One course of adjuvant PEB chemotherapy versus retroperitoneal lymph node dissection in patients with stage I non-seminomatous germ-cell tumors (NSGCT): Results of the German Prospective Multicenter Trial (Association of Urological Oncology [AUO]/German Testicular Cancer Study Group [GTCSG] Trial 01–94)

Abstract

4512 Background: The incidence of relapse was analyzed in patients with clinical stage I (CS I) NSGCT after either retroperitoneal lymph node dissection (RPLND) or one course of adjuvant cisplatin, etoposide, and bleomycin (PEB) chemotherapy. Methods: Between September 1996 and February 2005, 382 patients with stage I NSGCT were included in the German Prospective Multicenter Trial. After orchiectomy, patients were randomized to either RPLND (191 patients) or one cycle of cisplatin 20 mg/sqm d1–5, etoposide 100 mg/sqm d1–5, and bleomycin 30 mg d1, 8, 15 (PEB, 191 patients). Pathological stage II after RPLND (18% of CS I) was followed by adjuvant chemotherapy (2 × PEB). The primary endpoint was relapse rate. The trial was powered to show an advantage for chemotherapy (planned sample size 360 patients, alpha 5%, power 80%) after a median follow-up of 3 years. Results: Thirty-six patients were excluded due to violation of the inclusion criteria. Of the remaining 346 eligible cases, 172 patients were treated by RPLND and 174 patients received one course of PEB. Median time of follow-up was 47 months, with 323 patients (93%) followed-up for at least 1 year. Of the evaluable patients 331 (96%) have remained disease-free. Thirteen (8%) patients experienced relapse after RPLND and 2 (1%) after one course of adjuvant PEB (p = 0.0028). All patients with relapse have been successfully treated. Five patients developed pulmonary metastases, 3 patients relapsed with retroperitoneal metastases, 3 patients showed marker elevations, and 2 patients had an inguino-scrotal relapse after RPLND. The patients with one cycle of PEB relapsed with a tumor marker elevation and a mature teratoma retroperitoneal metastases, respectively. Conclusions: This randomized trial revealed only two relapses among 174 patients treated with one course of PEB. The low risk of recurrence supports one course of PEB over RPLND for the treatment of patients with clinical stage I NSGCT. No significant financial relationships to disclose.