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2020年9月2021 年10月14日，美国美国学会临床杂志》，，欧洲欧洲肿瘤内肿瘤内科学会科学会科学会《《肿瘤学报》发表发表发表发表发表发表发表发表发表发表发表发表22 cdk4 / 6抑制剂可显着改善激素激素受体阳性阴性阴性风险乳腺癌术后后内分泌分泌治疗治疗患者患者患者无无浸润病变生存和无远处复发无远处复发无远处复发无远处复发生存生存生存生存生存生存生存生存%、29% ，2年远处复发或死亡风险减少28% 。 monarchE (NCT03155997)：Abemaciclib 联合标准辅助内分泌治疗与单独标准辅助内分泌治疗在高危、淋巴结阳性、早期、激素受体阳性、人表皮受体 2 阴性患者中的随机、开放标签 3 期研究， 乳腺癌 前情提要 2022年12月6日，英国英国刀》和第第第第届圣安东尼奥乳腺癌大会同时发表英国伦敦皇家马斯登医院，日本京都大学医院医院医院国立nsabp基金会基金会，哈佛达纳法伯癌症，医学，旧金山加利福尼亚利福尼亚大学海伦迪勒海伦迪勒海伦迪勒家族综合中心，，礼来礼来，，，法国法国西部肿瘤肿瘤大学医院圣加仑医院医院墨西哥医疗路径，土耳其特拉基亚医院，波兰格但波兰格但斯克医科斯克医科大学大学大学医院医院，巴西巴西研究研究与教学教学教学医院医院，意大利热那亚意大利热那亚君主4的研究研究研究研究研究结果结果结果结果结果结果结果结果结果结果分析分析分析对激素激素激素阴性阴性阴性阴性阴性淋巴结阳性结阳性高风险早期早期治疗治疗±±±±±±±阿贝西利阿贝西利生存进行比。 
2017年7月17日年研究于对照对照对照对照对照对照三三期期临床临床临床临床研究于研究于研究于研究于研究于研究于研究于研究于研究于研究于研究于研究于研究于研究于研究于研究于研究于研究于研究于研究于研究于研究于研究于〜〜〜〜〜〜〜〜〜～119年8月12日12日38全球603个603603个个个个个（包括医院医院，，学术中心Her2阴性阴性淋巴结阳性，早期乳腺癌术后复发复发风险高，，状态状态评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分评分年龄年龄年龄年龄年龄年龄年龄年龄年龄年龄年龄≥18≥18≥18年龄）5637例0.6％） ，利用网络1∶1∶1∶：内：内内内2808例2808例例内2829例10± 10 ± 150毫克毫克毫克毫克每天口服口服口服口服口服口服口服持续持续持续持续持续次次次次年年年年全部全部治疗治疗治疗治疗都都以非盲非盲非盲方式进行进行进行。。为为3 3大小≥5≥5厘米厘米厘米（（（（（（（（。。。部分部分患者患者患者患者患者患者患者患者患者患者患者患者患者患者枚枚腋窝淋巴腋窝淋巴腋窝淋巴结阳性且且且且且且结阳性20％作为队列队列队列队列队列队列队列队列队列队列队列队列队列队列队列队列队列队列队列队列队列队列队列分析，计划于无浸润病生存主要结局分析2年后进行。 
结果，中位随访42个月（四分位37～47），对于全部意向治疗人群，内分波治疗±阿贝西利相比较： 4年浸润病变或死亡风险：减少33.6% （风险比：0.664，95%置信区间：0.578～0.762，估计P<0.0001） 4年无浸润病发生率：85.8%比79.4%（绝相对值差6.4% ，95%置信区间：84.2～87.3、77.5～81.1） 4年远地复发或死亡风险：减少34.1% （风险比：0.659，95%置信区间：0.567～0.767，估计P<0.0001） 4年无远处复活率：88.4%比82.5%（绝对相对值差5.9% ，95%置信区间：86.9～89.7、80.7～84.1） 4年总死亡风险：减少7.1% （风险比：0.929，95%置信区间：0.748～1.153，P=0.50） 4年总生存率：94.4%比93.9%（绝对值相差0.5% ）
亚组分析结果表明，无论及其他影响因素如何，内分流治疗±阿贝西利相比，无浸润病发生、无远处复发均显。 
对全部实际治疗患者，内分流治疗±阿贝西利（2791例、2800例）比较，不良事件发生率： 3～4级中性粒细胞减少：19.6%比0.9% 3～4级白细胞减少：11.4%比0.4% 3～4级腹胀：7.8%比0.2% 严重不良事件：15.5%比9.1% 治疗相关死亡：2例（由于腹痛和肺热）比0例
因此，该该研究年结果进一步证实证实证实证实证实证实证实证实进一步证实证实进一步进一步证实高风险风险早期早期早期2年年保持保持保持保持保持保持保持保持保持增加增加增加，进一步进一步类类类类患者服用阿贝西利阿贝西利阿贝西利。。由于总总仍然较少少少少少少否改善总存。 
柳叶刀 Oncol。2022 年 12 月 6 日。如果：54.433Abemaciclib 加内分泌治疗激素受体阳性、HER2 阴性、淋巴结阳性、高危早期乳腺癌 (monarchE)：结果来自地图重新计划的随机中期分析ise d，开放标签，3 期试验。Stephen RD Johnston, Masakazu Toi, Joyce O'Shaughnessy, Priya Rastogi, Mario Campone, Patrick Neven, Chiun-Seng Huang, Jens Huober, Georgina Garnica Jaliffe, Irfan Cicin, Sara M Tolaney, Matthew P Goetz, Hope S Rugo, Elzbieta Senkus , 劳拉·泰斯塔, 露西亚·德尔·马斯特罗, 清水千佳子, 冉薇, 阿什温·沙希尔, 玛丽亚·穆尼奥斯, 贝伦·圣安东尼奥, 瓦莱丽·安德烈, 娜迪亚·哈贝克, 米格尔·马丁农; monarchE委员会成员。The Royal Marsden NHS Foundation Trust, London, UK; Kyoto University, Kyoto, Japan; National Centre for Global Health and Medicine, Tokyo, Japan; Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, TX, USA; University of Pittsburgh/UPMC, NSABP Foundation, Pittsburgh, PA, USA; Dana-Farber Cancer Institute, Boston, MA, USA; Mayo Clinic, Rochester, MN, USA; University of California San Francisco Hellen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA; Eli Lilly and Company, Indianapolis, IN, USA; Loxo@Lilly, Indianapolis, IN, USA; Institute de Cancérologie de l'Ouest, Centre Rene Cauducheau, Saint-Herblain, Nantes, France; Universitaire Ziekenhuizen Leuven, Campus Gasthuisberg, Leuven, Belgium; National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan; Cantonal Hospital St Gallen, Breast Centre St Gallen, Switzerland; Grupo Medico Camino SC, Mexico City, Mexico; Trakya University Faculty of Medicine, Edirne, Turkey; Medical University of Gdańsk, Gdańsk, Poland; Instituto D'Or de Pesquisa e Ensino (IDOR), Sao Paulo, Brazil; IRCSS Ospedale Policlinico San Martino, Genoa, Italy; Università di Genova, Genoa, Italy; LMU University Hospital, Munich, Germany; Hospital General Universitario Gregorio Maranon, Universidad Complutense, CIBERONC, GEICAM, Madrid, Spain.BACKGROUND: Adjuvant abemaciclib plus endocrine therapy previously showed a significant improvement in invasive disease-free survival and distant relapse-free survival in hormone receptor-positive, human epidermal growth factor receptor 2 (HER2; also known as ERBB2)-negative, node-positive, high-risk, early breast cancer. Here, we report updated results from an interim analysis to assess overall survival as well as invasive disease-free survival and distant relapse-free survival with additional follow-up.METHODS: In monarchE, an open-label, randomised, phase 3 trial, adult patients (aged ≥18 years) who had hormone receptor-positive, HER2-negative, node-positive, early breast cancer at a high risk of recurrence with an Eastern Cooperative Oncology Group performance status of 0 or 1 were recruited from 603 sites including hospitals and academic and community centres in 38 countries. Patients were randomly assigned (1:1) by means of an interactive web-based response system (block size of 4), stratified by previous chemotherapy, menopausal status, and region, to receive standard-of-care endocrine therapy of physician's choice for up to 10 years with or without abemaciclib 150 mg orally twice a day for 2 years (treatment period). All therapies were administered in an open-label manner without masking. High-risk disease was defined as either four or more positive axillary lymph nodes, or between one and three positive axillary lymph nodes and either grade 3 disease or tumour size of 5 cm or larger (cohort 1). A smaller group of patients were enrolled with between one and three positive axillary lymph nodes and Ki-67 of at least 20% as an additional risk feature (cohort 2). This was a prespecified overall survival interim analysis planned to occur 2 years after the primary outcome analysis for invasive disease-free survival. Efficacy was assessed in the intention-to-treat population. Safety was assessed in all treated patients. The study is registered with ClinicalTrials.gov, NCT03155997, and is ongoing.FINDINGS: Between July 17, 2017, and Aug 12, 2019, 5637 patients were randomly assigned (5601 [99.4%] were women and 36 [0.6%] were men). 2808 were assigned to receive abemaciclib plus endocrine therapy and 2829 were assigned to receive endocrine therapy alone. At a median follow-up of 42 months (IQR 37-47), median invasive disease-free survival was not reached in either group and the invasive disease-free survival benefit previously reported was sustained: HR 0.664 (95% CI 0.578-0.762, nominal p<0.0001). At 4 years, the absolute difference in invasive disease-free survival between the groups was 6.4% (85.8% [95% CI 84.2-87.3] in the abemaciclib plus endocrine therapy group vs 79.4% [77.5-81.1] in the endocrine therapy alone group). 157 (5.6%) of 2808 patients in the abemaciclib plus endocrine therapy group died compared with 173 (6.1%) of 2829 patients in the endocrine therapy alone group (HR 0.929, 95% CI 0.748-1.153; p=0.50). The most common grade 3-4 adverse events were neutropenia (in 548 [19.6%] of 2791 patients receiving abemaciclib plus endocrine therapy vs 24 [0.9%] of 2800 patients in the endocrine therapy alone group), leukopenia (318 [11.4%] vs 11 [0.4%]), and diarrhoea (218 [7.8%] vs six [0.2%]). Serious adverse events occurred in 433 (15.5%) of 2791 patients receiving abemaciclib plus endocrine therapy versus 256 (9.1%) of 2800 receiving endocrine therapy. There were two treatment-related deaths in the abemaciclib plus endocrine therapy group (diarrhoea and pneumonitis) and none in the endocrine therapy alone group.解释：佐剂 abemaciclib 可降低复发风险。该益处在治疗完成后持续存在，在 4 年时绝对增加，进一步支持在高风险激素受体阳性、HER2 阴性早期乳腺癌患者中使用 abemaciclib。需要进一步随访以确定在这些患者中使用 abemaciclib 联合内分泌治疗是否可以改善总生存期。DOI : 10.1016/S1470-2045(22)00694-5
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