A phase II study of cisplatin plus epirubicin salvage chemotherapy in refractory germ cell tumors

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4526 Background: Initial cisplatin combination chemotherapy will cure 70% of patients with disseminated testicular cancer. Approximately 1/3 will be cured with subsequent salvage therapy. This phase II clinical trial evaluated the combination of cisplatin plus epirubicin in patients with refractory germ cell tumors (GCT) not amenable to cure with standard salvage therapy. Methods: Between march 2001 and October of 2004, 24 patients with refractory GCT were enrolled, of which 1 was too early to evaluate. Patients who had progressed within 4 weeks of prior platinum based chemotherapy were ineligible. All pts were male, with median age 36 (range 24–45). Median number of previous regimens was 2 (range 1–3). Five pts had extragonadal non-seminomatous germ cell tumor(NSGCT). Fifteen pts (68%) were late relapses (>2 years). Patients received epirubicin 90mg/m2 day 1 and cisplatin 20 mg/m2 on days 1–5 every 3 weeks for a maximum of four cycles. Support with granulocyte colony stimulating factor (GCSF) or pegfilgrastim was given to all pts. Results: Eighteen of 23 pts (78%) received all four cycles. Toxicity was primarily hematologic: grade 3/4 neutropenia, 3 pts (1 neutropenic fever); 2 pts had grade 3 thrombocytopenia, and 3 pts had grade 3/4 anemia. Non-hematologic toxicity was: grade 3 electrolyte wasting, 2 pts; grade 3 nausea/vomiting, 6 patients; grade 3 diarrhea, 1 patient. There were no cases of severe mucositis or cardiotoxicity, and no treatment related deaths. Twelve of 23 pts (52%) had objective response to therapy. Seven pts achieved a no evidence of disease status (NED), 2 of these after resection of persistent carcinoma, and 1 after resection of persistent teratoma. Five of these 7 pts remained NED at 3+, 3+, 19+, 32+, and 36+ months. Two additional pts remain alive with persistent radiological abnormalities but normal serum markers at +10 and +31 months. Conclusions: Cisplatin plus epirubicin is an active regimen in refractory GCT, with an acceptable toxicity profile. this regimen offers palliation but also a potential for long term disease-free survival in this refractory population. This trial was partially supported by Pharmacia. No significant financial relationships to disclose.