Phase I II C omparative S tudy o f H igh-Dose C isplatin Versus a C ombination o f P aclitaxel a nd C isplatin i n Patients W ith A dvanced N on-Small-Cell L ung C ancer

Purpose: New effective chemotherapy is needed to improve the outcome of patients with advanced non- small-cell lung cancer (NSCLC). Paclitaxel administered as a single agent or in combination with cisplatin has been shown to be a potentially new useful agent for the Results: Compared with the cisplatin-only arm, there was a 9% improvement (95% confidence interval, 0% to 19%) in overall response rate for the paclitaxel/cisplatin arm (17% v 26%, respectively; P 5 .028). Median time to progression was 2.7 and 4.1 months in the control and paclitaxel/cisplatin arm, respectively (P 5 .026). The study, however, failed to show a significant improvement 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 5 .862). There was more hematotoxicity, peripheral neuropathy, and arthralgia/myalgia on the paclitaxel/cisplatin arm, whereas the high-dose cisplatin arm produced more ototoxicity, nausea, vomiting, and nephrotoxicity. Quality of life (QOL) was similar overall between the two arms. Conclusion: This large randomized phase III trial failed to show a significant improvement in survival for the paclitaxel/cisplatin combination compared with high-dose cisplatin in patients with advanced NSCLC. However, the paclitaxel/cisplatin combination did pro- duce a better clinical response, resulting in an increased time to progression while providing a similar QOL. J Clin Oncol 18:3390-3399. © 2000 by American Society of Clinical Oncology.