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Adjuvant bevacizumab may not be effective for colon cancer

Allegra CJ. J Clin Oncol. 2010; 29:11-16.

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Addition of bevacizumab to a modified FOLFOX6 regimen failed to increase DFS in patients with early-stage colon cancer, according to study results.

Researchers from several sites in the US aimed to investigate the safety and efficacy of adding bevacizumab to a modified FOLFOX6 regimen for adjuvant treatment of stages 2 to 3 colon cancer.

The trial involved 2,672 patients with well-balanced baseline demographics. There were 1,354 patients in the experimental arm and 1,356 patients in the control arm. The primary outcome measure was DFS.

The addition of bevacizumab to the modified FOLFOX6 regimen did not result in an overall significant increase in DFS (HR=0.89; 95% CI, 0.76-1.04; P=.15), according to the results.

The point estimate for 3-year DFS for the overall study population was 77.4% in the experimental group, compared with 75.5% in the control group.

When broken down by stages, the point estimates for 3-year DFS were as follows:

• 87.4% for patients with stage 2 disease in the experimental arm
• 84.7% for patients with stage 2 disease in the control arm
• 74.2% for patients with stage 3 disease in the experimental arm
• 72.4% for patients with stage 3 disease in the control arm.

The effect of bevacizumab on DFS was different before and after a 15-month time point, according to results of an exploratory analysis (time-by-treatment interaction, P<.0001). The effect of bevacizumab was strong before the 15-month mark (HR=0.61; 95% CI, 0.48-0.78), but no significant effect of the drug was observed after this point (HR=1.22; 95% CI, 0.98-1.52).

There were 603 DFS events overall. The median follow-up duration was 35.6 months.

The modified FOLFOX6 regimen included IV leucovorin 400 mg/m² on day 1, IV bolus FU 400 mg/m² on day 1 followed by 2,400 mg/m² IV over 46 hours and IV oxaliplatin 85 mg/m² on day 1. Patients in the experimental bevacizumab arm received 5 mg/kg IV on day 1. All therapy was given every 2 weeks for 12 doses, for a duration of 6 months. Bevacizumab was given every 2 weeks for 26 doses in 1 year.

The National Surgical Adjuvant Breast and Bowel Project C-08 trial ran from September 2004 to October 2006, and the analysis included data collected by March 31, 2009.

“Given the lack of improvement in DFS, the use of bevacizumab cannot be recommended for use in the adjuvant treatment of patients with colon cancer,” the researchers wrote.

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