A phase II trial of ixabepilone in Asian patients with advanced gastric cancer previously treated with fluoropyrimidine-based chemotherapyReport as inadecuate




A phase II trial of ixabepilone in Asian patients with advanced gastric cancer previously treated with fluoropyrimidine-based chemotherapy - Download this document for free, or read online. Document in PDF available to download.

Cancer Chemotherapy and Pharmacology

, Volume 70, Issue 4, pp 583–590

First Online: 12 August 2012Received: 11 June 2012Accepted: 23 July 2012

Abstract

PurposeThe highest rates of gastric cancer occur in Eastern Asia. Fluoropyrimidine-based therapy is used initially in unresectable and metastatic disease, but no single standard of care exists following disease progression. Ixabepilone, an epothilone B analog, is a non-taxane microtubule-stabilizing agent with clinical activity across multiple tumor types approved by the United States Food and Drug Administration for treatment of metastatic breast cancer.

MethodsAsian patients with unresectable or metastatic gastric adenocarcinoma who had failed fluoropyrimidine-based chemotherapy received ixabepilone 40 mg-m by 3-h intravenous infusion every 3 weeks. The primary endpoint was objective response rate ORR.

ResultsFifty-two patients were treated 65.4 % men; median age: 56.5 years. The ORR was 15.4 % 95 % confidence interval CI 6.9–28.1; 8 patients achieved partial responses for a median duration of 3.1 months 95 % CI 2.6–4.1 months and 26 patients 50.0 % had stable disease. Median progression-free survival was 2.8 months 95 % CI 2.1–3.5 months. The most common grade 3 non-hematological toxicities were fatigue 9.6 %, decreased appetite 7.7 %, sensory neuropathy 5.8 %, and diarrhea 5.8 %. Grade 3-4 neutropenia occurred in 46.2 % of patients.

ConclusionsIxabepilone is active in Asian patients with advanced gastric cancer and shows a toxicity profile similar to those previously reported in other tumor types.

KeywordsGastric cancer Second-line therapy Asian patients Ixabepilone This study was sponsored by Bristol-Myers Squibb.

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Author: Yeul Hong Kim - Kei Muro - Hirofumi Yasui - Jen-Shi Chen - Min-Hee Ryu - Se-Hoon Park - Kent-Man Chu - Su-Pin Choo - Tere

Source: https://link.springer.com/







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