Literature DB >> 20060288

A randomised phase II study of combination chemotherapy with epirubicin, cisplatin and capecitabine (ECX) or cisplatin and capecitabine (CX) in advanced gastric cancer.

Jina Yun1, Jeeyun Lee, Se Hoon Park, Joon Oh Park, Young Suk Park, Ho Yeong Lim, Won Ki Kang.   

Abstract

BACKGROUND: Both cisplatin/capecitabine (CX) and epirubicin plus CX (ECX) have clearly demonstrated efficacy against advanced gastric cancer (AGC).
METHODS: Chemotherapy-naïve patients with histologically confirmed, measurable AGC were randomised to receive CX (cisplatin 75mg/m(2) iv on day 1 and capecitabine 1000mg/m(2) bid po on days 1-14) or ECX (epirubicin 50mg/m(2) plus CX) every 3weeks. The primary endpoint was progression-free survival (PFS).
RESULTS: Of the 91 registered patients, 45 patients were treated with CX and 44 with ECX. A total of 241 CX (median, 6; range, 1-12) and 201 ECX (median, 5; range, 1-11) cycles were delivered. Treatment duration was similar for both arms (4.4 for CX versus 4.2months for ECX). There was no relevant difference in the occurrence of overall grade 3 or 4 toxicities between the CX and ECX arms (80% versus 78%, respectively; P=0.516). However, none in the CX and 12% in the ECX arm discontinued treatment because of toxicity. There were no significant differences in therapeutic efficacy between CX and ECX with respect to the response rate (38% versus 37%, respectively) and PFS (6.4 versus 6.5months).
CONCLUSION: Both CX and ECX appear to be active as first-line chemotherapy for AGC, and the safety profiles are acceptable. Given the comparable efficacy results, CX could be a reasonable standard chemotherapy for untreated AGC patients. Copyright 2009 Elsevier Ltd. All rights reserved.

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Year:  2010        PMID: 20060288     DOI: 10.1016/j.ejca.2009.12.015

Source DB:  PubMed          Journal:  Eur J Cancer        ISSN: 0959-8049            Impact factor:   9.162


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