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Flexible chemotherapy regimen with gemcitabine and vinorelbine for metastatic nonsmall cell lung carcinoma
Author(s) -
Hirsh Vera,
Langleben Adrian,
Ayoub Joseph,
Cormier Yvon,
Pintos Javier,
Iglésias José L.
Publication year - 2001
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(20010815)92:4<830::aid-cncr1389>3.0.co;2-c
Subject(s) - vinorelbine , gemcitabine , medicine , regimen , chemotherapy , gastroenterology , phases of clinical research , antimetabolite , survival rate , surgery , oncology , cisplatin
BACKGROUND This Phase II study evaluated a flexible 3‐ or 4‐week dosing schedule of gemcitabine and vinorelbine to determine its effect on response rate and survival of patients with metastatic nonsmall cell lung carcinoma (NSCLC). METHODS Thirty‐four response‐evaluable patients, 24 with performance status (PS) 0–1 and 10 with a PS of 2, 30 with Stage IV, and 4 with Stage IIIB NSCLC were treated with gemcitabine 1000 mg/m 2 intravenously and vinorelbine 25 mg/m 2 intravenously (first 15 patients) or 30 mg/m 2 intravenously (next 19 patients) on Days 1, 8, and 15 of a 4‐week cycle, if on Day 15 neutrophils were ≥ 1500/uL and platelets ≥ 100,000/uL. If chemotherapy could not be administered on Day 15, then Day 22 became Day 1 of the next cycle. RESULTS When vinorelbine 25 mg/m 2 was given with gemcitabine 1000 mg/m 2 , 11 patients received 4‐week cycles, 3 patients 3‐week cycles, and 1 patient both 3‐ and 4‐week cycles. With vinorelbine 30 mg/m 2 and gemcitabine 1000 mg/m 2 , 7 patients received 4‐week cycles, 2 patients 3‐week cycles, and 10 patients both 3‐ and 4‐week cycles. The partial response rate for 34 patients was 53% (18 patients). Median survival (MS) was 11.1 months, and 1‐year survival 50% (17 patients). Patients with PS 0+1 had a MS of 17.5 months compared with patients with PS 2, who had MS of 3.3 months. Patients < 70 years of age had a MS of 18 months, and those ≥ 70 years had a MS of 5.5 months. CONCLUSION This flexible schedule with gemcitabine and vinorelbine enabled optimal dose delivery and suggested excellent efficacy but less toxicity than treatment with platinum regimens. Cancer 2001;92:830–5. © 2001 American Cancer Society.