Authors' objectives: To review the evidence on efficacy and safety of the treatment with Sorafenib, Sunitinib, and Temsirolimus in advanced, clear cell renal-cell carcinoma in terms of survival and adverse effects with any severity.

Authors' results and conclusions: Of the search, 451 references were achieved. The first selection was focused on erasing duplicates, excluding those papers whose titles did not match the topic to be assessed, and –through reading the summary- on selecting those papers which could meet the inclusion criteria. Therefore 37 papers were selected to be fully read. Of them, 26, which did notmet the inclusion criteria, were excluded. Hence there remained 11 for the systematic review. Only 3 of the included studies were phase III clinical trials (one for each drug), and included metastatic clear cell renal-cell cancer patients. The remaining 8 had several designs. Concerning efficacy, neither Sorafenib nor Sunitinib improved survival in a statistically significant way (the first of them against placebo as second-line treatment, and the second in contrast with Interferon Alfa as first-line treatment). Temsirolimus showed greater survival (3.6 months) than the comparator (Interferon Alfa as first-line treatment) in one out of two statistical analyses that were conducted; and the difference was not significant in the other one. These three drugs were associated with improvement in progression-free survival in a statistically significant way, which ranged between 2.7 months more with Sorafenib and 6 months more with Sunitinib. Two of the drugs (Sorafenib and Sunitinib) were associated with adverse effects happening more frequently than the comparator; however, Temsirolimus showed better safety profile than Interferon Alfa. The overall quality of the clinical trials on Sorafenib and Sunitinib was good, and it was medium for the trial on Temsirolimus.

Authors' recommendations: The evidence on the efficacy and safety of the treatment with Sorafenib, Sunitinib and Temsirolimus in metastatic clear cell renal-cell cancer is primarily based on only one phase III trial for every drug. The conditions, in which they were assessed, were: first-line treatment (Sunitinib and Temsirolimus, both of them as compared to Interferon Alfa) and second-line treatment (Sorafenib as against to placebo). The treatments with Sorafenib and with Sunitinib did not improve the overall survival in a statistically significant way, albeit they proved to delay the disease’s progression. Sunitinib also reached better scores in quality of life. The adverse effects of both drugs occurred more frequently than the control group’s ones, too. Temsirolimus showed results reporting more survival and less frequently-occurred adverse effects than Interferon Alfa in patients with poor prognosis. However the resultsshould be taken cautiously, since the quality of the clinical trial was medium.

Authors' methods: Review

Project Status: Completed

URL for project: https://www.aetsa.org/publicacion/eficacia-y-seguridad-de-las-nuevas-terapias-para-el-carcinoma-metastasico-de-celulas-renales-claras/

Year Published: 2007

URL for published report: https://www.aetsa.org/download/publicaciones/antiguas/AETSA_2007_11_P_Nuevas_Celulas.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: Andalusian Agency for Health Technology Assessment (AETSA)