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A phase II study of capecitabine and oral leucovorin as a third-line chemotherapy in patients with metastatic colorectal cancer

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Abstract

Purpose

This study was conducted to evaluate the efficacy and safety of the combination of capecitabine and oral leucovorin (LV) as a third-line chemotherapy for patients with metastatic colorectal cancer (CRC) showing resistance to irinotecan- and oxaliplatin-containing regimens.

Method

Patients who showed disease progression while receiving or within 6 months of discontinuing irinotecan- and oxaliplatin-containing regimens received capecitabine 825 mg/m2 in combination with oral LV at a fixed dose of 30 mg, twice a day for 2 weeks followed by a 1-week rest.

Results

Twenty-five patients were enrolled from July 2011 to June 2014. Three patients achieved PR, and 11 showed SD. The overall response rate was 12 %, and disease control rate was 56 %. With a median follow-up of 6.8 months, the median time to progression was 2.8 months and the median overall survival was 7.1 months. The most common non-hematologic toxicity was hand-foot syndrome (40 %), followed by mucositis (28 %) and diarrhea (12 %). Grade 3 hand-foot syndrome occurred in two patients (8 %), and grade 3 mucositis in one. Hematologic toxicities were mild, and only one patient developed grade 3 thrombocytopenia.

Conclusion

The combination of capecitabine and oral LV showed a modest activity and tolerable toxicity profile in metastatic CRC patients pretreated with irinotecan- and oxaliplatin-containing regimens. Oral LV seems to be able to reduce the usual dose of capecitabine when the two drugs are combined.

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Correspondence to Jung Han Kim.

Additional information

Dae Ro Choi and Sang Nam Yoon have equally contributed to this work.

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Choi, D.R., Yoon, S.N., Kim, H.S. et al. A phase II study of capecitabine and oral leucovorin as a third-line chemotherapy in patients with metastatic colorectal cancer. Cancer Chemother Pharmacol 75, 639–643 (2015). https://doi.org/10.1007/s00280-015-2688-9

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  • DOI: https://doi.org/10.1007/s00280-015-2688-9

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