Capecitabine in combination with oxaliplatin and bevacizumab (AXELOX) as 1st line treatment for fit and vulnerable elderly patients (aged > 70 years) with metastatic colorectal cancer (mCRC): a multicenter phase II study of the Hellenic Oncology Research Group (HORG)

Background: Colorectal cancer (CRC) is a disease of the elderly. However, geriatric patients are often excluded from clinical trials. The combination of capecitabine, oxaliplatin and bevacizumab (XELOX/BEV) has not been assessed in an elderly population. Methods: We conducted a phase II study of XELOX plus bevacizumab combination as first line treatment in elderly patients with metastatic CRC. Treatment consisted of capecitabine 750 mg/m(2) twice a day during days 1- 7, oxaliplatin 85 mg/m2 and bevacizumab 5 mg/kg on day 1. Treatment was repeated every 14 days. The primary endpoint was overall response rate. Results: In the 48 enrolled patients response rate according was 46.8% (95% CI: 32.54%- 61.07%), while 13 patients had stable disease, for an overall disease control rate of 74.4% (95% CI: 57.8- 91.2). Progression free survival was 7.9 months (95% CI: 5.9- 9.8 months) and the median overall survival 20.1 months (95% CI: 15.6- 25.7 months). Response rate and progression free survival has been correlated with baseline albumin and haemoglobin levels. There was one treatment- related death. Grade 3- 4 toxicities were asthenia (4.2%), neurotoxicity (2.1%) and diarrhea 6.3%). Conclusions: The combination of capecitabine, oxaliplatin and bevacizumab is an effective and safe combination for the treatment of elderly patients with metastatic CRC.