A Randomized Phase IIa Trial with Temsirolimus versus Sunitinib in Advanced Non-Clear Cell Renal Cell Carcinoma: An Intergroup Study of the CESAR Central European Society for Anticancer Drug Research-EWIV and the Interdisciplinary Working Group on Renal Cell Cancer (IAGN) of the German Cancer Society
Bergmann L, Grünwald V, Maute L, Grimm MO, Weikert S, Schleicher J, Klotz T, Greiner J, Flörcken A, Hartmann A, Gauler T (2020)
Publication Type: Journal article
Publication year: 2020
Journal
DOI: 10.1159/000508450
Abstract
Background: Non-clear cell renal cell cancers (nccRCC) are rare entities, and the optimal therapy in metastatic disease has still to be defined. Methods: In this small prospectively randomized phase IIa multicenter trial, we investigated temsirolimus (TEM) versus sunitinib (SUN) as first-line therapy in patients with metastatic nccRCC. The patients were randomized 1:1 to either TEM in a dose of 25 mg i.v. once a week or SUN with 50 mg p.o. daily for 4 weeks on and 2 weeks off. Primary endpoint was progression-free survival (PFS). In total, 22 patients were included with predominantly papillary RCC (16/22) followed by chromophobe RCC and others. Results: The male to female ratio was 16:6. The tumor control rate (CR + PR + SD) was 58% for TEM and 90% for SUN-treated patients. There was also a trend for improved PFS with 9.3 versus 13.2 months (HR 1.64; 95% CI 0.65-4.18) in favor of SUN. There was no trend for overall survival. Conclusions: Despite this trial had to be terminated earlier due to low recruitment, the results match the other studies published so far with the mTOR inhibitor everolimus and SUN, which show a trend in favor of SUN for ORR and PFS.
Authors with CRIS profile
Involved external institutions
Charité - Universitätsmedizin Berlin
Germany (DE)
Friedrich-Schiller-Universität Jena
Germany (DE)
Klinikum Stuttgart
Germany (DE)
Universitätsklinikum Essen
Germany (DE)
Kliniken Nordoberpfalz
Germany (DE)
Goethe-Universität Frankfurt am Main
Germany (DE)
Medizinische Hochschule Hannover (MHH) / Hannover Medical School
Germany (DE)
Vivantes - Netzwerk für Gesundheit GmbH
Germany (DE)
Germany (DE)
Friedrich-Schiller-Universität Jena
Germany (DE)
Klinikum Stuttgart
Germany (DE)
Universitätsklinikum Essen
Germany (DE)
Kliniken Nordoberpfalz
Germany (DE)
Goethe-Universität Frankfurt am Main
Germany (DE)
Medizinische Hochschule Hannover (MHH) / Hannover Medical School
Germany (DE)
Vivantes - Netzwerk für Gesundheit GmbH
Germany (DE)
How to cite
APA:
Bergmann, L., Grünwald, V., Maute, L., Grimm, M.O., Weikert, S., Schleicher, J.,... Gauler, T. (2020). A Randomized Phase IIa Trial with Temsirolimus versus Sunitinib in Advanced Non-Clear Cell Renal Cell Carcinoma: An Intergroup Study of the CESAR Central European Society for Anticancer Drug Research-EWIV and the Interdisciplinary Working Group on Renal Cell Cancer (IAGN) of the German Cancer Society. Oncology Research and Treatment. https://dx.doi.org/10.1159/000508450
MLA:
Bergmann, Lothar, et al. "A Randomized Phase IIa Trial with Temsirolimus versus Sunitinib in Advanced Non-Clear Cell Renal Cell Carcinoma: An Intergroup Study of the CESAR Central European Society for Anticancer Drug Research-EWIV and the Interdisciplinary Working Group on Renal Cell Cancer (IAGN) of the German Cancer Society." Oncology Research and Treatment (2020).
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