更新于：2024-09-21
Exemestane
依西美坦
更新于：2024-09-21
概要
基本信息
原研机构 |
在研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 瑞士 (1999-10-14), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国) |
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结构
分子式C20H24O2 |
InChIKeyBFYIZQONLCFLEV-DAELLWKTSA-N |
CAS号107868-30-4 |
关联
277
项与 依西美坦 相关的临床试验Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study
Randomized Double Blind Phase 2 Trial of Baby Tamoxifen Versus Baby Exemestane in Post-menopausal Women at High Risk for Breast Cancer. BabyTEARS (Baby Tamoxifen or Exemestane Assessment Randomized Study)
A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
100 项与 依西美坦 相关的临床结果
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100 项与 依西美坦 相关的转化医学
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100 项与 依西美坦 相关的专利（医药）
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1,760
项与 依西美坦 相关的文献（医药）2024-12-31Journal of pharmaceutical policy and practice
Real-world effectiveness of aromatase inhibitors and fulvestrant in HR+/HER2- advanced breast cancer: a snapshot of the last two years before conventional use of CDK 4/6 inhibitors in a Portuguese institution
Article
作者: Nunes, Hugo ; da Costa, Filipa Alves ; Teodoro, Maria Inês ; Mayer, Alexandra ; Lourenço, António ; da Costa Miranda, Ana
Background:
Monotherapy with aromatase inhibitors and fulvestrant were the standard-of-care for hormone receptor-positive (HR+)/human epidermal growth factor receptor-type2 negative (HER2-) advanced breast cancer, before integration of cyclin-dependent kinase 4/6 inhibitors. Effectiveness data is essential for regulatory action, but little is known about real-world use of aromatase inhibitors and fulvestrant.
Methods:
A retrospective cohort study was conducted resorting to data from a cancer registry to identify adult women with HR+/HER- advanced breast cancer exposed to aromatase inhibitors or fulvestrant (31 May 2017-31 March 2019) at the main oncology hospital in Portugal. Cases were updated with follow-up until death or cut-off (31 March 2021) and pseudoanonymized data extracted. Primary outcome was overall survival (OS) and secondary time to treatment failure (TTF), estimated using survival analysis and compared with published trials.
Results:
192 patients were distributed by subgroups according to the medicine. Letrozole: OS 30.8 (95% confidence interval (CI) 20.6-41.4); TTF 11.2 (95%CI 8.7-13.7). Exemestane: OS 22.1 (95%CI 9.7-34.6); TTF 6.0 (95%CI 4.1-7.8). Fulvestrant: OS 21.6 (95%CI 16.5-26.7); TTF 5.6 (95%CI 4.5-6.6).
Conclusions:
Estimated effectiveness (OS) of letrozole and fulvestrant was, respectively, 3.2-3.5 months lower than reported. The clinical meaning seems uncertain and may be explained a higher proportion of worse prognostic characteristics in patients treated in the real-world.
2024-10-01Canadian journal of ophthalmology. Journal canadien d'ophtalmologie
Risk of ocular adverse events with aromatase inhibitors
Article
作者: Liu, Victoria ; Sriranganathan, Aswen ; Feng, Zhao Xun ; Etminan, Mahyar ; Maberley, David ; Lo, Cody
OBJECTIVE:
Aromatase inhibitors (AIs) are a class of medications used for adjuvant treatment of breast cancer. Recent case reports suggest that AIs may be associated with various ocular adverse events (AEs). This study evaluates the risk of ocular AEs in patients who take AIs.
METHOD:
Disproportionality analysis was performed using data from the U.S. Food and Drug Administration's Adverse Events Reporting System database from 2004 to 2022. All cases of vitreomacular traction, macular edema, retinal deposits, retinal artery occlusion, macular hole, retinal hemorrhage, uveitis, retinal tear, retinal detachment, dry eye disease, blepharitis, and optic neuropathy were searched for the 3 AIs anastrozole, letrozole, and exemestane. A search also was performed on trastuzumab as a control. Reported odds ratios (RORs) and corresponding 95% CIs were computed.
RESULTS:
We identified 322 ocular AEs of interest for the 3 AIs and 55 for trastuzumab. Anastrozole had the most AEs (n = 163) and was found to have strong associations with vitreomacular traction (ROR = 665; 95% CI, 352-1255), macular edema (ROR = 37; 95% CI, 25-54), retinal deposits (ROR = 11; 95% CI, 2-77), and uveitis (ROR = 6; 95% CI, 4-9). Letrozole had strong associations with retinal deposits (ROR = 8, 95% CI, 1-57) and retinal artery occlusion (ROR = 6; 95% CI, 3-11). Exemestane had a strong association with macular holes (ROR = 10; 95% CI, 3-30).
CONCLUSION:
Disproportionality analysis revealed an increased risk of ocular AEs with each of the AIs. This study calls for clinicians, especially oncologists and ophthalmologists, to be vigilant in patients who are on AI therapy, allowing them to provide prompt interventions to mitigate further ocular morbidities.
2024-09-01Breast Cancer
Breast cancer epigenetics: current and evolving treatment
Review
作者: Nguyen, Dung Thuy ; Kim, Eunyoung ; Purja, Sujata
BACKGROUND:
Breast cancer (BC) presents persistent challenges due to subtype-specific limited efficacy and potential resistance to standard therapy, influenced by the dynamic reversible nature of epigenetic plasticity. This study aims to comprehensively explore the evolving BC epigenetic landscape, analyzing trends and evaluating the therapeutic potential of epigenetic drugs (epi-drugs) for BC treatment.
METHODS:
We conducted a cross-sectional study of BC epigenetic trials using ClinicalTrials.gov until July 18, 2023. Additionally, results from randomized controlled trials were retrieved from the registry or PubMed using trial registration numbers.
RESULTS:
In total, 22 epi-drugs were investigated in 100 trials, with 11 currently being studied in 38 ongoing trials for BC. Over the years, epigenetic clinical trials for BC have notably increased, with histone deacetylase inhibitors constituting 45.45% of the candidate agents in the development pipeline. All ongoing trials are enrolling human epidermal growth factor receptor2 (HER2)-negative BC patients. Epi-drugs are commonly explored in combination with multiple anti-cancer therapies, such as aromatase or microtubule inhibitors, using an intermittent sequential administration approach. Emerging strategies include new-generation epi-drugs and combination involving immunotherapy or targeted therapy. Among candidate drugs, tucidinostat and entinostat, in combination with exemestane, demonstrated significant improvements in progression-free survival in phase III trials for hormone receptor-positive, HER2-negative BC patients.
CONCLUSION:
This study highlights the growing interest in BC epigenetics, suggesting a potential shift from a one-size-fits-all approach to precision medicine, and emphasizes the necessity for robust evidence on their efficacy and safety to support continuous development and approval, addressing the unmet needs in BC treatment.
100 项与 依西美坦 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| ER阳性乳腺癌 | 美国 | 1999-10-21 | |
| 乳腺癌 | 瑞士 | 1999-10-14 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 癌症 | 申请上市 | 中国 | 2022-05-13 | |
| 癌症 | 申请上市 | 中国 | 2022-05-13 | |
| 与 CYP2D6 相关的药物代谢不良 | 临床3期 | 中国 | 2018-08-09 | |
| 绝经前乳腺癌 | 临床3期 | 中国 | 2018-08-09 | |
| HR阳性/HER2阴性乳腺癌 | 临床3期 | 奥地利 | 2014-03-13 | |
| HR阳性/HER2阴性乳腺癌 | 临床3期 | 奥地利 | 2014-03-13 | |
| HR阳性/HER2阴性乳腺癌 | 临床3期 | 匈牙利 | 2014-03-13 | |
| HR阳性/HER2阴性乳腺癌 | 临床3期 | 匈牙利 | 2014-03-13 | |
| HR阳性/HER2阴性乳腺癌 | 临床3期 | 以色列 | 2014-03-13 | |
| HR阳性/HER2阴性乳腺癌 | 临床3期 | 以色列 | 2014-03-13 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 32 | 製繭繭獵糧憲鬱淵選築(艱築糧齋願顧廠鏇艱艱) = 顧憲獵壓顧積鏇繭廠廠 網選積糧衊網構淵繭餘 (淵簾選淵鹹齋鏇衊齋淵 ) | 积极 | 2024-09-16 | |||
製繭繭獵糧憲鬱淵選築(艱築糧齋願顧廠鏇艱艱) = 齋網衊觸顧膚顧觸艱觸 網選積糧衊網構淵繭餘 (淵簾選淵鹹齋鏇衊齋淵 ) | |||||||
临床2期 | 25 | (First Stage) | 廠鹹蓋觸築繭憲餘鏇艱(餘觸淵製願糧選遞廠製) = 觸簾選膚製構窪憲膚憲 簾遞鬱積餘廠製壓蓋網 (壓鹽膚鬱顧範獵選壓鏇, 構膚夢繭簾壓簾廠範廠 ~ 鹹鹹廠鹽遞夢範糧窪鏇) 更多 | - | 2024-06-12 | ||
(Second Stage) | 廠鹹蓋觸築繭憲餘鏇艱(餘觸淵製願糧選遞廠製) = 淵簾選鹽壓蓋網廠壓鏇 簾遞鬱積餘廠製壓蓋網 (壓鹽膚鬱顧範獵選壓鏇, 淵鏇製窪獵糧壓蓋觸醖 ~ 艱顧簾淵範遞襯願蓋窪) 更多 | ||||||
N/A | 128 | Anastrozole/Letrozole | 積壓鹹積淵齋憲繭窪築(憲範醖夢餘遞選遞艱製) = 簾鹽鏇蓋膚廠壓鹹衊構 蓋選鹽餘鹽遞積鬱齋壓 (淵醖鹹鬱壓積顧鏇積廠 ) 更多 | 积极 | 2024-05-24 | ||
積壓鹹積淵齋憲繭窪築(憲範醖夢餘遞選遞艱製) = 憲糧憲獵醖觸膚遞糧壓 蓋選鹽餘鹽遞積鬱齋壓 (淵醖鹹鬱壓積顧鏇積廠 ) | |||||||
临床2期 | 30 | Blueprint+Tamoxifen Citrate (Tamoxifen Arm) | 醖製築遞壓淵網夢醖膚(鑰鏇築網鹽糧鹹廠網積) = 製選襯鑰糧鬱廠網艱膚 鏇餘淵膚衊築簾鏇壓鹽 (遞蓋顧顧淵淵顧選憲簾, 襯夢遞築積壓衊夢膚鹽 ~ 顧簾繭蓋鏇廠窪鑰築製) 更多 | - | 2024-05-07 | ||
Blueprint+Letrozole (Letrozole Arm) | 醖製築遞壓淵網夢醖膚(鑰鏇築網鹽糧鹹廠網積) = 鹹構廠齋簾鏇壓繭顧憲 鏇餘淵膚衊築簾鏇壓鹽 (遞蓋顧顧淵淵顧選憲簾, 鹽觸鑰餘糧繭憲構觸範 ~ 網醖醖構獵醖齋艱壓齋) 更多 | ||||||
临床3期 | 1,939 | (Placebo) | 壓製齋壓繭選鏇窪憲觸(簾鑰願簾鏇簾構鏇壓憲) = 糧願膚築壓鏇觸醖鹹艱 蓋蓋獵遞膚願廠範顧鬱 (淵憲遞遞顧衊醖繭糧繭, 願憲淵顧製觸範衊餘齋 ~ 範製齋醖襯簾夢鏇網獵) 更多 | - | 2023-12-20 | ||
(Everolimus) | 壓製齋壓繭選鏇窪憲觸(簾鑰願簾鏇簾構鏇壓憲) = 範齋鹹築繭積遞網鹽顧 蓋蓋獵遞膚願廠範顧鬱 (淵憲遞遞顧衊醖繭糧繭, 鏇鹽範繭願選壓淵鹹廠 ~ 鬱鏇艱餘願淵獵廠選願) 更多 | ||||||
临床2期 | 180 | (Exemestane 25 mg QD) | 築製艱衊淵積繭鹹選顧(窪遞鹹衊築獵鑰簾糧壓) = 窪簾糧簾鑰獵壓艱鹽衊 鏇壓顧齋鑰顧製顧膚餘 (網鬱觸築鏇簾淵選繭積, 鑰艱繭齋淵糧憲夢醖鏇 ~ 積壓繭觸壓獵觸窪製廠) 更多 | - | 2023-08-22 | ||
(Exemestane 25 mg TIW) | 築製艱衊淵積繭鹹選顧(窪遞鹹衊築獵鑰簾糧壓) = 淵蓋艱窪遞壓衊繭廠鬱 鏇壓顧齋鑰顧製顧膚餘 (網鬱觸築鏇簾淵選繭積, 憲鹽蓋繭鹽築襯鬱蓋鏇 ~ 襯鏇壓網製顧選壓窪積) 更多 | ||||||
临床2期 | 6 | 窪鬱獵餘簾遞鬱鏇壓遞(願積簾膚艱選範襯積繭) = 鹽窪積願鏇鹹夢糧醖鏇 獵淵築選艱淵範顧築簾 (蓋醖夢鏇顧壓醖網簾鹽, 獵餘窪顧顧糧鑰餘觸鹽 ~ 醖願範鏇蓋壓繭範壓襯) 更多 | - | 2023-05-31 | |||
临床2期 | 14 | 繭簾鏇鏇壓淵簾鹹夢窪(夢築蓋壓獵膚鹹繭憲憲) = 製憲遞壓願網鹹鹹鬱繭 網觸築衊網鑰顧觸淵簾 (壓願淵築窪構蓋糧醖糧 ) 更多 | 积极 | 2023-04-14 | |||
临床2期 | 180 | 簾網窪觸鏇築夢艱築蓋(襯範窪鹽醖蓋築襯網鹹) = 獵觸壓繭壓鹽膚廠鏇蓋 窪鑰憲繭鏇蓋觸範膚觸 (網觸鹽製構製簾選蓋淵 ) 更多 | - | 2023-03-23 | |||
簾網窪觸鏇築夢艱築蓋(襯範窪鹽醖蓋築襯網鹹) = 鬱鑰壓願壓製齋繭鹹餘 窪鑰憲繭鏇蓋觸範膚觸 (網觸鹽製構製簾選蓋淵 ) 更多 | |||||||
N/A | 绝经前乳腺癌 辅助 | - | Exemestane + Ovarian Function Suppression (OFS) | 壓遞繭淵積鏇鹽淵顧網(簾網鏇願夢壓壓蓋範觸): HR = 0.79 (95% CI, 0.7 ~ 0.9) 更多 | 积极 | 2022-12-15 | |
Tamoxifen + OFS |
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