Axitinib versus sorafenib as second-line therapy for metastatic renal cell carcinoma (mRCC): Results of phase III AXIS trial

Autor:	Thomas E. Hutson, C. Szczylik, Sinil Kim, Robert J. Motzer, Bernard Escudier, Brad Rosbrook, Jamal Tarazi, Andrey Kaprin, Piotr Tomczak, B. I. Rini
Rok vydání:	2011
Předmět:	Sorafenib Oncology Cancer Research medicine.medical_specialty Bevacizumab business.industry Sunitinib Pharmacology urologic and male genital diseases medicine.disease Temsirolimus Axitinib Regimen Internal medicine Clinical endpoint Medicine business Progressive disease medicine.drug
Zdroj:	Journal of Clinical Oncology. 29:4503-4503
ISSN:	1527-7755 0732-183X
Popis:	4503 Background: Axitinib is an oral, potent, and selective inhibitor of VEGF receptors 1, 2, and 3. This randomized, open-label, phase III trial compared the efficacy and safety of axitinib versus (vs) sorafenib as second-line therapy for mRCC. Methods: Eligible patients had clear-cell mRCC; measurable, RECIST-defined progressive disease after 1 prior first-line systemic therapy with a sunitinib-, bevacizumab-, temsirolimus-, or cytokine-based regimen; and Eastern Cooperative Oncology Group performance status (PS) of 0 or 1. Patients were stratified by PS and prior therapy, then randomized 1:1 to axitinib, administered at a starting dose of 5 mg BID, titrated to 7 mg BID and then to 10 mg BID as tolerated, or sorafenib 400 mg BID. The primary endpoint was progression-free survival (PFS) per blinded, independent radiographic review. The study had 90% power to detect a PFS of 7 months vs 5 months, corresponding to a hazard ratio (HR) of ≤0.714 (overall 1-sided α=0.025). Results: Seven-hundred twenty-three ...
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::d934c868ac875c4e5d869e960b2ec220 https://doi.org/10.1200/jco.2011.29.15_suppl.4503 Zobrazit plný text záznamu