Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 24, No 18S (June 20 Supplement), 2006: 4511
© 2006 American Society of Clinical Oncology

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Abstract

Single versus sequential high-dose chemotherapy (HDCT) in patients with relapsed or refractory germ-cell tumors (GCT)

University Hospital, Marburg, Germany; Klinik Reinhardshoehe, Bad Wildungen, Germany; University Hospital, Tuebingen, Germany; BC Cancer Agency, Vancouver, DC, Canada; Staedtische Kliniken, Oldenburg, Germany; University Hospital, Bonn, Germany; University Hospital, Muenster, Germany; Oberschwabenklinik, Ravensburg, Germany; University Hospital, Hamburg, Germany

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Background: Patients (pts) with relapsed or refractory GCT may be cured by HDCT. It is unknown whether single or sequential HDCT is superior. Methods: Between 11/99 and 11/04, 216 pts with relapsed or refractory GTC were treated in a prospective, randomized, multicenter phase III trial with either one cycle of cisplatin 100 mg/m², etoposide 375 mg/m² and ifosfamide 6 g/m² (VIP) plus three cycles of high-dose carboplatin 1500 mg/m² and etoposide 1500 mg/m² (CE, arm A) or three cycles of VIP plus one cycle of high-dose carboplatin 2200 mg/m², etoposide 1800 mg/m² and cyclophosphamide 6400 mg/m² (CEC, arm B) followed by reinfusion of autologous peripheral blood progenitor cells. Primary study endpoint was the event-free survival (EFS) one year after randomization. Secondary endpoints were progression-free survival (PFS), overall survival (OS) and toxicities. An event was defined as any deviation from the planned treatment, relapse, progression or death from any cause. The planned study size was 230 pts to detect a difference of 15% with an alpha error of 5% and a power of 80%. Results: The study was stopped after recruitment of 216 pts due to excess treatment-related mortality in arm B: 111 pts were randomized in arm A and 105 pts in arm B. Due to non-GCT histologies at review 5/216 pts had to be excluded from further analysis. With a median follow-up of 36 months, 109/211 (52%) evaluable pts are still alive and 91/211 (43%) are progression-free. At one year EFS; PFS and OS are 40%, 55% and 80% in arm A as compared to 37%, 49% and 61% in arm B. Treatment-related deaths mainly due to sepsis and cardiac toxicity were less frequent in arm A (4/111 pts, 4%) as compared to arm B (15/105 pts, 14%) (p = 0.01). Severe non-hematologic organ toxicities were also less frequent in arm A. Conclusions: Treatment with sequential high-dose carboplatin and etoposide is at least as effective but less toxic than single HDCT with carboplatin, etoposide and cyclophosphamide.

No significant financial relationships to disclose.

Abstract presentation from the 2006 ASCO Annual Meeting