Phase II study of oxaliplatin and gemcitabine salvage chemotherapy in patients with cisplatin-refractory nonseminomatous germ cell tumor.

Objective: Cisplatin-refractory germ cell tumors (GCTs) represent a subset of germinal neoplasms with a poor prognosis. Conventional-dose chemotherapy induces objective response in 10-20% of these patients with rare durable complete remissions. We investigated the activity and tolerance of a chemotherapeutic regimen with oxaliplatin and gemcitabine.

Patients And Methods: Treatment consisted of oxaliplatin 130 mg/m(2) day 1, and gemcitabine 1,250 mg/m(2), days 1 and 8, every three weeks.

Results: Eighteen patients were enrolled and were assessable for response and toxicity. Primary site was testis in twelve cases, retroperitoneum in four, and mediastinum in two. Seven patients (39%) were cisplatin-refractory, while eleven (61%) absolutely cisplatin-refractory. A median of three cycles (range, 1-6) per patient were given. One patient achieved a clinical complete remission, one a partial remission with negative marker in whom complete surgical resection of residual masses yielded mature teratoma only, and one a partial remission with positive marker in whom complete surgical resection of residual masses yielded viable tumor cells. These three cases were characterized by testicular primary embryonal carcinoma. They remained disease-free at 44+, 20+, and 18+ months of follow-up.

Conclusion: The oxaliplatin-gemcitabine combination is a safe and active standard-dose regimen for patients with cisplatin-refractory testicular primary GCT.