The FDA has approved Erbitux™ (cetuximab) in combination with FOLFIRI for first-line treatment of patients with metastatic colorectal cancer whose tumors have a wild-type (WT) KRAS gene.  Erbitux was first approved in 2004 for patients whose cancer was not responding to available treatments.

FDA’s action was prompted by results from a look back at patient outcomes and KRAS status from three trials:

• CRYSTAL:  phase 3, 1217 patients newly diagnosed with metastatic CRC, comparing FOLFIRI vs FOLFIRI + Erbitux
• OPUS: phase 2, 337 patients newly diagnosed with metastatic CRC, comparing FOLFOX vs FOLFOX + Erbitux
• CA225025: phase 3, 572 patients with metastatic CRC that stopped responding to available treatments, comparing Best Supportive Care (BSC) to BSC + Erbitux

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While there weren’t new blockbuster announcements for colorectal cancer this year at the American Society for Clinical Oncology’s (ASCO) Annual Meeting, there was plenty of focus on making what we already have work better and on choosing the patients who will benefit the most from treatments, as well as those who might not be helped at all. (Note, many of these issues will be discussed in detail on our upcoming patient webinar.)

Highlights:

• While adding oxaliplatin to 5-FU improves five year survival slightly for stage II colon cancer, it increases side effects, particularly tingling and numbness in the feet.  An analysis of several NSABP trials found that two or three more stage II patients out of every 100 would be alive five years later if they were given oxaliplatin in addition to 5-FU than if they only got 5-FU.  Risk of cancer returning was similar with an absolute improvement of 3 to 5 percent, depending on risk factors.  Doctors and patients need to think about whether the small benefit is worth the risk of neuropathy that may become permanent.
• Two speakers at the Saturday colorectal cancer oral abstract session addressed adding oxaliplatin to 5-FU as part of pre-surgical chemoradiation treatment for rectal cancer.  NSABP R-04 found that oxaliplatin did not help increase complete response rates, avoid colostomies, or downstage cancers. It did increase diarrhea significantly. On the other hand, early results from a German trial did find an increase in complete responses with oxaliplatin, and they didn’t see worse side effects.
• In the PRIME phase III clinical trial, patients receiving their first treatment for advanced colorectal cancer who had normal or wild-type KRAS genes in their tumor did better when Vectibix® (panitumumab) was added to FOLFOX chemotherapy.  But those patients whose tumor KRAS was mutated actually did worse than patients who only got chemotherapy.
• Side effects, while difficult for patients, may predict better outcomes from treatment.  Patients who got capecitabine as part of pre-surgical chemoradiation and developed hand-foot syndrome had fewer recurrences three years later and better survival at five years.  In another study of breast, lung, and colorectal cancer, patients who got high blood pressure while on Avastin® (bevacizumab) lived longer and it took longer before their cancer got worse.

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On Monday, April 25th, Fight Colorectal Cancer held a free patient webinar that tackled the somewhat complex but fascinating topic of personalized medicine.

Personalized medicine is what the cancer community calls treatments that are tailored to each patient’s genetic makeup. It is the future of cancer care and in some cases, it is already making a big difference in the ways patients are treated.

You can learn about these cutting edge treatments and about emerging findings in an archive of the webinar below.

Our thanks to Carolyn Grande, CRNP, AOCNP for leading the discussion. She a phenomenal educator on this topic and a member of our Medical Advisory Board. She graciously donated her time to bring this information to patients.

Medicine that is tailored to each patient’s genetic makeup is the future of cancer care. In some cases, it is already making a big difference in the ways patients are treated. Learn about these cutting edge treatments and about emerging findings that will be important for future diagnoses and treatments of colorectal cancer. Discussion led by Carolyn Grande, CRNP, AOCNP.

Dr. Lenz

We are making significant progress in understanding what genetic alterations in tumors really mean.

Over the last two years, we have learned or the first time that there is an alteration in a gene called KRAS in colon cancer, and tumors which have this mutation do not respond to treatment with Erbitux® (cetuximab) or Vectibix® (panitumumab).

This is the first time we have a marker to test for sensitivity of an antibody we have to treat colon cancer.

It is very important to know that patients with tumors who carry a KRAS mutation (alteration) are not doing worse overall. They just don’t have any benefit from an antibody which targets the Epithelial Growth Factor Receptor (EGFR). Read the rest of this entry »