Phase II study of bevacizumab in combination with capecitabine as first-line treatment in elderly patients with metastatic colorectal cancer.

The relative survival of elderly patients with metastatic colorectal cancer (mCRC) is generally worse than that of younger patients because of more advanced stage at presentation, comorbidity and reduced use of optimal therapy. We conducted a prospective phase II trial of the combination of bevacizumab and capecitabine in elderly patients with mCRC. In total 41 patients aged more than or equal to 70 years with mCRC, who had not received chemotherapy earlier for metastatic disease, were enroled. Patients received capecitabine (1000 mg/m twice daily on days 1-14) and bevacizumab (7.5 mg/kg of body weight on day 1). The treatment cycles were repeated every 3 weeks. The overall response rate was 65%, including 13% of patients with a complete response and 53% of patients with a partial response. A further 13% of patients maintained stable disease. The median progression-free survival was 11.5 months and the median overall survival was 21.2 months. Despite the advanced age of participants, the rate of bevacizumab-related and capecitabine-related adverse events was consistent with that reported earlier in the general mCRC population. The combination of bevacizumab and capecitabine is effective and has a favourable tolerability profile and should be considered as an option for the initial treatment of mCRC in elderly patients.