Gemcitabine plus cisplatin vs. gemcitabine plus carboplatin in stage IIIb and IV non-small cell lung cancer: a phase III randomized trial Petr Zatloukal a, *, Lubos ˇ Petruz ˇelka b , Milada Zemanova ´ b , Vı ´te ˇzslav Kolek c , Jana Skr ˇic ˇkova ´ d , Milos ˇ Pes ˇek e ,HanaFojtu˚ c , Ivona Gryga ´rkova ´ c , Dimka Sixtova ´ f , Jaromı ´r Roubec g , Eva Hor ˇenkova ´ g , Libor Havel a ,PetrPru˚s ˇa h , Leona Nova ´kova ´ h , Toma ´s ˇ Ska ´cel i , Milan Ku ˚ta j a Department of Pneumology and Thoracic Surgery, Postgraduate Medical School, 3rd Faculty of Medicine, Charles University, and Faculty Hospital Na Bulovce, Budı´nova 2, Prague 180 81, Czech Republic b Department of Oncology, 1st Faculty of Medicine, Charles University, General Faculty Hospital and Postgraduate Medical School, Prague, Czech Republic c Department of Pulmonary Diseases and TB, Palacky University, Olomouc, Czech Republic d Department of Respiratory Diseases and TB, University Hospital, Brno-Bohunice, Czech Republic e Department of Tuberculosis and Respiratory Diseases, Charles University, Plzen, Czech Republic f Department of Tuberculosis and Respiratory Diseases, Thomayer Faculty Hospital, Prague, Czech Republic g Department of Tuberculosis and Respiratory Diseases, Faculty Hospital, Ostrava, Czech Republic h Department of Tuberculosis and Respiratory Diseases, Kladno, Czech Republic i Department of Oncology, Kromeriz, Czech Republic j Department of Oncology, Chomutov, Czech Republic Received 9 January 2003; received in revised form 31 March 2003; accepted 8 April 2003 KEYWORDS Gemcitabine; Cisplatin; Carboplatin Summary Purpose: This randomized, multicenter, phase III trial was conducted to compare the tolerability of gemcitabine plus cisplatin (GP) vs. gemcitabine plus carboplatin (GC) in chemonaive patients with stage IIIb and IV non-small cell lung carcinoma (NSCLC). Secondary objectives were to evaluate response, duration of response, time to progressive disease (TTPD), and survival. Patients and methods: Eligible patients were required to have stage IIIb or IV NSCLC, no previous chemotherapy, Karnofsky performance status of at least 70, bidimensionally measur- able disease, and age 18  /75 years. Randomized patients in both arms were given gemcitabine 1200 mg/m 2 on days 1 and 8, followed on day 1 by cisplatin 80 mg/m 2 (GP) or carboplatin AUC /5 (GC). Treatment cycles were repeated every 21 days for a maximum of six cycles, or until disease progression or unacceptable toxicity occurred. Results: Enrolled patients in both arms, 87 in GP and 89 in GC, were well balanced for demographics and disease characteristics. Dose intensity was 93.8 and 92.7% for gemcitabine in GP/GC arms, respectively; 97.7% for cisplatin and 99.9% for *Corresponding author. Tel.:  /420-2-6608-2080; fax:  /420-2-8484-0840. E-mail address: zatloukp@fnb.cz (P. Zatloukal). Lung Cancer (2003) 41, 321  /331 www.elsevier.com/locate/lungcan 0169-5002/03/$ - see front matter – 2003 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/S0169-5002(03)00233-2