Phase II Study of Picoplatin As Second-Line Therapy for Patients With Small-Cell Lung Cancer

Purpose This study was designed to confirm the efficacy and safety of picoplatin, a cisplatin analog designed to overcome platinum resistance, in patients with small-cell lung cancer (SCLC) with platinum-refractory/-resistant disease. Patients and Methods All patients received intravenous picoplatin 150 mg/m(2) every 3 weeks. Tumor response, progression-free survival, and overall survival were evaluated. Adverse events were assessed for frequency, severity, and relationship to treatment. Quality of life was assessed with the Lung Cancer Symptom Scale instrument. Results Seventy-seven patients were treated with picoplatin (median number of cycles, two; range one to 10). Three patients (4%) had a partial response, 33 (43%) had stable disease (four of these were unconfirmed partial responses), 36 (47%) had progressive disease, and five were not assessable for response. Median progression-free survival was 9.1 weeks (95% CI, 7.0 to 12.1 weeks). Median overall survival was 26.9 weeks (95% CI, 21.1 to 33.4). The most common grade 3 and 4 toxicities were thrombocytopenia (48%), neutropenia (25%), and anemia (20%). The most commonly reported adverse events of any severity included thrombocytopenia (64%), anemia (49%), neutropenia (39%), nausea (27%), fatigue (16%), and dyspnea (16%). No severe neurotoxicity or nephrotoxicity were observed. There were no treatment-related deaths. Conclusion Picoplatin demonstrated clinical efficacy in platinum-refractory SCLC. The major toxicity was hematologic. These results warrant further evaluation in this patient population. J Clin Oncol 27: 2046-2051. (C) 2009 by American Society of Clinical Oncology