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
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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. / Seidel, Christoph; Oechsle, Karin; Lorch, Anja; Dieing, Annette; Hentrich, Marcus; Hornig, Mareike; Grünwald, Viktor; Cathomas, Richard; Meiler, Johannes; de Wit, Maike; Bokemeyer, Carsten.
In: UROL ONCOL-SEMIN ORI, Vol. 34, No. 4, 04.2016, p. 167.e21-8.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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T1 - 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
AU - Seidel, Christoph
AU - Oechsle, Karin
AU - Lorch, Anja
AU - Dieing, Annette
AU - Hentrich, Marcus
AU - Hornig, Mareike
AU - Grünwald, Viktor
AU - Cathomas, Richard
AU - Meiler, Johannes
AU - de Wit, Maike
AU - Bokemeyer, Carsten
N1 - Copyright © 2015 Elsevier Inc. All rights reserved.
PY - 2016/4
Y1 - 2016/4
N2 - 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.
AB - 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.
U2 - 10.1016/j.urolonc.2015.11.007
DO - 10.1016/j.urolonc.2015.11.007
M3 - SCORING: Journal article
C2 - 26699830
VL - 34
SP - 167.e21-8
JO - UROL ONCOL-SEMIN ORI
JF - UROL ONCOL-SEMIN ORI
SN - 1078-1439
IS - 4
ER -