Abstract

1540 Background: Through the use of cisplatin-based combination chemotherapy and radiotherapy, outcomes have improved for patients with intracranial germ cell tumor. An appropriate therapy for recurrent germ cell tumors, however, remains to be established. The present feasibility study investigates the toxicity and activity of a gemcitabine/docetaxel combination in patients with multiply relapsed germ cell tumor. Methods: Gemcitabine was administered at a dose of 1000 mg/m2 over 30 minutes on days 1, 8 followed by docetaxel (1 h-infusion) at a dose of 60 mg/m2 on day 8, with courses repeated every 21 days. Results: From 9/00 to 9/01 5 patients with a median age of 15 [13–32] years were enrolled. Patients had been pretreated with a median of 9 [3–16] platin-containing cycles and 1 patient had previously failed high-dose chemotherapy with PBSCT. All patients were considered cisplatin-refractory. Median number of applied cycles was 2 [2–4]. All patients achieved a radiological partial response with a tumor marker normalization resulting in an objective response rate of 100%. However, the remissions after chemotherapy alone were not durable. Three of the 5 patients received an additional low-dose of irradiation following the chemotherapy. Median progression-free interval was 26 [7–39+] months with 2 patients remaining without disease progression for more than 30 months. Toxicity was generally acceptable: CTC grade III/IV neutropenia of short duration occurred in all patients. No case of grade III/IV non-hematological adverse effect was observed. Conclusions: The combination of gemcitabine/docetaxel is feasible and associated with an acceptable toxicity in patients with multiply relapsed and cisplatin-refractory germ cell tumor. It exhibits a significant activity with responses observed in all patients. No significant financial relationships to disclose.

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