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

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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.

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

Fingerprint

irinotecan
Stomach Neoplasms
Combination Drug Therapy
Fluorouracil
Neoplasms
Prodrugs
capecitabine-irinotecan combination
Capecitabine
Neutropenia
Pharmaceutical Preparations
Colonic Neoplasms
Nausea
Disease-Free Survival
Vomiting

Keywords

  • Capecitabine
  • Irinotecan
  • Stomach neoplasms

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

@article{1d51fba06dcb4b0d881b4bb71fb5b17d,
title = "A phase II study of biweekly dose-intensified oral capecitabine plus irinotecan (bXELIRI) for patients with advanced or metastatic gastric cancer",
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-na{\"i}ve 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.",
keywords = "Capecitabine, Irinotecan, Stomach neoplasms",
author = "Oh, {Sang Cheul} and Sur, {H. Y.} and Sung, {Hwa Jung} and Choi, {I. K.} and Sungsoo Park and Seo, {Jae Hong} and Jeen, {Yoon Tae} and Hoon-Jai Chun and Shin, {Sang Won} and Mok, {Young Jae} and Kim, {Jun Suk} and Kim, {Yeul Hong}",
year = "2007",
month = "5",
day = "21",
doi = "10.1038/sj.bjc.6603752",
language = "English",
volume = "96",
pages = "1514--1519",
journal = "British Journal of Cancer",
issn = "0007-0920",
publisher = "Nature Publishing Group",
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T1 - A phase II study of biweekly dose-intensified oral capecitabine plus irinotecan (bXELIRI) for patients with advanced or metastatic gastric cancer

AU - Oh, Sang Cheul

AU - Sur, H. Y.

AU - Sung, Hwa Jung

AU - Choi, I. K.

AU - Park, Sungsoo

AU - Seo, Jae Hong

AU - Jeen, Yoon Tae

AU - Chun, Hoon-Jai

AU - Shin, Sang Won

AU - Mok, Young Jae

AU - Kim, Jun Suk

AU - Kim, Yeul Hong

PY - 2007/5/21

Y1 - 2007/5/21

N2 - 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.

AB - 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.

KW - Capecitabine

KW - Irinotecan

KW - Stomach neoplasms

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U2 - 10.1038/sj.bjc.6603752

DO - 10.1038/sj.bjc.6603752

M3 - Article

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SP - 1514

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JO - British Journal of Cancer

JF - British Journal of Cancer

SN - 0007-0920

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