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Disclaimer:
The information and services provided by Fight Colorectal Cancer are for
general informational purposes only. The information and services are not
intended to be substitutes for professional medical advice, diagnoses or
treatment.
If you are ill, or suspect that you are ill, see a doctor immediately. In an
emergency, call 911 or go to the nearest emergency room.
Fight Colorectal Cancer never recommends or endorses any specific
physicians, products or treatments for any condition.
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 MD
Memorial 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 +
Oxaliplatin
FOLFIRI: 5-Fluororuacil + Leucovorin +
Irinotecan
Capeox = XELOX = Capecitabine and Oxaliplatin
Capeiri : 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 + Oxaliplatin
FOLFIRI: 5-Fluororuacil + Leucovorin + Irinotecan
Capeox (XELOX): Capecitabine and Oxaliplatin
Capeiri: 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 FOLFOX
FOLFOX Capeox
Medications 5-Fluorouracil,
leucovorin, and
oxaliplatin
Capecitabine and oxaliplatin
Method of administration IV
Requires 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 2012
Ascopost.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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Chemo In a Bottle: Oral Chemotherapy for Colorectal Cancer

  • 1. Our webinar will begin shortly. WELCOME!
  • 2. • Speaker(s): Dr. Anna Varghese • Archived Webinars: FightColorectalCancer.org/Webinars • AFTER THE WEBINAR: Expect an email with links to the material & a survey. If you fill it out, we’ll send you a Blue Star pin. • Ask a question in the panel on the RIGHT SIDE of your screen • Follow along via Twitter – use the hashtag #CRCWebinar Today’s Webinar:
  • 3. Established in 2006, our Lisa Fund has raised thousands of dollars and directly funded talented scientists focused on late-stage (stage III & IV) colorectal cancer research. 100% of the funds donated go directly to our research grant. Learn more or donate: FightColorectalCancer.org/LisaFund Funding Science:
  • 4. Get Involved! It’s easy to join the movement! POST! LIKE! COMMENT! SHARE!
  • 5. Disclaimer: The information and services provided by Fight Colorectal Cancer are for general informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnoses or treatment. If you are ill, or suspect that you are ill, see a doctor immediately. In an emergency, call 911 or go to the nearest emergency room. Fight Colorectal Cancer never recommends or endorses any specific physicians, products or treatments for any condition.
  • 6. 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.
  • 7. Oral Chemotherapy for Colorectal Cancer Anna Varghese MD Memorial Sloan Kettering Cancer Center 3/11/15
  • 8. Outline • Commonly used medications for colorectal cancer • Standard oral chemotherapy for colorectal cancer – Capecitabine – Regorafenib • Experimental oral chemotherapy – TAS-102
  • 9. 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
  • 10. Commonly used medications for colorectal cancer Commonly given combinations: FOLFOX : 5-Fluorouracil + Leucovorin + Oxaliplatin FOLFIRI: 5-Fluororuacil + Leucovorin + Irinotecan Capeox = XELOX = Capecitabine and Oxaliplatin Capeiri : Capecitabine and Irinotecan Chemotherapy 5-Fluorouracil Oxaliplatin Irinotecan Cetuximab Bevacizumab Panitumumab Capecitabine Regorafenib
  • 11. Commonly used medications for colorectal cancer Commonly given combinations: FOLFOX: 5-Fluorouracil + Leucovorin + Oxaliplatin FOLFIRI: 5-Fluororuacil + Leucovorin + Irinotecan Capeox (XELOX): Capecitabine and Oxaliplatin Capeiri: 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
  • 13. 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
  • 14. 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
  • 15. 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.
  • 16. 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
  • 17. Capecitabine: Who should not take it? • People with poor kidney function. • People who cannot metabolize the drug.
  • 18. 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?
  • 19. 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?
  • 20. Adjuvant Capeox vs. Adjuvant FOLFOX FOLFOX Capeox Medications 5-Fluorouracil, leucovorin, and oxaliplatin Capecitabine and oxaliplatin Method of administration IV Requires 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
  • 21. Capecitabine: How do you think you get it? Doctor writes a prescription. Pharmacy mails drug to your home.
  • 22. 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.
  • 23. 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.
  • 24. Capecitabine: How do you take it? • Twice a day • Within 30 minutes of eating a meal • Swallow whole
  • 26. 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
  • 27. Regorafenib: When can you use it? • Metastatic colorectal cancer that has progressed or grown despite 5-FU, capecitabine, oxaliplatin, irinotecan, cetuximab, and panitumumab
  • 28. 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
  • 29. 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?
  • 30. 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.
  • 31. Regorafenib: How do you take it? • Once a day at the same time each day • Swallow whole • Take with a meal
  • 32. Oral chemo: How do you remember to take it? • Alarms • Pill box – separate from your other medications
  • 33. 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
  • 34. 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
  • 36. TAS-102: The Basics • What is it? – Inhibits DNA synthesis directly – Inhibits an enzyme important for DNA replication • How is it given? – Oral – Tablets
  • 37. TAS-102: Promising studies Lancet Oncology 2012 Ascopost.com
  • 38. TAS-102: What side effects have been seen? • Fatigue • Diarrhea • Nausea and Vomiting • Poor appetite • Lowering of the blood counts – neutrophils, platelets, and hemoglobin
  • 39. 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.
  • 40. Question & Answer: SNAP A #STRONGARMSELFIE Bayer HealthCare will donate $1 for every photo posted (up to $25,000). Flex a “strong arm” & post it to Twitter or Instagram! (Use the hashtag!)