title: Chemotherapy with 5-fluorouracil (5-FU) and cisplatin or 5-FU, cisplatin, and vinblastine for advanced non-small cell lung cancer. A randomized phase II study of the cancer and leukemia group B.
abstract: Two hundred forty-seven patients with previously untreated nonresectable non-small cell lung cancer (NSCLC) were entered in a prospective, randomized Phase II trial. Response assessment was possible in 232 patients, and 237 patients were evaluable for survival. Thirteen partial responses (11%) and 5 regressions (4%) of evaluable disease were obtained for the 116 patients treated with 5-fluorouracil (5-FU) and cisplatin (C) (95% confidence interval [CI], 8.5% to 21.5%). The median time to progression was 2.2 months and the median survival time was 4.6 months for 5-FU plus C. Twenty-three partial responses (20%) and 4 regressions (3%) of evaluable disease were obtained for the 116 patients treated with 5-FU, C, and vinblastine (V) (95% CI, 15.3% to 30.7%). The median time to progression was 2.8 months and the median survival time was 5.6 months for 5-FU, C, and V. The 5-FU and C doses were equivalent in the two treatment regimens. Sixteen of 85 patients (19%) with a performance status of 0 and 18 of 103 patients (17%) with a performance status of 1 responded, whereas only 2 of 44 patients (5%) with a performance status of 2 or greater responded (P = 0.009). Patients who had received locoregional radiation therapy had a lower overall response rate then those in the no prior radiation therapy group (P = 0.028). The median survival time for patients with a performance status of 0 or 1 was 6.3 months compared with 1.9 months for patients with a performance status of 2 or greater (P less than 0.001). Performance status also appeared to be a significant factor for time to progression. More frequent and severe leukopenia, fever, genitourinary (GU) toxicity, and pulmonary toxicity was reported with 5-FU, C, and V. There were three treatment-related deaths with 5-FU, C, and V and one treatment-related death with 5-FU plus C. Grade III/VI myelotoxicity was not influenced by prior radiation therapy or performance status. Neither regimen is active enough to be considered as standard therapy for advanced NSCLC.
authors.affiliation: Cancer Center, Wake Forest University, Winston-Salem, North Carolina.
authors.forename: F
authors.initials: F
authors.lastname: Richards
authors.forename: D J
authors.initials: DJ
authors.lastname: Perry
authors.forename: M
authors.initials: M
authors.lastname: Goutsou
authors.forename: C
authors.initials: C
authors.lastname: Modeas
authors.forename: E
authors.initials: E
authors.lastname: Muchmore
authors.forename: V
authors.initials: V
authors.lastname: Rege
authors.forename: A P
authors.initials: AP
authors.lastname: Chahinian
authors.forename: V
authors.initials: V
authors.lastname: Hirsh
authors.forename: B
authors.initials: B
authors.lastname: Poiesz
authors.forename: M R
authors.initials: MR
authors.lastname: Green
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000473:pathology / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D004341:Drug Evaluation; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012044:Regression Analysis; D012074:Remission Induction; D015996:Survival Rate; D013997:Time Factors; D014747:Vinblastine / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D005472:Fluorouracil