS

Novartis Oncology Ipsen Sirtex

Specialised Therapeutics Australia

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GI Cancer Institute and AGITG 2014 Annual Report 9

The presentations were on:

• Perioperative chemotherapy plus selective chemoradiation verses chemotherapy plus radiation therapy in patients with operable rectal cancer;

• Pre-operative sequencing of oxaliplatin based chemotherapy and chemoradiation for locally advanced rectal cancer; comparing standard radiotherapy concurrently with 5-Flurourcil verses interdigitating mFOLFOX with concurrent split course radiotherapy as preoperative therapy for locally advanced rectal cancer;

• Infusional FU/LV with panitumumab V FU/LV/capecitabine with bevacizumab as first line therapy for never resectable, RAS and RAF wild type metastatic colorectal cancer;

• First-line nab-paclitaxel versus gemcitabine in elderly patients with metastatic pancreatic cancer who are unsuitable for combination chemotherapy; and

• Metastatic colorectal cancer (mCRC) with BRAF mutation – early switch versus triplet regimen (both plus bevacizumab); and utilizing ctDNA to prospectively determine the evolution of cetuximab resistance prior to radiologic progression in metastatic colorectal cancer.

Thanks to our industry sponsors, the AGITG was delighted to present six international keynote speakers:

• Prof Jordan Berlin from Vanderbilt University, USA

• Dr David Ilson from Memorial Sloan Kettering Cancer Center, Memorial Hospital, USA

• Dr Maarten Hulshof from Academic Medical Centre, The Netherlands

• Dr Robert Kerbel from Sunnybrook Health Sciences Centre, Canada

• Prof Christophe Mariette from University Hospital, C. Huriez, France

• Dr Matthew Seymour from Cancer Research UK and University of Leeds, UK

A seventh keynote speaker was:

• Prof Paul Waring from the University of Melbourne

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GI Cancer Institute and AGITG 2014 Annual Report10

Clinical TrialsClinical trials are not about laboratories and test tubes. They are about real people fighting disease and getting access to the most effective medical treatments.

As all people and cancer tumours are different, clinical trials are needed to define which combination of medical treatments, surgery and radiation work best for particular groups of tumours and people.

Treatments generally include a combination of surgery, radiotherapy and specialist drugs (chemotherapy).

These treatments need to be administered in the optimal combination to ensure the best patient outcomes are achieved.

Benefits of clinical trials for patients

• Patients have immediate access to the latest treatments.

• New treatments can be introduced many years earlier if clinical trials are conducted in Australia.

• Improved cure rates.

• Improved quality of life during treatment.

AGITG Trials

The Australasian Gastro-Intestinal Trials Group (AGITG) designs and conducts clinical trials within Australia and New Zealand and through collaborations with international research groups in Asia, Canada and across Europe.

Clinical trials are divided into four categories:

1. Trials in development – Trials currently being developed which have been assessed and approved by the Scientific Advisory Committee and Consumer Advisory Panel.

2. Trials open to patient accrual – These trials are recruiting patients at hospital sites. The trial managers and coordinators work closely with hospital staff to collect data and monitor patient progress.

3. Trials in follow-up – These trials have reached their recruitment target. Patients may still be receiving treatment and their progress is being monitored and assessed for long-term effects of treatment, whilst data is being collected. Initial results are being processed and may be presented at research conferences.

4. Completed trials – These trials have ended. Patients are no longer being treated and the results of the study may be published in scientific journals and in the media. Often the results will affect clinical practice, the treatment of future patients and new trial development.

Full details of each trial and its schema are available at agitg.org.au

Riding the research wave to a longer life

Sarah McGoram has “ridden the wave of research” to a longer life – lived to the full.

Diagnosed at 18 years of age with a rare Gastro-Intestinal Stromal Tumour (GIST), she was told there was no treatment and given 18 months to live.

Then in 2000, Sarah (pictured) was invited to an AGITG clinical trial EORTC 62005. At first apprehensive, she found her questions answered by the trial team - and access to latest information and treatment helped extend her life. Later, she participated in another AGITG trial, REGISTER.

Almost twenty years after diagnosis, she has graduated from university, married Tom, juggled a teaching career and is raising her beautiful son George - now eight.

“One of my doctors from twenty years ago walked past and was shocked to see me,” says Sarah. “He told his colleagues ‘This young lady has ridden the wave of medical research - and is winning”.

“I won’t lie - cancer is no fun. But once I realised my choice was to fight this disease or give up, it was clear what I had to do.”

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GI Cancer Institute and AGITG 2014 Annual Report 11

Oesophageal Cancer Oesophageal cancer in Australia continues to grow at an alarming rate. 2011 saw 1,395 new diagnoses and by 2020 this is predicted to rise to 1,800. Oesophageal cancer generally occurs in people over the age of 50, more commonly in men than in women. In 2012, it claimed 1,203 lives – most within 12 months of diagnosis.

The oesophagus or food pipe is part of the digestive system. It is the tube that carries food from your mouth to your stomach.

Cancer can develop anywhere along the oesophagus but it most commonly occurs in the lower third, towards the stomach end. There are two main types of oesophageal cancer, squamous cell and adenocarcinoma. The risk factors for developing oesophageal cancer include a condition called Barrett’s Oesophagus, excessive alcohol consumption and smoking. However, oesophageal cancer can arise when none of these risk factors are present.

Oesophageal cancer is usually diagnosed by endoscopy, where a flexible tube with a camera on the end is passed down from the mouth, and samples of tissue, called biopsies, are taken and tested. Barium x-rays and CT scans are also used to diagnose oesophageal cancer.

The treatment of oesophageal cancer depends on its site within the oesophagus and how advanced it is at the time of diagnosis. Treatment options include surgery, radiotherapy and chemotherapy. These treatments are sometimes used in combination.

What is the AGITG doing about oesophageal cancer?

Active trials

• The DOCTOR study is the first to focus on patients who have not responded to pre-operative chemotherapy. It aims to improve disease and survival outcomes for patients with oesophageal cancer by identifying a potential treatment combination of chemotherapy, targeted biological therapy and radiation therapy for localised oesophageal cancer that can be removed by surgery. It will also provide valuable data for individualising therapy according to tumour characteristics.

Trials in follow-up

• Currently, there are few effective treatment options for patients with advanced oesophago-gastric cancer. INTEGRATE is testing a drug that has shown promising results for other GI cancers. It will determine if this drug can extend life and provide a better quality of life for patients. The INTEGRATE study is also looking to identify people with oesophageal cancer who may be more responsive to this drug.

INTEGRATE is an international clinical trial designed and led by the AGITG. Patients are recruited from Australia, New Zealand, Korea and Canada.

Mathematician defies the odds

After a lifetime of only minor health problems, Ian Lisle’s life was turned upside down in 2010 when he was diagnosed with cancer of the oesophagus.

Dr Lisle (pictured), Assistant Professor of Mathematics at the University of Canberra, found himself locked into a year of aggressive treatment – surgery, chemotherapy and radiotherapy.

He returned to work and took a six-month sabbatical, visiting universities in New Zealand, Canada and the UK.

Then came the news that his disease had recurred. Ian was told his prospects were poor - that the cancer was incurable.

“But that was in many ways just the beginning of the story”, he says.

With the help of new treatments, including participation in AGITG’s INTEGRATE trial, Ian is still alive today – more than three years after recurrence.

“Early detection, combined with careful attention to lifestyle factors such as diet and fitness have put me in a position to receive successful treatment that would normally not be available to patients with such advanced disease.”

Ian presented on “Survivorship” at the GI Cancer Institute’s Engage Community Forum in Canberra on November 25, 2014 – sharing some of the lessons he’s learned from the experience.

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Unicorn shows collaboration key to success

Losing their sister Kate at 34 to a rare NET prompted John and Simone Leyden (pictured) to launch their Unicorn Foundation to improve NET treatments and patient information.

In 2014, the Unicorn Foundation granted $200,000 to AGITG’s CONTROL NETS trial.

Says Dr John Leyden, Unicorn Foundation: “We knew of AGITG as a peak body of very bright minds – and CONTROL NETS is the first randomised study

in the world to examine Radiopeptide treatment of NETs by itself and in comparison or conjunction with chemotherapy.”

Unicorn Foundation CEO Simone Leyden adds: “Not being pharmacy-backed, this trial needed financial support from elsewhere.” Unicorn hopes to make further contributions.

Dr Leyden points out that well-run research like AGITG’s has spillover benefit to cancer and medical research generally. And multi-national collaboration brings more meaningful results – especially in rare cancer. This helps overcome the cut-throat competitiveness in the fight for scarce research funding.

His sister agrees: “With good collaboration, and a bit of hard work, anything is possible.”

Stomach Cancer, GIST and NETsAlthough stomach cancer (also known as gastric cancer) is on the decline in Australia, it still affects a significant number of people: in 2011 an estimated 2,093 people were diagnosed – and in 2012, 1,143 people died from it.

The stomach is a sack-like organ that receives and stores food from the oesophagus. With the help of gastric juices, the stomach breaks down food into a thick liquid passed from the stomach to the small bowel, where nutrients are absorbed into the bloodstream.

There are several different types of stomach cancer:

• Adenocarcinomas: about 90% of stomach cancers develop in the cells that line the inside surface of the stomach. They are called gastric adenocarcinomas.

• Lymphomas: cancer of specialised cells that are part of the immune system. These can arise in the stomach or other parts of the digestive tract.

• Gastro-Intestinal Stromal Tumours (GISTs): cancer arising from cells that control stomach wall muscle contractions. GISTs can also develop in other parts of the digestive tract but most frequently occur in the stomach.

• Carcinoid or neuroendocrine tumours (NETs): cancer of hormone-producing cells. These can arise in the stomach as well as in other parts of the digestive tract.

The symptoms of stomach cancer are vague but may include: indigestion, early fullness after eating, loss of appetite, unexplained weight loss, blood loss and pain.

Stomach cancer is usually diagnosed by an endoscopy, where a flexible tube with a camera on the end is passed down from the mouth and into the stomach. Other tests used to help with the diagnosis include barium x-rays and CT scans.

The treatment of stomach cancer depends where it is within the stomach and the type and stage of the cancer. Surgery to remove part or all of the stomach is the most common treatment, but radiotherapy and chemotherapy may also be used.

What is AGITG doing about stomach cancer (including GIST and NETs)?

Trials in development

• Participants in the ALT GIST trial (due to open recruitment early in 2015) will alternate imatinib with regorafenib. The study will assess whether using an alternating treatment approach improves disease control in patients with advanced GIST. If found beneficial and tolerable, this approach would be further studied in a larger Phase 3 trial.

• The CONTROL NETS trial promises to lead the world in developing quality evidence to guide management of NETs. The trial compares combined radiopeptide therapy and chemotherapy with either on its own in controlling advanced NETs. Finding the best of these promising treatments would allow its further investigation.

Active trials

• TOPGEAR is a globally significant AGITG-designed and led clinical trial with the potential to change clinical practice worldwide. It aims to determine whether chemotherapy combined with radiotherapy is better than chemotherapy alone for patients with operable stomach cancer. TOPGEAR aims to recruit 752 patients from hospitals across Australia, New Zealand, Europe and Canada.

Trials in follow-up

• AG0102 GIST / EORTC 62005 is a multi-centre, international trial to determine the relation between dose and clinical activity of chemotherapy tablet STI-571 (Glivec®) in patients with a malignant GIST that has spread or can’t be removed by resection, and who express the c-kit receptor tyrosine kinase (CD117).

• EORTC 62024 is a study of intermediate and high-risk localised, completely resected GIST expressing c-kit receptor. It is a controlled randomised trial on adjuvant imatinib mesylate (Glivec®) versus no further therapy after completing surgery to remove GISTs and at intermediate-high risk of relapse.

• REGISTER is a multicentre trial, using dose escalations of imatinib followed by nilotinib in patients with advanced or metastatic gastro-intestinal stromal tumour.

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Pancreatic cancerPancreatic cancer is amongst the most lethal of all adult cancers – its five-year survival rate just 6.1%. 2,524 people died from it in Australia in 2012. An estimated 2,748 people were diagnosed with pancreatic cancer in 2011. The risk increases with age and the average age of diagnosis is 71 years.

Survival rates for pancreatic cancer have increased in Australia but remain low – between the periods 1982–1987 and 2007–2011, five-year relative survival increased from 3.0 per cent to 6.1 per cent.

The pancreas is a narrow gland that lies between the stomach and spine. It is about 15 cm long and is joined by the pancreatic duct to the first part of the small bowel (called the duodenum). More than 90% of pancreatic cancers start from the cells in the inner lining of the pancreatic ducts. These are called adenocarcinomas. It can then move into the body of the pancreas before spreading into the blood vessels and nerves around the pancreas, obstructing the bile duct.

If the cancer blocks the bile duct jaundice, itchiness and pale-coloured stools can result. Other symptoms include loss of appetite, weight loss, pain and fatigue. Pancreatic cancer is generally advanced when diagnosed. It is usually diagnosed with radiology tests such as ultrasound, CT scan or MRI scan. A biopsy is sometimes needed.

The main treatment for pancreatic cancer that is diagnosed at an early stage is surgery. Chemotherapy and radiotherapy can also be used, often in combination. If the cancer is obstructing the bile duct and cannot be removed surgically, a stent (plastic or metal tube) can be inserted to maintain the flow of bile and prevent jaundice. Chemotherapy can also be used if the cancer has spread to other parts of the body.

Up to 20–25% of pancreatic cancers are attributable to cigarette smoking and genetic history. Diabetes, chronic cirrhosis, pancreatitis and prior cholecystectomy are also associated with an increased risk of the disease.

What is the AGITG doing about pancreatic cancer?

Active trials

• IMPaCT examines individualising treatments for patients with metastatic pancreatic cancer. It will assess benefits of a chemotherapy treatment called gemcitabine compared to personalised treatment based on tumour molecular signature in these patients. The study aims to evaluate feasibility of and impact on progression-free survival.

The IMPaCT trial, conducted in Australia and New Zealand, is a multidisciplinary collaboration between the AGITG, NHMRC Clinical Trials Centre, Sydney Catalyst and the Australian Pancreatic Cancer Genome Initiative.

Trials in follow-up

• GAP, a trial for patients with resectable pancreatic cancer, will determine if preoperative chemotherapy (chemotherapy prior to having surgery) can improve surgical and/or long-term outcomes for patients. It aims to improve knowledge regarding treatment-related toxicity and treatment effectiveness.

Walking for research and awareness

Jane Irwin is an inspiration for GI cancer carers.

After losing her father to pancreatic cancer, Jane lost her husband David (pictured) to the same disease in 2013. She had to dig deep to find the strength and determination to keep moving forward.

Jane set up her own Everyday Hero webpage to raise funds for AGITG clinical trials. In the first three months, she raised over $1100, easily surpassing her original target.

“It’s unbelievable,” she says. “People have been so supportive. There have been so many wonderful messages, and so much encouragement.”

Jane walked in the City2Surf in Sydney in August 2014 to raise funds for research. Her dedication to improving GI cancer treatment and care reaches beyond fund-raising: she co-facilitates a support group in Casula for GI cancer patients, a varied group of people at different stages of care.

“Our motto is ‘Don’t be afraid to ask’”, says Jane. “You need to ask questions and seek help. It’s really heartening to know that other people are going through what you are going through”.

Jane has been through plenty – but is showing the courage to turn her losses into positive actions. As she says, “I don’t want people to go through what my family did. We’re doing whatever we can to make sure people don’t have to go through the same things”.

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Liver Cancer

What is the AGITG doing about liver cancer?

Trials

• AGITG has no current trial in liver cancer. A recently completed trial, EORTC 40983, aimed to see if adding chemotherapy for three months before and after surgery can improve the cure and recurrence rates of patients whose bowel cancer has spread to the liver. Results revealed that adding chemotherapy improved progression-free survival, but did not demonstrate a significant improvement in overall survival.

Timely liver transplant saves Ian’s life

As a former police officer and rugby union referee for over 20 years, Ian Hatswell (pictured) would tell you he was reasonably fit. That is, until 2011 when at the age of 57 he learned that he had cirrhosis of the liver and at risk for liver cancer. In March 2014, an MRI scan confirmed Ian had liver cancer and would need an urgent liver transplant to survive.

Shortly after his diagnosis, Ian recalls being in hospital for an unrelated operation. “The cancer had grown 2 ½ centimetres in six weeks and I’d been given a month to live,” he says, “so I was over the moon when they told me a new liver was available and the wait was over.”

Worldwide, liver cancer is one of the leading causes of death. It is estimated that 1,446 people were diagnosed with liver cancer in Australia in 2011, and 1,490 people died in 2012 as a result of it.

Secondary liver cancer is the most common type of liver cancer. It occurs when a cancer spreads to the liver via the bloodstream. The kinds of cancers that can spread to the liver include all of the other gastro-intestinal tumours, especially bowel cancer.

Primary liver cancer occurs when the cancer arises from the liver cells. The most common type is called hepatocellular carcinoma (HCC). HCC usually occurs in people who have had underlying liver disease for many years resulting in liver scarring (cirrhosis). There are other rarer types of liver cancer, including hepatoblastoma, which affects very young children.

Liver cancer does not usually cause symptoms until it is advanced. Symptoms may include jaundice, abdominal swelling, loss of appetite, pain and weight loss.

Liver cancer is usually diagnosed using special radiology tests, such as ultrasound, computed tomography (CT) scan and Magnetic resonance imaging (MRI). A blood test is often used to help the diagnosis and occasionally a biopsy is required.

The treatment of primary liver cancer depends on how far the cancer has spread and whether there is underlying liver disease. Treatments include surgery to remove part of the liver (liver resection) or removal of the whole liver (liver transplantation), ablation (a way to destroy the cancer cells without having to remove that part of the liver surgically), chemotherapy given into the blood vessels supplying the tumour (chemoembolisation), and biological agents (drugs that interfere with the signaling pathways in cancer cells).

The treatment of secondary liver cancer depends on the primary cancer type. Some are treated with chemotherapy and some may be suitable for surgical removal. Ablation is also used sometimes.

The prognosis for liver cancer depends on many factors, including whether it is primary or secondary, how advanced it is at the time of diagnosis and whether it is possible to remove all of the cancer with surgery.

Photo credit - Jude Keogh, Central Western Daily

Fortunately, Ian has a positive outlook and a supportive family, both necessary to survive the ordeal of eight hours in surgery to replace his liver. Since the transplant, Ian travels from his home in Orange to Sydney every month for tests but he feels great and thanks his new liver when people tell him he looks ten years younger.

Now, as part of the planning committee for the Engage Community Forum in Orange, Ian is raising awareness of GI cancer by sharing his experience, knowing that people will find hope in his story.

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Gallbladder and biliary tract cancerCancer of the gallbladder and bile ducts is relatively rare, with 771 new diagnoses in Australia in 2011. It caused 254 deaths in 2012. While males and females were equally likely to be diagnosed with the disease, females were more likely to die from it.

Gallbladder cancer is often diagnosed at an advanced stage making it difficult to treat. However, survival from gallbladder cancer has increased significantly. Between the periods 1982 – 1987 and 2006 – 2010, five year survival doubled from 10% to 20%.

The gallbladder is connected to the bile ducts. It is a small pouch that stores and concentrates the bile that is made by the liver. The gallbladder and bile ducts are known as the biliary tract.

The gallbladder is lined by the same type of cells that line the bile ducts, and gallbladder cancer is therefore similar to biliary tract cancer, which is also known as cholangiocarcinoma. These cancers are most common in people over the age of 60. Gallbladder cancer usually occurs in people who have gallstones. Chronic inflammation of the bile ducts predisposes a person to bile duct cancer, but it can also occur in the absence of this condition.

Bile duct cancers often cause jaundice but gallbladder cancer does not usually cause symptoms until it is advanced. However, it may be discovered at an earlier stage due to pain from the gallstones.

Radiology tests such as a CT scan or an MRI are done to help diagnose and stage the cancer and to determine the best treatment options.

The main treatment for gallbladder and biliary tract cancer is surgery. This is only suitable if the cancer has not spread. Other treatments such as chemotherapy and radiotherapy may be used, and blockages of the bile duct can usually be alleviated with stents (a plastic or metal tube inserted through the blocked section).

Unfortunately, most people are diagnosed with biliary tract cancer once the tumour is too large to remove surgically or has spread to other parts of the body. This means that only 10% to 30% of people with the disease are eligible for surgery. Even so, the average five-year survival rate for all patients is only 12%. For those who are ineligible for surgery, chemotherapy remains the main treatment option. Gemcitabine and cisplatin are two chemotherapy agents commonly used to treat biliary tract cancer. The aim of this treatment is to slow the cancer and maintain quality of life.

What is the AGITG doing about gallbladder cancer?

Trials

• Patients with locally advanced or metastatic biliary tract cancer with wild-type K-Ras are usually treated with two chemotherapy drugs. Our recently-completed TACTIC trial aimed to determine whether the addition of a new antibody treatment called panitumumab was safe and would improve the chance of survival.

New Trials in development

• ACTICCA-1, is an international multi‐centre trial led by the German groups AIO/DGAV/DGVS and coordinated by the University Cancer Centre in Hamburg, Germany. This randomised, multidisciplinary phase III trial is looking at cholangiocarcinoma - a type of cancer that develops in the bile ducts. The bile ducts carry bile from the liver and gallbladder through the pancreas to the small intestine. Bile is a dark-green or yellowish-brown fluid secreted by the liver to digest fats and helps rid the liver of waste products. This type of cancer is rare, with only a few hundred cases in Australia and it occurs more frequently in the older population.

Trials undergoing primary analysis or ongoing analyses

• TACTIC, This study aims to evaluate the safety and efficacy of combining panitumumab with the standard cisplatin and gemcitabine treatment for advanced biliary tract cancer. The secondary objectives are to assess the tolerability and safety of the study treatment, overall survival, progression free survival, time to treatment failure, quality of life and tissue biomarkers of participating patients.

Rachel takes Dad’s memory to African heights

Rachel Livingston will take her Dad’s memory to the top of Mt Kilimanjaro in November 2015.

Rachel’s father, John Livingston (pictured with Rachel on her wedding day), died in 2014 from gallbladder cancer – after being diagnosed during a holiday with Rachel’s Mum and told he had only eight weeks to live.

“We were devastated”, says Rachel. “We had no idea he had been living with such a sinister, terminal illness.”

Rachel, of Ainslie ACT, will honour her father’s memory and raise money to help others avoid the same fate, by joining the GI Cancer Institute’s week-long Gutsy Challenge to the top of Africa’s highest mountain.

“I chose the GI Cancer Institute because its research has led to breakthroughs in gallbladder cancer treatment, and I wanted to climb for a small, trusted charity so that I would know for sure that my money is going towards research.”

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Bowel, Small Intestine and Anal CancersBowel (large colon and rectal) cancer is the most common type of GI cancer; Australia has one of the highest rates of bowel cancer in the world. Small intestine and anal cancers, by contrast, are rare. In Australia in 2011 an estimated 15,962 people were diagnosed with bowel, small intestine and anal cancers – 15,151 of them with bowel cancer. 4,178 people died from them in 2012. They have the highest survival rates of the GI cancers – large colon/rectal 66.9%, anal 64.5%, small colon 58.4%.

In 2009, the risk of being diagnosed with bowel cancer by 85 years of age was 1 in 10 for males and 1 in 15 for females. In 2010 the risk of dying from bowel cancer by 85 years of age was 1 in 37 for males and 1 in 57 for females.

The bowel connects the stomach to the anus, and is divided into two parts: the small bowel (also known as the small intestine) and the large bowel (or the large intestine). Nearly all bowel cancers arise in the large bowel. Most develop from small benign growths, called polyps, on the inside lining of the bowel. Not all polyps become cancerous and the risk of developing cancer in a polyp depends on the type of polyp and its size.

About 5% of bowel cancers occur as a result of changes in genes (familial bowel cancer). This can be diagnosed by special tests to detect genetic changes, and is more common in young patients and those with a strong family history of cancer.

The symptoms of bowel cancer include a change in bowel habit, bleeding from the bowel, abdominal pain, bloating and unexplained anaemia (on a blood test).

Risk of bowel cancer increases with high intakes of red and processed meat, drinking alcohol and being overweight.

Physical activity and increased consumption of foods high in dietary fibre decreas the risk of bowel cancer.

Bowel cancer is usually diagnosed by colonoscopy (a procedure in which a flexible tube with a camera is passed through the anus and around the bowel) but radiology tests and a special type of CT scan called CT colonography can also be used to diagnose bowel cancer.

Surgery to remove the affected part of the bowel is the main treatment for bowel cancer. Additional treatment with chemotherapy is sometimes required, depending on the stage of the cancer. Radiotherapy is sometimes used in addition to surgery and chemotherapy to treat rectal cancer.

Survivor is grateful to her great team

Jilli Blackler (pictured) spoke on Survivorship at our Engage Community Forum in Perth in November 2014 – from deep experience of a ten-year personal struggle.

The former airline employee was first diagnosed with rectal cancer in 2000 at the age of 48 and underwent surgery. The cancer had spread, including to her lung and brain. Several operations followed – including two craniotomies and years of radiotherapy and chemotherapy.

During this time Jilli was helped by family, friends and colleagues – her workmates from Ansett brought meals and provided transport. Jilli says “Through all of it, I never felt like I was alone.”

She’s also grateful to “A great team of doctors – I take my hat off to them.” Her oncologist was AGITG member Dr David Ransom, also a speaker at the Engage forum.

Jilli’s last treatment was in 2005 - and she’s been clear of cancer ever since.

“People don’t talk about these cancers nearly enough”, she says. “We have to get it out in the open more.”

Her advice for people with GI cancer: “You have to keep your sense of humour - and you’ve gotta have hope!”

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What is the AGITG doing about bowel, small intestine and anal cancers?

Active trials

• ASCOLT, led by the National Cancer Centre of Singapore, opened for recruitment in 2014. It will determine if aspirin improves survival rates and prevents bowel cancer returning for patients who have had surgery and chemotherapy. If aspirin is found to be helpful, it will be a cost effective, tolerable and readily available treatment for bowel cancer patients.

ASCOLT is an important example of consumer directed research - as it was through an AGITG Prioritising Gaps in Colorectal Cancer consensus meeting, led by an expert committee of consumers, clinicians and researchers, that the issue of aspirin in GI cancer came to the fore.

• Our ICECREAM trial compares the effectiveness of cetuximab, a targeted cancer drug, alone or in combination with chemotherapy in patients with bowel cancer that has spread to other organs. There is evidence that cetuximab is only effective in patients who have a specific gene mutation in their tumours, so only patients with these mutations can participate in the study.

By conducting this study we hope to introduce a more effective treatment for patients with advanced colon cancer tailored by the presence of specific mutations. The trial involves sites in Australia, New Zealand, Spain, Italy, Belgium and the United Kingdom.

New Trials in Development

• InterAACT, is an international multi centre anal cancer trial led by Dr Sheela Rao at Royal Marsden Hospital, London. It is a trial comparing Cisplatin plus 5 fluorouracil versus Carboplatin plus weekly Paclitaxel in patients with inoperable locally recurrent or metastatic disease. Anal cancer is relatively rare – about 150 cases are diagnosed in Australia each year. For people whose cancer has spread or relapsed after initial treatment, unfortunately the outlook is generally poor, with no agreed standard chemotherapy treatment. This is what InterAACT is aiming to address.

Trials in follow-up

• The ATTACHE trial compares the effectiveness of six months of chemotherapy given after surgery with the same chemotherapy given three months before and three months after surgery for patients with bowel cancer that has spread to the liver. The aim is to discover which option is more beneficial in outcome and quality of life for patients. The ATTACHE study will also look at how side-effects of chemotherapy can be reduced and the cancer eliminated or managed longer-term.

• The current major treatment for rectal cancer is surgical removal of the cancer, requiring a large cut through the abdomen. The A La CaRT trial looks at a whether less invasive laparoscopic resection is as safe and effective as the current procedure.

• For patients who have had surgery to remove all of their bowel cancer, the SCOT trial will determine if 12 weeks of chemotherapy treatment is as effective as, and less toxic than, 24 weeks. If successful, the SCOT trial will significantly minimise short- and long-term side-effects of chemotherapy and will decrease the financial burden of treatment.

• The AGITG is working in collaboration with the National Cancer Institute of Canada on a very large global study called CO.23 which looks at the impact of a new type of drug for people with advanced bowel cancer for patients who have exhausted all other therapies. This drug is in a class of drugs known as cancer stem cell inhibitors.

• An international study led by the European Organisation for the Research and Treatment of Cancer (EORTC), PETACC-6 is testing whether adding the new chemotherapy drug oxaliplatin to standard chemotherapy and radiotherapy before and after surgery improves disease-free survival.

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3. Deputy Chair Professor Michael Findlay MBChB FRACP MD

4. Director, Group Coordinator Professor John Simes MD MBBS BSc SM FRACP

5. Director Ms Mary Padbury BA LLB (Hons)

6. Director, Treasurer Conjoint Clinical Professor David Goldstein MBBS FRCP (UK), FRACP

7. Director, Chair - Public Affairs and Fundraising Committee Ms Christine M. Liddy, AO BA FAICD

8. Director Associate Professor Eva Segelov MBBS (Hons 1) PhD FRACP

9. Director, Annual Scientific Meeting Convenor Associate Professor Niall Tebbutt BA (Hons) BM BCh PhD MRCP FRACP

10. Director Doctor Colin Sutton DEng PhD BSc (UNSW) FAICD Retired 31 December 2014

11. Director Professor David Watson MBBS FRACS MD

12. Director Associate Professor Trevor Leong MBBS FRANZCR MD

13. Director Mr Michael Gordon

BBus

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Board of Directors

1. Chair (retired May 2014) Professor John Raymond Zalcberg OAM MB BS PhD FRACP FRACMA FAICD

2. Chair (from May 2014) Associate Professor Tim Price MB BS DHthSc (Med) FRACP

It’s a great honour to be invited to chair a Board of Directors so rich with experience, expertise and commitment to improving treatments and outcomes for people with GI cancers.

— Associate Professor Tim Price

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Operations Executive Committee1. Committee Chair,

Director, Group Coordinator Professor John Simes MD MBBS BSc SM FRACP

2. AGITG & Scientific Advisory Committee Chair (retired May 2014) Professor John Zalcberg, OAM MB BS PhD FRACP, FRACM, FAICD

3. AGITG & Scientific Advisory Committee Chair (from May 2014) Associate Professor Tim Price MBBS DHthSc (Med) FRACP

4. Executive Officer Russell Conley

5. Oncology Program Manager Burcu Vachan B.Soc.Sci. (Hons) MPH

6. Oncology Program Manager Doctor Sonia Yip BSc (Hons) PhD

7. Director of Clinical Trials Program Doctor Wendy Hague MBBS MBA PhD

8. Associate Oncology Program Manager Kate Wilson BA (Soc.Sci) MPH

9. Clinical Lead - CTC Doctor Katrin Sjoquist MB BS FRACP

10. Associate Oncology Manager - Operations Eric TsobanisB.Sc.N(Honors)MBA

11. Associate Oncology Manager - Development Margot Gorzeman MSc

12. Associate Oncology Program Manager - Operations Cheryl Friend RN MN

13. Research Fellow Doctor Aflah Roohullah MBChB FRACP

14. Research Fellow Doctor Manju Chandrsegaram MBChB, DCLin Surg, FRACS

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Scientific Advisory CommitteeThe Scientific Advisory Committee (SAC) is the focal point for widespread discussion of research ideas. Its members, who are drawn from the AGITG and the NHMRC Clinical Trials Centre (CTC), are experts in the fields of medical oncology, surgery, radiation oncology, biological research, quality of life research, statistics, study coordination and consumers.

The SAC’s key role is to determine the research priorities of the AGITG and to review both national and international trials and research projects for AGITG participation. The committee’s open dialogue leads to the development of a common language, interaction and commitment to trials by a broad range of medical specialists, allied health professionals and consumers.

SAC meetings foster a spirit of collaboration and cohesion between a diverse group of people who share a common goal: to improve patient care through GI cancer clinical trials.

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1. Professor John Zalcberg, OAM AGITG Chair (to May 2014), Medical Oncologist

2. Associate Professor Tim Price AGITG Chair (from May 2014), Medical Oncologist

3. Professor Steve Ackland Medical Oncologist

4. Doctor Andrew Barbour Surgeon

5. Doctor Lorraine Chantrill Medical Oncologist

6. Professor Stephen Clarke Medical Oncologist

7. Professor Michael Findlay Medical Oncologist

8. Professor Val Gebski Statistician

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9. Conjoint Clinical Professor David Goldstein Medical Oncologist

10. Mr Peter Hewett Colorectal Surgeon

11. Ms Mary Padbury AGITG Director

12. Professor Rob Padbury Surgeon

13. Professor David Joseph Radiation Oncologist

14. Mr Dan Kent Chair, Consumer Advisory Panel, joined 2012

15. Associate Professor Trevor Leong Radiation Oncologist

16. Ms Christine M. Liddy, AO AGITG Director

17. Associate Professor Eva Segelov Medical Oncologist

18. Doctor Jennifer Shannon Medical Oncologist CAP/SAC liaison

19. Mrs Anne Smith Study Coordinator

20. Professor John Simes Group Coordinator & Medical Oncologist

21. Doctor Katrin Sjoquist Medical Oncologist

22. Associate Professor Mark Smithers Upper GI Surgeon

23. Clinical Professor Nigel Spry Radiation Oncologist

24. Doctor Andrew Stevenson Colorectal Surgeon

25. Doctor Colin Sutton AGITG Director, retired Dec 2014

26. Associate Professor Niall Tebbutt Medical Oncologist

27. Professor Paul Waring Pathologist

28. Professor David Watson Oesophago-gastric Surgeon

29. Doctor Nikolajs Zeps Biological Scientist

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Upper & Lower GI Working Parties

“Everyday I realise how important the work of the Upper and Lower GI Working Parties is, when someone sits in front of me with gastro-intestinal cancer, we don’t want to be impotent. When we say to them ‘I don’t have a new treatment but I do have an investigational trial – do you want to participate and help future patients?’ they jump at the opportunity to participate.”

Dr Lorraine Chantrill Chair, Upper GI Working Party

The AGITG’s Upper GI and Lower GI Working Parties are the working parties of the Scientific Advisory Committee (SAC).

The working parties represent medical oncology, surgery, radiation oncology, statistics, translational science and study coordination. The Upper GI Working Party focuses on cancers of the oesophagus, gallbladder and pancreas, stomach and liver; whereas the Lower GI Working Party looks at cancer of the bowel and anus.

The working parties meet to:

• Identify gaps in research activities

• Develop and/or facilitate new clinical research concepts

• Review the scientific merit of research proposals

• Explore funding and feasibility opportunities in liaison with the Operations Executive Committee

• Nominate Principal Investigators

• Nominate Trial Management Committee members.

Upper GI Working Party

Dr Lorraine Chantrill Chair, Medical Oncologist

Associate Professor Tim Price Medical Oncologist

Professor Michael Findlay Medical Oncologist

Associate Professor Trevor Leong Radiation Oncologist

Clinical Professor Nigel Spry Radiation Oncologist

Doctor Andrew Barbour Surgeon

Associate Professor Val Gebski Statistician

Doctor Katrin Sjoquist Medical Oncologist

Nicole Wong Associate Oncology Program Manager

Doctor Yu Jo Chua Medical Oncologist

Associate Professor Lara Lipton Medical Oncologist

Associate Professor Mark Smithers Upper GI Surgeon

Professor Jonathan Fawcett Surgeon

Doctor Karoush Haghighi Surgeon

Associate Professor Alex Boussioutas Translational Scientist

Doctor Sonia Yip Translational Research Fellow

Margo Gorzeman Associate Oncology Program Manager

Jan Mumford Consumer Advisory Panel Member

Associate Professor Nick Pavlakis Medical Oncologist

Doctor Peter Grimison Medical Oncologist

Professor John Simes Medical Oncologist

Lower GI Working Party

Associate Professor Niall Tebbutt Chair, Medical Oncologist

Associate Professor Jeremy Shapiro Medical Oncologist

Doctor Jayesh Desai Medical Oncologist

Professor Bridget Robinson Medical Oncologist

Associate Professor Eva Segelov Medical Oncologist

Associate Professor Chris Karapetis Medical Oncologist

Professor David Joseph Radiation Oncologist

Associate Professor Sam Ngan Radiation Oncologist

Mr Peter Hewett Colorectal Surgeon

Associate Professor Paul McMurrick Colorectal Surgeon

Professor Alexander Heriot Colorectal Surgeon

Anne-Sophie Veillard Statistician

Kate Wilson Associate Oncology Program Manager

Doctor Nikolajs Zeps Translational Scientist

Professor Val Gebski Statistician

Doctor Sonia Yip Translational Research Fellow

Dan Kent Consumer Advisory Panel Chair

Professor John Simes Medical Oncologist

Doctor Matthew Burge Medical Oncologist

Doctor Louise Nott Medical Oncologist

Doctor Ben Markman Medical Oncologist

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GI Cancer Institute and AGITG 2014 Annual Report 23

Study ChairsAGITG trials are conducted in more than 85 sites in Australia, New Zealand, Asia, Europe, Canada and the UK, allowing teams of clinicians and allied health professionals who treat cancer patients access to innovative cancer research and cutting edge clinical knowledge.

The clinical trials are led by Study Chairs, who are responsible for overseeing the development, execution and reporting of the trial. The trials allow doctors and medical researchers to investigate new drugs in an effort to treat cancer, reduce the side-effects of current treatments and to improve the quality of life of patients affected by gastrointestinal cancer.

Clinical trials are the only true way to accurately measure the benefits of new therapies. Patients who have participated in AGITG trials selflessly contribute through their own cancer own experiences to the international pool of cancer research, data and knowledge.

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1. Professor Andrew Biankin Co-Chair – IMPACT

2. Doctor Andrew Barbour Chair – DOCTOR, Co-Chair- GAP

3. Doctor Lorraine Chantrill Co-Chair – IMPACT

4. Doctor Yu Jo Chua Chair – PAN1

5. Doctor Jayesh Desai Chair – REGISTER

6. Professor Jonathan Fawcett Chair – ATTACHE

7. Professor Michael Findlay Chair – C07

8. Conjoint Clinical Professor David Goldstein Co-Chair – LAP07, INTEGRATE, GAP, ESPAC-3 Chair – PA3, ATTACHE

9. Doctor Andrew Haydon Chair – SCOT

10. Doctor Dusan Kotasek Chair – Adjuvant GIST

11. Associate Professor Trevor Leong Chair – TOP GEAR

12. Doctor Louise Nott Co-Chair – CO.23

13. Doctor Rob Padbury Co-Chair – ESPAC3

14. Associate Professor Nick Pavlakis Co-chair – INTEGRATE Chair – CONTROL NETS

15. Professor Cameron Platell Co-Chair – SUPER

16. Associate Professor Eva Segelov Co-Chair – SCOT, ICECREAM

17. Doctor Jenny Shannon Co-Chair – LAP07 Chair – TACTIC Chair – ACTICCA1

18. Professor John Simes Co-Chair – IMPACT

19. Associate Professor Jeremy Shapiro Chair – CO.20 Co-Chair – CO.23, ICECREAM

20. Doctor Andrew Stevenson Chair – A La CaRT

21. Associate Professor Niall Tebbutt Chair – ATTAX, ATTAX 2, ATTAX 3

22. Associate Professor Euan Walpole Chair – Liver Metastases

23. Professor John Zalcberg Chair – Advanced GIST

24. Doctor Desmond Yip Chair – ALT GIST

25. Doctor Amitesh Roy Chair – InterAACT

26. Associate Professor Chris Karapetis Chair – CO17

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GI Cancer Institute and AGITG 2014 Annual Report24

Consumer Advisory Panel

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The AGITG Consumer Advisory Panel (CAP) was established in 2008 as a group that could provide the AGITG with advice on general research directions and priorities from a consumer perspective.

Key activities include the review of new trial concepts, identifying gaps in research, assisting with the ease of understanding of trial patient information and consent forms and advising on patient recruitment strategies.

The CAP also supports the GI Cancer Institute with its initiatives such as the Engage Community Forum Program and Gutsy Challenge.

2014 highlights

• Reviewed new clinical trial concepts and protocols with Principal Investigators and reported the CAP’s review consensus to the AGITG Scientific Advisory Committee.

• Reviewed Draft Patient Information and Consent Forms (PICs).

• Attended the AGITG Annual General Meeting (Brisbane) and Open Scientific Advisory Committee (Sydney) Meetings and visited cancer treatment/research organisations as part of training.

• Following an extended period of review and consideration the CAP presented a listing of consumer identified gaps in GI cancer research to the AGITG Executive Officer for presentation to the appropriate working parties/committee.

• Played a key role in developing a Grant Application to Cancer Australia to allow the successful Engage Community Forums to be taken to Regional areas .in 2015 /2016. The Grant Application was successful and the CAP have been deeply involved in identifying regions and developing the strategy to deliver these Forums. Along with clinicians, CAP members have also been involved in presenting at metropolitan Engage Forums during the year. The Forums help people understand the challenges of GI cancer and the latest advancements in medical research

• Several CAP members are also members of various AGITG Committees and/or the Upper or Lower GI Working Parties. The CAP Chair also represents the AGITG on the Cancer Trials Consumer Network facilitated by the Clinical Oncology Society of Australia.

• Broadened membership so that the CAP is now represented in the five mainland Australian states.

In August 2014 we farewelled Shane Patella from Victoria and welcomed Melva Stone from Western Australia to to the team. Melva’s skills, experiences and contacts will prove invaluable to the CAP, AGITG andthe GI Cancer Institute.

1. Chair – Dan Kent, Bundaberg, QLD Colorectal cancer survivor

2. Christine Bishop, Sydney Carer

3. Linda Codling, Sydney Pancreatic cancer survivor

4. Nicholas Goodall, Southern Highlands, NSW Oesophageal cancer survivor, resigned October 2014

5. Johanna Hall, Sydney Carer

6. Judith Honor, Gin Gin, QLD Colorectal cancer, secondary liver cancer survivor

7. Joseph Levin, Sydney Colorectal cancer survivor

8. Julie Marker, Adelaide Colorectal cancer survivor

9. Robin Mitchell, Sydney Colorectal cancer survivor

10. Roger Moulton, Ballarat, VIC Carer and prostate cancer survivor

11. Jan Mumford, Blaxland, NSW Pancreatic cancer survivor

12. Shane Patella, Melbourne Gastro-oesophageal carer, resigned August 2014

13. Melva Stone OAM, Perth Oesophageal cancer survivor, joined December 2014

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GI Cancer Institute and AGITG 2014 Annual Report 25

Treasurer’s Report

Professor David Goldstein

The 2014 financial year has seen several changes occur within the operations of the AGITG.The departure of Prof John Zalcberg OAM from both his role as Chair and as a member of the Board, is a significant change given the central role which he has taken in the company, since its incorporation. Many initiatives have been instigated under Prof Zalcberg’s initiative, guidance and/or support. In my capacity as Treasurer, I take this opportunity to express our gratitude for his leadership and contribution to the financial aspects of the Company over his term as Chair. Much of the sound financial standing of the organisation stems from his actions over this period, ranging from his instigation of trial activities, involvement in managing stakeholders, to his support of my role as Treasurer.

Since May 2014, A/Professor Tim Price has shown the AGITG continues to operate under sound and forward thinking leadership. The strengths of the financial operations of the Group have continued seamlessly during the financial year. I have every confidence that the financial aspects of the Company will continue be managed under positive and focused leadership.

The scientific trial activities of the AGITG increasingly operate under milestone management processes. These processes require increased management of the progress of trial activities including

co-ordination of all stakeholders associated with the various scientific trials undertaken. Further complexities arise from the increasing collaboration and contracting of sites outside Australia. Whilst international activity is not new to the AGITG, the need to operate outside of Australia has become increasingly necessary to achieve the benefits of the scientific trials initiated or supported by the AGITG. The finance team have admirably managed this change through the instigation, contracting and management of these new trials.

The result for the 2014 financial year is another sound financial outcome for the AGITG, both at the level of the surplus achieved for the year of $138,934 and the financial position as at 31 December 2014 being net assets of $4,644,313. This is pleasing in the context of the changes impacting the Company over the year.

The fund raising and marketing structures within the GI Cancer Institute (AGITG) continue to develop. Several changes have been made during the 2014 year with a view to increasing the financial benefits from the fund raising activities of the Company. The donor support continues to grow, and the Company recognises this support by reserving all donor support for use on scientific research. This requires the AGITG to fund the costs associated with the administration and development of this structure from other sources. This continues to be achieved through a combination of sponsorship support and on-going financial management.

During the 2014 year, the finance team in conjunction with the Board have instigated some initiatives to explore new trial activities under the funding from donations reserves held. These are exciting initiatives as they provide an increased opportunity to the members of the AGITG to collaborate and explore scientific questions to the benefit of our community both here and overseas.

Thank you

I would like to thank Ms Christine Liddy AO and Dr Colin Sutton for their vital contribution to the Finance and Risk Management Committee. By the end of the 2014 year, Dr Sutton had relinquished his membership to the Committee and we are thankful for his time and valuable contribution. We welcome to the Committee a new member in Mr Michael Gordon. His work qualifications and experience will enrich the role that the Finance and Risk Management Committee plays in the organisation as a whole.

Lastly, I say thanks to our External Accountant Scott Arnold, Finance Officer Pamela Moriarty, Executive Officer Russell Conley and all the AGITG staff for their diligence and dedication so that AGITG realizes its mission to continually achieve better health outcomes for patients with gastro-intestinal cancers by conducting and promoting clinical and related biological research in Australasia and internationally, addressing key unanswered questions.

Conjoint Clinical Professor David Goldstein MMBS MRCP (UK) FRACP

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GI Cancer Institute and AGITG 2014 Annual Report26

Income StatementStatement of profit or loss and other comprehensive income for the year ended 31 December 2014

2014 2013$ $

Revenue 5,851,453 6,236,820

Other income 859,139 838,645

Administration/Infrastructure expense (482,613) (449,426)

Depreciation and amortisation expense (13,618) (23,533)

Trial and Site Costs (5,157,972) (5,653,104)

Scientific Events (491,428) (306,751)

Marketing/Fund Raising costs (426,027) (447,325)

SURPLUS BEFORE INCOME TAX 138,934 195,326

Income tax expense - -

SURPLUS FOR THE YEAR 138,934 195,326

Surplus for the year

Other comprehensive income after income tax 138,934 195,326

OTHER COMPREHENSIVE INCOME FOR THE YEAR, NET OF TAX - -

TOTAL COMPREHENSIVE INCOME FOR THE YEAR 138,934 195,326

TOTAL COMPREHENSIVE INCOME ATTRIBUTABLE TO MEMBERS OF THE ENTITY 138,934 195,326

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GI Cancer Institute and AGITG 2014 Annual Report 27

Balance SheetStatement of financial position as at 31 December 2014

2014 2013ASSETS $ $

CURRENT ASSETS

Cash and cash equivalents 4,257,089 7,958,772

Financial Assets 5,016,571 -

Trade and other receivables 1,072,113 487,065

Other assets 111,622 177,083

TOTAL CURRENT ASSETS 10,457,395 8,622,920

NON-CURRENT ASSETS

Property, plant and equipment - -

Intangible assets 65,909 64,020

TOTAL NON-CURRENT ASSETS 65,909 64,020

TOTAL ASSETS 10,523,304 8,686,940

LIABILITIES

CURRENT LIABILITIES

Trade and other payables 192,282 438,728

Other short term liabilities 3,284,927 3,402,123

TOTAL CURRENT LIABILITIES 3,477,209 3,840,851

NON-CURRENT LIABILITIES

Long-term provisions 46,596 41,051

Other long term liabilities 2,355,186 702,505

TOTAL NON-CURRENT LIABILITIES 2,401,782 743,556

TOTAL LIABILITIES 5,878,891 4,584,407

NET ASSETS 4,644,313 4,102,533

EQUITY

Reserves 1,582,455 1,208,812

Retained Earnings 3,061,858 2,893,721

TOTAL EQUITY 4,644,313 4,102,533

CONTINGENT LIABILITY 75,998 72,716

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GI Cancer Institute and AGITG 2014 Annual Report28

Grants AwardedInfrastructure Grants

Funds provided by Cancer Australia and the Cancer Institute New South Wales to support AGITG infrastructure are managed by the University of Sydney NHMRC Clinical Trials Centre and therefore are not reported in the financial accounts of the AGITG, unless transferred in support of specific expenses incurred by the AGITG.

Grants contributing to AGITG infrastructure costs during the 2014 financial year are outlined below.

Funding Cancer Australia infrastructure grants: 1 July 2013 to 30 June 2016 - $1,400,936. During 2014 $230,635 was transferred to the AGITG and was reported in the 2014 financial accounts.

Research Grants

Funds provided by Cancer Australia, Cancer Council and the National Health and Medical Research Council in support of trial coordination are also managed by the University of Sydney NHMRC Clinical Trials Centre and therefore are not reported in the financial accounts of the AGITG. However, funds to support site payments and insurance costs relating to these studies are transferred to the AGITG and are reflected in these financial accounts.

Grants contributing to AGITG trials conducted during the 2014 financial year are outlined as follow.

A La CaRT: A phase III prospective randomised trial comparing laparoscopicassisted resection versus open resection for rectal cancer.

Funding NHMRC Grant: $932,586 (2011) GICI NZ Grant: $8,000 (2014)

Funds were received by AGITG in 2014 ($195,400) for site payments and insurance costs. This income and associated expenditure are included in the 2014 Income Statement.

ASCOLT: An international randomised, double blind, placebo controlled phase III multi-centre trial, investigating the effect of aspirin or disease free and overall survival as adjuvant treatment in patients with resected stage II and III colorectal cancer.

Funding Cancer Australia Grant: $328,000 (2014)

Funds were received by AGITG in 2014 ($9,000) for site payments and insurance costs. This income and associated expenditure are included in the 2014 Income Statement.

DOCTOR: A randomised phase II trial of pre-operative cisplatin, 5-fluorouracil

and docetaxel or cisplatin, 5-fluorouracil, docetaxel plus radiotherapy based on poor early response to standard chemotherapy for resectable adenocarcinoma of the oesophagus and/or oesophageal junction.

Funding NHMRC Grant: $387,000 (2011)

Funds were received by AGITG in 2014 ($35,250) for site payments and insurance costs. This income and associated expenditure are included in the 2014 Income Statement.

PETACC6: A phase III randomised study of preoperative chemoradiotherapy and post- operative chemotherapy with capecitabine and oxaliplatin versus capecitabine alone in locally advanced rectal cancer.

Funding Cancer Australia: $477,800 (2008)

No funds were received by AGITG prior to 2014. Expenditure on this trial is included in the 2014 Income Statement.

TOP GEAR: A randomised phase II/III trial of pre-operative chemoradiotherapy versus pre-operative chemotherapy for resectable gastric cancer.

Funding Cancer Australia: $541,183 (2009) $756,137 (2014) Cancer Council: $18,480 (2009), $18,480 (2010), $17,557 (2011), $924.67 (2012)

Funds were received in 2014 ($175,755). Expenditure on this trial is included in the 2014 Income Statement.

Community Grants

Funds provided by Cancer Australia in support of the gastro-intestinal cancer community forum program. The forums will bring GI cancer patients and their families together with service providers, researchers and clinicians, to develop and enhance linkages in local communities. Additional support was received from commercial institutions.

Funding Cancer Australia: $80,000 (2014) Royal Bank of Canada $5,000 (2014) Clayton Utz Foundation $5,000 (2014)

Funds were received in 2014 ($90,000). Expenditure on this program is included in the 2014 Income Statement.

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Support Our Work There are many ways you can support our work through the GI Cancer Institute. Please help to save or improve the lives of over 24,000 Australians diagnosed with gastro-intestinal cancers each year through clinical trials research.

Make a donation

Any donation, no matter what size, will help us conduct our clinical trials and lead to better health outcomes for patients. Donate online at gicancer.org.au or post a cheque to GI Cancer Institute, Locked Bag M250, Camperdown NSW 2050

Take a Gutsy Challenge

Get gutsy for GI Cancer and take a Gutsy Challenge. Have some fun and raise much-needed funds for vital research to find a cure for GI cancer.

Host a healthy lunch or morning tea, participate in a fun run, a cycle challenge or other sporting event, hold an auction or give up a vice for a week – whatever is gutsy and suits you.

You can take the Gutsy Challenge by yourself or, better still, engage your friends, family, work colleagues or club to help the GI Cancer Institute raise funds. Find out more about the Gutsy Challenge by calling 1300 666 769 or visit gutsychallenge.com

Leave a Gift in your Will

Leaving a gift to the GI Cancer Institute in your Will and a legacy for future generations, whether large or small, makes a difference and enables cutting edge research into new treatments for patients, beyond your lifetime. For a confidential conversation, please contact Russell Conley, Executive Officer, on (02) 9562 5072.

Honour a loved one

Losing a loved one to GI cancer is very difficult but sometimes our last moments can make an enduring difference to others.

In lieu of flowers please consider In Memory donations to support innovative research for improved outcomes for future generations.

We also have the ability to create an online memorial to share precious memories with family and friends.

Volunteer

Our volunteers are highly valued and make a real difference to our ability to fund our clinical trials. If you have expertise, a business skill, a story as a cancer survivor, or even some time to spare, we are always looking for volunteers to help us promote our initiatives at the GI Cancer Institute.

For more information on how to get involved, please contact us on 1300 666 769 or visit gicancer.org.au

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Participating CentresIn 2014 the AGITG conducted 18 trials in 142 metropolitan and regional hospitals and medical centres in Australia, New Zealand, and twelve other countries – in Asia, Canada, Europe and the Middle East. Many patients were also accrued to AGITG hospitals in Europe and Canada through collaborations with the National Cancer Institute of Canada (NCIC) and the European Organisation for Research and Treatment of Cancer (EORTC)

AUSTRALIA

Australian Capital Territory

Canberra Hospital

NSW

Armidale Hospital

Bankstown-Lidcombe Hospital

Calvary Mater- Newcastle

Campbelltown Hospital

Concord Hospital

Coffs Harbour

Gosford Hospital

John Hunter Hospital

Lifehouse Australia

Lingard Private Hospital

Lismore Base Hospital

Liverpool Hospital

Manning Rural Referral Hospital

Muswellbrook Hospital (satellite of

Nepean Cancer Centre

Nepean Private Hospital

Newcastle Private Hospital

NCCI - Coffs Harbour Health Campus

North Shore Private Hospital

Orange Hospital

Port Macquarie Base Hospital/NCCI

Prince of Wales Hospital

Prince of Wales Private

Riverina Cancer Centre, Wagga Wagga

Royal North Shore Hospital

Royal Prince Alfred Hospital

Southern Medical Day Care

St George Hospital

St George Private

St Vincents Hospital, Sydney

Sydney Haematology & Oncology Clinic

Sydney Adventist Hospital (San Clinical Trials Unit)

Sydney Southwest Private Hospital

Tamworth Base Hospital

The Tweed Hospital

Westmead Hospital

Wollongong Hospital - Illawarra Cancer Centre

Northern Territory

Royal Darwin Hospital

Queensland

Allamanda Private Hospital

Brisbane Mater Adult Hospital (satellite of PA)

Cairns Base Hospital

Gold Coast Hospital

Greenslopes Private Hospital

Holy Spirit Northside Private Hospital

Sunshine Coast Cancer Service (Nambour Base Hospital)

John Flynn Hospital

Princess Alexandra Hospital

Royal Brisbane and Women’s Hospital

St Andrew’s Hospital Toowoomba

Toowoomba Base Hospital

Townsville Hospital

HOCA Wesley

South AustraliaAshford Cancer Centre

Flinders Medical Centre

Lyell McEwin Hospital

Queen Elizabeth Hospital

Royal Adelaide Hospital

Tasmania

Launceston General Hospital

North West Regional Hospital - Burnie

Royal Hobart Hospital

St John’s Campus Calvary Healthcare

Victoria

Alfred Hospital

Andrew Love Cancer Centre

Austin Health

Ballarat Base Hospital

Ballarat Oncology & Haematology

Bendigo Hospital

Border Medical Oncology

Box Hill Hospital

Cabrini Hospital

Frankston Hospital/Peninsula Health

Geelong Hospital/Barwon Health

Goulburn Valley Health

Mersey Community Health

Monash Medical Centre

Northern Health

Peter MacCallum Cancer Centre

Peninsula Health

Royal Melbourne Hospital

St Vincents Hospital, Melbourne

Warrnambool & District Base Hospital

Western Hospital

Western Australia

Fremantle Hospital

Mount Hospital

Royal Perth Hospital

Sir Charles Gairdner Hospital

St John of God Hospital, Bunbury

St John of God, Murdoch

St John of God Hospital, Subiaco

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GI Cancer Institute and AGITG 2012/2013 Annual Report 31

“ Clinical trials save lives and improve quality of life – and local and international collaboration is essential in achieving this.”

— Russell Conley, Executive Officer, AGITG.

NEW ZEALAND

Auckland City Hospital

Christchurch Hospital

Dunedin Hospital

North Shore Hospital

Palmerston North Hospital

St George Private Hospital

Waikato Hospital

Wellington Hospital

BELGIUM

AZ Klina

AZ Damiaan

AZ Turnhout - Campus Sint Elisabeth

Hopital De Jolimont

AZ Groeninge Kortrijk

CHRU de Besancon - Hopital Jean Minjoz

Centre Hospitalier Peltzer - La Tourelle

Universitair Ziekenhuis Antwerpen

UZ Leuven - Campus Gasthuisberg

CANADA

QE II Health Sciences Centre

Odette Cancer Centre

McGill University Health Centre

Hopital Notre-Dame

St Michaels Hospital

Ottawa Health Research Institute

UHN, Princess Margaret Hospital

Mount Sinai Hospital

CancerCare Manitoba

Saskatoon Cancer Centre

Atlantic Health Sciences Corporation

BCCA Fraser Valley

London Regional Cancer Program

Allen Blair Cancer Centre

Sherbrooke

Toronto East General

Grand River Regional Cancer entre

BCCA Vancouver Cancer Centre

CZECH REPUBLIC

Charles University Hospital

FRANCE

Centre Hospitalier de Belfort-Montbeliard - site du Mittan

HONG KONG

Queen Mary Hospital

Prince of Wales Hospital

ISRAEL

Rambam Medical Center

Tel Aviv Sourasky Medical Centre

ITALY

degli Studi di Napoli

SINGAPORE

National Cancer Centre Singapore

SLOVENIA

The Institute of Oncology

SOUTH KOREA

Gangnam Severance Hospital

Asan Medical Centre

Korea University Hospital

Samsung Medical Centre

Seoul National University Hospital

Severance Hospital, Yonsei University Hospital

SPAIN

Barcelona

UNITED KINGDOM

Beatson Oncology Centre, Glasgow

Christie Hospital, Manchester

Royal Marsden Hospital, London

Hammersmith Hospital

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Making a regular or one-off donation to the GI Cancer Institute will help us to continue to fund important clinical trials to find better treatments for people with gastro-intestinal cancer.

Leaving a gift to the GI Cancer Institute in your Will is a wonderful way to ensure that your legacy continues to make a difference to the lives of people suffering from GI cancer.

To make a bequest or a donation fill out the form below and post the form to Russell Conley or alternatively call us on 1300 666 769.

Please copy this form and complete your details

Name: (Mr/Mrs/Ms/Dr)

Address:

Postcode: Contact phone: ( )

Mobile: Email:

Birth date (optional): / /

I do not want to receive occasional information from the GI Cancer Institute.

Bequest

I would like to discuss making a bequest. Please contact me with more information.

I intend to include the GI Cancer Institute in my Will.

I have already remembered the GI Cancer Institute in my Will.

Donate

I would like to donate: one-off monthly annually

Please debit my: Visa MasterCard American Express

For the amount of $

Card number:

Expiry date: / CVV:

Signature:

OR

I have enclosed a cheque for the amount of $ payable to the GI Cancer Institute.

Donate or leave a bequest to the GI Cancer Institute

Please return to: Russell Conley Executive Officer GI Cancer Institute Locked Bag M250 Missenden Road NSW 2050

Thank you for your support!

GI Cancer Institute and AGITG 2014 Annual Report32

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PLATINUM SPONSORS

GOLD SPONSORS SILVER SPONSORS

BRONZE SPONSORS

Pfizer Oncology

Amgen

GI Cancer Institute and AGITG 2014 Annual Report

GI Cancer Institute sponsorsThanks to the generosity of our sponsors, along with the public and the clinicians who freely give their time, we continue to change medical practice in Australia and throughout the world.

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GI Cancer Institutegicancer.org.au

Locked Bag 250, Camperdown NSW 2050

AGITGagitg.org.au

Locked Bag 77, Camperdown NSW 1450Phone: 1300 666 769 Fax: (02) 9562 5348

ABN 34 093 854 267