TY  - JOUR
A1  - Bergmann, Lothar
A1  - Grünwald, Viktor
A1  - Maute, Luise
A1  - Grimm, Marc-Oliver
A1  - Weikert, Steffen
A1  - Schleicher, Jan
A1  - Klotz, Theodor
A1  - Greiner, Jochen
A1  - Flörcken, Anne
A1  - Hartmann, Arndt
A1  - Gauler, Thomas
T1  - 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
T2  - Oncology research and treatment
N2  - 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.
KW  - Non-clear cell renal cell cancer
KW  - Sunitinib
KW  - Temsirolimus
KW  - Randomized trial
KW  - Phase II trial
Y1  - 2020
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/63332
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-633329
SN  - 2296-5262
N1  - This study was supported by a grant from Pfizer Germany.
N1  - 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.
VL  - 43
IS  - 7-8
SP  - 333
EP  - 338
PB  - Karger
CY  - Basel
ER  -