Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial
| العنوان: | Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial |
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| المؤلفون: | Choueiri, Toni K., Escudier, Bernard, Powles, Thomas, Tannir, Nizar M., Mainwaring, Paul N., Rini, Brian I., Hammers, Hans J., Donskov, Frede, Roth, Bruce J., Peltola, Katriina, Lee, Jae Lyun, Heng, Daniel Y. C., Schmidinger, Manuela, Agarwal, Neeraj, Sternberg, Cora N., McDermott, David F., Aftab, Dana T., Hessel, Colin, Old, Christian Scheff, Schwab, Gisela, Hutson, Thomas E., Pal, Sumanta, Motzer, Robert J., METEOR Investigators |
| المساهمون: | Department of Oncology, Clinicum |
| المصدر: | Translational Andrology and Urology Choueiri, T K, Escudier, B, Powles, T, Tannir, N M, Mainwaring, P N, Rini, B I, Hammers, H J, Donskov, F, Roth, B J, Peltola, K, Lee, J L, Heng, D Y C, Schmidinger, M, Agarwal, N, Sternberg, C N, McDermott, D F, Aftab, D T, Hessel, C, Scheffold, C, Schwab, G, Hutson, T E, Pal, S, Motzer, R J & METEOR Investigators 2016, ' Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial ', The Lancet Oncology, vol. 17, no. 7, pp. 917-27 . https://doi.org/10.1016/S1470-2045Test(16)30107-3 |
| بيانات النشر: | Elsevier BV, 2016. |
| سنة النشر: | 2016 |
| مصطلحات موضوعية: | Male, 0301 basic medicine, Pyridines, law.invention, chemistry.chemical_compound, TARGETED THERAPY, PROGNOSTIC-FACTORS, 0302 clinical medicine, Randomized controlled trial, law, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, Anilides, Hazard ratio, Middle Aged, Prognosis, CANCER, Kidney Neoplasms, 3. Good health, Survival Rate, Editorial, Oncology, 030220 oncology & carcinogenesis, SURVIVAL, Female, medicine.drug, Sorafenib, medicine.medical_specialty, Cabozantinib, 3122 Cancers, Urology, 03 medical and health sciences, medicine, Humans, Everolimus, COMBINATION, Carcinoma, Renal Cell, Survival rate, Aged, Neoplasm Staging, III TRIAL, business.industry, EAU GUIDELINES, EFFICACY, Interim analysis, Surgery, SORAFENIB, 030104 developmental biology, chemistry, METASTASIS, business, Follow-Up Studies |
| الوصف: | BACKGROUND: Cabozantinib is an oral inhibitor of tyrosine kinases including MET, VEGFR, and AXL. The randomised phase 3 METEOR trial compared the efficacy and safety of cabozantinib versus the mTOR inhibitor everolimus in patients with advanced renal cell carcinoma who progressed after previous VEGFR tyrosine-kinase inhibitor treatment. Here, we report the final overall survival results from this study based on an unplanned second interim analysis. METHODS: In this open-label, randomised phase 3 trial, we randomly assigned (1:1) patients aged 18 years and older with advanced or metastatic clear-cell renal cell carcinoma, measurable disease, and previous treatment with one or more VEGFR tyrosine-kinase inhibitors to receive 60 mg cabozantinib once a day or 10 mg everolimus once a day. Randomisation was done with an interactive voice and web response system. Stratification factors were Memorial Sloan Kettering Cancer Center risk group and the number of previous treatments with VEGFR tyrosine-kinase inhibitors. The primary endpoint was progression-free survival as assessed by an independent radiology review committee in the first 375 randomly assigned patients and has been previously reported. Secondary endpoints were overall survival and objective response in all randomly assigned patients assessed by intention-to-treat. Safety was assessed per protocol in all patients who received at least one dose of study drug. The study is closed for enrolment but treatment and follow-up of patients is ongoing for long-term safety evaluation. This trial is registered with ClinicalTrials.gov, number NCT01865747. FINDINGS: Between Aug 8, 2013, and Nov 24, 2014, 658 patients were randomly assigned to receive cabozantinib (n=330) or everolimus (n=328). The median duration of follow-up for overall survival and safety was 18·7 months (IQR 16·1-21·1) in the cabozantinib group and 18·8 months (16·0-21·2) in the everolimus group. Median overall survival was 21·4 months (95% CI 18·7-not estimable) with cabozantinib and 16·5 months (14·7-18·8) with everolimus (hazard ratio [HR] 0·66 [95% CI 0·53-0·83]; p=0·00026). Cabozantinib treatment also resulted in improved progression-free survival (HR 0·51 [95% CI 0·41-0·62]; p |
| تدمد: | 1470-2045 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e4bc4d936baaba5695527e426e9f6234Test https://doi.org/10.1016/s1470-2045Test(16)30107-3 |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....e4bc4d936baaba5695527e426e9f6234 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14702045 |
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