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A phase II study of biweekly dose-intensified oral capecitabine plus irinotecan (bXELIRI) for patients with advanced or metastatic gastric cancer.
- Source :
-
British Journal of Cancer . 5/21/2007, Vol. 96 Issue 10, p1514-1519. 6p. 1 Chart, 2 Graphs. - Publication Year :
- 2007
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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 [ABSTRACT FROM AUTHOR]
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 00070920
- Volume :
- 96
- Issue :
- 10
- Database :
- Academic Search Index
- Journal :
- British Journal of Cancer
- Publication Type :
- Academic Journal
- Accession number :
- 25054886
- Full Text :
- https://doi.org/10.1038/sj.bjc.6603752