Phase III Comparative Study of High-Dose Cisplatin Versus a Combination of Paclitaxel and Cisplatin in Patients With Advanced Non–Small-Cell Lung Cancer

• DOI: 10.1200/jco.2000.18.19.3390
• Publication Date: 2017-02-24T09:24:33Z
• Authors: Ulrich Gatzemeier; Joachim von Pawel; Maya Gottfried; G.P. M. ten Velde; Karin Mattson; Filipo DeMarinis; Peter Harper; Franco Salvati; Gilles Robinet; Antonio Lucenti; Jan Bogaerts; Gilles Gallant
• Keywords: Ototoxicity

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 cisplatin has been shown be potentially new useful for treatment NSCLC.Between January 1995 and April 1996, 414 stage IIIB IV NSCLC were randomized received either control arm high-dose (100 mg/m(2)) paclitaxel (175 mg/m(2), 3-hour infusion) (80 every 21 days.Compared cisplatin-only arm, there was 9% improvement (95% confidence interval, 0% 19%) overall response rate paclitaxel/cisplatin (17% v 26%, respectively; P=.028). Median time progression 2.7 4.1 months respectively (P=.026). The study, however, failed show significant median survival (8.6 8.1 P=.862). There more hematotoxicity, peripheral neuropathy, arthralgia/myalgia on whereas produced ototoxicity, nausea, vomiting, nephrotoxicity. Quality life (QOL) similar between two arms.This large phase III trial compared NSCLC. However, did produce better clinical response, resulting an increased while providing QOL.