Oxaliplatin and irinotecan plus granulocyte-colony stimulating factor (G-CSF) as third-line treatment in relapsed or cisplatin-refractory germ-cell tumor (GCT) patients: A phase II study

Abstract

4535 Background: Oxaliplatin is an active agent in patients with cisplatin-refractory GCT, while the combination of irinotecan with platinum compounds has also induced responses in such patients. Given the synergistic activity of the two agents, we investigated the efficacy and tolerability of their combination in patients with relapsed or cisplatin-refractory GCT. Methods: Eighteen patients with relapsed or cisplatin-refractory GCT were treated with oxaliplatin 85mg/m2 (days 1,15) and irinotecan 80mg/m2 (days 1,8,15) every 4 weeks for a maximum of 6 cycles. Results: All patients were assessable for response and toxicity. Seven patients (40%) achieved a favorable response (4 complete and 3 partial responses). One of the complete responders relapsed after 2.5 months and, despite treatment with high dose chemotherapy, he died 2 months later; the rest 3 patients are continuously disease-free for 11+, 14+ and 19+ months. The partial responders progressed subsequently and died after 2, 3 and 4.5 months, respec...