A phase II trial of ixabepilone in Asian patients with advanced gastric cancer previously treated with fluoropyrimidine-based chemotherapy.

Autor: Kim, Yeul, Muro, Kei, Yasui, Hirofumi, Chen, Jen-Shi, Ryu, Min-Hee, Park, Se-Hoon, Chu, Kent-Man, Choo, Su-Pin, Sanchez, Teresa, DelaCruz, Christine, Mukhopadhyay, Pralay, Lainas, Ioannis, Li, Chung-Pin
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Zdroj: Cancer Chemotherapy & Pharmacology; Oct2012, Vol. 70 Issue 4, p583-590, 8p
Abstrakt: Purpose: The 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. Methods: Asian 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). Results: Fifty-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. Conclusions: Ixabepilone is active in Asian patients with advanced gastric cancer and shows a toxicity profile similar to those previously reported in other tumor types. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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