Comparison of survival and quality of life in advanced non-small-cell lungcancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin: Results of an eastern cooperativeoncology group trial

purpose: Treatment with cisplatin-based chemotherapy provides a modest surv ival advantage over supportive care alone in advanced non-small-cell lung c ancer (NSCLC). To determine whether a new agent, paclitaxel, would further improve survival in NSCLC, the Eastern Cooperative Oncology Group conducted a randomized trial comparing paclitaxel plus cisplatin to a standard chemo therapy regimen consisting of cisplatin and etoposide. Patients and Methods: The study was carried out by a multi-institutional co operative group in chemotherapy-naive stage IIIB to IV NSCLC patients rando mized to receive paclitaxel plus cisplatin or etoposide plus cisplatin. Pac litaxel was administered at two different dose levels (135 mg/m(2) and 250 mg/m(2)), and etoposide was given at a dose of 100 mg/m(2) daily on days 1 to 3. Each regimen was repeated every 21 days and each included cisplatin ( 75 mg/m(2)). Results: The characteristics of the 599 patients were well-balanced across the three treatment groups. Superior survival was observed with the combine d paclitaxel regimens (median survival time, 9.9 months; 1-year survival ra te, 38.9%) compared with etoposide plus cisplatin (median survival time, 7. 6 months; 1-year survival rate, 31.8%; P = .048). Comparing survival for th e two dose levels of paclitaxel revealed no significant difference. The med ian survival duration for the stage IIIB subgroup was 7.9 months for etopos ide plus cisplatin patients versus 13.1 months for all paclitaxel patients (P = .152). For the stage N subgroup, the median survival time for etoposid e plus cisplatin was 7.6 months compared with 8.9 months for paclitaxel (P = .246). With the exceptions of increased granulocytopenia on the low-dose paclitaxel regimen and increased myalgias, neurotoxicity, and, possibly, in creased treatment-related cardiac events with high-dose paclitaxel, toxicit y was similar across all three arms. Quality of life (QOL) declined signifi cantly over the 6 months. However, QOL scores were not significantly differ ent among the regimens. Conclusion: As a result of these observations, paclitaxel (135 mg/m(2)) com bined with cisplatin has replaced etoposide plus cisplatin as the reference regimen in our recently completed phase III trial. J Clin Oncol 18:623-631 . (C) 2000 by American Society of Clinical Oncology.