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- Title
A phase II study of biweekly dose-intensified oral capecitabine plus irinotecan (bXELIRI) for patients with advanced or metastatic gastric cancer.
- Authors
Oh, S. C.; Sur, H. Y.; Sung, H. J.; Choi, I. K.; Park, S. S.; Seo, J. H.; Jeen, Y. T.; Chun, H. J.; Shin, S. W.; Mok, Y. J.; Kim, J. S.; Kim, Y. H.
- 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.British Journal of Cancer (2007) 96, 1514–1519. doi:10.1038/sj.bjc.6603752 www.bjcancer.com Published online 1 May 2007
- Subjects
STOMACH cancer patients; DRUG tolerance; TUMORS; PRODRUGS; COLON cancer; ADENOCARCINOMA; ANTINEOPLASTIC agents; CAMPTOTHECIN; CLINICAL trials; COMPARATIVE studies; DRUG administration; DOSE-effect relationship in pharmacology; FLUOROURACIL; RESEARCH methodology; MEDICAL cooperation; METASTASIS; ORAL drug administration; RESEARCH; STOMACH tumors; EVALUATION research; TREATMENT effectiveness; DEOXYCYTIDINE
- Publication
British Journal of Cancer, 2007, Vol 96, Issue 10, p1514
- ISSN
0007-0920
- Publication type
journal article
- DOI
10.1038/sj.bjc.6603752