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 C

Non-clear cell renal cell cancers (nccRCC) are rare entities, and the optimal therapy in metastatic disease has still to be defined.

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.

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.

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.

Oncology research and treatment. 2020 Jun 15 [Epub ahead of print]

Lothar Bergmann, Viktor Grünwald, Luise Maute, Marc-Oliver Grimm, Steffen Weikert, Jan Schleicher, Theodor Klotz, Jochen Greiner, Anne Flörcken, Arndt Hartmann, Thomas Gauler

Medical Clinic II, J.W. Goethe University, Frankfurt, Germany, ., Hematology and Medical Oncology, Medizinische Hochschule Hannover, Hannover, Germany., Medical Clinic II, J.W. Goethe University, Frankfurt, Germany., Clinic for Urology, Friedrich-Schiller University, Jena, Germany., Clinic for Urology, Vivantes Humboldt-Klinikum, Berlin, Germany., Clinic for Hematology and Oncology, Klinikum Stuttgart, Stuttgart, Germany., Clinic for Urology and Andrology, Kliniken Nordoberpfalz AG, Weiden, Germany., Clinic for Hematology and Oncology, Diakonie Klinikum, Stuttgart, Germany., Department of Hematology, Oncology, and Tumor Immunology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Virchow-Klinikum, Berlin, Germany., Institut for Pathology, University Hospital, Erlangen-Nürnberg, Germany., Department of Medical Oncology, West German Cancer Center, University Hospital Essen of the University Duisburg-Essen, Essen, Germany.