dc.contributor.author
Bergmann, Lothar
dc.contributor.author
Grünwald, Viktor
dc.contributor.author
Maute, Luise
dc.contributor.author
Grimm, Marc-Oliver
dc.contributor.author
Weikert, Steffen
dc.contributor.author
Schleicher, Jan
dc.contributor.author
Klotz, Theodor
dc.contributor.author
Greiner, Jochen
dc.contributor.author
Flörcken, Anne
dc.contributor.author
Hartmann, Arndt
dc.contributor.author
Gauler, Thomas
dc.date.accessioned
2021-09-06T13:28:16Z
dc.date.available
2021-09-06T13:28:16Z
dc.identifier.uri
https://refubium.fu-berlin.de/handle/fub188/31858
dc.identifier.uri
http://dx.doi.org/10.17169/refubium-31591
dc.description.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.
en
dc.subject
Non-clear cell renal cell cancer
en
dc.subject
Temsirolimus
en
dc.subject
Randomized trial
en
dc.subject
Phase II trial
en
dc.subject.ddc
600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit
dc.title
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
dc.type
Wissenschaftlicher Artikel
dcterms.bibliographicCitation.doi
10.1159/000508450
dcterms.bibliographicCitation.journaltitle
Oncology Research and Treatment
dcterms.bibliographicCitation.number
7-8
dcterms.bibliographicCitation.originalpublishername
Karger
dcterms.bibliographicCitation.pagestart
333
dcterms.bibliographicCitation.pageend
338
dcterms.bibliographicCitation.volume
43
dcterms.rightsHolder.note
Copyright applies in this work.
dcterms.rightsHolder.url
http://rightsstatements.org/vocab/InC/1.0/
refubium.affiliation
Charité - Universitätsmedizin Berlin
refubium.note.author
Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG geförderten) Allianz- bzw. Nationallizenz frei zugänglich.
de
refubium.note.author
This publication is shared with permission of the rights owner and made freely accessible through a DFG (German Research Foundation) funded license at either an alliance or national level.
en
refubium.resourceType.isindependentpub
no
dcterms.accessRights.openaire
open access
dcterms.bibliographicCitation.pmid
32541143
dcterms.isPartOf.issn
2296-5270
dcterms.isPartOf.eissn
2296-5262