[A randomized study of docetaxel plus cisplatin versus paclitaxel plus cisplatin in previously untreated advanced non-small cell lung cancer.].

BACKGROUND: Docetaxel is an active agent in the second-line treatment for non-small cell lung cancer (NSCLC), many clinical trials have demonstrated that it has similar efficacy to common first-line regimens for NSCLC. A randomized study was conducted to compare docetaxel plus cisplatin (DC) versus paclitaxel plus cisplatin (PC) for patients with advanced non-small cell lung cancer as the first-line regimen. METHODS: Ninety patients with previously untreated advanced non-small cell lung cancer were randomly assigned to receive either DC or PC. Patients received docetaxel 75mg/m(2) on day 1 and cisplatin 75mg/m(2) divided into two doses on days 2 to 3 in DC group and paclitaxel 150mg/m(2) on day 1 and cisplatin 75mg/m(2) divided into two doses on days 2 to 3 in PC group. The cycle of two regimens was repeated every 3 weeks. Response and toxicity were evaluated in patients who completed two cycles of chemotherapy at least. RESULTS: Overall survival rate was 31.1% in DC group and 33.3 % in PC group. The median survival time was 10.2 months in DC group and 10.4 months in PC group. Median time to tumor progression was 4.4 months in DC group and 4.9 months in PC group. 1- and 2-year survival rate were 35.6% and 8.9% in DC group and 37.8% and 11.1% in PC group respectively. There were no significant differences in response rate, median survival time, median time to tumor progression and survival rate between two groups (P >0.05). Leucopenia, anemia, nausea and vomiting, and alopecia were the most common grade III and IV toxicities in DC and PC groups, there were no significant differences in grade III and IV toxicities between two groups(P >0.05). There were no treatment-related deaths in both groups. CONCLUSIONS: DC has similar response rate and survivals with PC, and its toxicity is well-tolerated. Docetaxel plus cisplatin is an effective first-line treatment of non-small cell lung cancer.