Phase II clinical trial on docetaxel in the treatment of non-small-cell lung cancer

Purpose:To investigate the efficacy and safety of docetaxel and two docetaxel plus cisplatin regimens in patients with non-small-cell lung cancer (NSCLC).Methods:Patients with NSCLC were randomly assigned to receive single-agent docetaxel (AISU) every 3 weeks (A);docetaxel (AISU) 75 mg/m 2 plus cisplatin 75 mg/m 2 every 3 weeks (B);docetaxel (Taxotere) 75 mg/m 2 plus cisplatin 75 mg/m 2 every 3 weeks (C). Results:104 of 115 patients were evaluable for efficacy. Overall response rates of A,B and C were 8.10%,23.53% and 27.27%, respectively. Response with B was similar to C. The major toxicities were neutropenia,anemia,febrile neutropenia,fever,alopecia,nausea,vomiting and fatigue. Neutropenia was more common with C than with B ( P 0.05). Conclusions:Two docetaxel plus cisplatin regimens are an effective and well-tolerated treatment in patients with NSCLC.