دورية أكاديمية
Overall survival analysis of EXAM, a phase III trial of cabozantinib in patients with radiographically progressive medullary thyroid carcinoma
| العنوان: | Overall survival analysis of EXAM, a phase III trial of cabozantinib in patients with radiographically progressive medullary thyroid carcinoma |
|---|---|
| المؤلفون: | Schlumberger, M, Elisei, R, Müller, S, Schöffski, P, Brose, M, Shah, M, Licitra, L, Krajewska, J, Kreissl, M C, Niederle, B, Cohen, E EW, Wirth, L, Ali, Haythem Y, Clary, D O, Yaron, Y, Mangeshkar, M, Ball, D, Nelkin, B, Sherman, S |
| المصدر: | Hematology/Oncology Articles |
| بيانات النشر: | Henry Ford Health Scholarly Commons |
| سنة النشر: | 2017 |
| المجموعة: | Henry Ford Health System Scholarly Commons |
| مصطلحات موضوعية: | Aged, Anilides, Carcinoma, Medullary, Diagnostic Imaging, Double-Blind Method, Female, Follow-Up Studies, Humans, International Agencies, Male, Prognosis, Pyridines, Survival Rate, Thyroid Neoplasms |
| الوصف: | Background: Primary analysis of the double-blind, phase III Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer (EXAM) trial demonstrated significant improvement in progression-free survival with cabozantinib versus placebo in patients with progressive medullary thyroid cancer (MTC). Final analysis of overall survival (OS), a key secondary endpoint, was carried out after long-term follow-up. Patients and methods: EXAM compared cabozantinib with placebo in 330 patients with documented radiographic progression of metastatic MTC. Patients were randomized (2:1) to cabozantinib (140 mg/day) or placebo. Final OS and updated safety data are reported. Results: Minimum follow-up was 42 months. Kaplan-Meier analysis showed a 5.5-month increase in median OS with cabozantinib versus placebo (26.6 versus 21.1 months) although the difference did not reach statistical significance [stratified hazard ratio (HR), 0.85; 95% confidence interval (CI), 0.64-1.12; P = 0.24]. In an exploratory assessment of OS, progression-free survival, and objective response rate, cabozantinib appeared to have a larger treatment effect in patients with RET M918T mutation-positive tumors compared with patients not harboring this mutation. For patients with RET M918T-positive disease, median OS was 44.3 months for cabozantinib versus 18.9 months for placebo [HR, 0.60; 95% CI, 0.38-0.94; P = 0.03 (not adjusted for multiple subgroup analyses)], with corresponding values of 20.2 versus 21.5 months (HR, 1.12; 95% CI, 0.70-1.82; P = 0.63) in the RET M918T-negative subgroup. Median treatment duration was 10.8 months with cabozantinib and 3.4 months with placebo. The safety profile for cabozantinib remained consistent with that of the primary analysis. Conclusion: The secondary end point was not met in this final OS analysis from the trial of cabozantinib in patients with metastatic, radiographically progressive MTC. A statistically nonsignificant increase in OS was observed for cabozantinib compared with placebo. Exploratory analyses ... |
| نوع الوثيقة: | text |
| اللغة: | unknown |
| العلاقة: | https://scholarlycommons.henryford.com/hematologyoncology_articles/40Test; http://sfxhosted.exlibrisgroup.com/hfhs?sid=Entrez:PubMed&id=pmid:29045520Test |
| الإتاحة: | https://scholarlycommons.henryford.com/hematologyoncology_articles/40Test http://sfxhosted.exlibrisgroup.com/hfhs?sid=Entrez:PubMed&id=pmid:29045520Test |
| رقم الانضمام: | edsbas.B0E0DDA4 |
| قاعدة البيانات: | BASE |
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