Docetaxel/gemcitabine or cisplatin/gemcitabine followed by docetaxel in the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC): results of a multicentre randomized phase II trial.

摘要: Most patients (pts) with metastatic non-small cell lung cancer (NSCLC) receive either single agents or chemotherapy doublets. Recent studies have demonstrated that triple-agent therapies may improve the response rate, but are associated significant toxicity, and frequently do not prolong survival. A sequential schedule combine acceptable tolerability good efficacy. We therefore conducted a multicentre, prospectively randomized study evaluates three-drug platinum-free doublet regimen. The pts union international contre le (UICC) stage IV NSCLC were to one of two schedules: in arm Doc-Gem, they received gemcitabine (900 mg/m2, 30 min infusion) on days 1 8, docetaxel (75 mg/m2, 1 h day 1, repeated every 3 weeks up six cycles. In Cis-Gem→Doc, 8) cisplatin (70 mg/m2, infusion, 1) given for three cycles, followed by cycles (100 mg/m2, 3 weeks). One hundred thirteen arms Doc-Gem (55 pts) Cis-Gem→Doc (58 pts). With 20.4% responded treatment whereas 31.0% (overall response, intent-to-treat, difference significant). median time progression was 3.6 months [95% confidence interval (CI) 1.4, 5.9] 5.2 months (95% CI 3.1, 7.3). survival 8.7 months 5.7, 11.6) 9.4 months 7.8, 11.0). 1-year rates 34 35%, respectively. Mild moderate leukopenia seen both schedules. Other common adverse events (AE) nausea/vomiting, thrombocytopenia, anaemia, diarrhoea, infections. No differences AEs observed between schedules except which occurred more Cis-Gem→Doc. therapy comprising cisplatin, gemcitabine, promising tumour control combination (docetaxel/gemcitabine) very well tolerated. However, resulted comparable recent large trials advanced NSCLC. present results justify further phase III investigation.