title: Randomized, double-blind, phase II trial comparing gemcitabine-cisplatin plus the LTB4 antagonist LY293111 versus gemcitabine-cisplatin plus placebo in first-line non-small-cell lung cancer.
abstract: BACKGROUND
  In this phase II study, patients with stage IIIB/IV non-small-cell lung cancer were randomly assigned (1:1:1) to receive LY293111 (200 mg twice daily [200 LY293111] or 600 mg twice daily [600 LY293111]) or placebo for 7 days, followed by concurrent cisplatin (75 mg/m2; day 1) and gemcitabine (1250 mg/m2; days 1 and 8), every 21 days.The primary endpoint was progression-free survival, (PFS), with 75% power to detect 33% improvement compared with placebo (5 months).
  
  
  METHODS
  Of 200 randomized patients, 195 were treated. Demographics were well balanced across treatment arms: 65% of the patients were men; median age was 62 years; 85% had stage IV disease; and patients had an Eastern Cooperative Oncology Group performance status of 0 (36%) or 1 (64%).
  
  
  RESULTS
  The most frequent study drug-related toxicities were nausea, vomiting, and fatigue. Response rates were similar across treatment arms (200 LY293111: 20%; 600 LY293111: 25%; placebo: 31%).
  
  
  CONCLUSIONS
  Median PFS (95% confidence interval) was not significantly different across treatment arms (200 LY293111: 4.6 months [3.2-5.0]; 600 LY293111: 5.6 months [4.1-6.8]; placebo: 6.0 months [5.2-7.5]). LY293111 combined with gemcitabine-cisplatin did not increase median PFS compared with placebo plus gemcitabine-cisplatin in patients with non-small-cell lung cancer.
authors.affiliation: *Department of Medical Oncology, Dana-Farber Cancer Institute and Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts; †IBIS (Virgen del Rocio Hospital, Seville University & CSIC), Seville, Spain; ‡Cancer Care Center of Frederick, Frederick, Maryland; §Asklepios Klinik Harburg, Hamburg, Germany; ‖Royal Victoria Hospital, Division of Medical Oncology, Montreal, Canada; ¶Eli Lilly and Company, Indianapolis, Indiana; and #Asklepios Klinikum Gauting, Munich, Germany.
authors.forename: Pasi A
authors.initials: PA
authors.lastname: Jänne
authors.forename: Luis
authors.initials: L
authors.lastname: Paz-Ares
authors.forename: Yun
authors.initials: Y
authors.lastname: Oh
authors.forename: Corinna
authors.initials: C
authors.lastname: Eschbach
authors.forename: Vera
authors.initials: V
authors.lastname: Hirsh
authors.forename: Nathan
authors.initials: N
authors.lastname: Enas
authors.forename: Leslie
authors.initials: L
authors.lastname: Brail
authors.forename: Joachim
authors.initials: J
authors.lastname: von Pawel
mesh_terms: D052242:Adiponectin / Q000097:blood; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001565:Benzoates / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007975:Leukotriene B4 / Q000037:antagonists & inhibitors; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D000093542:Gemcitabine
chemical_list: D052242:Adiponectin; D001565:Benzoates; C094099:LY 293111; D003841:Deoxycytidine; D007975:Leukotriene B4; D002945:Cisplatin; D000093542:Gemcitabine