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

  • 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.

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Author:Lothar BergmannORCiDGND, Viktor Grünwald, Luise Maute, Marc-Oliver GrimmORCiDGND, Steffen Weikert, Jan Schleicher, Theodor Klotz, Jochen Greiner, Anne Flörcken, Arndt Hartmann, Thomas Gauler
Parent Title (English):Oncology research and treatment
Place of publication:Basel
Document Type:Article
Date of Publication (online):2020/06/15
Date of first Publication:2020/06/15
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2021/10/20
Tag:Non-clear cell renal cell cancer; Phase II trial; Randomized trial; Sunitinib; Temsirolimus
Page Number:6
First Page:333
Last Page:338
This study was supported by a grant from Pfizer Germany.
Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.
This publication is with permission of the rights owner freely accessible due to an Alliance licence and a national licence (funded by the DFG, German Research Foundation) respectively.
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (German):License LogoDeutsches Urheberrecht