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/m2 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.
Highlights
Gastric cancer was newly diagnosed in an estimated 989,600 people and caused an estimated 738,000 deaths worldwide in 2008 [1]; it was the third leading cause of cancer deaths in men and fifth leading cause in women
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
Ixabepilone is active in Asian patients with advanced gastric cancer and shows a toxicity profile similar to those previously reported in other tumor types
Summary
Gastric cancer was newly diagnosed in an estimated 989,600 people and caused an estimated 738,000 deaths worldwide in 2008 [1]; it was the third leading cause of cancer deaths in men and fifth leading cause in women. In Japan, cisplatin plus the oral fluoropyrimidine S–1 has emerged as a preferred first-line regimen producing median survival of 13 months [12]. There is no established second-line regimen; options include paclitaxel, docetaxel, or irinotecan given alone or in doublet regimens, which produced median survival of 4–8 months in prospective clinical trials [14,15,16,17,18]. These survival data underscore the need for more effective therapy in metastatic gastric cancer
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