Abstract

AbstractMany agents have been evaluated as maintenance therapy for metastatic colorectal cancer (mCRC), but there is no consensus on the optimal regimen. This study assessed the effect of single-agent capecitabine maintenance therapy on the survival outcomes of mCRC patients. A comprehensive literature search was performed according to prespecified inclusion and exclusion criteria for randomized controlled trials (RCTs) comparing capecitabine as maintenance monotherapy versus active monitoring for mCRC patients. Data on overall survival (OS), progression-free survival (PFS), time to tumor progression (TTP), adverse events, and quality of life (QoL) scores were extracted. Three RCTs with a total of 576 patients were included. Pooled analyses found neither OS benefit (HR:0.85, 95% CI:0.64–1.13) nor reduction in mortality at 24 months (RR:0.88, 95% CI:0.66–1.17) with capecitabine maintenance. Compared with active monitoring, capecitabine maintenance therapy improved PFS (HR:0.36, 95% CI:0.26–0.61) and reduced the risk of progression at 6 months (HR:0.78, 95% CI:0.56–1.10). The incidence of any grade ≥ 3 toxicity was higher with maintenance therapy than with observation (OR:2.02, 95% CI:1.42–2.88). No difference in terms of QoL was observed. Single-agent capecitabine as maintenance for patients with mCRC provides no OS benefit but results in statistically significant improvement in PFS with increased risk of toxicity. Hence, it may be considered particularly for patients who wish to delay the need for second-line treatment and who can tolerate it well.

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