title: A phase II trial of ixabepilone in Asian patients with advanced gastric cancer previously treated with fluoropyrimidine-based chemotherapy.
abstract: OBJECTIVE
  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(2) 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.
authors.affiliation: Division of Oncology and Hematology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
authors.forename: Yeul Hong
authors.initials: YH
authors.lastname: Kim
authors.forename: Kei
authors.initials: K
authors.lastname: Muro
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Yasui
authors.forename: Jen-Shi
authors.initials: JS
authors.lastname: Chen
authors.forename: Min-Hee
authors.initials: MH
authors.lastname: Ryu
authors.forename: Se-Hoon
authors.initials: SH
authors.lastname: Park
authors.forename: Kent-Man
authors.initials: KM
authors.lastname: Chu
authors.forename: Su-Pin
authors.initials: SP
authors.lastname: Choo
authors.forename: Teresa
authors.initials: T
authors.lastname: Sanchez
authors.forename: Christine
authors.initials: C
authors.lastname: DelaCruz
authors.forename: Pralay
authors.initials: P
authors.lastname: Mukhopadhyay
authors.forename: Ioannis
authors.initials: I
authors.lastname: Lainas
authors.forename: Chung-Pin
authors.initials: CP
authors.lastname: Li
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D034261:Epothilones / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D050257:Tubulin Modulators / Q000627:therapeutic use*
chemical_list: D034261:Epothilones; D050257:Tubulin Modulators; C430592:ixabepilone; D005472:Fluorouracil