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A phase II randomized trial of gemcitabine-docetaxel versus gemcitabine-cisplatin in patients with advanced non-small cell lung carcinoma.

Author(s): Rubio JC, Vazquez S, Vazquez F, Amenedo M, Firvida JL, Mel JR, Huidobro G, Alvarez E, Lazaro M, Alonso G, Fernandez I, Galician Group of Lung Cancer (GGCP in the Spanish acronym)

Affiliation(s): Department of Medical Oncology, Hospital do Meixoeiro, C/Meixoeiro, s/n, 36200, Vigo (Pontevedra), Spain. joaquin.casal.rubio@sergas.es

Publication date & source: 2009-07, Cancer Chemother Pharmacol., 64(2):379-84. Epub 2009 Jan 13.

Publication type: Clinical Trial, Phase II; Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

PURPOSE: To test efficacy and tolerability of non-platinum regimens for advanced non-small-cell lung cancer (NSCLC). METHODS: Chemonaive patients with measurable stage IIIB/IV NSCLC treated with gemcitabine and cisplatin (GC), or gemcitabine and docetaxel (GD), maximumsix cycles in a phase IIB trial. RESULTS: A total of 108 patients were randomized. Response rates (GC vs. GD, respectively): complete 3.6/2.0%, Partial 30.9/38.0%. Median Overall Survival (OS): 8.9 months in both groups (P = 0.53); and median time to progression (TTP): 6.2/5.5 months respectively (P = 0.61). Toxicities included (GC vs. GD, respectively): grade 3-4 neutropenia 49.1/41.2%; grade 3 thrombocytopenia 30.9/3.9%; grade 3 anemia 14.5/3.9%. Non-haematological toxicity was similar, except for nausea and vomiting, (16.3/2%); renal toxicity (3.7/0%) and hepatic toxicity (5.6/12.7%). CONCLUSIONS: With a higher overall response rate and lower toxicity, GD is a good first treatment option for advanced NSCLC.

Page last updated: 2009-10-20

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