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 withgemcitabine 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.
RCT Entities:
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.
Authors: N Kentepozidis; P Economopoulou; Ch Christofyllakis; L Chelis; A Polyzos; N Vardakis; F Koinis; L Vamvakas; P Katsaounis; K Kalbakis; Ch Nikolaou; V Georgoulias; A Kotsakis Journal: Clin Transl Oncol Date: 2016-08-04 Impact factor: 3.405