Background: The optimal treatment of patients with recurrent or refractory germ cell tumors is still a debated topic. High dose chemotherapy (HDCT) with autologous stem cell rescue (ASCR) might be promising for intensification of first or subsequent salvage treatment. However, the long-term results of this approach remain largely unknown.
Methods: Between August 1989 and September 1992, 74 patients with recurrent and/or refractory germ cell tumors were treated in a Phase I/II trial with HDCT consisting of carboplatin (1500-2000 mg/m2), etoposide (1200-2400 mg/m2), and ifosfamide (0-10 g/m2). In September 1995 all patients were reevaluated to determine overall response, late toxicities, and survival.
Results: Two patients died from treatment-related toxicity shortly after HDCT, and 47 had recurrence or progression of disease after a median of 3 months (range, 1-44 months). Of these latter patients, three were living continuously disease free at the conclusion of this study after a second HDCT regimen, salvage surgery, or chronic oral etoposide treatment. The results were an overall survival of 38% (95% confidence interval, 27-50%) and a failure free survival of 31% (95% confidence interval, 21-43%) at 5 years. There were no long-term survivors among patients whose disease progressed while they were receiving conventional doses of cisplatin before HDCT. Late toxicities consisted mainly or renal impairment (in 21% of patients), paresthesias (in 29%), and ototoxicity (in 18%).
Conclusions: HDCT can be curative for patients with germ cell tumors who do not become disease free after conventional dose chemotherapy but respond to this treatment.