GAMEC – a new intensive protocol for untreated poor prognosis and relapsed or refractory germ cell tumours

There is no consensus as to the management of untreated poor prognosis or relapsed/refractory germ cell tumours. We have studied an intensive cisplatin-based regimen that incorporates high-dose methotrexate (HD MTX) and actinomycin-D and etoposide every 14 days (GAMEC). Sixty-two patients were enrolled in a phase 2 study including 27 who were untreated (IGCCCG, poor prognosis) and 35 with progression despite conventional platinum based chemotherapy. The pharmacokinetics of the drugs were correlated with standard outcome measures. Twenty of the untreated patients were progression free following GAMEC and appropriate surgery, as were 18 individuals in the pretreated group. None of the established prognostic factors for therapy for pretreated patients could identify a poor-prognosis group. Five out of nine late relapses to prior chemotherapy were progression free following GAMEC and appropriate surgery. All patients had at least one episode of febrile neutropenia and there were five (8%) treatment-related deaths. PK values were not predictive of efficacy or toxicity, although the dose intensity in the pretreated group of patients, especially of HD MTX, was significantly correlated with progression-free survival (PFS). GAMEC is a novel intensive regimen for this group of patients producing encouraging responses, although with significant toxicity. For those in whom it fails, further therapy is still possible with durable responses being seen

BOMP/EPI intensive alternating chemotherapy for IGCCC poor-prognosis germ-cell tumors: The Spanish Germ-Cell Cancer Group experience (GG)

Summary Background: Patients with poor-prognosis germ-cell tumors according to the IGCCC have a poor long-term survival. This study evaluates the e¤cacy and toxicity of the intensive alternating chemotherapy regimen BOMP/EPI in these patients. Patients and methods: Patients with IGCCC poor-prognosis germ-cell tumors treated at 13 centres were studied. Treatment consisted of bleomycin 30 mg, vincristine 2 mg, methotrexate 300 mg/m 2 and cisplatin 100 mg/m 2 (BOMP), alternating after a 14-day interval with etoposide 120 mg/m 2 day 1^4, ifosfamide 1.3 g/m 2 day 1^4 and cisplatin 25 mg/m 2 day 1^4 (EPI). BOMP was administered 21 days after the EPI. Bleomycin was administered weekly per 12 weeks. Results: Thirty-eight patients were treated. The median number of cycles administered was 7 (1^10 cycles). Eighteen patients achieved complete responses with chemotherapy alone (12 had necrosis and 2 mature teratoma at postchemotherap