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

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.

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.

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.

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.

Urologic oncology. 2015 Dec 11 [Epub ahead of print]

Christoph Seidel, Karin Oechsle, Anja Lorch, Annette Dieing, Marcus Hentrich, Mareike Hornig, Viktor Grünwald, Richard Cathomas, Johannes Meiler, Maike de Wit, Carsten Bokemeyer

Department of Oncology, Hematology and Bone Marrow Transplantation With Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.  Department of Oncology, Hematology and Bone Marrow Transplantation With Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. , Department of Urology, Genitourinary Medical Oncology, University Hospital Düsseldorf, Düsseldorf, Germany. , Department of Hematology and Oncology, Vivantes MVZ, Am Urban, Berlin, Germany. , Department of Hematology and Oncology, Rotkreuzklinikum München, München, Germany. , Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany. , Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany. , Department of Internal Medicine, Cantonal Hospital Graubünden, Chur, Switzerland. , Department of Medical Oncology, West German Cancer Center, University Hospital Essen, Essen, Germany. , Department of Hematology and Oncology, Vivantes Klinikum Neukoelln, Berlin, Germany. , Department of Oncology, Hematology and Bone Marrow Transplantation With Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

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