title: Randomized comparison of two combination regimens versus minimal chemotherapy in nonsmall-cell lung cancer: a Southeastern Cancer Study Group Trial.
abstract: Patients with advanced nonsmall-cell lung cancer (NSCLC), good performance status, and no prior chemotherapy were randomized to receive one of three regimens: intravenous vindesine (V) 3 mg/m2 every 2 weeks; V 3 mg/m2 weekly for 5 weeks, followed by a dose every 2 weeks plus mitomycin (VM) 20 mg/m2 day 1 and then 15 mg/m2 every 6 weeks; or V at the more intensive dose rate plus cisplatin (VC) 120 mg/m2 with forced diuresis on days 1 and 29 and then every 6 weeks. A total of 435 patients were enrolled in the trial, with 410 (94%) assessable for prognostic characteristics and survival. Among the 375 patients assessable for response, only 58 (15%) achieved objective response. Single-agent V every 2 weeks was inactive (response rate less than 1%), effectively acting as a no-treatment arm. Among assessable patients receiving VM, 33 (27%) responded; among patients receiving VC, 24 (19%) responded. There was no statistically significant survival difference among the treatment arms, with median survival among those treated with V 14.8 weeks, VM 20.4 weeks, and VC 24.7 weeks; VC achieved borderline significance (P = .06) compared with V. In a prognostic factor analysis, treatment was not a significant factor (P = .447) for survival. Thus, in this large multicenter trial, neither a high-dose cisplatin combination nor a noncisplatin regimen (VM) with a comparable response rate had a significant survival advantage over minimal chemotherapy. New approaches are needed in advanced NSCLC.
authors.affiliation: St Louis University, MO.
authors.forename: D W
authors.initials: DW
authors.lastname: Luedke
authors.forename: L
authors.initials: L
authors.lastname: Einhorn
authors.forename: G A
authors.initials: GA
authors.lastname: Omura
authors.forename: P R
authors.initials: PR
authors.lastname: Sarma
authors.forename: A A
authors.initials: AA
authors.lastname: Bartolucci
authors.forename: R
authors.initials: R
authors.lastname: Birch
authors.forename: F A
authors.initials: FA
authors.lastname: Greco
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D016009:Chi-Square Distribution; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D008937:Mitomycins / Q000008:administration & dosage / Q000009:adverse effects; D015337:Multicenter Studies as Topic; D009503:Neutropenia / Q000139:chemically induced; D011379:Prognosis; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic; D012074:Remission Induction; D015996:Survival Rate; D014481:United States; D014751:Vindesine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D008937:Mitomycins; D002945:Cisplatin; D014751:Vindesine