title: Efficacy and safety of gemcitabine, oxaliplatin, and paclitaxel in cisplatin-refractory germ cell cancer in routine care--Registry data from an outcomes research project of the German Testicular Cancer Study Group.
abstract: BACKGROUND
  Chemotherapy (CTX) with gemcitabine, oxaliplatin, and paclitaxel (GOP) has demonstrated efficacy with an overall response rate (ORR) of approximately 50% in patients with multiply relapsed or cisplatin-refractory germ cell cancer (GCC) or both within a phase II study. We analyzed the efficacy and safety of GOP in routine clinical practice within a registry of the German Testicular Cancer Study Group.
  
  
  METHODS
  Overall, 63 patients with refractory GCC, who received GOP because of progression under cisplatin-based treatment or relapse after high-dose CTX, were included in this database. Patient characteristics, response rate, toxicity, progression-free and overall survival (OS) were analyzed. For further risk stratification, univariate and multivariate analyses were performed.
  
  
  RESULTS
  GOP was applied as second to eighth treatment line (median fourth) after cisplatin-based CTX. The ORR was 44% with complete remissions achieved in 8 patients (4 patients with CTX plus additional residual tumor resections and 4 patients with CTX alone) and partial remissions achieved in 19 of all for best response evaluable patients. The median progression-free survival and OS were 4.0 months (95% CI: 3.08-4.94) and 13.3 months (95% CI: 9.50-17.06), respectively. Long-term OS of>2 years was achieved in 13 (21%), and grade III and IV toxicities, mainly thrombocytopenia and leukopenia, occurred in 29 patients.
  
  
  CONCLUSIONS
  Our results were similar compared with the previous results from the phase II study with a distinct activity with an ORR of 44%, and a long-term OS in 21% of the patients. Our data support the recommendation to use GOP ± secondary surgery in patients with multiply refractory metastatic GCC.
authors.affiliation: Department of Oncology, Hematology and Bone Marrow Transplantation With Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address: c.seidel@uke.de.
authors.forename: Christoph
authors.initials: C
authors.lastname: Seidel
authors.affiliation: Department of Oncology, Hematology and Bone Marrow Transplantation With Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Karin
authors.initials: K
authors.lastname: Oechsle
authors.affiliation: Department of Urology, Genitourinary Medical Oncology, University Hospital Düsseldorf, Düsseldorf, Germany.
authors.forename: Anja
authors.initials: A
authors.lastname: Lorch
authors.affiliation: Department of Hematology and Oncology, Vivantes MVZ, Am Urban, Berlin, Germany.
authors.forename: Annette
authors.initials: A
authors.lastname: Dieing
authors.affiliation: Department of Hematology and Oncology, Rotkreuzklinikum München, München, Germany.
authors.forename: Marcus
authors.initials: M
authors.lastname: Hentrich
authors.affiliation: Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.
authors.forename: Mareike
authors.initials: M
authors.lastname: Hornig
authors.affiliation: Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.
authors.forename: Viktor
authors.initials: V
authors.lastname: Grünwald
authors.affiliation: Department of Internal Medicine, Cantonal Hospital Graubünden, Chur, Switzerland.
authors.forename: Richard
authors.initials: R
authors.lastname: Cathomas
authors.affiliation: Department of Medical Oncology, West German Cancer Center, University Hospital Essen, Essen, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Meiler
authors.affiliation: Department of Hematology and Oncology, Vivantes Klinikum Neukoelln, Berlin, Germany.
authors.forename: Maike
authors.initials: M
authors.lastname: de Wit
authors.affiliation: Department of Oncology, Hematology and Bone Marrow Transplantation With Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Carsten
authors.initials: C
authors.lastname: Bokemeyer
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D006801:Humans; D008297:Male; D008875:Middle Aged; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy* / Q000473:pathology; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D017239:Paclitaxel / Q000627:therapeutic use*; D012042:Registries; D012189:Retrospective Studies; D016019:Survival Analysis; D013736:Testicular Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000093542:Gemcitabine
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D017239:Paclitaxel; D002945:Cisplatin; D000093542:Gemcitabine
keywords: Cisplatin-refractory germ cell cancer; GOP chemotherapy; Gemcitabine; Oxaliplatin; Paclitaxel