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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
Author(s) -
Ii Frederick Richards,
Perry David J.,
Goutsou Maria,
Modeas Caron,
Muchmore Elaine,
Green Mark R.,
Rege Vishram,
Philippe Chahinian A.,
Hirsh Vera,
Poiesz Bernard
Publication year - 1991
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19910615)67:12<2974::aid-cncr2820671206>3.0.co;2-x
Subject(s) - medicine , vinblastine , performance status , fluorouracil , lung cancer , gastroenterology , chemotherapy , progressive disease , phases of clinical research , surgery , radiation therapy , cancer , randomized controlled trial , cisplatin
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 < 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.