A phase II study of biweekly dose-intensified oral capecitabine plus irinotecan (bXELIRI) for patients with advanced or metastatic gastric cancer

S. C. Oh, H. Y. Sur, H. J. Sung, I. K. Choi, S. S. Park, J. H. Seo, Y. T. Jeen, H. J. Chun, S. W. Shin, Y. J. Mok, J. S. Kim, Y. H. Kim

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15 Citations (Scopus)

Abstract

Capecitabine, a prodrug of 5-FU, has been reported to generate maximal tumour activity at tumour sites and/or to improve drug tolerability as compared with 5-FU infusion, and it has also been demonstrated to act synergistically with irinotecan against some solid cancers. A previous study concluded that dose-intensified biweekly capecitabine seems to be more effective at increasing both response rate and progression-free survival time than conventional dose and schedule of capecitabine in colon cancer. We conducted this study to ascertain the efficacy and toxicity of dose-intensified biweekly capecitabine and irinotecan combination chemotherapy in chemotherapy-naïve advanced or metastatic gastric cancer patients. Patients were treated with irinotecan 130 mg m-2 intravenously for 90 min on days 1 and 15. Capecitabine at 3500 mg m-2 day-1, divided into two sessions per day, was administered for seven consecutive days from days 1 and 15, and followed by a 7-day drug-free period, respectively. Fifty-five eligible patients were enrolled in this study from November 2003 to April 2006. There were 22 women and 33 men: median patient age was 54 years (range: 27-81). A total of 200 treatment cycles were administered at a median number of four per patient (range: 1-9). Intent-to-treatment analysis showed that one patient achieved complete response (1.8%), 23 partial response (41.8%), 15 stable disease (27.3%), 10 progressive disease (18.2%) and 6 were non-evaluable (10.9%). The overall response rate was 43.6% (95% confidence interval: 30.2-56.9). The common grade 3-4 toxicities were neutropenia in 12 (21.8%), nausea/vomiting in 3 (5.4%) and diarrhea in 4 (7.2%) patients. Median time to progression was 5 months (range: 0.5-11 months), median survival duration was 11 months (range: 0.5-45 months) and median response duration was 6 months (range: 0.5-9 months). Biweekly dose-intensified capecitabine and irinotecan combination chemotherapy was active for the treatment of advanced or metastatic gastric cancers with a tolerable safety profile.

Original languageEnglish
Pages (from-to)1514-1519
Number of pages6
JournalBritish Journal of Cancer
Volume96
Issue number10
DOIs
Publication statusPublished - 2007 May 21

Keywords

  • Capecitabine
  • Irinotecan
  • Stomach neoplasms

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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