title: Phase II study of oxaliplatin and gemcitabine salvage chemotherapy in patients with cisplatin-refractory nonseminomatous germ cell tumor.
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.
  
  
  METHODS
  Treatment consisted of oxaliplatin 130 mg/m(2) day 1, and gemcitabine 1,250 mg/m(2), 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.
  
  
  CONCLUSIONS
  The oxaliplatin-gemcitabine combination is a safe and active standard-dose regimen for patients with cisplatin-refractory testicular primary GCT.
authors.affiliation: Department of Oncology and Hematology, Istituto Oncologico Romagnolo, Santa Maria delle Croci Hospital, Ravenna, Italy. ugo_degiorgi@yahoo.com
authors.forename: Ugo
authors.initials: U
authors.lastname: De Giorgi
authors.forename: Giovanni
authors.initials: G
authors.lastname: Rosti
authors.forename: Michele
authors.initials: M
authors.lastname: Aieta
authors.forename: Franco
authors.initials: F
authors.lastname: Testore
authors.forename: Luciano
authors.initials: L
authors.lastname: Burattini
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Fornarini
authors.forename: Emanuele
authors.initials: E
authors.lastname: Naglieri
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lo Re
authors.forename: Federica
authors.initials: F
authors.lastname: Zumaglini
authors.forename: Maurizio
authors.initials: M
authors.lastname: Marangolo
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols; D002945:Cisplatin / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019008:Drug Resistance, Neoplasm; D006801:Humans; D008875:Middle Aged; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy*; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D000077150:Oxaliplatin; D016879:Salvage Therapy; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine