OBJECTIVE: Treatment options are still limited in patients with cisplatin-refractory and multiply relapsed germ cell tumors. We evaluated the efficacy and tolerability of lenalidomide within a compassionate use concept. PATIENTS AND METHODS: Four patients multiply relapsed after platin-based chemotherapies without any further standard treatment option received 25 mg lenalidomide orally on days 1-21 of a 28-day cycle. RESULTS: All four patients were pretreated with a median number of seven lines of previous chemotherapy (range 4-8), all including platin-based high-dose chemotherapy. After 4 weeks of lenalidomide treatment all patients had progressive disease with increase in serum tumor markers and progression in computed tomography. Median survival time was 8 weeks (range 5-17). The toxicity profile was favorable. No severe toxicities related to lenalidomide occurred in these patients. CONCLUSION: Lenalidomide was well tolerated and showed efficacy in heavily pretreated patients with cisplatin-refractory and multiply relapsed germ cell tumors.
