C-08 Avastin Trial Didn't Meet Primary Goal

When Avastin® (bevacizumab) was added to standard chemotherapy after surgery, it didn’t reduce the risk that early stage colon cancer would return, according to a press release this morning from Genentech.

NSABP C-08 randomly assigned patients with stage II or III colon cancer to FOLFOX chemotherapy with or without additional Avastin.  During the Phase III clinical trial, all patients received FOLFOX (oxaliplatin, leucovorin, and infused 5-FU) every two weeks for six months.  Half also got Avastin with each treatment plus an additional six months of Avastin only.

The study’s primary objective was disease-free survival, defined as lack of recurrence, another new cancer, or death for any reason.  According to Genentech, adding Avastin to chemotherapy didn’t do any better job of meeting this goal than chemotherapy alone.

Information from the trial will be presented at the American Society of Clinical Oncology (ASCO) annual meeting at the beginning of June.

Hal Barron, M.D., senior vice president and chief medical officer at Genentech said,

While we are disappointed the C-08 study did not meet its primary endpoint, our initial review of the data leads us to continue to believe Avastin may be active in patients with early-stage colon cancer and look forward to NSABP’s presentation at ASCO. We remain fully committed to the ongoing Avastin adjuvant programs in early-stage colon, breast and lung cancers.

Side effects and safety information were consistent with the initial report presented last year at ASCO.

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  1. Kathleen says

    Hi Dr. Lenz –

    After surgery and 12 rounds of Folfox 6 in a Stage 111c cancer patient cancer has returned in a lymph node. Avastin plus Folfiri is being recommended. Is there a reason that Avastin is tried first before Erbitux? Which drug gives better results?

    Thank you.

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