Combination chemotherapy with gemcitabine, oxaliplatin, and paclitaxel in patients with cisplatin-refractory or multiply relapsed germ-cell tumors: a study of the German Testicular Cancer Study Group

Ann Oncol. 2008 Mar;19(3):448-53. doi: 10.1093/annonc/mdm526. Epub 2007 Nov 15.

Abstract

Background: The aim of this study is to determine feasibility and efficacy of the combination regimen gemcitabine, oxaliplatin, and paclitaxel (GOP) in patients with cisplatin-refractory or multiply relapsed germ-cell tumors.

Patients and methods: From April 2003 to October 2006, 41 patients refractory to cisplatin-based chemotherapy or with relapse after high-dose chemotherapy (HDCT) plus stem-cell support (peripheral blood stem-cell transplantation: PBSCT) received 800 mg/m2 gemcitabine, 80 mg/m2 paclitaxel (Taxol), both on days 1 + 8, and oxaliplatin 130 mg/m2 on day 1 of a 3-week cycle for a minimum of two cycles. Primary end point was response rate. Patients were pretreated with a median of two lines of platin-based chemotherapy (range, 1-3), and 78% had relapsed after HDCT/PBSCT.

Results: Seventy-three percent of patients had relapsed within 3 months after the last cisplatin-based chemotherapy. Five percent of the patients achieved a complete response, and 34% and 12% a marker-negative and marker-positive partial response, respectively (overall response rate 51%). After a median follow-up of 5 months (range, 0-20), 15% of the patients remain in complete remission after GOP chemotherapy +/- residual tumor resection with a median response duration of 8 months (1 to 17+). Main toxicity was leucocytopenia grade 3/4 in 15%, anemia in 7%, and thrombocytopenia in 49% of the patients.

Conclusion: Combination chemotherapy with GOP is feasible and effective with acceptable toxicity in patients with treatment-refractory germ-cell tumors.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anemia / chemically induced
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives
  • Drug Resistance, Neoplasm
  • Feasibility Studies
  • Humans
  • Leukopenia / chemically induced
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Neoplasms, Germ Cell and Embryonal / drug therapy*
  • Neoplasms, Germ Cell and Embryonal / pathology
  • Neoplasms, Germ Cell and Embryonal / secondary
  • Organoplatinum Compounds / administration & dosage
  • Oxaliplatin
  • Paclitaxel / administration & dosage
  • Testicular Neoplasms / drug therapy*
  • Testicular Neoplasms / pathology
  • Thrombocytopenia / chemically induced
  • Treatment Outcome

Substances

  • Organoplatinum Compounds
  • Oxaliplatin
  • Deoxycytidine
  • gemcitabine
  • Paclitaxel