There is no benefit from the addition of bevacizumab to capecitabine in the adjuvant setting for colorectal cancer, according to results from a clinical trial.
Bevacizumab, along with other angiogenesis inhibitors, have demonstrated efficacy in the treatment of metastatic colorectal cancer, but their success in the adjuvant setting has not been clearly established. In a clinical trial led by Rachel S Kerr, FRCP, University of Oxford, United Kingdom, investigators examined whether bevacizumab could improve disease-free survival in patients with colorectal cancer after the resection of the primary tumor.
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At total of 1952 patients were enrolled in the trial, of whom 1941 had assessable data. Patients were randomly assigned to receive an eight-week cycle of capecitabine alone or that same regimen of capecitabine plus 16 cycles of bevacizumab. Aside from disease-free survival, instigators also examined the toxic effects of each regimen.
Overall, investigators found that the addition of bevacizumab not only failed to improve disease-free survival, but that it was also significantly more toxic. At three years, disease free survival was 75.4% in the capecitabine plus bevacizumab group and 78.4% in the group that only received capecitabine.
Additionally, more patients receiving the combination regimen experienced all-grade hypertension (320 [33%] vs 75 [8%]), proteinuria (197 [21%] vs 49 [5%]), and wound healing problems (30 [3%] vs 17 [2%]). Patients in the cap plus bevacizumab group also experienced a slightly higher number of grade 3-4 adverse events, the most common being hand–foot syndrome (201 [21%] of 963 in the capecitabine alone group vs 257 [27%] of 959 in the capecitabine and bevacizumab group) and diarrhea (102 [11%] vs 104 [11%]). Further, 15 patients in the capecitabine and bevacizumab group died within 6 months of randomization while only 6 died in the group treated only with cap.
Thus, investigators concluded that the addition of bevacizumab to capecitabine in the adjuvant setting for colorectal cancer has little clinical benefit and should therefore not be used in this patient population.
