Bedano PM et al. (2007) Phase II study of cisplatin plus epirubicin salvage chemotherapy in refractory germ cell tumors. J Clin Oncol 24: 5403–5407

The majority of patients with disseminated testicular cancer can be cured with first-line cisplatin-based combination chemotherapy. Some patients do not respond to either first-line or standard salvage chemotherapy, however; new treatments are needed for these patients, whose prognosis is poor.

Bedano et al. reported the results of a Phase II study of cisplatin and epirubicin chemotherapy in patients with refractory germ cell tumors. The patients had worsening disease after initial cisplatin-based combination therapy, and their tumors were unresponsive to standard salvage chemotherapy.

The study included 30 male patients (median age 36 years). Of these, 21 had experienced late relapses more than 2 years after first-line chemotherapy. They were treated with 90 mg/m2 epirubicin administered intravenously on day 1 and 20 mg/m2 intravenous cisplatin on days 1–5, repeated every 21 days, for a maximum of four cycles. Toxic effects were predominantly hematologic. A response to treatment was seen in 17 of 30 patients, and the median survival was 14.5 months. Seven patients had no evidence of disease at their final assessment (25–48 months after treatment). Two patients became disease-free after chemotherapy alone, and four became disease-free after chemotherapy followed by surgery.

The authors conclude that this combination of cisplatin and epirubicin offers the possibility of prolonged survival in patients with refractory germ cell tumors, with an acceptable toxicity profile. Combination chemotherapy followed by resection could offer patients who were not surgical candidates at relapse the chance to achieve disease-free status.