For 30 months we have treated 115 non-pretreated non-seminomatous germ cell tumour (NSGCT) patients with poor risk characteristics. Patients were allocated randomly to either arm A: NCI regimen with vinblastine, etoposide (E), bleomycin and double dose cisplatin (P2) (PVeBV) 3 or 4 cycles Q3W, or arm B:modified PVeBV protocol (bleomycin in continuous infusion) Q4W then a cycle of high-dose E+cyclophosphamide+P2 (PEC) and autologous bone marrow transplantation (ABMT). 114 patients are evaluable: 81 testicular, 18 mediastinal and 15 retroperitoneal primaries. Results: Arm A 57 patients: 7 patients did not complete the treatment. There were 15 failures, 9 PR, 33 CR. Seven patients relapsed. The 2-year survival is 82%. Arm B 57 patients: 16 patients did not complete the treatment. There were 26 failures, 7 PR and 24 CR. Nine patients relapsed. The 2-year survival is 60%. Both CR rates and survival are not statistically different. This trial fails to show any benefit of early intensified chemotherapy+ ABMT to increase the CR and survival rates in poor risk NSGCT.

Keywords:
Intensified chemotherapy, Autologous bone marrow transplantation, Poor-risk patients, Non-seminomatous germ cell tumours, Testicular germ cell tumours, Extragonadal germ cell tumours, Phase III trial
1993
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