title: Long-term survival with paclitaxel and gemcitabine for germ cell tumors after progression following high-dose chemotherapy with tandem transplant.
abstract: OBJECTIVE
  Germ cell tumor patients progressing after high-dose chemotherapy (HDCT) have a dismal prognosis. A prior retrospective study of paclitaxel and gemcitabine enrolled 32 patients. All failed first-line chemotherapy and salvage therapy with HDCT. We now present long-term results.
  
  
  METHODS
  Eligible patients received BEP or similar first-line chemotherapy and subsequent HDCT. They were treated with paclitaxel (100 mg/m) on days 1, 8, and 15 and gemcitabine (1000 mg/m) on days 1, 8, and 15 every 4 weeks for a maximum of 6 cycles.
  
  
  RESULTS
  Ten of 32 (31%) had an objective response (4 partial remissions and 6 complete responses). Four patients (12.5% of total) have enjoyed long-term survival; 3 are continuously disease free for 64, 94, and 122 months. None of these 3 received subsequent chemotherapy or surgery. A fourth patient relapsed after 72 months, and has now reachieved remission for 36+ months after treatment with the same regimen. These patients had 2, 2, 2, and 4 prior therapies, respectively, and a rising serum human chorionic gonadotropin (69 and 138 mIU/mL), α-fetoprotein (525 ng/mL), or increasing intrathoracic metastases. Longest prior response ranged from 5 to 24 months.
  
  
  CONCLUSIONS
  Paclitaxel and gemcitabine salvage chemotherapy can offer long-term survival and probable cure in relapsed/refractory germ cell tumor patients after HDCT. This is an appropriate regimen in a taxane-naive and gemcitabine-naive patient population. This is the first example of a nonplatinum curative chemotherapy regimen in patients progressing after HDCT.
authors.affiliation: *Hematology Oncology of Indiana †Division of Hematology/Oncology, Indiana University Simon Cancer Center, Indianapolis, IN.
authors.forename: Brian P
authors.initials: BP
authors.lastname: Mulherin
authors.forename: Mary J
authors.initials: MJ
authors.lastname: Brames
authors.forename: Lawrence H
authors.initials: LH
authors.lastname: Einhorn
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001761:Bleomycin / Q000627:therapeutic use; D006063:Chorionic Gonadotropin / Q000378:metabolism; D002945:Cisplatin / Q000627:therapeutic use; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives; D005047:Etoposide / Q000627:therapeutic use; D006801:Humans; D008137:Longitudinal Studies; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000556:secondary; D008297:Male; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy* / Q000378:metabolism / Q000556:secondary; D017239:Paclitaxel / Q000008:administration & dosage; D012074:Remission Induction; D012186:Retroperitoneal Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000556:secondary; D012189:Retrospective Studies; D016879:Salvage Therapy; D033581:Stem Cell Transplantation; D013736:Testicular Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D016896:Treatment Outcome; D000509:alpha-Fetoproteins / Q000378:metabolism; D000093542:Gemcitabine
chemical_list: D006063:Chorionic Gonadotropin; D000509:alpha-Fetoproteins; D003841:Deoxycytidine; D001761:Bleomycin; D005047:Etoposide; D017239:Paclitaxel; D002945:Cisplatin; D000093542:Gemcitabine