Oral Chemotherapy for Colorectal Cancer

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Speakers:Dr. Anna Varghese is an assistant attending in the Gastrointestinal Oncology Service at Memorial Sloan-Kettering Cancer Center. She completed medical school at Case Western Reserve University in Cleveland, Ohio, her internal medicine residency at Beth Israel Deaconess Medical Center in Boston, Massachusetts, and her medical oncology fellowship training at MSKCC in New York City. At MSKCC, her clinical and research interests center on developing new treatments for patients with colorectal cancers and cancers of unknown primary.

Oral Chemotherapy for Colorectal Cancer

Anna Varghese MDMemorial Sloan Kettering Cancer Center

3/11/15

Outline

• Commonly used medications for colorectal cancer

• Standard oral chemotherapy for colorectal cancer– Capecitabine– Regorafenib

• Experimental oral chemotherapy– TAS-102

Commonly used medications for colorectal cancer

Chemotherapy Brand Name Other Names Intravenous (IV) or oral

5-Fluorouracil Adrucil ™ 5-FU Intravenous

Oxaliplatin Eloxatin™ Oxali Intravenous

Irinotecan Camptosar™ CPT-11, Irino Intravenous

Cetuximab Erbitux™ Cetux Intravenous

Bevacizumab Avastin™ Bev Intravenous

Panitumumab Vectibix™ P-mab Intravenous

Capecitabine Xeloda™ Cape Oral

Regorafenib Stivarga™ Oral

Commonly used medications for colorectal cancer

Commonly given combinations:

FOLFOX : 5-Fluorouracil + Leucovorin + OxaliplatinFOLFIRI: 5-Fluororuacil + Leucovorin + IrinotecanCapeox = XELOX = Capecitabine and OxaliplatinCapeiri : Capecitabine and Irinotecan

Chemotherapy

5-Fluorouracil

Oxaliplatin

Irinotecan

Cetuximab

Bevacizumab

Panitumumab

Capecitabine

Regorafenib

Commonly used medications for colorectal cancer

Commonly given combinations: FOLFOX: 5-Fluorouracil + Leucovorin + OxaliplatinFOLFIRI: 5-Fluororuacil + Leucovorin + IrinotecanCapeox (XELOX): Capecitabine and OxaliplatinCapeiri: Capecitabine and Irinotecan

Chemotherapy Brand Name Other Names Intravenous (IV) or oral

5-Fluorouracil Adrucil ™ 5-FU Intravenous

Oxaliplatin Eloxatin™ Oxali Intravenous

Irinotecan Camptosar™ CPT-11, Irino Intravenous

Cetuximab Erbitux™ Cetux Intravenous

Bevacizumab Avastin™ Bev Intravenous

Panitumumab Vectibix™ P-mab Intravenous

Capecitabine Xeloda™ Cape Oral

Regorafenib Stivarga™ Oral

CAPECITABINE

Capecitabine: The Basics

• What is it? – Oral form of 5-FU

• How is it given? – Oral – Tablets

• 150mg or 500mg tablets

• How often do you have to take it? – Twice a day– Multiple possible schedules

• 3 week schedule: 2 weeks on / 1 week off• 2 week schedule: 1 week on / 1 week off

Genentech.com

Capecitabine: When can you use it?

• Stage II or Stage III colon cancer– 6 months of adjuvant chemotherapy

• Oral / IV option: Capeox • All IV option: FOLFOX

• Stage II or III rectal cancer– Chemotherapy with FOLFOX or Capeox– Concurrent radiation therapy and chemotherapy

• Stage IV colorectal cancer

Capecitabine: Is the pill as good as the intravenous form of 5-FU?

• Yes!• We use these interchangeably.• Capecitabine is as effective as 5-FU.

– Studies comparing capeox and FOLFOX demonstrated that capeox is no worse than FOLFOX in first-line treatment.

Capecitabine: What are the common side effects?

• Lowering of the neutrophil count (neutropenia)• Lowering of the platelet count (thrombocytopenia)• Rash on the hands and feet (hand-foot syndrome)• Nausea and vomiting• Diarrhea or constipation• Poor appetite• Cardiac complications

Ascopost.com

Capecitabine: Who should not take it?

• People with poor kidney function. • People who cannot metabolize the drug.

Capecitabine: How do you know if it’s right for you?

• Your doctor can help you decide, but only you can know this.

• How do you feel about a mediport? • How important is it to limit visits to the clinic? • Are you the kind of person who can take pills

reliably?• Will the burden of twice daily medications

become overwhelming?

Example

• You have just undergone surgery for your colon cancer and were found to have stage III colon cancer in which 2 lymph nodes had evidence of cancer.

• Your doctor has recommended 6 months of “adjuvant” chemotherapy with either FOLFOX or Capeox.

• How do you decide which one?

Adjuvant Capeox vs. Adjuvant FOLFOXFOLFOX Capeox

Medications 5-Fluorouracil, leucovorin, and oxaliplatin

Capecitabine and oxaliplatin

Method of administration IVRequires mediport

Oral and IV

Visits Every 2 weeks Every 3 weeks

Number of treatments / clinic visits

12 8

PROS •Requires a mediport •Does not require a mediport or 48 hour infusion•Fewer visits

CONS •Requires a mediport•More visits

•Fewer doses of oxaliplatin higher dose of oxaliplatin increased side effects•Increased pressure on patient•Adherence

Capecitabine: How do you think you get it?

Doctor writes a prescription.

Pharmacy mails drug to your home.

Capecitabine: How should you get it?

Doctor writes a prescription.

Doctor’s office calls your insurance company to find out what specialty pharmacy to use.

Doctor’s office sends prescription to specialty pharmacy.

Doctor’s office may need to complete a prior authorization form.

Pharmacy then coordinates mailing the drug to your home.

Capecitabine: How do you actually get it?

Doctor writes a prescription.

Doctor’s office calls your insurance company to find out what specialty pharmacy to use.

Doctor’s office sends prescription to specialty pharmacy.

Doctor’s office may need to complete a prior authorization form.

Pharmacy then coordinates mailing the drug to your home.

Patient calls doctor’s office.Patient calls insurance.Patient calls pharmacy.

Patient calls doctor’s office.Patient calls insurance.Patient calls pharmacy.

Patient calls doctor’s office.Patient calls insurance.Patient calls pharmacy.

Capecitabine: How do you take it?

• Twice a day• Within 30 minutes of eating a meal• Swallow whole

REGORAFENIB

Regorafenib: The Basics

• What is it? – Blocks several different proteins thought to be

important in cancer growth• How is it given?

– Oral – 40mg Tablets

• How often do you have to take it? – Once a day– 4 tablets– 4 week schedule: 3 weeks on / 1 week off

Regorafenib: When can you use it?

• Metastatic colorectal cancer that has progressed or grown despite 5-FU, capecitabine, oxaliplatin, irinotecan, cetuximab, and panitumumab

Regorafenib: What are the side effects?

• Fatigue and weakness• Rash on the hands and feet (hand-foot syndrome)• Bleeding• High blood pressure (hypertension)• Neurologic abnormalities• Bowel perforation• Impaired wound healing• Liver damage

Regorafenib: How do you know if it’s right for you?

• Your doctor can help you decide, but only you can know this.

• Are you the kind of person who can take pills reliably?

• Will the burden of taking daily medications become overwhelming?

Regorafenib: How do you get it?

Doctor writes a prescription.

Doctor’s office calls your insurance company to find out what specialty pharmacy to use.

Doctor’s office sends prescription to specialty pharmacy.

Doctor’s office may need to complete a prior authorization form.

Pharmacy then coordinates mailing the drug to your home.

Regorafenib: How do you take it?

• Once a day at the same time each day• Swallow whole• Take with a meal

Oral chemo: How do you remember to take it?

• Alarms• Pill box – separate from your other

medications

When should you call your doctor or go to a local Emergency Room?

Question ER or 911 Call your doctor

If you develop chest pain, chest pressure, or unexplained shortness of breath?

X

If you develop new neurologic changes? X

If you develop a rash on your hands and feet?

X

If you develop unexplained fatigue, but you can still get out of bed and take care of your personal care?

X

If you develop darkening of your skin, eyes, or urine, but you still otherwise feel OK?

X

If you are worried about a symptom? XXXXXXX

Question Do Don’t

What if I miss my dose? Do skip the dose. Do not take extra or double the dose.

What if I can’t swallow the pills?

Do talk to your doctor. Do take the pills whole.

Do not crush the pills unless you talk with your doctor or pharmacist.

What if I’m having side effects?

Do talk to your doctor. Do not ignore your symptoms! Trust your instincts.

Dos and Don’ts of Oral Chemotherapy

NEW DRUGS: TAS-102

TAS-102: The Basics

• What is it? – Inhibits DNA synthesis directly– Inhibits an enzyme important for DNA replication

• How is it given? – Oral – Tablets

TAS-102: Promising studies

Lancet Oncology 2012Ascopost.com

TAS-102: What side effects have been seen?

• Fatigue• Diarrhea• Nausea and Vomiting• Poor appetite• Lowering of the blood counts – neutrophils,

platelets, and hemoglobin

Summary

• Oral chemotherapy is an option for patients with stages II, III, and IV colorectal cancer.

• The two FDA approved oral agents for colorectal cancer are capecitabine and regorafenib.

• Oral chemotherapy is not right for everyone, but it can be a good option for the right patient.

• Oral chemotherapy is still chemotherapy and comes with risks.

Question & Answer:

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