Capecitabine Monotherapy Maintenance Supported In Metastatic CRC

Phase III trial results suggest that maintenance therapy with single-agent capecitabine could be a valid option for patients with metastatic colorectal cancer

medwireNews: A Chinese research team finds that XELOX- or FOLFOX-treated patients with metastatic colorectal cancer (CRC) derive a significant progression-free survival (PFS) benefit from maintenance treatment with single-agent capecitabine compared with observation alone.

The phase III trial included 274 patients with metastatic adenocarcinoma of the colon or rectum who had at least achieved stable disease after 18–24 weeks of induction with XELOX or FOLFOX. Only patients who had not received prior chemotherapy for metastatic disease were eligible for inclusion.

Over a median follow-up of 29 months, median PFS from randomisation was significantly prolonged for the 136 patients assigned to receive maintenance capecitabine 1000 mg/m2 twice a day for 2 weeks of a 3-week cycle compared with the 138 patients who underwent observation, at 6.43 and 3.43 months, respectively, giving a hazard ratio of 0.54.

The induction regimen did not have an effect on the PFS benefit accorded by capecitabine, with capecitabine-treated patients demonstrating significantly longer PFS regardless of whether they received XELOX (6.67 vs 3.43 months) or FOLFOX (6.27 vs 3.33 months).

Overall survival (OS) was also longer in the maintenance capecitabine than in the observation arm, at 25.63 versus 23.30 months, but the difference did not reach statistical significance. The researchers note, however, that the OS results were quite favourable compared with those of other trials evaluating maintenance treatments in this patient population.

Treatment-related side effects of grade 3 or worse were more common in the capecitabine group compared with the observation group, at 41.9% and 22.4%, respectively.

And grade 3 or 4 neutropenia (12.5 vs 6.5%), thrombocytopenia (6.6 vs 4.3%), mucositis (5.9 vs 2.9%) and hand–foot syndrome (5.9 vs 0.7%) occurred significantly more frequently among capecitabine-treated participants.

Rui-hua Xu, from Sun Yat-sen University Cancer Center in Guangzhou, and co-authors explain that as metastatic CRC patients tend to undergo prolonged chemotherapy resulting in cumulative toxicity, such as oxaliplatin -induced neuropathy and irinotecan -induced steatohepatitis, maintenance regimens with low toxicity that do not compromise survival are urgently needed.

And on the basis of their findings and available evidence, the study authors conclude that “maintenance therapy with capecitabine can be considered an appropriate option”.


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.Ann Oncol 2016; Advance online publication 2 March. doi:10.1093/annonc/mdw101

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