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Open Access Research article

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)

Lambros Vamvakas, Alexios Matikas, Athanasios Karampeazis, Dora Hatzidaki, Stelios Kakolyris, Charalampos Christophylakis, Ioannis Boukovinas, Aris Polyzos, Vassilis Georgoulias and John Souglakos*

Author Affiliations

Hellenic Oncology Research Group (HORG), 55 Lomvardou str, 11470 Athens, Greece

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BMC Cancer 2014, 14:277  doi:10.1186/1471-2407-14-277

Published: 22 April 2014

Abstract

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/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.

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.

Trial registration

Clinical trials NCT01024504, 26 November 2010.

Keywords:
XELOX; Capecitabine; Oxaliplatin; Bevacizumab; mCRC; Colorectal cancer; Elderly patients