دورية أكاديمية
BOLERO-5: a phase II study of everolimus and exemestane combination in Chinese post-menopausal women with ER + /HER2- advanced breast cancer
| العنوان: | BOLERO-5: a phase II study of everolimus and exemestane combination in Chinese post-menopausal women with ER + /HER2- advanced breast cancer |
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| المؤلفون: | Zhi-Ming Shao, Li Cai, Shusen Wang, Xichun Hu, Kunwei Shen, Haibo Wang, Huiping Li, Jifeng Feng, Qiang Liu, Jing Cheng, Xinhong Wu, Xiaojia Wang, Hongyuan Li, Ting Luo, Jinping Liu, Khalid Amin, Khemaies Slimane, Yongping Qiao, Yongmin Liu, Zhongsheng Tong |
| المصدر: | Discover Oncology, Vol 15, Iss 1, Pp 1-12 (2024) |
| بيانات النشر: | Springer, 2024. |
| سنة النشر: | 2024 |
| المجموعة: | LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens |
| مصطلحات موضوعية: | Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282 |
| الوصف: | Abstract Background The global BOLERO-2 trial established the efficacy and safety of combination everolimus (EVE) and exemestane (EXE) in the treatment of estrogen receptor positive (ER +), HER2-, advanced breast cancer (ABC). BOLERO-5 investigated this combination in a Chinese population (NCT03312738). Methods BOLERO-5 is a randomized, double-blind, multicenter, placebo controlled, phase II trial comparing EVE (10 mg/day) or placebo (PBO) in combination with EXE (25 mg/day). The primary endpoint was progression-free survival (PFS) per investigator assessment. Secondary endpoints included PFS per blinded independent review committee (BIRC), overall survival (OS), overall response rate (ORR), clinical benefit rate (CBR), pharmacokinetics, and safety. Results A total of 159 patients were randomized to EVE + EXE (n = 80) or PBO + EXE (n = 79). By investigator assessment, treatment with EVE + EXE prolonged median PFS by 5.4 months (HR 0.52; 90% CI 0.38, 0.71), from 2.0 months (PBO + EXE; 90% CI 1.9, 3.6) to 7.4 months (EVE + EXE; 90% CI 5.5, 9.0). Similar results were observed following assessment by BIRC, with median PFS prolonged by 4.3 months. Treatment with EVE + EXE was also associated with improvements in ORR and CBR. No new safety signals were identified in BOLERO-5, with the incidence of adverse events in Chinese patients consistent with the safety profile of both drugs. Conclusion The efficacy and safety results of BOLERO-5 validate the findings from BOLERO-2, and further support the use of EVE + EXE in Chinese post-menopausal women with ER + , HER2- ABC. NCT03312738, registered 18 October 2017. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 2730-6011 62942484 |
| Relation: | https://doaj.org/toc/2730-6011 |
| DOI: | 10.1007/s12672-024-01027-8 |
| URL الوصول: | https://doaj.org/article/54f05c5481a746a1854d62942484ed79 |
| رقم الأكسشن: | edsdoj.54f05c5481a746a1854d62942484ed79 |
| قاعدة البيانات: | Directory of Open Access Journals |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 27306011 62942484 |
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| DOI: | 10.1007/s12672-024-01027-8 |