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Patients with poor risk germ cell cancer (non-testicular germ cell cancer with a mediastinal primary, liver metastasis, markedly elevated tumor markers) have an approximate cure rate of 40-50% with conventional chemotherapy. High-dose chemotherapy with PBSC support has been investigated as salvage therapy for patients with metastatic germ-cell cancer who had failed chemotherapy with the suggestion that this is superior to conventional dose chemotherapy. Recently, physicians in Germany further evaluated HDC with PBSC support as initial therapy for patients with aggressive poor risk germ cell cancer. They compared the results of HDC in 146 patients to conventional-dose therapy in similar patients. They observed a 3 year cancer-free survival of 72% in patients receiving HDC with PBSC support compared to 59% for patients receiving conventional chemotherapy. This analysis provided the basis for a proposed randomized controlled trial that will directly compare HDC with PBSC support to conventional therapy for patients with poor risk metastatic germ cell cancer in the United States. (Proceedings of American Society of Clinical Oncology, Vol 18, Abstract 1169, 1999).

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