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Salvage Treatment With Paclitaxel, Ifosfamide, and Cisplatin Plus High-Dose Carboplatin, Etoposide, and Thiotepa Followed by Autologous Stem-Cell Rescue in Patients With Relapsed or Refractory Germ Cell Cancer

From the Departments of Hematology and Oncology, Charité, Campus Virchow Klinikum, Berlin; Eberhard-Karls Universität, Tübingen; Städtische Kliniken, Oldenburg; Universität Rostock, Rostock; Klinikum Nord, Nürnberg, Universität des Saarlandes, Homburg; Martin Luther Universität, Halle; Johannes Gutenberg Universität, Mainz; Klinikum Grosshadern, München; and Universität Münster, Münster, Germany.

Address reprint requests to J. Beyer, MD, Department of Hematology and Oncology, Philipps Universität Marburg, Baldinger Strasse, 35033 Marburg, Germany; email joerg.beyer{at}mailer.uni-marburg.de

PURPOSE: To study feasibility and efficacy of a new salvage regimen in patients with relapsed and/or refractory germ cell tumors.

PATIENTS AND METHODS: Between May 1995 and February 1997, 80 patients were entered onto a phase II study. Conventional-dose salvage treatment with three cycles of paclitaxel 175 mg/m², ifosfamide 5 x 1.2 g/m², and cisplatin 5 x 20 mg/m² (TIP) was followed by one cycle of high-dose chemotherapy (HDCT) with carboplatin 500 mg/m² x 3, etoposide 600 mg/m² x 4, and thiotepa 150 to 250 mg/m² x 3 (CET). In 23 patients, one additional cycle of paclitaxel 175 mg/m² and ifosfamide 5 g/m² (TI) was given immediately before TIP to improve stem-cell mobilization.

RESULTS: Fifty-five (69%) of 80 patients responded to TIP, 24 (30%) of 80 patients had stable disease (n = 5) or tumor progression (n = 19), and one patient died. Only 62 (78%) of 80 patients received subsequent HDCT. Among those, 41 (66%) of 62 patients responded and 20 (32%) of 62 patients had stable disease (n = 3) or tumor progression (n = 17). One patient died after HDCT from multiorgan failure. Survival probabilities at 3 years were 30% for overall and 25% for event-free survival. Peripheral neurotoxicity with sensorimotor impairment grade 2 through 4 in 29%, paresthesias grade 2 through 4 in 24%, and skin toxicity grade 2 through 3 in 15% of patients were the most relevant side effects.

CONCLUSION: Treatment with TIP followed by high-dose CET is feasible and can induce long-term remissions in 25% of patients with relapsed or refractory germ cell tumors. Peripheral nervous toxicity in approximately one third of patients is a disadvantage of this salvage strategy.

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