title: A phase II multicenter study of oxaliplatin in combination with paclitaxel in poor prognosis patients who failed cisplatin-based chemotherapy for germ-cell tumors.
abstract: BACKGROUND
  The aim of this study is to determine feasibility and efficacy of the combination regimen oxaliplatin and paclitaxel in patients with cisplatin (CDDP)-refractory germ-cell tumors (GCT).
  
  
  METHODS
  Patients with either a cisplatin absolute-refractory GCT defined as progressive disease (PD) during or within 1 month of CDDP administration or with a poor prognosis relapse, defined as PD between the second and the sixth month after CDDP administration, were treated with a combination of oxaliplatin (130 mg/m(2)) and paclitaxel (175 mg/m(2)) administered every 21 days. Primary end point was efficacy.
  
  
  RESULTS
  Twenty-seven patients were included. Patients were pretreated with a median of two lines of cisplatin-based chemotherapy (range 1-5). Sixteen patients were absolute refractory. Five patients had relapsed after high-dose chemotherapy plus stem-cell support. There were no complete responses but there was one marker-positive partial response and nine disease stabilization (34, 6%). After a median follow-up of 65 months, two patients are disease-free survivors. Main toxicity was leucocytopenia grade 3/4 in 30% of the patients.
  
  
  CONCLUSIONS
  Combination chemotherapy with oxaliplatin and paclitaxel is feasible with acceptable toxicity and may be effective if combined with additional treatment in patients with CDDP-refractory GCT.
authors.affiliation: Department of Medicine, Institut Gustave Roussy, Villejuif. Electronic address: c.theodore@hopital-foch.org.
authors.forename: C
authors.initials: C
authors.lastname: Theodore
authors.affiliation: Department of Medicine, Institut Claudius Regaud, Toulouse.
authors.forename: C
authors.initials: C
authors.lastname: Chevreau
authors.affiliation: Department of Oncology, Sanofi aventis pharmaceuticals Paris.
authors.forename: Y
authors.initials: Y
authors.lastname: Yataqhene
authors.affiliation: Department of Medicine, Institut Gustave Roussy, Villejuif.
authors.forename: K
authors.initials: K
authors.lastname: Fizazi
authors.affiliation: Department of Medicine, Institut Claudius Regaud, Toulouse.
authors.forename: J-P
authors.initials: JP
authors.lastname: Delord
authors.affiliation: Department of Medicine, Hopital Tenon, Paris.
authors.forename: J-P
authors.initials: JP
authors.lastname: Lotz
authors.affiliation: Department of Oncology, Centre Alexis Vautrin, Nancy.
authors.forename: L
authors.initials: L
authors.lastname: Geoffrois
authors.affiliation: Department of Medicine, Centre Eugène. Marquis, Rennes.
authors.forename: P
authors.initials: P
authors.lastname: Kerbrat
authors.affiliation: Department of Medicine, Institut Bergoniè, Bordeaux.
authors.forename: V
authors.initials: V
authors.lastname: Bui
authors.affiliation: Department of Medicine, Centre. Léon Bérard, Lyon, France.
authors.forename: A
authors.initials: A
authors.lastname: Flechon
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy*; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D000077150:Oxaliplatin; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D012008:Recurrence; D013736:Testicular Neoplasms / Q000188:drug therapy*
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D017239:Paclitaxel