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Title: Anti-Angiogenesis Agent Bevacizumab Extends Survival in Metastatic Colorectal Cancer Patients: Presented at ASCO

"Anti-Angiogenesis Agent Bevacizumab Extends Survival in Metastatic Colorectal Cancer Patients: Presented at ASCO"

By Charlene Laino CHICAGO, IL -- June 6, 2003 -- The anti-angiogenesis agent bevacizumab significantly improves survival by nearly 5 months in previously untreated patients with metastatic colorectal cancer, a phase III trial shows. Herbert Hurwitz, MD, an assistant professor of medicine at Duke University, in Durham, North Carolina, presented the findings here on June 1st at the 39th Annual Meeting of the American Society of Clinical Oncology. The study was undertaken after a phase II open-label study showed that bevacizumab appeared to increase time to progression and response rates, Dr. Hurwitz said. The current trial randomized about 800 patients with metastatic colon cancer to receive standard chemotherapy with irinotecan, 5-fluorouracil, and leucovorin or the same regimen plus bevacizumab. Median survival was 20.3 months in patients who received the bevacizumab combination, compared with 15.6 months for those on standard chemotherapy, the study showed. This corresponds to a hazard ratio of 0.65 (P = 0.00003), Dr. Hurwitz said. Bevacizumab was also associated with a delay in median time to cancer progression -- 10.6 months versus 6.2 months for the standard chemotherapy, he reported. Also, the overall response rate was 35% in patients receiving standard chemotherapy alone, compared with 45% in patients taking the bevacizumab and chemotherapy combination. The duration of response increased from 7.1 months in the chemotherapy group, compared with 10.4 months for bevacizumab plus chemotherapy, the study showed. The only side effect that was clearly increased by the bevacizumab regimen was grade 3 hypertension, which was managed with oral medications, Dr. Hurwitz said. Nearly 11% of patients in the bevacizumab arm developed grade 3 hypertension, compared with 2.3% of patients in the control group. About 19% of patients the bevacizumab arm developed thromboembolisms, compared with 16.1% of those in the standard chemotherapy arm. Fewer than 1% of patients in both groups experienced grade 3 proteinuria, and bleeding occurred in 3.1% of patients given bevacizumab, compared with 2.5% of those on standard chemotherapy. While the study offers proof of principle that an anti-angiogenesis inhibitor works against advanced colorectal cancer, Dr. Hurwitz cautioned that the drug did not cure patients. "We still have a long way to go," he said. "We need to validate this drug in other cancer and we need more phase III data to confirm these results." The study was funded by Genentech, Inc.

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