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)
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Hellenic Oncology Research Group (HORG), 55 Lomvardou str, 11470 Athens, Greece
BMC Cancer 2014, 14:277 doi:10.1186/1471-2407-14-277Published: 22 April 2014
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.
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/m2 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.
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%).
The combination of capecitabine, oxaliplatin and bevacizumab is an effective and safe combination for the treatment of elderly patients with metastatic CRC.
Clinical trials NCT01024504, 26 November 2010.