Palbociclib

点击上方蓝字 关注我们编者按：2025年全国乳腺癌大会于4月11～13日在北京召开，此次大会上，备受瞩目的《CSCO乳腺癌诊疗指南》（CSCO BC指南）迎来了重要更新。新版《CSCO BC指南》进一步细化分层治疗策略，强调了精准治疗和联合治疗的重要性，为临床医生提供了更加详细和精准的治疗指导。为深入了解新版指南的更新要点，肿瘤瞭望特邀天津市肿瘤医院空港医院郝春芳教授，就激素受体（HR）阳性晚期乳腺癌患者的内分泌治疗更新情况进行详细介绍。本次全国乳腺癌大会上我们再次迎来了《CSCO BC指南》的更新，请您为大家从2024版《CSCO BC指南》上勾画出此次指南更新要点？在您看来，此次更新将为乳腺癌诊疗的临床实践带来哪些改变？郝春芳教授：众所周知，过去一年乳腺癌领域有很多新药临床研究报告了重要的研究结果，也有很多新药在中国获批上市，使得激素受体阳性晚期乳腺癌患者的治疗药物变得越来越丰富，治疗药物选择也从传统的内分泌治疗到多样化的靶向治疗，可以说激素受体阳性晚期乳腺癌的治疗进入到了ADC药物治疗和新型靶向药物治疗时代。在这里，我结合2024版《CSCO BC指南》为大家介绍新版指南中激素受体阳性晚期乳腺癌的更新要点。在2024版《CSCO BC指南》中，我们可以看到激素受体阳性晚期乳腺癌的解救内分泌治疗分层诊疗路径清晰，治疗中非常重要的一个特点就是以内分泌联合治疗为主，尤其是以CDK4/6抑制剂联合内分泌治疗为主要核心点。纳入新药物，细化分层治疗，强调内分泌联合与精准检测，推进HR+晚期乳腺癌的精准治疗新版《CSCO BC指南》激素受体阳性晚期乳腺癌的解救内分泌治疗中，这一个特点依然不变，仍旧是“清晰的分层诊疗路径、优选内分泌联合治疗”，尤其CDK4/6抑制剂联合内分泌治疗依旧是优选推荐方案，只要没有用过CDK4/6抑制剂的激素受体阳性晚期乳腺癌患者，我们在考虑诊疗方案时都会将其作为优选方案。新版指南中最大的改变在于“TAM治疗失败、非甾体类AI治疗失败和甾体类AI治疗失败”患者的治疗选择路径，对于这些患者，除了CDK4/6抑制剂联合治疗外，还新增其他的靶向联合内分泌治疗推荐，如大家非常关注的PAM通路抑制剂，包括PI3K抑制剂伊那利塞等。在INAVO120研究中，伊那利塞联合哌柏西利和氟维司群展现了优异的临床效果，伊那利塞显著延长患者的中位PFS（15.0 vs.7.3个月，HR=0.43，P＜0.0001），降低了57%的疾病进展或死亡风险。基于该研究数据和结果，3月11日，中国国家药品监督管理局（NMPA）正式宣布批准伊那利塞联合哌柏西利和氟维司群方案，适用于内分泌治疗耐药（包括在辅助内分泌治疗期间或之后出现复发）、PIK3CA突变、激素受体阳性、人表皮生长因子受体2阴性的局部晚期或转移性乳腺癌成人患者。在2024版《CSCO BC指南》中，对于CDK4/6抑制剂治疗失败的患者，AKT抑制剂+内分泌治疗已经是HR+乳腺癌患者的推荐方案了。在中国，今年我们预期也会迎来AKT抑制剂卡匹色替上市的好消息，因此，在新版指南更新中，我们也会看到AKT抑制剂+内分泌治疗（卡匹色替+氟维司群）在CDK4/6抑制剂治疗失败和非甾体/甾体类AI治疗失败分层中进行III级推荐。在HR+晚期乳腺癌内分泌治疗这一篇章中，我们整体看到的变化不会太多，一句话总结来说就是：精准内分泌治疗时代要到来了。但是大家要注意，我们新批准的这些精准内分泌治疗靶向药物和CDK4/6抑制剂唯一不同的是，这些药物应用时，需要对患者进行精准检测。因此，我们临床应用时要注意“检测先行”。激素受体阳性晚期乳腺癌治疗领域，除内分泌治疗外，还会有ADC药物、PARP抑制剂等治疗药物，也会在指南的其他章节有所体现，我们共同拭目以待。郝春芳 教授医学博士、硕士生导师天津市肿瘤医院空港医院天津市肿瘤医院空港医院乳腺内科科主任中国临床肿瘤学会乳腺癌专家委员会委员中国抗癌协会乳腺癌专业委员会委员中国抗癌协会肿瘤防治科普专业委员会委员中国女医师协会乳腺专委会常务委员北京癌症防治学会乳腺癌青年委员会副主任委员北京癌症防治学会乳腺癌个体化诊疗及MDT专委会常务委员北京乳腺病防治学会健康管理专业委员会常务委员天津市药理学会肿瘤药理专委会委员（来源：《肿瘤瞭望》编辑部）声 明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

Truqap has been approved patients with the most common type of breast cancer on the NHS. Image credit: Shutterstock/Yakobckuk Viacheslav. AstraZeneca’s Truqap (capivasertib) has been approved for use by the National Health Service (NHS) in England and Wales, providing a new targeted therapy option that significantly increases progression-free survival (PFS) in breast cancer patients. National Institute for Health and Care Excellence (NICE), the spending watchdog for the NHS, has recommended the drug to be used in combination with AstraZeneca’s already-marketed breast cancer drug Faslodex (fulvestrant). Adults with hormone receptor (HR)-positive HER2-negative breast cancer that has one or more PIK3CA, AKT1 or PTEN gene alterations and is locally advanced or metastatic are eligible for the therapy. NICE estimates around 1,100 patients will be able to take the new twice-a-day tablet, with London’s Institute of Cancer Research (ICR) forecasting that the combo therapy will eventually benefit around 3,000 a year. Truqap will likely become a key revenue driver for AstraZeneca. The drug is forecast to reach blockbuster status by 2027, whilst 2031 global sales are expected to hit nearly $2bn, as per GlobalData’s Pharma Intelligence Centre. As well as the UK, Truqap is also approved in the US , the European Union (EU), and Japan, amongst others. GlobalData is the parent company of Pharmaceutical Technology . The HR-positive HER2-negative breast cancer drug market also includes Pfizer’s Ibrance (palbociclib), Eli Lilly’s Verzenio (abemaciclib), and Novartis’ Kisqali (ribociclib). Breast cancer is the most common cancer in the UK, affecting one in seven women. Treatments have progressed over the past few decades, meaning 75% of patients survive for 10 years or more after diagnosis. HR-positive HER2-negative breast cancer is the most common type of breast cancer. Results from the Phase III CAPItello-291 trial (NCT04305496) showed that Truqap doubled the time it took for cancer to progress in 708 women with HR-positive HER2-negative breast cancer patients. The median PFS was 7.3 months in those who received Truqap and Faslodex, compared to 3.1 months in patients who received hormone therapy alone. The NHS availability of Truqap is a ‘triumph’ according to Professor Kristian Helin, chief executive of ICR. “This announcement is a triumph that will improve treatment for these patients with the most common type of advanced breast cancer. Around half of patients with this kind of breast cancer have mutations in one or more of the genes and for these patients, Truqap can halt disease progression. I’m delighted that access to the drug is being expanded to NHS patients in England and Wales who are in desperate need of better options,” Professor Helin commented. Patients with advanced HR-positive HER-2 negative breast cancer in the UK are currently offered the option to continue Faslodex or chemotherapy. Faslodex on its own is often ineffective and chemotherapy carries side effects, the ICR stated. “People with advanced breast cancer would value treatments like [Truqap] that can be given when limited options exist and because it may delay the need for chemotherapy and its associated side-effects,” NICE’s director of medicines evaluation Helen Knight said. Truqap works by inhibiting all three isoforms of the AKT protein. AKT kinases enable cancer cell growth and multiplication. NICE said that whilst there have been no clinical trials directly comparing the new combo therapy to existing approved regimens, indirect comparisons suggest non-inferiority. The recommendation by NICE represents a U-turn after the agency initially rejected the therapy due to uncertainties over its cost-effectiveness. Breast Cancer Now’s chief executive Claire Rowney said this meant “patients faced unnecessary delays in accessing” the treatment. She added that “NHS England must now put in place prompt genetic testing to ensure those eligible to receive [Truqap] without further delay.”