Randomized, multicenter, phase II study of gemcitabine plus cisplatin versus gemcitabine plus carboplatin in patients with advanced non-small cell lung cancer

• Published in: Lung cancer (Amsterdam, Netherlands) Netherlands), 2003-07, Vol.41 (1), p.81-89
• Main Authors: Mazzanti, Paola, Massacesi, Cristian, Rocchi, Marco B.L., Mattioli, Rodolfo, Lippe, Paolo, Trivisonne, Raffaele, Buzzi, Franco, De Signoribus, Giorgio, Tuveri, Guido, Rossi, Giorgio, Di Lullo, Liberato, Sturba, Fabio, Morale, Donatella, Catanzani, Sergio, Pilone, Alberta, Bonsignori, Maurizio, Battelli, Tullio
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Antimetabolites, Antineoplastic - administration & dosage; Antimetabolites, Antineoplastic - adverse effects; Antimetabolites, Antineoplastic - therapeutic use; Antineoplastic agents; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carboplatin; Carboplatin - administration & dosage; Carboplatin - adverse effects; Carboplatin - therapeutic use; Carcinoma, Non-Small-Cell Lung - drug therapy; Chemotherapy; Cisplatin; Cisplatin - administration & dosage; Cisplatin - adverse effects; Cisplatin - therapeutic use; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Deoxycytidine - therapeutic use; Female; Gemcitabine; Humans; Lung Neoplasms - drug therapy; Male; Medical sciences; Middle Aged; Non-small cell lung cancer; Pharmacology. Drug treatments; Phase II; Pneumology; Prognosis; Prospective Studies; Randomized; Survival Rate; Treatment Outcome; Tumors of the respiratory system and mediastinum
• ISSN: 0169-5002; 1872-8332
• DOI: 10.1016/S0169-5002(03)00140-5

Background: We conducted a phase II randomized study to assess the efficacy, with response as the primary endpoint, and the toxicity of gemcitabine/cisplatin (GP) and gemcitabine/carboplatin (GC) in patients with advanced non-small cell lung cancer (NSCLC). Methods: Patients were randomized to GP (gemcitabine 1200 mg/m 2, days 1 and 8 plus cisplatin 80 mg/m 2 day 2) or GC (gemcitabine 1200 mg/m 2, days 1 and 8 plus carboplatin AUC=5 day 2). Cycles were repeated every 3 weeks. Results: Sixty-two patients were randomized to GP and 58 to GC. A total of 533 cycles were delivered (264 GP, 269 GC), with a median of four cycles/patient. The objective response rate was 41.9% (95% C.I., 29.6–54.2%) for GP and 31.0% (95% C.I., 18.2–42.8%) for GC ( P=0.29). No significant differences between arms were observed in median survival (10.4 months GP, 10.8 months GC) and median time to progression (5.4 months GP, 5.1 months GC). Both regimens were very well tolerated with no statistical differences between arms in grade 3/4 toxicities. When all toxicity grades were combined, emesis, neuropathy and renal toxicity occurred more frequently on the GP arm ( P