Phase III comparative study of high-dose cisplatin versus a combination ofpaclitaxel and cisplatin in patients with advanced non-small-cell lung cancer

Purpose: New effective chemotherapy is needed to improve the outcome of pat ients with advanced nonsmall-cell lung cancer (NSCLC). Paclitaxel administe red as a single agent or in combination with cisplatin has been shown to be a potentially new useful agent for the treatment of NSCLC, Patients and Methods: Between January 1995 and April 1996, 414 patients wit h stage IIIB or IV NSCLC were randomized to received either a control arm o f high-dose cisplatin (100 mg/m(2)) or a combination of paclitaxel (175 mg/ m(2), 3-hour infusion) and cisplatin (80 mg/m(2)) every 21 days. Results: Compared with the cisplatin-only arm, there was ct 9% improvement (95% confidence interval, 0% to 19%) in overall response rate for the pacli taxel/cisplatin arm (17% v 26%, respectively; P =.028). Median time to prog ression was 2.7 and 4.1 months in the control and paclitaxel/cisplatin arm, respectively (P =.026). The study, however, failed to show a significant i mprovement in median survival for the paclitaxel/cisplatin arm (8.6 months in the control arm v 8.1 months in the paclitaxel/ cisplatin arm, P =.862), There was more hematotoxicity, peripheral neuropathy, and arthralgia/myalg ia on the paclitaxel/cisplatin arm, whereas the high-dose cisplatin arm pro duced more ototoxicity, nausea, vomiting, and nephrotoxicity. Quality of li fe (QOL) was similar overall between the two arms. Conclusion: This large randomized phase III trial failed to show a signific ant improvement in survival for the paclitaxel/cisplatin combination compar ed with high-dose cisplatin in patients with advanced NSCLC. However, the p aclitaxel/cisplatin combination did produce a better clinical response, res ulting in an increased time to progression while providing ct similar QOL. J Clin Oncol 18:3390-3399, (C) 2000 by American Society of Clinical Oncolog y.