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Combination Chemotherapy With Gemcitabine Plus Oxaliplatin in Patients With Intensively Pretreated or Refractory Germ Cell Cancer: A Study of the German Testicular Cancer Study Group

From the Department of Hematology/Oncology, University of Tuebingen Medical Center, Tuebingen; Department of Hematology/Oncology, University of Marburg, Marburg; Department of Hematology/Oncology, University of Muenster, Muenster; Department of Hematology/Oncology, University of Hannover Medical School, Hannover; Department of Hematology/Oncology, Klinikum Oldenburg, Oldenburg; Department of Hematology/Oncology, Charite, University of Berlin, Berlin; Department of Hematology/Oncology, Hegau-Klinikum, Singen; and Department of Hematology/Oncology, University of Goettingen, Goettingen, Germany

Address reprint requests to C. Bokemeyer, MD, Department of Hematology/Oncology, University of Tuebingen Medical Center, Otfried-Mueller-Str 10, 72076 Tuebingen, Germany; e-mail: carsten.bokemeyer{at}med.uni-tuebingen.de

PURPOSE: Long-term survival is rarely achieved in patients with cisplatin-refractory germ cell cancer (GCT). Both single-agent gemcitabine and oxaliplatin have shown activity in patients who experience relapse or are refractory to cisplatin treatment. This study investigates the activity of a gemcitabine plus oxaliplatin regimen in these patients.

PATIENTS AND METHODS: Gemcitabine was administered at a dose of 1,000 mg/m² on days 1 and 8; oxaliplatin was administered at a dose of 130 mg/m² on day 1. Response was evaluated every 4 weeks.

RESULTS: Thirty-five patients with a median age of 37 years (range, 21 to 54 years) were enrolled onto the study. Primary tumor localization was gonadal, retroperitoneal, or mediastinal in 30, one, and four patients, respectively. Patients had been pretreated with a median of six platinum-containing cycles (range, four to 13 cycles) and 89% of patients previously had experienced treatment failure after high-dose chemotherapy with peripheral-blood stem-cell transplantation. Sixty-three percent of patients were considered absolutely cisplatin-refractory or cisplatin-refractory. A median of two cycles (range, 1 to 6 cycles) per patient were applied. Toxicity consisted mainly of myelosuppression, with Common Toxicity Criteria grade 3 occurring in 54% of patients. Only 9% of patients developed neutropenic fever. Three patients attained a complete remission (CR), two patients attained a marker-negative partial remission, and 11 patients attained a marker-positive partial remission, resulting in an overall response rate of 46% (95% CI, 30% to 64%). All three patients with CR and one patient with a marker-negative partial remission remained disease free at 16+, 12+, 4+, and 2+ months of follow-up. Seven (44%) of these 16 responses, including one CR, occurred in cisplatin-refractory patients.

CONCLUSION: Gemcitabine plus oxaliplatin demonstrates antitumor activity with acceptable toxicity in heavily pretreated patients with relapsed or cisplatin-refractory GCT, and may offer a chance of long-term survival for selected patients.

Supported by an educational grant from Sanofi-Synthelabo Inc, Berlin, Germany.

These data were presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology Meeting, Chicago, IL, May 31-June 3, 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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