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.

CONCLUSION:

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: Christoph Seidel, Karin Oechsle, Anja Lorch, Annette Dieing, Marcus Hentrich, Mareike Hornig, Viktor Grünwald, Richard Cathomas, Johannes Meiler, Maike de Wit, Carsten Bokemeyer
• Journal: Urologic oncology (Urol Oncol) Vol. 34 Issue 4 Pg. 167.e21-8 (Apr 2016) ISSN: 1873-2496 [Electronic] United States
• PMID: 26699830 (Publication Type: Journal Article, Multicenter Study)
• Copyright: Copyright © 2016 Elsevier Inc. All rights reserved.

Chemical References

• Organoplatinum Compounds
• Oxaliplatin
• Deoxycytidine
• Paclitaxel
• Cisplatin
• Gemcitabine

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Cisplatin (administration & dosage, adverse effects)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Disease-Free Survival
• Humans
• Male
• Middle Aged
• Neoplasms, Germ Cell and Embryonal (drug therapy, pathology)
• Organoplatinum Compounds (administration & dosage, adverse effects)
• Oxaliplatin
• Paclitaxel (therapeutic use)
• Registries
• Retrospective Studies
• Survival Analysis
• Testicular Neoplasms (drug therapy, pathology)
• Gemcitabine