Phase II Study of Oxaliplatin and Gemcitabine Salvage Chemotherapy in Patients with Cisplatin-Refractory Nonseminomatous Germ Cell Tumor

Ugo De Giorgi, Giovanni Rosti, Michele Aieta, Franco Testore, Luciano Burattini, Giuseppe Fornarini, Emanuele Naglieri, Giovanni Lo Re, Federica Zumaglini, Maurizio Marangolo

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: Cisplatin-refractory germ cell tumors (GCTs) represent a subset of germinal neoplasms with a poor prognosis. Conventional-dose chemotherapy induces objective response in 10-20% of these patients with rare durable complete remissions. We investigated the activity and tolerance of a chemotherapeutic regimen with oxaliplatin and gemcitabine. Patients and methods: Treatment consisted of oxaliplatin 130 mg/m2 day 1, and gemcitabine 1250 mg/m2, days 1 and 8, every three weeks. Results: Eighteen patients were enrolled and were assessable for response and toxicity. Primary site was testis in twelve cases, retroperitoneum in four, and mediastinum in two. Seven patients (39%) were cisplatin-refractory, while eleven (61%) absolutely cisplatin-refractory. A median of three cycles (range, 1-6) per patient were given. One patient achieved a clinical complete remission, one a partial remission with negative marker in whom complete surgical resection of residual masses yielded mature teratoma only, and one a partial remission with positive marker in whom complete surgical resection of residual masses yielded viable tumor cells. These three cases were characterized by testicular primary embryonal carcinoma. They remained disease-free at 44+, 20+, and 18+ months of follow-up. Conclusion: The oxaliplatin-gemcitabine combination is a safe and active standard-dose regimen for patients with cisplatin-refractory testicular primary GCT.

Original languageEnglish
Pages (from-to)1032-1039
Number of pages8
JournalEuropean Urology
Volume50
Issue number5
DOIs
Publication statusPublished - Nov 2006

Keywords

  • Cisplatin-refractory
  • Gemcitabine
  • Germ cell tumor
  • Oxaliplatin
  • Salvage chemotherapy

ASJC Scopus subject areas

  • Urology

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