Phase II Trial of Capecitabine Plus Bevacizumab for Elderly Patients With Metastatic Colorectal Cancer: OGSG 1102.

Abstract

Background/aim: The combination of capecitabine and bevacizumab is a standard first-line chemotherapy regimen for vulnerable patients with unresectable colorectal cancer. However, the safety and efficacy of this regimen in Japanese patients have not been sufficiently investigated.

Patients and methods: This phase II study included patients aged ≥76 years or those aged 65-75 years who were unsuitable for intensive chemotherapy. Capecitabine at 2000 mg/m²/day (days 1-14) plus bevacizumab at 7.5 mg/kg (day 1) were administered every 3 weeks. The primary endpoint was progression-free survival. Secondary endpoints included overall survival, response rate, disease control rate, and toxicities.

Results: Thirty-six patients were enrolled between July 2011 and July 2014, of whom 33 were included in the analysis. The median patient age was 78 years (range=67-86 years). A total of 28 patients had a performance status of 0 or 1, and five of 2. The median progression-free and overall survival were 10.3 (95% confidence interval=9.2-15.4) and 27.9 (95% confidence interval=24.2-50.1) months, respectively. The response and disease control rates were 30.3% and 91.0%, respectively. The major grade 3 or 4 toxicities were hypertension (n=12, 36%) and hand-foot syndrome (n=4, 12%). One patient experienced a grade 4 gastrointestinal perforation.

Conclusion: The combination of capecitabine and bevacizumab demonstrated favorable efficacy and tolerability in Japanese patients with metastatic colorectal cancer who were unsuitable for intensive chemotherapy.