Irinotecan plus cisplatin has substantial antitumor effect as salvage chemotherapy against germ cell tumors.

Background: Only 20-30% of patients with refractory or recurrent germ cell tumors (GCT) are cured by salvage chemotherapy. Irinotecan, a new derivative of camptothecin, is a potent anticancer agent against a variety of solid cancers. The current pilot study investigated the efficacy of salvage chemotherapy with irinotecan in combination with cisplatin (CDDP) or nedaplatin (NDP), a derivative of cisplatin, for GCT.

Methods: The combination chemotherapy consisted of 100-150 mg/m(2) irinotecan on Days 1 and 15 or 200-300 mg/m(2) on Day 1 in combination with 20 mg/m(2) CDDP on Days 1-5 or 100 mg/m(2) NDP on Day 1 every 4 weeks. Patients with refractory GCT, ranging in age from 17 to 43 years, received 2-11 cycles of the combination chemotherapy. The median duration of follow-up is 28 months (8-140 months).

Results: Twenty patients entered this study, 18 of whom were assessed for response and toxicity. The response rate was 50 % (two complete responses and seven partial responses). Nine patients remain alive without disease. However, six patients died of the disease and one patient died of a brain glioma. The 5-year survival rate was approximately 53%. Myelosuppression was the major toxicity, but was manageable.

Conclusions: This pilot study demonstrates that the chemotherapy with irinotecan in combination with CDDP or NDP showed significant anticancer activity for patients with refractory GCT, without serious side effects. Although this study comprised only a few patients, these findings suggest that the combination chemotherapy may be one of the options of salvage chemotherapy for patients with refractory GCT.