Second-Line Treatment of Advanced Urothelial Cancer with Paclitaxel and Everolimus in a German Phase II Trial (AUO Trial AB 35/09)

Niegisch G, Retz M, Thalgott M, Balabanov S, Honecker F, Ohlmann CH, Stoeckle M, Boegemann M, Vom Dorp F, Gschwend J, Hartmann A, Ohmann C, Albers P (2015)

Publication Type: Journal article

Publication year: 2015

Journal

Oncology Karger

Book Volume: 89

Pages Range: 70-8

Journal Issue: 2

DOI: 10.1159/000376551

Abstract

The efficacy of second-line treatment after failure of platinum-based chemotherapy in patients with advanced urothelial cancer is limited. Based on encouraging preclinical and clinical phase I data, we evaluated the safety and efficacy of the combination of paclitaxel and everolimus in these patients.In this trial, patients having failed to respond to prior platinum-based combination treatment of urothelial cancer were treated with paclitaxel (175 mg/m(2) i.v., 3-weekly) and the mTOR-inhibitor everolimus (10 mg p.o., once daily). The patients were treated until tumor progression or until a maximum of 6 cycles was completed. A one-stage design was used to evaluate the objective response rate (ORR) as the primary endpoint.A total of 27 patients (67% male; median age 63 years) were enrolled. The most frequent grade III/IV toxicities were anemia (28%), peripheral neuropathy (28%), and fatigue (24%). No treatment-related deaths were reported. Complete and partial remissions were observed in 0/24 and 3/24 patients eligible for efficacy analysis, respectively (ORR 13%). Progression-free survival was 2.9 months [95% confidence interval (95% CI) 1.9-4.2], and the median overall survival was 5.6 months (95% CI 4.8-10.2).The combination of paclitaxel and everolimus has not achieved the expected efficacy in second-line treatment of urothelial cancer and should not be further explored.

Authors with CRIS profile

Arndt Hartmann Lehrstuhl für Allgemeine Pathologie und Pathologische Anatomie

Involved external institutions

Heinrich-Heine-Universität Düsseldorf DE Germany (DE) Technische Universität München (TUM) DE Germany (DE) Universität Duisburg-Essen (UDE) DE Germany (DE) Westfälische Wilhelms-Universität (WWU) Münster DE Germany (DE) Universität des Saarlandes (UdS) DE Germany (DE) Universitätsklinikum Hamburg-Eppendorf (UKE) DE Germany (DE)

How to cite

APA:

Niegisch, G., Retz, M., Thalgott, M., Balabanov, S., Honecker, F., Ohlmann, C.H.,... Albers, P. (2015). Second-Line Treatment of Advanced Urothelial Cancer with Paclitaxel and Everolimus in a German Phase II Trial (AUO Trial AB 35/09). Oncology, 89(2), 70-8. https://doi.org/10.1159/000376551

MLA:

Niegisch, Guenter, et al. "Second-Line Treatment of Advanced Urothelial Cancer with Paclitaxel and Everolimus in a German Phase II Trial (AUO Trial AB 35/09)." Oncology 89.2 (2015): 70-8.

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