Newsletter - SAKKsakk.ch/.../Publications/Newsletter/SAKK_newsletter_issue4-15.pdf · ETOP 25-26 Swiss Cancer League 26 ... tigate if the used more modern RT technique will increase

NewsletterNo 4 / 2015 December 17

The Swiss Oncology Research Network

EDITORIAL If SAKK did not exist, we would have to invent it

An exciting year of celebrations and events comes soon to an end – the 50 years anniversary was rounded off with a scientific symposium and a jubilee apéro during the

semi-annual meeting in Zurich. What is more, for the first time in SAKK's history, a patient representative board will advise the organization on communication, trial development and strategy. The board comprises five members and was elected by the SAKK board. More on the topic on page 4.

It is an important goal to increase the phase I activities at the designated SAKK phase I centers and the systematic acquisi-tion of innovations within SAKK. This resulted in the creation of the new unit «Innovation and Development», headed by Dr. Simona Berardi Vilei. Read more on page 3.

50 years ago, SAKK was founded as an innovative association of a few centers. Today, we are a strong cooperative group with 20 members – we especially welcome our newest member the Solothurner Spitäler AG. Likewise, our organization elected its 9th president: PD Dr. Roger von Moos from the Cantonal Hospital in Chur.

The anniversary year was a great success, launched with the public event on Bundesplatz in May and supported by 50 ambassadors among them Swiss personalities known from politics, sports and show business (http://sakk.ch/en/50-years/sakk-ambassadors/). Also our member centers actively participated and organized 11 events at their hospitals. It can be said that the overall goal, enhancing SAKK’s visibility in the public as well in the hospitals, was achieved.

We hope taking the anniversary spirit into the coming years and thank you all for your support and effort.

A merry Christmas and Happy New Year to all our readers!

SAKK News 2-5SAKK Anniversary 5-8SAKK Semi-Annual Meeting 9-12Network Outcomes Research 12-14Trial News 14-21Publications, Presentations 21-23IBCSG 23-24ETOP 25-26Swiss Cancer League 26Grants, Events, Dates 27-30Flag 31

Contents

Prof. Dr. A. Christe

2 December 17, 2015 SAKK Newsletter


SAKK NEWSNews from the SAKK board

At its board meeting on November 3 in Bern, the SAKK board approved of the following trial proposals:

Subproject SAKK 17/04: coordinating investigator Oliver Riesterer

Subanalysis RadiotherapyThis project is based on the SAKK 17/04 trial. It will inves-tigate if the used more modern RT technique will increase tumor control and the loco-regional relapse-free survival and analysis in the relapse pattern in patients who re-ceived radiotherapy compared to those who did not. The board members agreed to conduct this subproject.

SAKK 28/12: coordinating investigator Zsuzsanna Varga

Ki-67 assessment in breast cancer, validation phase. The SAKK board approved of this project by e-mail voting on October 28.

Subproject SAKK 41/07: coordinating investigator Thomas Winder

Immunogenicity of rectal cancer before and after immu-ne-radio-chemo-therapy in the SAKK 41/07 trial.This is a translational research project based on the sam-ples of the SAKK 41/07 (Neopan) trial. The primary ob-jective of the trial is to investigate by multiplex immu-nohistochemistry the number of infiltrating immune cells expressing, CD3, CD8, CD4, CD45RO, FOXP3 & the mu-tational load before and after neo-adjuvant therapy. The board members agreed to conduct the project under the condition that financing can be found for the analyzing of the samples

SAKK 41/16 (RECAP trial): coordinating investigator Sara Bastian

Impact of neoadjuvant treatment with Regorafenib and Capecitabine combined with radiotherapy in locally ad-vanced rectal cancer. A Phase Ib trial.This trial proposal is a follow-up project of NeoSor (SAKK 41/08). The combination of Regorafenib and Capecitabine requires a phase I part, as toxicities are overlapping and drugs interact concerning pharmacokinetics. The board members agreed to conduct the trial.

SAKK 35/15: coordinating investigator Anastasios Stathis

A phase I study of GA101 in combination with ABT199 in follicular lymphoma patients.In this trial, two new drugs with single agent activity across several lymphoma subtypes will be combined in patients with follicular lymphoma (FL) The phase I study will provide information on the safety and tolerability to-gether with evidence of early activity of Obinutuzumab (GA101) in combination with ABT-199 in the treatment of FL. Additionally, it is aimed implementing this clinical study with a parallel translational research project with the objective to define predictive biomarkers of response to bcl2 inhibition in combination with anti-CD20 mono-clonal antibody therapy in patients with FL. The trial shall prove that GA101/ABT199 is a safe combination and a valid option for a subset of patients, and let us under-stand predictive biomarkers of response in untreated patients through the translational research. The patients obtain the chance to avoid toxic chemo treatment. The board members agreed to conduct the trial.

Furthermore, the board members approved of the goals of the SAKK CC and the according budget for 2016. PD Dr. Thomas Ruhstaller was confirmed for another term as president of the project group Breast Cancer.

Promotions and staff news

Prof. Dr. Andreas Christe was ap-pointed professor for radiology at the University of Bern. He is lead-ing physician at the University in-stitute for diagnostic, interventional and pediatric radiology in Bern and member of the SAKK working group Imaging in Diagnostic and Therapy Monitoring and the project group Lung Cancer.

PD Dr. Arnoud Templeton received his habilitation at the University of Basel. He is leading physician at the Canton-al Hospital in St.Gallen and member of the SAKK proejct group Urogenital Tumors.

Dr. S. Berardi

P. Brauchli thrown in by his executive committee members

SAKK Newsletter December 17, 2015 3


SAKK NEWSWelcome at the SAKK CC• Antoinette Heldner, Contract Manager, January 1• Céline Hummel-Schibler, Head of Monitoring and

Clinical Project Management, January 1• Olivier Schmitt, Clinical Data Manager, January 1

FarewellAnnik Steiner, communications manager, will leave the coordinating center end of January. Scarlett Keunecke, CRA, and Stavros Milatos will quit the SAKK CC end of February. Caroline Kaminski, event manager, and Heike Kenner, Clinical Project Manager, will leave end of March.

We thank them for their commitment and dedication to SAKK and we wish them all the best for their future.

For information about job vacancies at SAKK, please con-tact us and/or refer to http://sakk.ch/en/download/19

New unit at the SAKK CC: Innovation and Development

It is an important strategic goal to bring forward innovations to clinical use and to exploit the po-tential from bench to bedside. In order to achieve this goal, the 30 % staff position innovation and de-velopment manager will be trans-ferred in an own unit (ID) effective January 2016 and headed by Dr. Simona Berardi Vilei. She will be supported by Dr. Katrin Eckhardt and a second ID positon will be ad-vertised soon. For the time being, Simona keeps some of her duties as head of clinical project management with a 40 % workload. She will also be member of the SAKK CC Executive Board.

This new unit shall bring innovative projects to the mem-bers of SAKK, promote early development of molecules and also new approaches against cancer with the final aim to make these new technologies available to the pa-tients as soon as possible. Thereto affiliated are phase I trials but also new concepts which are being tested in phase II or III trials. Simona will intensify the cooperation with biotechnology and pharmaceutical companies, the universities and other organizations as well as gain ac-cess to new financial resources. We congratulate Simona on this promotion and wish her success for the challenges ahead.

New premises for the SAKK CC

Due to building regulations, the foundation «Haus der Krebsliga» cannot realize the originally planned exten-sions and has to sell the adjoining buildings on Effinger-strasse 54 to 60. Furthermore, the Swiss Cancer League needs additional office space in the main building. For this reason, SAKK, SPOG and IBCSG will move into new premises close to the current location. Therewith, the can-cer research organizations stay in close proximity to the Swiss Cancer League and can still benefit from the joint use of meeting rooms and other services. The move of the SAKK CC is planned in the first quarter of 2016 – the net-work will be informed on further proceedings.

SAKK Coordinating Center raises money for Movember

The hairiest month of the year has passed and the SAKK Coordinating Center did its bit for Movember. Through-out November collaborators of the Coordinating Center were cooking soups or baking cakes, varnished finger nails, took part in table football tournaments, crocheted or grew real moustaches – all for a good cause. A high-light of the activities was the «Aare Challenge» where CEO Dr. Peter Brauchli was thrown into the 10 degrees

H. Baumgartner (left) and N. Backes, two of the many SAKK Movember heroes

Visit of the SSIC council at the SAKK CC



SAKK NEWScold river Aare by his executive committee colleagues and swam 4 minutes against the stream. The SAKK Coordinat-ing Center raised a total of CHF 1'481 for the Movember Foundation. The money will be used to support projects to improve men's health in a number of areas, including prostate and testicular cancer.

The Foundation is a global organization that seeks to make a contribution to men living happier, healthier, long-er lives. Since 2003 millions of people have joined the Mo-vember movement, raising no less than 622 million francs in donations and funding over 1'000 programs focusing on prostate cancer, testicular cancer, poor mental health and physical inactivity.

Visit of the Swiss Science and Innovation Council (SSIC)The Swiss Science Innovation Council was established by the Federal Council on 23 March 1965. Together with SAKK it is celebrating its 50th anniversary this year.

The SSIC is the advisory body to the Federal Council for issues related to science, higher education, research and innovation policy. The goal of the SSIC, in conformity with its role as an independent consultative body, is to promote the framework for the successful development of the Swiss higher education, research and innovation system (see http://www.swir.ch/en/the-ssic/organization/the-council for the members of the council).

In this matter, the council visited the SAKK CC on Novem-ber 12 and talked to CEO Dr. Peter Brauchli and president Prof. Dr. Beat Thürlimann as well as to representatives of SPOG. Currently, the council is visiting all 30 institu-tions which are supported by the State Secretariat for

Education, Research and Innovation (SERI) according to article 15 of the federal law on the advancement of re-search and innovation (Bundesgesetz über die Förderung der Forschung und der Innovation FIFG). As the federal government has announced cost cuts in education and research, this visit was very important regarding the new performance agreement between the SERI and SAKK from 2017 to 2020.

SAKK establishes patient representative boardPatient orientation is one of SAKK's core values. As a non-profit organization, we are committed to improving can-cer patients' chances of recovery.

Since nobody knows better what it is like to deal with a di-agnosis of cancer and the condition itself than the people affected and their families, SAKK has decided to establish a patient representative board to advise the organization on communication, trial development and strategy. «By partnering with the SAKK patient representative board, we intend to improve the dialogue between scientists and patients», says CEO Dr. Peter Brauchli. «Moreover, we are hoping this will give our researchers new impetus which will result in our research projects being even more closely aligned to patients' needs».

The patient representative board comprises a maximum of seven people who are elected by the SAKK board. At present it comprises five members. The members are ei-ther former cancer patients themselves, have looked after close friends or family members with the condition or are representatives of a patient organization.

Prof. Dr. H.-J. Lenz

Dr. D. Lacombe



50 years SAKK

Medical oncology afternoon in Sion

The Oncology Department of the Centre Hospitalier du Valais Romand (CHVR) organized a medical oncology af-ternoon in Sion. The Oncology Department at CHVR has been participating in SAKK's clinical trials ever since it was set up and is one of SAKK's recognized regional centers. The future of oncology is increasingly focused on person-alized treatments which often require the joint efforts of a network. To mark the 50th anniversary of SAKK's foun-dation and the establishment of an oncology network in French-speaking Switzerland, the Oncology Department at CHVR illustrated certain topics using clinical cases and discussions with colleagues from Geneva and Lausanne University Hospitals, to give an insight into the impor-tance of these developments.

SAKK NEWS & SAKK ANNIVERSARYSAKK anniversary symposium at the DGHO congress

From 9 to 13 October 2015 some 5'500 experts took part in the annual congress of the German Society for Haematology and Medical Oncology (DGHO) in Basel and made the most of the high-quality presentations, discussions and workshops on offer, not to mention the opportunity to share their views with colleagues in other disciplines.

On Monday 12 October, SAKK was represented at the congress in the form of an anniversary symposium. In the first part of the symposium, Prof. Dr. Heinz-Josef Lenz, USC Norris Comprehensive Cancer Center, Los Angeles, spoke on the future of cooperative study groups in the U.S. Dr. Denis Lacombe, Director General of the EORTC in Belgium, showed the challeng-es of clinical cancer research and possible solutions. Thanks to their studies, cooperative groups have hitherto made a crucial contribution to thera-peutic standards.

In the second part of the sym-posium the speakers looked back on 50 years of SAKK. Prof. Dr. Beat Thürlimann, SAKK President, spoke about the be-ginnings of SAKK, when oncology had been a new and exotic discipline of internal medicine. Today, according to Thürlimann, oncology has become the driving force behind almost the whole of medicine. But oncology still faces major challenges as a result of the ever-changing environment.

The patient representative board will meet with SAKK representatives at least twice a year.

Initial projects include involvement in structuring the SAKK's symposium programme and in assessing com-munication tools such as patient information brochures and the SAKK website to ensure that they meet patients' needs. SAKK would also like the patient representative board to propose and submit projects at its own initiative. In the medium term, moreover, cooperation is to be de-veloped with the SAKK project and working groups with the aim of developing more patient-friendly studies. For further information on the patient representative board, please visit http://sakk.ch/en/sakk-provides/for-patients/patient-representative-board/.

ContactDr. Peter DurrerHead QA & RA & Safety [email protected]

R. Demmer

PD Dr. T. Ruhstaller

Dr. G. Germann

Professionals and visitors at the open day



Jubilee symposium at the Cantonal Hospital St. Gallen (KSSG)

On October 29, the Oncology De-partment of the KSSG invited to a series of interesting presentations on clinical research. The presenta-tions were followed by an apéro riche. Among the renowned speak-ers was Dr. Felix Jung, former presi-dent of the Cantonal ethics commit-tee, who spoke of the beginning of the research activities at the KSSG. Dr. Susanne Driessen, president

of the Cantonal ethics commit-tee, explained what challenges have to be managed in an ethics committee and pointed out that the quality of the submissions of SAKK was very high. SAKK Presi-dent, Prof. Dr. Beat Thürlimann, showed SAKK’s accomplishments of the past 50 years and men-tioned that since the beginning the KSSG is one of the top recruit-ing SAKK centers. Also present-ing were Dr. Daniel Germann, CEO of the KSSG, Ruth Demmer, CRC, and

PD Dr. Thomas Ruhstaller. All speakers came to the conclusion that research is a prove of quality for a center but can on the long term only be conducted in a na-tional network such as SAKK.

Oncology open day at HFR Fribourg cantonal hospitalTo mark the 50th anniversary of SAKK, Fribourg cantonal hospital (HFR) organized an open day entitled «Cancer – from diagnosis to treatment» on 14 November.

The HFR opened up to the public and one could take a glance behind the scenes of the oncology unit. The event addressed cancer prevention, early detection, the latest treatment methods and support for cancer patients and

SAKK ANNIVERSARYtheir families during a tour of various departments and interactive workshops. At the same time, various pres-entations were given throughout the day. Specialist staff members were available to answer questions after each presentation.

Final ceremonies of the SAKK jubilee yearAn exciting year of celebrations and events comes soon to an end – the 50 years anniversary was rounded off with a scientific symposium and a jubilee apéro during the semi-annual meeting in Zurich. The anniversary year was a great success, launched with the public event on Bundesplatz in May and supported by 50 ambassadors among them Swiss personalities known from politics, sports and show business (http://sakk.ch/en/50-years/sakk-ambassadors/).

Also our member centers actively participated and organ-ized 11 events at their hospitals. It can be said that the overall goal, enhancing SAKK’s visibility in the public as well in the hospitals, was achieved.

SAKK 50 years symposium

The SAKK symposium featured various speakers on current topics such as Big Data, Target Medicine and Data Protection and closed with a podium discussion. The welcome speech was given by the president elect, PD Dr. Roger von Moos. He presented the milestones of the past and some results of the first SAKK trials and ex-plained how the SAKK founders tried to bring cancer on the political agenda with the Motion Schaller in 1969 (see for details: http://sakk.ch/en/50-years/history-of-sakk/). To complete the history to date, he presented some facts

Prof. V. Mooser

Prof. E. Hafen

Prof. M. Salathé

Prof. B. Rudin



SAKK ANNIVERSARYand figures, major SAKK publications and stressed out the collaborations with foreign organizations. He thanked all collaborators in the SAKK network.

Prof. Vincent Mooser, Head Lab Department at the Cen-tre Hospitalier Universitaire Vaudoise in Lausanne, con-tinued with his talk on the topic «Targeted Medicine vs Big Data». He states: «Data protection is a serious issue, but demonstration of clinical utility is a much bigger chal-lenge». This means challenges are to collect, store and secure high quality data, convert data into knowledge, and convert knowledge into clinical utility. In addition he reports promising experiences from the CHUV with a general consent for a prospective, system-atic biobank designed to support research in genomic medicine, what resulted in a high participation rate.

Prof. Ernst Hafen, Deputy Head at the Institute for Molecu-lar Systems Biology in Zurich, presented the project MIDATA.coop which shall be democ-ratizing the personal data economy and implementing person-alized medicine in the

existing healthcare systems. MIDATA.coop is a federation of national personal data cooperatives (PDC) with a com-mon data structure and exchange platform (like SWIFT). All profit stays in the national PDCs and this solution is accepted within Europe and could be implemented worldwide. MIDATA.coop enables citizens to securely store, manage and control access to their personal data by helping them to establish and own national/regional not-for-profit MIDATA cooperatives. This project is still in developing process, three pilot projects will start in 2016. See also the website: http://www.midata.coop/.

Prof. Marcel Salathé, École polytechnique fédérale in Lausanne, spoke of digital epidemiology. An increasingly large fraction of what we do and say – including epide-miologically relevant behaviors is stored electronically.

Extracting meaningful in-formation from this data deluge is challenging, but holds unparalleled poten-tial for epidemiology. Thus, there is great potential to deepen understanding of disease dynamics through the analysis of digital traces. See Salathé et al. on http://journals.plos.org/ploscompbiol/article?id=10.1371/journal.pcbi.1002616.

The legal point of view was presented by Prof. Beat Rudin, representative of data protection of the Canton of Basel-Stadt. He explained why an informed consent of the patient is needed even if people themselves are dis-playing their lives carelessly on social media platforms. He stated: «research needs and deserves trust but trust needs to be earned».

Jubilee Apéro – 50 years ago

The jubilee apéro had the motto «50 years ago» – food and decoration sent the guests on a travel back in time to the sixties, the founding years of SAKK. The apéro was opened by CEO Dr. Peter Brauchli and moderated by Tanja Gutmann, TV and event presenter. In the podium discussion, Prof. Dr. Hans-Jörg Senn, SAKK founding father and past president, reported on SAKK’s past and development.

Prof. Felix Gutzwiller, councilor of states and social and pre-ventive and medicine specialist, spoke of the importance of political support for cancer research. Last but not least, am-bassador Mathias Seger, ice hockey player ZSC Lions and captain of the national ice hockey team, talked about his mo-tives to support SAKK and cancer research. The future was

T. Gutmann, Dr. P. Brauchli

T. Gutmann, Prof. H.-J. Senn, Prof. F. Gutzwiller, M. Seger (from left to right)

M. Seger

Guests with sixties ladies and T. Gutmann

Travelling back in time to the swinging sixties



SAKK ANNIVERSARYrepresented by President elect, PD Dr. Roger von Moos. The approximately 250 guests included many members of our network, representatives of partner groups and pharmaceuti-cal companies, the media, past presidents and collaborators as well as SAKK CC staff.

More pictures can be found on http://sakk.ch/en/50-years/sakk-jubilee-apero/.

PD Dr. R. von Moos

Awardees with representatives of RTFCCR and SAKK



SAKK GENERAL ASSEMBLY & SEMI-ANNUAL MEETINGSAKK General Assembly

Meeting of the SAKK board, group presidents, SAKK CC executive commit-tee and head physicians of the member centers

The SAKK board invited to this meeting to exchange opin-ions between the project group presidents, representa-tives of the SAKK members and head physicians of the centers and the SAKK board. The participants discussed animatedly on strategy, further development and lessons learnt.

New SAKK president elected

During the General Assembly, which took place on November 25 at the Marriott Hotel in Zurich, the member representatives elected PD Dr. Roger von Moos from the Cantonal Hospital Graubünden – the current vice-presi-dent – as new SAKK president. Von Moos will take over the duties from Prof. Beat Thürlimann end of June 2016. The SAKK board will have to choose a new vice-president in its next board session in January 2016 and the vacant board position will be open for application in Spring 2016. An announcement with the re-quirements for candidates will follow in the next newsletter.

The members already thanked Thürlimann for his great con-tribution over the past years and wished him success for his future projects.

Prof. Dr. Stephan Bodis from the Cantonal Hospital Aarau resigned from his board membership and Prof. Dr. Ludwig Plasswilm, Cantonal Hospital St. Gallen, was elected as new representative of radiation oncology in the board.

Solothurner Spitäler AG (soH) becomes new member of SAKK

As of this year, the Solothurn region is part of the network of SAKK. The General Assembly admitted the new mem-ber in the form of Solothurner Spitäler AG, which includes Solothurn public hospital, Olten cantonal hospital and Dornach hospital.

Revised SAKK publication guideline

The publication guideline has been revised and the mem-bers of the General Assembly have accepted the changes. Primarily, the timelines for the first author of a manuscript and the consequence to lose the right of first author-ship in case he/she does not adhere to the timeline have changed. The revised guideline can be found on http://sakk.ch/en/sakk-provides/for-research/scientific-publica-tions/.

Semi-annual meeting in Zurich

The SAKK winter semi-annual meeting took place in Zu-rich, on November 26 and 27. The various research groups of SAKK met to discuss and develop new proposals for trials. The meeting also offers the opportunity for further training and participation in scientific symposia. The Gate-way/RTF-CCR/SAKK Research Grant was presented at this year's winter semi-annual meeting. During the event, the SAKK/Amgen Research Grant and the GIST Group Swit-zerland's GIST Prize were awarded, and the new SAKK/Celgene Grant introduced. SAKK's 50th anniversary cel-ebrations were concluded with a symposium and a jubilee apéro.

USD 1'500'000 for cancer research-ers in Switzerland and SpainThe 2015 SAKK/RTFCCR/Gateway Research Grant has been awarded to five different research projects address-ing pivotal challenges in clinical cancer research. This joint research grant is being awarded for the third year by SAKK, the Rising Tide Foundation for Clinical Cancer Research (RTFCCR) and the U.S.-based non-profit organi-zation, Gateway for Cancer Research (Gateway).

Prof. B. Thürlimann, E. Mumenthaler, M. Ruggeri

Prof. B. Thürlimann, E. Mumenthaler, Prof. A. Ochsenbein

Prof. B. Thürlimann, E. Mumenthaler, Dr. S. Rothschild



Founded in 2011, this strategic partnership seeks to accel-erate innovative and relevant oncology research that may lead to more potent, less toxic and potentially life-saving treatment options for cancer patients.

Eveline Mumenthaler, Director of RTFCCR, presented the grant awards to the winners during the semi-annual meeting of SAKK in Zurich. This included Dr. Sacha Rothschild, Basel University Hospital, PD Dr. Nicholas Mach, Geneva University Hospital, Prof. Dr. Adrian Ochsenbein, Inselspital Bern, Monica Ruggeri of the International Breast Cancer Study Group (IBCSG) Coordinating Center in Bern and Dr. Jordi Rodón, Vall d'Hebron University Hospital in Barcelona, Spain.

«Cancer remains a worldwide health problem. With over 100 different known cancers that affect humans, factors such as an aging population together with the evolution of lifestyle continue to make cancer a major societal chal-lenge. While new discoveries have brought about innova-tive diagnostic approaches and effective therapies, a con-tinuous strong financial support is required to advance novel and evidence-based research. This is why we are enthusiastic about the prospects of our third-year of grant partnership with SAKK and Gateway, which increased from 450’000 USD for one project to USD 1,500,000 for five projects», said Eveline Mumenthaler.

Prof. Beat Thürlimann, SAKK President, is especially de-lighted that the grant endowment has been increased to mark the SAKK's 50th anniversary in 2015 and that re-

SEMI-ANNUAL MEETINGsearch in a number of categories is eligible for support: «The aim of the grant is to support five academic research projects. This is entirely in keeping with the SAKK's mis-sion. As an academic research institute, we have been committed for the past 50 years to finding the best pos-sible cancer therapy for patients in Switzerland».

Scientists applying for the research grant were able to submit their projects in five categories: increasing the efficacy of cancer diagnostics and therapeutics through targeted and personalized medicine; development of ap-proaches for metastatic disease; overcoming drug resist-ance; improving quality of life; and use of repurposed drugs. All submissions were reviewed in a two-stage pro-cess by an international committee comprising scientific experts from SAKK, RTFCCR and Gateway. The final deci-sion was reached in October 2015. Details on the project titles can be found on http://sakk.ch/en/about-sakk/news/listview/news/2015/11/26/usd-1500000-for-cancer-re-searchers-in-switzerland-and-spain/.

Dr. C. Balmelli, Dr. C. Merkle, Amgen Switzerland AG, Prof. V. Hess



SEMI-ANNUAL MEETINGSatellite symposium by Astellas Pharma AGA highlight of the SAKK semi-annual meeting was the satellite symposium with the title «On the way to per-sonalized medicine in prostate cancer – where do we stand» held with the presentations of the experts Dr. Richard Cathomas, Chur, Prof. Dr. Nicolas James, Coventry, UK, and Dr. Christian Ruiz, Basel. Today, many new therapies are entering the market bringing various therapeutic options to the oncologists and their patients. Alongside with the discussion of the potential optimal sequencing of the treatments, the demand for predictive markers arises. It is believed that the new treatment op-tions together with the development of biomarkers will shape the management of patients with prostate cancer considerably and help to define personalized treatment strategies as it has become a standard in Lung Cancer. The satellite symposium was kindly sponsored by Astellas Pharma AG.

Researchers from Basel receive SAKK/Amgen Research Grant

This year’s SAKK/Amgen Research Grant went to three re-searchers from the University Hospital Basel: Dr. Cathrin Balmelli, Dr. Christoph Berger and Prof. Dr. Viviane Hess. SAKK and Amgen Switzerland AG distribute the grant every two years for outstanding and novel translational cancer research in Switzerland that improves patient’s lives. The grant is endowed with CHF 50'000.

The researchers are awarded for their translational re-search project that investigates the impact of physical activity on adaptive and innate immune functions of pa-tients with metastatic colorectal cancer. They hypothesize that exercise-induced enhanced immune functions – both of the adaptive and innate immune system – account for better clinical outcomes in physically active patients.

Researchers or a research team independent of their nationality and age, working at a Swiss hospital or in-stitution can apply for the SAKK/Amgen research grant. The grant should contribute to an independent research project and cover a relevant scientific part of the project. The next SAKK/Amgen Research Grant will be awarded in 2017.

SAKK and Celgene to award their new Life GrantSAKK and Celgene will be awarding a joint research grant worth CHF 20'000. The Life Grant will be awarded to pro-jects that aim to improve the quality of life of patients with pancreatic cancer. Eligible research projects should have the potential to reduce the disease-related burden on patients and/or their families and must be conducted in Switzerland. Members of the medical and nursing profes-sions in Switzerland can apply. The grant will be awarded for the first time at the summer semi-annual meeting of SAKK in June 2016.

More information can be found on http://sakk.ch/en/sakk-provides/for-research/research-grants/.

Prof. B. Thürlimann, Dr. M. Montemurro, H. Meyer, GIST Group, Prof. S. Bauer



SEMI-ANNUAL MEETINGThe 2015 GIST award goes to Prof. Sebastian BauerThe GIST Group Switzerland, the support group for pa-tients with gastrointestinal stromal tumor (GIST), has awarded its science prize for the sixth time. The 2015 GIST prize, worth CHF 10'000, was awarded to Prof. Sebastian Bauer, University Hospital, Essen, Germany, for his paper «Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors» published in the British Journal of Cancer (Br J Cancer. 2014 Mar 4;110(5):1155-62). In awarding this prize to Bauer, the group also recognized his many other publications and his commitment to patients with GISTs.

«Choosing Wisely» Symposium, September 25 in Lugano In the 1990s in-vestigators from McMaster's Uni-versity began using the term «Evidence Based Medicine» (EBM), defined as «a systemic approach to an-alyze published research as the basis of clinical decision making». Later on Sacket et al. defined the term more formally and stated that EBM was «the conscientious and judicious use of current best evidence from clinical care research in the management of individual patients». Within the paradigm of EBM modern medical guidelines based on an examination of current evidence emerged. They usually include summarized consensus statements on best practice in healthcare. A healthcare provider is thought to be obliged to know the medical guidelines of his or her profession, and has to decide whether or not to follow the recommendations of a guideline for an individual treatment. Clinical guidelines in addition aim to standardize medical care, to raise quality of care, to reduce several kinds of risk (to the patient, to the health-care provider, to medical insurers and health plans) and to achieve the best balance between cost and medical pa-rameters such as effectiveness, specificity, sensitivity and

NETWORK FOR OUTCOMES RESEARCHmany more. However, the introduction of these new ap-proaches and instruments guiding clinicians and patients in medical decision making did not decrease disparities in patient care and many patients today are confronted with over-diagnosis and over-treatment issues.

Despite EMB and guidelines, currently it is thought that 30 % of given care does not improve value or may even harm patients. The reasons are manifold and have to be sought at the physicians as well as at the patient’s side. Whether driven by financial incentives or consumer be-haviour, the idea that, «more is better», is well estab-lished in the head of physicians and patients alike.

As a consequence, a new initiative was proposed by Ho-ward Brody in 2010. He published the article «Medicine’s Ethical Responsibility for Health Care Reform – The Top Five List» in the New England Journal of Medicine. In this piece, Dr. Brody called on U.S. medical specialty societies to identify five tests and treatments that were overused in their specialty and did not provide meaningful benefit for patients. Building on this work in 2012, the «Advanc-ing Medical Professionalism to Improve Health Care and the Consumer Reports», formally launched the Choosing Wisely campaign with the release of the «Top Five» lists with «DON’Ts» from nine specialty societies.

To participate in Choosing Wisely, each medical society



NETWORK FOR OUTCOMES RESEARCHhas to develop a list of five (or more) tests, treatments, or services which that specialty commonly overuses. The so-ciety shares this information with their members, as well as organizations who can publicize to local community groups, and in each community patients and doctors can consider the information as they like. As of February 2013, there were 135 recommendations targeting a range of procedures to either question or to avoid without special consideration.

At the symposium, examples of the implementation of the Choosing Wisely campaign from different countries were presented. In Canada it became clear that patients have to be educated as well, for example with this video cam-paign: https://www.youtube.com/watch?v=FqQ-JuRDkl8. Furthermore, when a diagnostic test or clinical interven-tion is ordered, the health care professional is directed to the choosing wisely website of the hospital. In Italy, the campaign is called «Slow Medicine» and some hospitals have made a list of «DON’Ts» for routine hospital care. Further examples from the Netherlands, Germany or the UK were presented. They also stressed out the need for health services research in order to detect geographic dis-parities in care delivery, which might indicate an over- (or under-) use of medical care.

In Switzerland the campaign is called «Smarter Medicine» and hospitals in Ticino, Geneva and Bern are actively im-plementing lists. In Oncology, the American Society of Clinical Oncology published a first list of 5 DON’Ts in can-cer patients (Additional 6-10 points were added in 2013). The list can be found on http://www.choosingwisely.org/societies/american-society-of-clinical-oncology/

How far the ideas of «Choosing Wisely» will be able to change medical practice remains unsettled. As many stakeholders profit from established practises and pa-tients have been educated for years to «consume», it will take a while until these new approaches take effect. How-ever, with health care consuming more and more of tight national budgets, the time has come to find solutions be-fore the entire system collapses.

«Less is More», SAMW Symposium, November 9 in BernA second symposium with a similar subject was held in the framework of the health services research program of the SAMW and the national research program 74 «Ge-sundheitsversorgung». One of the topics presented was

on what appropriate care is and how to find over-, un-der- or misuse of care. Appropriateness implies ethical, financial, clinical, individual issues and is a socio-political process in which all stakeholders should be involved. Prof. Steve Pearson (National Institute of Health, USA) addressed the issue of «Waste» (inefficient system or ma-terial, administrative and/or clinical waste) in health care and how difficult it may be to reduce waste. In many situ-ations the reason for waste may be the lack of evidence. Experimental treatments without comparative evidence are used because patients are desperate and are willing to do anything. Also, the off-label use of drugs is accept-ed due to desperate situations of patients. On the other hand, physicians rely on useless care, as they claim that their patients are unique and do not fit the study results found so far or patients are willing to pay high prices to gain very small benefit. From the top-five lists as men-tioned above, most of the items belong to issues where the evidence is available.

Prof. Thomas Rosemann, presented results on the over use of heart catheterization. He stressed the fact that even if we now talk about over-use, we should not forget that many procedures and drugs do save lives and help patients to get cured. Still also in heart diseases the gap between performed numbers of diagnostic procedures and those which are followed by an intervention is get-ting increasingly larger.

Another contribution by Dr. Klaus Eichler showed the impact of recommendations by the Swiss medical Board on routine care in Switzerland. He concluded that such recommendations are not sustainable and after a short effect, interventions go on as usual.

In the afternoon Roberto Grilli talked about Health Servic-es Research HSR in Italy and the problem of doing «noth-ing». Physicians are reimbursed for performing which in-creases the passion to order procedures, even if they add no value to the given care. Furthermore he stressed out the HSR communication between researchers and policy makers. Without a consensus between these parties the complex HSR cannot have an impact.

Doing something instead of nothing, even if that would be a better choice in the given circumstances, was also the topic of the panel discussion. With the DRG-system in place, doing «nothing» does not seem to be an option for many physicians. But it was also stated that one should not only speak of overuse. Certain interventions may as



well be underused and especially geographic disparities in the delivery and use of health care interventions should be studied to detect variability in supply sensitive, prefer-ence based or effective care.

The symposium was accompanied by a poster session. Fifty eight posters were presented and the participants of the symposium were invited to vote. The poster presented by the Network for Outcomes Research «A retrospective database study investigating days spent in acute care hospitals during the last 90 days of life of cancer patients from four Swiss cantons (SAKK 89/09)» was awarded with the third price.

Dr. Klazien Matter-Walstra, Network Outcomes Research, SAKK / [email protected]

Referenceshttp://blogs.bmj.com/bmj/2012/12/17/richard-smith-the-case-for-slow-medicinehttp://consumerhealthchoices.org/campaigns/choosing-wiselyhttp://www.choosingwisely.orghttp://www.choosingwiselycanada.orghttp://www.kwaliteitskoepel.nl/assets/structured-files/Verstandig%20Kiezen/Choosing%20Wisely%20Netherlands.pdfhttp://www.oecd.org/health/healthpoliciesanddatahttp://www.oecd-ilibrary.org/social-issues-migration-health/health-at-a-glance-2011_health_glance-2011-enhttp://www.slowmedicine.it/fare-di-piu-non-significa-fare-meglio/pratiche-a-rischio-di-inappropriatezza-in-italia.html

NETWORK FOR OUTCOMES RESEARCH

TRIAL NEWSSAKK 36/13 patients needed

The trial SAKK 36/13 for patients with relapsed or refractory mantle cell lymphoma is open for accrual since August 2015. Two patients were already accrued in this trial and tolerate the treatment so far well. We would appreciate if we could col-laborate with you on a new treatment option for mantle cell lymphoma especially for elderly patients.

The attractiveness of the treatment can be explained by the non-over-lapping toxicities and in the in vitro synergy of the combination of ibru-tinib and bortezomib. Bortezomib inhibits among others the NF-kB- sig-nalling cascade. MCL patients with low or no response to ibrutinib have mutations in diverse genes in this signaling cascade. This combination therapy is especially for elderly patients not eligible for allogeneic stem cell transplantation and high dose chemotherapy. The trial is supported by Janssen-Cilag AG and both drugs are provided free of charge by the pharma company.

The phase I of the trial is currently offered at the university hospitals of Bern and Geneva, (the CHUV will follow in Q2 2016), and at the Can-tonal hospitals in Bellinzona, Luzern, Liestal, Aarau, Chur, St. Gallen and the Hirslanden in Zürch. In the phase II part of the trial, further centers in Italy and Switzerland will be activated.

If you have any questions to this trial, I would be pleased to be at your disposal.

PD Dr. Urban Novak, coordinating investigator SAKK 36/[email protected]



TRIAL NEWSTrials to be activated 2016

Trial Trial Name Opening of the first site

SAKK 16/14 Perioperative anti-PD-L1 antibody MEDI4736 in addition to standard neoadjuvant chemo-therapy in non-small cell lung cancer (NSCLC) patients with mediastinal lymph node metas-tases (stage IIIA, N2)

Q1 2016

SAKK 41/13 Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients. A randomized, double-blinded, placebo-controlled, phase III trial.

Q1 2016

SAKK 41/14 Active-2

Physical activity program in patients with metastatic colorectal cancer who receive palliative first-line chemotherapy. A multicenter open label randomized controlled phase III trial

Q1 2016

GRAALL-2014 Treatment of adult acute lymphoblastic leukemia (ALL), evaluating the addition of a second late intensification course in B-lineage PH-negative ALL, the addition of Nelarabine in high-risk T-lineage ALL, and the reduction of chemotherapy intensity in Ph+ ALL

Q1 2016*

IBCSG 50-14/BIG 6-13

Arandomised,double‐blind,parallelgroup,placebocontrolledmulti‐centrePhaseIIIstudytoassess the efficacy and safety of olaparib vs placebo as adjuvant treatment in patients with highriskgermlineBRCAmutatedHER2‐negativebreastcancerwhohavecompleteddefini-tive local and systemic neoadjuvant/adjuvant treatment

Q1 2016*

IELSG-42 An international phase II trial assessing tolerability and efficacy of sequential Methotrexate-Aracytin-based combination and R-ICE combination followed by high-dose chemotherapy supported by autologous stem cell transplant in patients with systemic DLBCL with CNS involvement at diagnosis or relapse (MARIETTA regimen)

Q1 2016*

IELSG-43 High-dose chemotherapy and autologous stem cell transplant consolidating conventional chemotherapy in primary CNS lymphoma -randomized phase III trial

Q1 2016*

SAKK 08/14 IMPROVE

Enzalutamide in combination with metformin vs. enzalutamide in patients with CRPC pro-gressing on androgen deprivation therapy (ADT)

Q1-2 2016

SAKK 21/12 (Phase II part)

A Phase I and stratified, multicenter Phase II trial of transdermal CR1447 (4-OH-tes tosterone) in endocrine responsive-HER2 negative and triple negative-androgen receptor positive meta-static or locally ad vanced breast cancer

Q1-2 2016

HOVON 103 SEL SAKK 30/10

A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral selinexor (KPT-330) to standard induction therapy in AML high risk myelodysplasia (MDS) (IPSS-R risk score >4.5) in patients aged ≥ 66 years

Q2 2016*

SAKK 67/15-CDA CDI-CS-003

An open-label Phase 1/2a study of BAL101553 administered as a continuous intravenous infusion in adult patients with advanced solid tumors

Q2 2016

HD21 Treatment optimization trial in the first-line treatment of advanced stage Hodgkin Lympho-ma: comparision of 6 cycles of escaleted BEACOPP with 6 cycles of BrECADD

Q2 2016*

PRODIGE 32 Randomised phase II-III strategic trial in operable oesophageal cancer in case of clinical complete response after chemoradiation: systematic surgery vs surveillance with selective salvage surgery in case of operable recurrence

Q2 2016*

MCL young/TRIANGLE

Efficacy of Ibrutinib during R-CHOP/R-DHAP induction and after or in comparison to au-tologous stem cell transaplantation (ASCT) in previously untreated patients with mantle cell lymphoma

Q2-3 2016*

SAKK 24/14 A phase II study of anti-EGFR-ILs loaded with doxorubicin in patients with advanced triple negative breast cancer (TNBC)

Q3 2016

*Dependent on the cooperative group, just an estimated opening for accrual

Updated



TRIAL NEWSTrials to be activated 2016

SAKK 41/16 Impact of neoadjuvant treatment with Regorafenib and Capecitabine combined with radio-therapy in locally advanced rectal cancer. A Phase Ib trial (RECAP)

Q3 2016

SAKK 35/15 A phase I study of GA101 in combination with ABT199 in follicular lymphoma patients Q3-4 2016

SAKK 08/15ProMET

Multicenter, Randomized, Double Blind, Placebo Controlled Phase II Trial of Salvage Radio-therapy +/- Metformin HCL after Prostatectomy Failure

on hold due to financial reasons

Disease Group

Trial Name Trial Description Accrual Target

Current Accrual*

Estimated Closure forAccrual

Trial Coordinator

Urogenital Cancers

SAKK 01/10 Involved Node Radiotherapy and Car-boplatin Chemotherapy in Stage IIA/B Seminoma

115 52 15.06.2017 [email protected]

Urogenital Cancers

SAKK 06/14 A phase I/II open label clinical trial as-sessing safety and efficacy of intravesi-cal instillation of VPM1002BC in patients with recurrent non-muscle invasive blad-der cancer after standard BCG therapy


Urogenital Cancers

SAKK 63/12 Prospective cohort study with collection of clinical data and serum of patients with prostate disease

1930 194 15.10.2016 [email protected]

Urogenital Cancers

SAKK 96/12 Prevention of Symptomatic Skeletal Events with Denosumab Administered every 4 Weeks versus every 12 Weeks – A Non-Inferiority Phase III Trial

1380 103 (total 202)

16.01.2019 [email protected]

Urogenital Cancers

STAMPEDE Systemic Therapy in Advancing or Meta-static Prostate Cancer: Evaluation of Drug Efficacy A 5-stage multi-arm randomised controlled trial

54 31.12.2016 estelle.cassoly @sakk.ch

Lung Cancers

SAKK 15/12 Early prophylactic cranial irradiation with hippocampal avoidance in patients with limited disease small-cell lung cancer. A multicenter phase II trial


Lung Cancers

SAKK 16/08 Preoperative chemotherapy and radio-therapy with concomitant Cetuximab in non-small cell lung cancer (NSCLC) patients with IIIB disease. A multicenter phase II trial

69 65 31.03.2016 heike.kenner @sakk.ch

Trials Open for Accrual November 2015

*Current accrual as of end of November, 2015. Accrual for non-SAKK trials only includes patients enrolled at SAKK centers.

Updated





TRIAL NEWS

Disease Group


Current Accrual*


Trial Coordinator

Lung Cancers

SPLENDOUR A randomised, open-label phase III trial evaluating the addition of denosumab to standard first-line anticancer treatment in advanced NSCLC

1000 53 30.03.2018 [email protected]

Lung Cancers

EORTC LungArt

Phase III study comparing post-operative conformal radiotherapy to no post-oper-ative radiotherapy in patients with com-pletely resected non-small cell lung can-cer and mediastinal N2 involvement


Breast Cancers

SAKK 22/10 A randomized phase II trial of pertu-zumab in combination with trastuzumab with or without chemotherapy, both fol-lowed by T-DM1 in case of progression, in patients with HER2-positive metastatic breast cancer

208 198 30.01.2016 marie-aline. [email protected]

Breast Cancers

SAKK 23/13 Randomized Controlled Trial to Evaluate the Impact of a Surgical Sealing Patch on Lymphatic Drainage after Axillary Lymph Node Dissection for Breast Cancer


Breast Cancers

SAKK 25/14 Eribulin as 1st line treatment in elderly patients (>= 70 years) with advanced breast cancer: a multicenter phase II trial


Breast Cancers

SAKK 96/12 Prevention of Symptomatic Skeletal Events with Denosumab Administered every 4 Weeks versus every 12 Weeks – A Non-Inferiority Phase III Trial

1380 99 (total 202)

16.01.2019 [email protected]

Breast Cancers

EORTC 10085 PRO

EORTC 10085 prospective part, Clinical and biological characterization of Male Breast Cancer: an international EORTC, BIG and NABCG intergroup study

26 30.06.2016 [email protected]

Breast Cancers

IBCSG 43-09 HOHO

Prospective observational study of young women (£ 40 years at diagnosis) with breast cancer. Data analyzed will include serial patient surveys and medical record information

300 84 Q1 2016 Monica.Ruggeri @ibcsg.org

Breast Cancers

IBCSG 48-14/BIG 8-13

A study evaluating the pregnancy out-comes and safety of interrupting endo-crine therapy for young women with endocrine responsive breast cancer who desire pregnancy

500 3 31.12.2018 Monica.Ruggeri @ibcsg.org

Updated




TRIAL NEWS

Disease Group


Current Accrual*


Trial Coordinator

Leukemias SAKK 33/14 Effects of sympathicomimetic agonists on the disease course and mutant allele bur-den in patients with JAK2-mutated my-eloproliferative neoplasms A multicenter phase II trial


Leukemias APL 2006 Randomized phase III trial assessing the role of arsenic trioxide and/or ATRA during consolidation course in newly di-agnosed acute promyelocytic leukemia (APL)

800 65 15.05.2016 vincent.tchang @sakk.ch

Leukemias CML V Treatment optimization of newly diag-nosed Ph/BCR-ABL positive patients with chronic myeloid leukemia (CML) in chron-ic phase with nilotinib vs. nilotinib plus interferon alpha induction and nilotinib or interferon alpha maintenance therapy


Leukemias EBMT HCT vs CT

Compare conventinal chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation as consolidation therapy


Leukemias HOVON 103- TOS

A randomized phase II multicenter study with a safety run-in to assess the toler-ability and efficacy of the addition of oral tosedostat to standard induction chemo-therapy in AML and high risk myelodys-plasia (MDS) (IPSS-R > 4.5) in patients aged ≥ 66


Leukemias HOVON 132 Randomized study with a run-in dose-selection phase to assess the added value of lenalidomide in combination with stan-dard remission-induction chemotherapy and post-remission treatment in patients aged 18-65 years with previously untreat-ed acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (IPSS-R risk score > 4.5)


Lymphomas SAKK 35/14 Rituximab with or without ibrutinib for untreated patients with advanced follicu-lar lymphoma in need of therapy. A ran-domized, double-blinded, SAKK and NLG collaborative Phase II trial

190 1 31.10.2017 [email protected] [email protected]


Updated




*Current accrual as of end of November 2015. Accrual for non-SAKK trials only includes patients enrolled at SAKK centers.

TRIAL NEWS

Disease Group


Current Accrual*


Trial Coordinator

Lymphomas SAKK 36/13 Combination of ibrutinib and Bortezomib followed by ibrutinib maintenance to treat patients with relapsed and refrac-tory mantle cell lymphoma. A multicenter Phase I/II trial


Lymphomas SAKK 39/10 Nelfinavir and lenalidomide/dexametha-sone in patients with progressive multiple myeloma that have failed lenalidomide-containing therapy. A single arm phase I/II trial

33 27 31.03.2016 piera.gargiulo@ sakk. ch

Lymphomas SAKK 39/13 Nelfinavir as Bortezomib-sensitizing drug in patients with proteasome inhibitor-nonresponsive myeloma


Lymphomas HD 17 Therapieoptimierungsstudie in der Primär-therapie des intermediären Hodgkin Lym-phoms: Therapiestratifizierung mittels FDG-PET

1100 58 01.12.2016 katrin.eckhardt@ sakk. ch

Lymphomas IELSG-37 A randomized, open-label, multicentre, two-arm phase III comparative study as-sessing the role of involved mediastinal radiotherapy after Rituximab containing chemotherapy regimens to patients with newly diagnosed Primary Mediastinal Large B-Cell Lymphoma (PMLBCL)

540 8 31.12.2016 simona.berardi @sakk.ch

Lymphomas T-cell project Das T-Cell project ist eine Registrierstudie mit Referenzpathologie um Daten zu seltenen malignen Erkrankungen der T-Zell Linie zu gewinnen

34 31.12.2016 simona.berardi @sakk.ch

Gastro-intestinal Cancers

Alliance/PROSPECT

A phase II/III trial of neoadjuvant folfox, with selective use of combined modality chemo-ra-diation vs. preoperative combined modal-ity chemoradiation for locally advanced rec-tal cancer patients undergoing low anterior resec-tion with total mesorectal excision.


New Drugs SAKK 66/12 A Phase I, open-label, multi-center, dose escalation study of oral CGM097, a p53/HDM2-interaction inhibitor, in adult patients with se-lected advanced solid tumors char-acterized by wild-type TP53


New Drugs SAKK 66/13 INC280 Combination with BKM120 for glioblastoma patients, Phase I/II trial

58 2 02.05.2016 simona.berardi @sakk.ch

Updated




TRIAL NEWS

New Drugs SAKK 69/13 Phase IB of oral BGJ398 (pan FGFR inhibitor) and oral BYL719 (a specific PI3K inhibitor) in adult patients with selected solid tumors


Gynae-cological Cancers

Mito/ Mango 16b

A multicenter phase III randomized study with second line chemotherapy plus or mi-nus bevacizumab in patients with platinum sensitive epithelial ovarian cancer recurrence after a bevacizumab/chemotherapy first line


Gynae-cological Cancers

INOVATYON Phase III international, randomized study of tra-bectedin plus Pegylated Liposomal Doxorubicin (PLD) versus Carboplatin plus PLD in patients with ovarian cancer progressing within 6-12 months of last platinum


*Current accrual as of end of November 2015. Accrual for non-SAKK trials only includes patients enrolled at SAKK centers.

Activated trials

SAKK 35/14 Rituximab with or without ibrutinib for untreated patients with advanced follicular lymphoma in need of therapy. A randomized, double-blinded, SAKK and NLG collaborative Phase II trialActivated October 15, 2015Coordinating investigator Emanuele Zucca, BellinzonaClinical project manager [email protected], [email protected]

Authorized trials

SAKK 41/13 Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients. A randomized, double-blinded, placebo-controlled, phase III trialApproved by EC August 12, 2015Submitted to Swissmedic August 31, 2015Coordinating investigator Ulrich Güller, BaselClinical project manager [email protected]

HOVON 103 - SEL A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral selinexor (KPT-330) to standard induction chemotherapy in AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) in patients aged 66 yearsSubmitted to EC August 14, 2015Submitted to Swissmedic August 14, 2015Coordinating investigator Georg Stüssi, BellinzonaClinical project manager [email protected]

Approval pending



TRIAL NEWSApproval pending

SAKK 41/14 ACTIVE-2 Physical activity program in patients with metastatic colorectal cancer who receive palliative first- line chemotherapy. A multicenter open label randomized controlled phase III trialSubmitted to EC September 16, 2015Coordinating investigator Viviane Hess, BaselClinical project manager [email protected]

PUBLICATIONS Q4 2015Urogenital CancerSAKK 09/10Ghadjar P, Hayoz S, Bernhard J, Zwahlen DR, Hölscher T, Gut P, Guckenberger M, Hildebrandt G, Müller AC, Plasswilm L, Pa-pachristofilou A, Stalder L, Biaggi-Rudolf C, Sumila M, Kranzbühler H, Najafi Y, Ost P, Azinwi NC, Reuter C, Bodis S, Kaouthar K, Wust P, Thalmann GN, Aebersold DM. Acute Toxicity and Quality of Life After Dose-Intensified Salvage Radiation Therapy for Biochemically Recurrent Prostate Cancer After Prostatectomy: First Results of the Randomized Trial SAKK 09/10. Nov 02 J CLIN ONCOL. IF 18.428

Lung CancerSAKK 17/04Stahel RA, Riesterer O, Xyrafas A, Opitz I, Beyeler M, Ochsenbein A, Früh M, Cathomas R, Nackaerts K, Peters S, Mamot C, Zip-pelius A, Mordasini C, Caspar CB, Eckhardt K, Schmid RA, Aebersold DM, Gautschi O, Nagel W, Töpfer M, Krayenbuehl J, Ribi K, Ciernik LF, Weder W. Neoadjuvant chemotherapy and extrapleural pneumonectomy of malignant pleural mesothelioma with or without hemithoracic radiotherapy (SAKK 17/04): a randomised, international, multicentre phase 2 trial. Oct 30. LANCET ONCOL. IF 24.69

Breast CancerBIG 1-98Leyland-Jones B, Gray KP, Abramovitz M, Bouzyk M, Young B, Long B, Kammler R, Dell'Orto P, Biasi MO, Thürlimann B, Harvey V, Neven P, Arnould L, Maibach R, Price KN, Coates AS, Goldhirsch A, Gelber RD, Pagani O, Viale G, Rae JM, Regan MM; BIG 1-98 Collaborative Group. ESR1 and ESR2 polymorphisms in the BIG 1-98 trial comparing adjuvant letrozole versus tamoxifen or their sequence for early breast cancer. Nov 21. BREAST CANCER RES TR. IF 3.94

IBCSG TEXT & SOFTRegan MM, Pagani O, Francis PA, Fleming GF, Walley BA, Kammler R, Dell'Orto P, Russo L, Szke J, Doimi F, Villani L, Pizzolitto S, Öhlschlegel C, Sessa F, Peg Cámara V, Rodríguez Peralto JL, MacGrogan G, Colleoni M, Goldhirsch A, Price KN, Coates AS, Gelber RD, Viale G; SOFT and TEXT Investigators and International Breast Cancer Study Group. Predictive value and clinical utility of centrally assessed ER, PgR, and Ki-67 to select adjuvant endocrine therapy for premenopausal women with hormone receptor-positive, HER2-negative early breast cancer: TEXT and SOFT trials. Oct 22. BREAST CANCER RES TR. IF 3.94

LymphomaCORALVan Den Neste E, Schmitz N, Mounier N, Gill D, Linch D, Trneny M, Milpied N, Radford J, Ketterer N, Shpilberg O, Dührsen U,

|www| All information on SAKK trials can also be found under www.sakk.ch in the members’ section



Ma D, Brière J, Thieblemont C, Salles G, Moskowitz CH, Glass B, Gisselbrecht C. Outcome of patients with relapsed diffuse large B-cell lymphoma who fail second-line salvage regimens in the International CORAL study. Sep 14. BONE MARROW TRANSPL. IF 3.57.

Palliative CareSAKK 95/06Strasser F, Blum D, von Moos R, Cathomas R, Ribi K, Aebi S, Betticher D, Hayoz S, Klingbiel D, Brauchli P, Haefner M, Mauri S, Kaasa S, Koeberle D; Swiss Group for Clinical Cancer Research (SAKK). The effect of real-time electronic monitoring of patient-reported symptoms and clinical syndromes in outpatient workflow of medical oncologists: E-MOSAIC, a multicenter cluster-randomized phase III study (SAKK 95/06). Dec 8. ANN ONCOL. IF 7.04.

OtherFeller A, Mark MT, Steiner A, Clough-Gorr KM. Time trends in avoidable cancer mortality in Switzerland and neighbouring Euro-pean countries 1996-2010. Oct 02. SWISS MED WKLY. IF 1.895.

Volk V, Cathomas R, Mark M, von Moos R, Klingbiel D, Brossart P, Mey U. Weekly carboplatin in combination with weekly pa-clitaxel in the treatment of metastatic non-small cell lung cancer: a single center 10-year experience. Nov 09. SUPPORT CARE CANCER. IF 2.364.

Baty F, Klingbiel D, Zappa F, Brutsche M. High-throughput alternative splicing detection using dually constrained correspond-ence analysis (DCCA). Oct 16. J Biomed Inform.

Presentations Q4 2015

2015 ASTRO's Annual Meeting

PosterHerrmann E. et al. External Beam Radiotherapy For Unresectable Hepatocellular Carcinoma. An International Multicenter Phase I Trial, SAKK 77/07.

2015 San Antonio Breast Cancer Symposium

Poster discussionBorgquist S. et al. Cholesterol, cholesterol lowering medication use, and breast cancer outcomes in the BIG 1-98 study

PostersZweifel M. et al. Phase 1 evaluation of the androgen receptor modulator CR1447 in patients with advancedbreast cancer (SAKK 21/12).

Pruneri G. et al. Tumor-infiltrating lymphocytes (TILs) are a powerful prognostic marker in patients with triple negative breast cancer treated by induction chemotherapy with or without oral low dose cyclophosphamide-methotrexate mainte-nance chemotherapy (CMM) (IBCSG 22-00)

Pagani O. et al. POSITIVE: A study evaluating pregnancy and disease outcome and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer who desire pregnancy (IBCSG 48-14/BIG 8-13)

Denkert C. et al. Systematic analysis and modulation of Ki67 interobserver variance in 9069 patients from three clinical trials – How much pathologist concordance is needed for meaningful biomarker results?

Willis S. et al. Immune related gene expression signatures predict benefit of letrozole over tamoxifen in BIG 1-98

PUBLICATIONS & PRESENTATIONS Q4 2015



IBCSG

Clinical trials

IBCSG 42-12 SNAPThe trial evaluates in a randomized phase II fashion three different schedules of nab-Paclitaxel in patients with his-tologically or cytologically confirmed HER2-negative met-astatic (stage IV) breast cancer who have not received any prior chemotherapy. Based on a recommendation from the DSMC, IBCSG decided to increase the total sample size from 240 to 258. The corresponding protocol amend-ment in early 2015. On August 7, 2015, the recruitment was stopped after having successfully reached the revised recruitment goal. The recruitment rate was higher than originally anticipated and reached about 15 per month in 2014. Amendment 2 was not activated by all sites, and the accrual rates dropped quite a bit in 2015. Swiss sites have contributed 75 patients, ICORG 61, SOLTI 42, Italy 40, Belgium 33 and Slovenia 7. Kantonsspital St.Gallen was the highest recruiter with a total of 27 patients. We would like to thank all Swiss investigators for their great effort and commitment to this trial. The treatment of pa-tients and the follow-up is continuing as planned. The fi-nal evaluation of the trial is planned for early 2017.

IBCSG’s Program for Young Patients:IBCSG 43-09 HOHO IBCSG 43-09 is the Young Women’s Breast Cancer Study, and HOHO stands for «Helping Ourselves Helping Oth-

ers». It is a longitudinal cohort study of 300 young women with breast cancer (early or advanced) in selected institu-tions in Europe. All eligible patients treated at each center are invited to join the cohort. Patient surveys and medical record review are utilized. Women are surveyed every 6 months for the first 3 years after diagnosis, then yearly thereafter for an additional 7 years (for a total follow-up of 10 years following diagnosis).

The study has two main objectives:1. To identify in selected institutions in Europe a cohort

of young women (age 18-40) newly diagnosed with breast cancer (early or advanced) to assess a broad range of variables at baseline and over the course of the ensuing 10 years.

2. To characterize this population at diagnosis and in follow-up regarding disease and psychosocial out-comes (e.g., presentation and disease characteristics, fertility and menopausal issues, and long term out-come).

At present 12 centers in Italy and 6 centers in Switzerland are participating in the trial and have accrued 295 pa-tients up to end of November 2015, 84 of them by Swiss sites.

IBCSG 48-14/BIG 8-13 POSITIVE The best available evidence suggests that pregnancy after breast cancer does not negatively impact disease

Accrual of open clinical trials

(As of November 30, 2015)

Trials Current accrual Current accrual SAKK Total target accrual

42-12 SNAP 258 75 258; closed for accrual

43-09 HOHO 295 84 300

48-14 POSITIVE 26 3 500

2015 ASH Annual Meeting

Oral presentationDavies A. et al. A prospective randomised trial of targeted therapy for diffuse large B-cell lymphoma (DLBCL) based upon real-time gene expression profiling: The REMoDL-B study of the UK NCRI and SAKK lymphoma groups, ISRCTN51837425

PRESENTATIONS Q4 2015



IBCSGoutcome and is safe for the offspring but no definitive information is available to recommend a safe interval from BC diagnosis to pregnancy. The POSITIVE trial will investigate endocrine therapy (ET) interruption to enable conception for young women between 18 and 42 years of age with endocrine responsive early breast cancer who received adjuvant ET for 18 to 30 months and wish to at-tempt pregnancy. The main objectives are:

1. To assess the risk of breast cancer relapse associated with temporary interruption of endocrine therapy to permit pregnancy

2. To evaluate factors associated with pregnancy suc-cess after interruption of endocrine therapy.

The trial will also allow for the testing of biologic corre-lates of pregnancy and disease outcome.

A psycho-oncological companion study evaluating psy-chological distress, fertility concerns and decisional con-flict in young women who participate in POSITIVE has been developed and will be activated in sites interested and capable to conduct it.. As of now, the trial has been activated in 27 sites from 8 countries (Switzerland-SAKK, Australia, Italy, Belgium, Spain-SOLTI, Greece-HORG, Slovenia and USA) In these countries, several sites are going to be activated or are in the IRB process. Other 9 participating countries are anticipated in the near future (Canada-CTG, Portugal, Japan-JBCRG, Hungary, Israel, Netherlands-BOOG, Sweden-SABO and UK-ICR). Groups/sites from some other countries have shown great interest in the trial.

A total of 500 patients are planned to be recruited into the trial from centers worldwide in approximately 4 years. The trial is currently being activated in Switzerland, 12 out of 13 planned sites are open. The Institute of Oncology of Southern Switzerland is the first site which has opened the trial worldwide, and has accrued the first patient in December 2014; Brustkrebszentrum Zürich and Kantons-spital Baden have accrued the 2nd and the 3rd patient respectively.

Latest IBCSG publicationsEarly Breast Cancer Trialists’ Collaborative Group (EBCTCG). Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the ran-domised trials. Lancet 2015 Jul 23.

Regan MM. Predicting benefit of endocrine therapy for early breast cancer. The Breast 2015, Aug 5.

Metzger Filho O, Giobbie-Hurder A, Mallon EA, Gusterson B, Viale G, Winer EP, Thurlimann B, Gelber RD, Colleoni M, Ejlertsen B, Debled M, Price KN, Regan MM, Coates AS, Goldhirsch A. Relative effectiveness of letrozole com-pared with tamoxifen for patients with lobular carcinoma in the BIG 1-98 trial. J Clin Oncol 33:2772-2779, 2015. (BIG 1-98).

Coates AS, Winer EP, Goldhirsch A, Gelber RD, Gnant M, Piccart-Gebhart M, Thürlimann B, Senn HJ; Panel mem-bers. Tailoring therapies - improving the management of early breast cancer: St Gallen International Expert Con-sensus on the Primary Therapy of Early Breast Cancer 2015. Ann Oncol. 26: 1533-1546, 2015. (Commentary).

Sonnenblick A, Francis PA, Azim HA Jr, de Azambuja E, Nordenskjöld B, Gutiérez J, Quinaux E, Mastropasqua MG, Ameye L, Anderson M, Lluch A, Gnant M, Goldhirsch A, Di Leo A, Barnadas A, Cortes-Funes H, Piccart M, Crown J. Fi-nal 10-year results of the Breast International Group 2–98 phase III trial and the role of Ki67 in predicting benefit of adjuvant docetaxel in patients with oestrogen receptor positive breast cancer. Eur J Cancer. 51:1481-1489, 2015 (IBCSG 20-98).

Bernhard, J, Luo W, Ribi K, Colleoni M, Burstein HJ, Tondini C, Pinotti G, Spazzapan S, Ruhstaller T, Puglisi F, Pavesi L, Parmar V, Regan MM, Pagani O, Fleming GF, Francis PA, Price KN, Coates AS, Gelber RD, Goldhirsch A, Walley BA. Patient-reported outcomes with adjuvant exemestane versus tamoxifen in premenopausal women with early breast cancer undergoing ovarian suppression (TEXT and SOFT): a combined analysis of two phase 3 randomised trials. Lancet Oncol 16:848-858, 2015. (IBCSG 24-02 and 25-02).

Goldhirsch A, Colleoni M, Regan M. Improved adjuvant endocrine therapy for premenopausal women with en-docrine responsive disease. Ecancermedicalscience. 2015 Jun 9;9:544. eCollection 2015 (Review).

The complete IBCSG publication list can be downloaded from http://www.ibcsg.org/Member/Publi/IBCSG_Publi/Pages/default.aspx

Dr. Rudolf MaibachIBCSG Coordinating Center (www.ibcsg.org)



ETOPClinical trials

ETOP 2-11 BELIEF: selected as «Best Abstract Presentation» at the ECC2015 in Vienna

BELIEF is an open-label, single-arm, phase II multicenter trial exploring whether first line erlotinib plus bevacizum-ab improves PFS in NSCLC patients with activating EGFR mutations (del19 or L858R). The outcomes are tested overall and separately in patients with (sub-study 1) and without (sub-study 2) a pre-treatment T790M EGFR gate-keeper mutation.

The accrual goal of 102 patients was reached in October 2014. An abstract with the results for the T790M cohort (sub-study 1) has been submitted to the 18th ECCO – 40th ESMO European Cancer Congress (ECC2015) in Vienna and was selected as best abstract for oral presentation in one of the presidential sessions. Rolf A. Stahel, ETOP president and trial co-chair presented the work on behalf of the trial team.

Pre-treatment T790M mutations were centrally identified based on laser micro-dissection and TaqMan assays in the presence of a specific peptide–nucleic acid to inhibit the amplification of the wild-type allele. DNA from PC9 cells containing an ultra-low allele frequency (0.004%) of T790M mutation were used as negative and NCI-H1975 (T790M+) cells as positive controls. With this sensitive PC9 cutoff method, the presence of T790M at diagnosis was documented in 37 (34%) of the 109 recruited pa-tients with classical activating EGFR mutations.

The combination of erlotinib and bevacizumab resulted in an overall 1-year PFS of 56.7% and a median PFS of 13.8 months (95% CI: 10.3 - 21.3). In patients with docu-mented T790M mutation at diagnosis, the 1-year PFS was 72.4% and the median PFS 16.0 months (95% CI:13.1 - NE), which means that the predefined endpoint criterion for success was reached.

Further investigation using multiple orthogonal methods including digital PCR and multiplex next generation se-quencing is ongoing and the final analysis with updated efficacy results overall and by sub-study will be performed as soon as all patients have reached one year of follow-up.

ETOP 4-12 STIMULI

ETOP / IFCT 4-12 STIMULI – A randomised open-label phase II trial of consolidation ipilimumab in limited-stage SCLC after chemo-radiotherapy

The ETOP / IFCT 4-12 STIMULI trial has been activated in France, Switzerland, Spain and the Netherlands. As of 27 November 2015, 33 patients have been enrolled and 16 randomized so far. The recruitment is clearly behind schedule and the trial committee has decided to take ac-tion. Several changes will be introduced to the protocol, in particular to relax the inclusion criteria in order to en-hance recruitment of patients into the STIMULI trial. At the same time, recently published results suggest that the combination of ipilimumab with nivolumab may yield substantially higher efficacy.

In accordance with BMS, the manufacturer of both drugs, the STIMULI trial protocol will be amended to revise the induction phase of the immunotherapy by adding nivolumab to ipilimumab, and to continue in the main-tenance phase with a flat dose of nivolumab alone. The introduced changes present a chance to make the trial substantially more attractive. The amended protocol was released on 21 September 2015 and site activation is on-going

ETOP 5-12 SPLENDOUR

SPLENDOUR is a randomised, open-label phase III tri-al evaluating the ad¬dition of denosumab to standard first-line anticancer treatment in advanced NSCLC

Denosumab is a monoclonal antibody targeting and in-hibiting RANKL, a protein that acts as the primary sig-nal for bone resorption. The purpose of this study is to investigate the potential of the combination of standard treatment (chemotherapy) with denosumab as compared to the standard treatment alone to increase survival of patients with advanced NSCLC with or without bone me-tastasis in advanced unselected treatment-naïve patients.

ETOP is the sponsor of this trial, which is conducted in collaboration with EORTC as coordinating group. 1000 patients will be enrolled within approximately 3 years. Meanwhile, all 8 participating SAKK sites have been acti-vated and the current overall accrual as of 27 November 2015 is 261 patients, with 53 being contributed by SAKK sites.



ETOPETOP 7-14 NICHE

The primary objective of this trial is to evaluate the ability of afatinib, a selective irreversible small molecule inhibitor of the erbB family of proteins, to control disease in pretreated patients with advanced NSCLC harbouring HER2 exon 20 mutations. The trial will be conducted at six sites from five different countries, with Spain and Switzerland being already activated. In Switzerland, the University Hospital Zürich and the CHUV Lausanne will participate in the NICHE trial. The first patient was enroled in September 2015 in Spain.

Prof. Dr. Solange PetersScientific Coordinator

Heidi RoschitzkiETOP Coordinating Officewww.etop-eu.org

Report «Cancer Research in Switzerland», Edition 2015

Despite the numerous advances that medicine has made in the fight against tumours, these dis-eases cause more than 16 000 deaths in Switzerland each year, making cancer the second most common cause of death. This is why research is as important as ever: It is the basis of the hope that survival rates and the quality of life of persons with cancer will continue to improve.

The new edition of the report «Cancer Research in Switzerland» has appeared. The report docu-ments the concerted commitment of the Swiss Cancer Research foundation (SCR), the Swiss Can-cer League (SCL), as well as the cantonal and regional cancer leagues in funding patient-centred cancer research projects. In 2014 the partner organizations provided a total of 22.9 million francs – a new record sum.

The new edition appears in a somewhat slimmer form than before. The report renounces for the first time to list the ab-stracts of all funded research work, but presents instead the results of some completed research projects. The abstracts of all funded research projects since 2005 can now be found online in a public research project database at www.swisscancer.ch/researchprojects.

To download the report go to:http://www.krebsliga.ch/de/fachpersonen/literatur/krebsforschung_in_der_schweiz/

ContactDr. Ori SchipperCommunications [email protected]

SWISS CANCER LEAGUE



FUND & TRAINING

SAKK fund for academic clinical cancer research

The SAKK fund for academic clinical cancer research is aimed at funding scientific research projects that are insufficiently supported by pharmaceutical companies, foundations or other donators. By this fund, SAKK finances particu-larly academic clinical trials independet from the pharmaceutical industry, translational research as well as education of researchers. Funds are only provided, if there exists a connection with an SAKK project.

SAKK thanks its main donator of the fund in 2015:

Roche Pharma (Schweiz) AG

Applicants for the SAKK fund for academic clinical cancer research are researchers from the SAKK network or other persons involved in SAKK activities.

SAVE-THE-DATESAKK Investigators'education

March 10 & 17, 2016

October 27 & November 3, 2016

For members of the SAKK network and SPOG the course is free of charge. More information: http://sakk.ch/en/calendar/education/

Supported by



TRAINING & GRANTS

SAKK Training course for CRCs & CTNs

January 28, 2016

&

August 25, 2016

For members of the SAKK network and SPOG the course is free of charge. More information: http://sakk.ch/en/calendar/education/

Supported by

SAKK/Celgene GrantKey information about the grant:

• Grant is endowed with CHF 20'000• Application deadline is April 30, 2016• Read more on the application form, rules and regulations here: http://sakk.ch/en/sakk-provides/for-research/research-grants/

You

• are a practising physician, clinical researcher or professional in a patient care institution or patient society• have your primary place of research in Switzerland

For more information please contact: Dennis Ammann, SAKK Coordinating Center, «Life Grant»Effingerstrasse 40, 3008 Bern, Tel +41 31 389 94 72E-Mail: [email protected]



GRANTS & EVENTS

SAKK/Dr. Paul Janssen Fellowship

SAKK and Janssen-Cilag AG have decided to jointly award a fellowship endowed with CHF 30'000. The edu-cational grant is aimed at offering young doctors the opportunity to spend three to four months at a renowned research center abroad to gain experience and acquire the necessary know-how and tools to develop and conduct top-quality clinical trials in oncology / hematology .

Doctors who train as oncologists / hematologists at Swiss hospitals and are associated with SAKK are herewith invited to apply for the educational grant. The research grant will be awarded at the SAKK semi-annual meeting on June 30, 2016.

Submission deadline: April 30, 2016 submission to [email protected]

The SAKK / Dr. Paul Janssen Fellowship regulations can be obtained at http://sakk.ch/en/sakk-provides/for-research/research-grants/. Contact: Dennis Ammann, Marketing Manager, [email protected]

10th Swiss PostASCOJune 16, 2016

Event & Kongresszentrum, Stade de SuisseChampions Lounge, Bern

Information and registration: www.swisspostasco.ch

SAVE-THE-DATE

Orphan Malignancies SeminarAugust 26, 2016, Zurich

Information and registration: http://sakk.ch/en/calendar/



EVENTS

• January 26, Board Meeting• January 28, Training course for CRCs and CTNs• March 10 & 17, Investigators'Education• March 17, 2nd SLC Symposium Bern• May 12 & 13, Board Meeting and Retreat• June 16, 10th Swiss PostASCO Bern• June 29, General Assembly• June 30 & July 1, Semi-Annual Meeting Zurich• August 25, Training course for CRCs and CTNs• August 26, Orphan Malignancies Seminar Zurich• August 30, Board Meeting• October 27 & November 3, Investigators'Education• November 8, Board Meeting• November 23, General Assembly• November 24 & 25, Semi-Annual Meeting Zurich

SAKK DATES 2016


FlagSwiss Group for Clinical Cancer ResearchCoordinating Center Effingerstrasse 403008 BernTel. +41 31 389 91 91Fax +41 31 389 92 00E-mail: [email protected]

Claudia [email protected] Brauchli

Documents

Newsletter - SAKKsakk.ch/.../Publications/Newsletter/SAKK_newsletter_issue4-15.pdf · ETOP 25-26 Swiss Cancer League 26 ... tigate if the used more modern RT technique will increase