Maintenance therapy with single-agent capecitabine is an appropriate therapeutic option following first-line induction with XELOX (capecitabine, leucovorin, oxaliplatin) or FOLFOX (fluorouracil, leucovorin, oxaliplatin) in patients with metastatic colorectal cancer (mCRC), a study published in the journal Annals of Oncology has shown.1

Because the optimal strategy of maintenance therapy for patients with mCRC is controversial, researchers sought to assess the efficacy and safety of capecitabine maintenance compared with observation following induction chemotherapy in treatment-naïve patients.

For the multicenter, open-label, phase 3 trial, researchers enrolled 274 patients with mCRC who received 18 to 24 weeks of XELOX or FOLFOX induction and achieved disease control. Participants were randomly assigned 1:1 to receive maintenance therapy with single-agent capecitabine or observation until disease progression.

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Results showed that after a median follow-up time from randomization of 29.0 months, median progression-free survival was 6.43 months (95% CI, 5.26 – 7.71) with capecitabine compared with 3.43 months (95% CI, 2.83 – 4.16) for the observation group (HR, 0.54; 95% CI, 0.42 – 0.70; P < .001).

Unlike progression-free survival, there was no statistically significant difference in median overall survival between capecitabine (25.63 months; 95% CI, 22.46 – 27.80) and observation (23.30 months; 95% CI, 19.68 – 26.92; HR, 0.85; 95% CI, 0.64 – 1.11; P = .2247).

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In terms of safety, similar safety profiles were observed in both treatment groups. The most frequently reported grade 3 or 4 toxicities in the capecitabine arm were neutropenia, hand-foot syndrome, and mucositis.


  1. Luo HY, Li YH, Wang W, et al. Single-agent capecitabine as maintenance therapy after induction of XELOX (or FOLFOX) in first-line treatment of metastatic colorectal cancer: randomized clinical trial of efficacy and safety [published online ahead of print March 2, 2016]. Ann Oncol. doi: 10.1093/annonc/mdw101.