BACKGROUND:Paclitaxel plus cisplatin is an effective regimen in the treatment of non-small cell lung cancer (NSCLC), but it has severe adverse toxicities. The aim of this clinical trial is to evaluate the effect and safety of paclitaxel plus oxaliplatin compared with paclitaxel plus cisplatin in the treatment of advanced NSCLC. METHODS:From January, 2002 to October, 2004, 83 initially treated patients with advanced NSCLC were randomized into two groups: the trial group was treated with paclitaxel 175mg/m², and oxaliplatin 130mg/m² on day 1;and the control group was treated with paclitaxel 175mg/m² and cisplatin 80mg/m² on day 1. Both of them were repeated every 21 days and 2-6 cycles were given to patients. The evaluation of efficacy and safety was performed after chemotherapy regularly. RESULTS: All patients were evaluable and received 2 cycles chemotherapy at least. The response rate of the trial group and control group was 34.1% (14/41) and 33.3% (14/42) respectively, median time to progression of them was 6.0 months and 5.5 months, median survival time was 10.7 months and 10.5 months, 1-year survival was 39.0% (16/41) and 40.5% (17/42) respectively. The following adverse effects of the two groups were different: the incidence rate of III+IV leukopenia was 4.9% and 28.6% in the trial group and the control group respectively, III+IV thrombocytopemia was 0 and 14.3%, III+IV nausea and vomiting was 7.3% and 26.2%. The difference of the incidence rate of III+IV nerve abnormality (9.8% and 9.5%), imparied renal function (0 and 7.1%), myalgia and anthralgia (0 and 2.4%) was insignificant. CONCLUSIONS: The regimen of paclitaxel plus oxaliplatin have the similar efficacy and less adverse toxicities as compared to Paclitaxel plus Cisplatin in treatment of advanced NSCLC.
RCT Entities:
BACKGROUND:Paclitaxel plus cisplatin is an effective regimen in the treatment of non-small cell lung cancer (NSCLC), but it has severe adverse toxicities. The aim of this clinical trial is to evaluate the effect and safety of paclitaxel plus oxaliplatin compared with paclitaxel plus cisplatin in the treatment of advanced NSCLC. METHODS: From January, 2002 to October, 2004, 83 initially treated patients with advanced NSCLC were randomized into two groups: the trial group was treated with paclitaxel 175mg/m², and oxaliplatin 130mg/m² on day 1;and the control group was treated with paclitaxel 175mg/m² and cisplatin 80mg/m² on day 1. Both of them were repeated every 21 days and 2-6 cycles were given to patients. The evaluation of efficacy and safety was performed after chemotherapy regularly. RESULTS: All patients were evaluable and received 2 cycles chemotherapy at least. The response rate of the trial group and control group was 34.1% (14/41) and 33.3% (14/42) respectively, median time to progression of them was 6.0 months and 5.5 months, median survival time was 10.7 months and 10.5 months, 1-year survival was 39.0% (16/41) and 40.5% (17/42) respectively. The following adverse effects of the two groups were different: the incidence rate of III+IV leukopenia was 4.9% and 28.6% in the trial group and the control group respectively, III+IV thrombocytopemia was 0 and 14.3%, III+IV nausea and vomiting was 7.3% and 26.2%. The difference of the incidence rate of III+IV nerve abnormality (9.8% and 9.5%), imparied renal function (0 and 7.1%), myalgia and anthralgia (0 and 2.4%) was insignificant. CONCLUSIONS: The regimen of paclitaxel plus oxaliplatin have the similar efficacy and less adverse toxicities as compared to Paclitaxel plus Cisplatin in treatment of advanced NSCLC.