(ChemotherapyAdvisor) – Bevacizumab plus capecitabine prolonged progression-free survival (PFS) in elderly patients with metastatic colorectal cancer (mCRC), according to results from the first prospective randomized study to demonstrate a benefit in this population, reported in advance of a presentation during the 10th annual Gastrointestinal Cancers Symposium on January 26th in San Francisco, CA.
“Based on the efficacy and safety results, bevacizumab plus capecitabine might be an optimal treatment approach to improve outcomes in elderly patients,” stated David Cunningham, MD, of The Royal Marsden Hospital, London and Surrey, United Kingdom, and colleagues. Although the elderly comprise the majority of patients diagnosed with mCRC, they are generally under-represented in clinical trials, he added.
The global open-label phase 3 AVEX (Avastin in Elderly with Xeloda) trial randomly assigned 280 previously untreated patients 70 years or older with mCRC to receive first-line capecitabine 1,000 mg/m2 alone on days 1-14 (n=140) or in combination with bevacizumab 7.5 mg/kg every 3 weeks (n=140).
At enrollment, median age was 76 (range, 70-87 years) and most patients (91.1%) had an Eastern Cooperative Oncology Group performance status of 0–1. Baseline characteristics were balanced between the two groups.
Bevacizumab plus capecitabine was associated with significantly prolonged PFS, the primary end point, compared with capecitabine alone: a median of 9.1 versus 5.1 months (HR, 0.53; 95% CI: 0.41–0.69; P<0.001).
Overall response rate was also significantly improved in the bevacizumab plus capecitabine arm: 19.3% versus 10.0% in the capecitabine-alone arm (P=0.042). Overall survival (OS), a secondary end point, was longer in patients in the combination arm—median of 20.7 versus 16.8 months (HR, 0.79; 95% CI: 0.57-1.09; P=0.182)—however, the difference did not reach statistical significance and the study was not powered to show a difference in OS between treatment arms, Dr. Cunningham reported.
Grade ≥3 adverse events occurred in 59% of the patients in the bevacizumab plus capecitabine arm and 44.1% of those in the capecitabine-alone arm.
“Treatment was in general well tolerated and the safety profile consistent with previously reported data for bevacizumab plus capecitabine,” he noted.
The 2013 Gastrointestinal Cancers Symposium is co-sponsored by the American Gastroenterological Association (AGA) Institute, the American Society of Clinical Oncology (ASCO), the American Society for Radiation Oncology (ASTRO), and the Society of Surgical Oncology (SSO).