The FINANCIAL — Full results from the first phase III trial of Avastin (bevacizumab) in early-stage colon cancer, known as NSABP C-08, were announced on May 30. The study evaluated the use of Avastin plus chemotherapy (FOLFOX) for the treatment of colon cancer immediately following surgery (adjuvant therapy) compared to chemotherapy alone.
The study showed the addition of one year of Avastin to chemotherapy did not result in a statistically significant improvement in overall disease-free survival (DFS). However, during the year of Avastin treatment there was an early and significant improvement in disease-free survival that diminished over the course of the study. These data were featured at a press briefing during the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) and will be presented on Sunday (May 31).
“During the year that patients received Avastin treatment there was a 40 percent lower risk of cancer returning; however, this initial improvement over chemotherapy alone gradually diminished over time,” said Norman Wolmark, M.D., Chairman, NSABP (National Surgical Adjuvant Breast and Bowel Project). “These results suggest longer durations of Avastin treatment should be considered for future studies in early-stage colon cancer to further reduce the risk of the cancer coming back.”
No new safety signals for Avastin were observed in the study and careful review of the data did not provide evidence that cancer returns faster or more aggressively after Avastin therapy was stopped.
“These results are encouraging and suggest that Avastin may have an important role in early cancer treatment. We are committed to the ongoing programme of Avastin in early-stage cancers and believe that these results could help us optimise the use of Avastin for the benefit of patients,’’ said William M. Burns, CEO of Roche’s Pharmaceutical Division.
Avastin based therapy is the standard of care in advanced colon cancer treatment which will be further confirmed throughout ASCO with 53 efficacy and safety data presentations including more than 6,000 patients.
NSABP C-08 Study Results
Overall in the study, there was 12 percent improvement in DFS that was not statistically significant (hazard ratio=0.89, p=0.15; risk reduction 11 percent). In the first year of the study, while patients received Avastin in addition to a standard six-months of adjuvant chemotherapy, disease-free survival improved by 67 percent compared to chemotherapy alone (hazard ratio=0.60; risk reduction of 40 percent). However, this early improvement in DFS began to diminish after the first year, and overall DFS was not improved.
NSABP C-08 included a comprehensive safety analysis that showed no new or unexpected safety events related to Avastin in the study. Specific severe (Grade 3 or greater) adverse events (AEs) that occurred with increased frequency in patients who received Avastin versus chemotherapy alone were: hypertension (12 percent vs. 1.8 percent), pain (11.1 percent vs. 6.3 percent), proteinuria (2.7 percent vs. 0.8 percent) and wound-healing complications (1.7 percent vs. 0.3 percent).
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