For patients with metastatic colorectal cancer, the Food and Drug Administration (FDA) has approved a new use of Avastin® (bevacizumab): It can be continued as part of ‘second-line’ combination therapy, even if it was used in first-line therapy.

When stage IV cancer progresses despite use of Avastin plus either FOLFOX (5FU plus Eloxatin® or oxalyplatin) or FOLFIRI (5FU plus Camptosar® or irinotecan)-based chemotherapy, the FDA has now approved continued use of Avastin when second-line treatment switches to the other chemotherapy.

Avastin is a monoclonal antibody (a “targeted drug”) that helps prevent a cancer from stimulating growth of new blood-vessels that then help the tumor get bigger.

The FDA’s approval is based on a large, randomized Phase III trial which showed that median overall survival was 11.2 months when patients continued Avastin along with the second-line chemotherapy, compared to a 9.8-month median survival with just the second-line chemotherapy without Avastin. Participants in the trial averaged about 63 years old, and were able to carry out normal activities or at least housework or office work (i.e., ECOG performance status of 0-1).

There was no significant increase in adverse events (such as worse side effects) in those continuing Avastin, versus those who stopped the drug for second-line treatment.

FDA approval for the new use clears the way for insurers to cover the drug’s use, which averages roughly $5,100 a month.

Sources: Jan. 25, 2013 FDA press release; “Avastin Wins New Colorectal Cancer Indication,” Jan. 24 2013 MedPage Today ; “Genentech’s Avastin approved for wider use in colorectal cancer,” Jan. 24 San Francisco Business Times.

Disclosure: Fight Colorectal Cancer accepts  unrestricted educational grants and charitable donations from Genentech, the manufacturers of Avastin. Fight Colorectal Cancer has ultimate control over website content.

Memorial Sloan-Kettering Cancer Center made a very public announcement—and explanation—today in a New York Times op-ed about why they will not offer the new drug Zaltrap® (ziv-aflibercept) to its metastatic colorectal cancer patients.

The authors, all world-renowned cancer specialists at the world’s oldest cancer center, in an op-ed headlined “In Cancer Care, Cost Matters,” essentially challenged other cancer centers to take action where politicians fear to tread.

“We recently made a decision that should have been a no-brainer,” wrote Drs. Peter B. Bach, Leonard B. Saltz and Robert E. Wittes. “The drug, Zaltrap, has proved to be no better than a similar medicine we already have for advanced colorectal cancer, while its price—at $11,063 on average for a month of treatment—is more than twice as high.” Read the rest of this entry »

Although FDA Commissioner Margaret Hamburg announced a final decision on November 18 to drop breast cancer from the Avastin label, metastatic colorectal cancer continues to be an approved use.

The Avastin® (bevacizumab) label includes the following approved indication:

Metastatic colorectal cancer, with intravenous 5-fluorouracil–based chemotherapy for first- or second-line treatment.

It is important to know that there is currently no approval or evidence for using Avastin alone or in early stage colon or rectal cancer.

The FDA has changed the package insert for Avastin® (bevacizumab) to include information about newly identified risks for the drug including

• Loss of ovarian function (ovarian failure).
• Bone death in the jaw (osteonecrosis).
• Bleeding and additional blood clots in patients who have already had a clot in their veins while on Avastin.

Changes to the Avastin label were announced on September 30, 2011. Read the rest of this entry »

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.

Read the rest of this entry »