title: Long-term survival after treatment with gemcitabine and oxaliplatin with and without paclitaxel plus secondary surgery in patients with cisplatin-refractory and/or multiply relapsed germ cell tumors.
abstract: BACKGROUND
  Chemotherapy including gemcitabine, oxaliplatin, and/or paclitaxel has shown efficacy in germ cell tumor patients after progression during cisplatin-based chemotherapy or relapse after high-dose chemotherapy including complete responses in 5-15%.
  
  
  OBJECTIVE
  Most studies have been published with a short follow-up. We present the long-term outcome of two previously reported trials.
  
  
  METHODS
  Two phase 2 trials have evaluated chemotherapy with gemcitabine plus oxaliplatin alone (GO) or plus paclitaxel (GOP) including a total of 76 patients (35 GO and 41 GOP). At first publication, 29 patients were still alive and 9 patients (12%) were free of disease after chemotherapy with or without surgery: GO, 3 of 35 (9%) and GOP, 6 of 41 (15%).
  
  
  METHODS
  Survival and follow-up time were calculated using the Kaplan-Meier method from the beginning of study treatment until the date of death or the date of the last follow-up.
  
  
  CONCLUSIONS
  After a median follow-up of 19 mo (2-86 mo) for the 29 patients still alive, 11% of all patients (8 of 76) were free of disease for >2 yr: 1 of 35 patients (3%) after GO and 7 of 41 patients (17%) after GOP. Three patients with complete remission (CR), two after GO and one after GOP, relapsed. Two others treated with GOP were rendered disease free: One patient with partial remission and short follow-up underwent secondary surgery, and another patient, who had relapsed 2 mo after GOP, achieved a CR after salvage treatment. Overall survival time is ≥33 mo (range: ≥ 28-59 mo) in these eight patients.
  
  
  CONCLUSIONS
  Long-term survival can be achieved in about 10-15% of patients with cisplatin-refractory or multiply relapsed germ cell tumor with GO(P) chemotherapy. Aggressive secondary surgery following partial remission is a crucial part of this salvage treatment.
authors.affiliation: Department of Oncology/Hematology/Bone Marrow Transplantation/Pneumology, University Medical Center Eppendorf, Hamburg, Germany. k.oechsle@uke.uni-hamburg.de
authors.forename: Karin
authors.initials: K
authors.lastname: Oechsle
authors.forename: Christian
authors.initials: C
authors.lastname: Kollmannsberger
authors.forename: Friedemann
authors.initials: F
authors.lastname: Honecker
authors.forename: Frank
authors.initials: F
authors.lastname: Mayer
authors.forename: Cornelius F
authors.initials: CF
authors.lastname: Waller
authors.forename: Jörg T
authors.initials: JT
authors.lastname: Hartmann
authors.forename: Ina
authors.initials: I
authors.lastname: Boehlke
authors.forename: Carsten
authors.initials: C
authors.lastname: Bokemeyer
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy / Q000401:mortality* / Q000601:surgery; D009944:Organoplatinum Compounds / Q000627:therapeutic use*; D000077150:Oxaliplatin; D017239:Paclitaxel / Q000627:therapeutic use*; D012189:Retrospective Studies; D016879:Salvage Therapy; D013736:Testicular Neoplasms / Q000188:drug therapy / Q000401:mortality* / Q000601:surgery; D016896:Treatment Outcome; D055815:Young Adult; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D017239:Paclitaxel; D002945:Cisplatin; D000093542:Gemcitabine