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2026 年 10 月 23–27 日 · Madrid · 共 4873 条

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NATALEE

★★★

47 人 · 60 条

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当前热度 2·可比范围峰值 4(10月26日 03:00)·近 24 小时可比范围变化 –·当前参与者 6

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0123410月25日18:0010月26日02:0010月26日09:0010月26日17:00
深度解读

激素受体阳性、HER2 阴性早期乳腺癌,手术之后加 CDK4/6 抑制剂能不能把无病生存做上去,NATALEE 已经用无侵袭性疾病生存(iDFS)回答过一轮:ribociclib 400 mg(3 周开 1 周停,36 个月)加非甾体芳香化酶抑制剂,对比单用内分泌,入组比 monarchE 宽,含一部分淋巴结阴性的 II 期。NEJM 2024 报的是 iDFS,当时总生存不成熟。[2] Annals of Oncology 终分析 iDFS 风险比 0.749,3 年率 90.7% 对 87.6%。[3] 方案计划 5101 人,主终点一直是 iDFS,总生存是次要终点。[1]

本届 LBA25 现场在报的是六年总生存,不是把 2024 年那条 iDFS 再报一遍。现场帖:六年总生存 91.86% 对 89.73%,绝对差 2.1 个百分点(风险比 0.809;95% 置信区间 0.661–0.989;名义单侧 P=0.019)。绝对差小、区间贴着 1:这是描述性总生存有信号,不是一条新的主终点。分层、停药率和后续治疗以会上为准。

JAMA Oncology 的四年更新和 ESMO Open 的五年随访是已经发表的更早快照,不是这次的六年总生存。两套数字不能叠成一条「又复发更少又活得更长」的新结论,除非幻灯把同一分析集写清楚。monarchE(abemaciclib)是另一项试验、另一群人,本页不做间接比较。

现场
  1. Yakup Ergün

    今天,在 #ESMO26 上将展示 NATALEE 的 6 年结果。在此次报告之前,我个人对辅助 CDK4/6 抑制剂带来的生存获益的看法…… NATALEE 中的 6 年 OS 率为 91.86% vs 89.73%:绝对获益为 2.1 个百分点(HR 0.809;95% CI 0.661–0.989;名义单侧 p=0.019)。 monarchE 中 7 年 OS 的绝对获益为 1.8 个百分点(HR 0.842;p=0.027)。我认为,不应将这些获益轻视为“仅 2%”。 在 EBCTCG 分析中,在以蒽环类药物为基础的化疗中加入紫杉烷类药物——这是多年来我们一直认可的标准治疗——带来的 5 年 OS 绝对获益约为 1.9 个百分点。研究人群和随访时间存在差异,因此无法直接比较治疗疗效。然而,我们用来判断几个百分点生存获益的标准应当保持一致。 此外,monarchE 中 95.4% 的患者此前已经接受过化疗。这一生存获益是在化疗和内分泌治疗基础上带来的额外获益。 患者筛选、毒性、治疗时长和成本当然值得讨论。然而,对于经过适当筛选的患者,辅助 CDK4/6 抑制剂的生存获益不应被低估。

    引用@

    #ESMO26 | NATALEE – 6-year results (Pre-presentation abstract) 6-year OS: 92.73% vs 89.38% (HR 0.809; nominal p=0.019). iDFS: HR 0.741; absolute benefit of 4.1% at 6 years. In monarchE, a 7-year OS benefit was demonstrated (HR 0.842; p=0.027). NATALEE also shows a promising OS signal; however, formal statistical significance has not yet been established. Looking forward to the presentation....

    ★★★同题 NATALEE · 47 人7508 浏览57 赞16 转发5 回复
  2. Yakup Ergün

    #ESMO26 今天我们可能会花大部分时间讨论 NATALEE! 6年时,OS:91.9% vs 89.7%(HR 0.81;名义 p=0.019)。 BCSS 获益也令人鼓舞(HR 0.71)。

    引用@

    Today at #ESMO26, the 6-year results of NATALEE will be presented. Ahead of the presentation, my personal view on the survival gains with adjuvant CDK4/6 inhibitors… The 6-year OS rates in NATALEE were 91.86% vs 89.73%: an absolute gain of 2.1 percentage points (HR 0.809; 95% CI 0.661–0.989; nominal one-sided p=0.019). The absolute 7-year OS gain in monarchE was 1.8 percentage points (HR 0.842; p=0.027). I do not think these gains should be dismissed as “only 2%.” In the EBCTCG analysis, adding taxanes to anthracycline-based chemotherapy—an approach we have accepted as standard for years—provided an absolute 5-year OS gain of approximately 1.9 percentage points. The populations and follow-up periods differ, so we cannot directly compare treatment efficacy. However, the standards we use to judge a few percentage points of survival benefit should be consistent. Moreover, 95.4% of patients in monarchE had already received chemotherapy. This survival gain represents an additional benefit on top of chemotherapy and endocrine therapy. Patient selection, toxicity, treatment duration, and cost certainly deserve discussion. However, the survival benefit of adjuvant CDK4/6 inhibitors in appropriately selected patients should not be underestimated.

    ★★★同题 NATALEE · 47 人3491 浏览28 赞11 转发4 回复
  3. OncoAlert

    🚨 每日 OncoAlert 通讯现已从马德里 🇪🇸 正式上线 #ESMO26 免费注册 👉 https://buff.ly/N5gYtAc 每天早晨直接送达您的收件箱 #ESMO26 第一天资讯如下: 📌 NATALEE 6 年 OS 📌 PANKU-Breast01 + Lancet 发表 📌 KEYNOTE-866 与 ENERGIZE 在 MIBC 中均为阴性 📌 HERIZON-GEA-01 3 年 OS 面向同行……由同行打造 🤝 订阅 👉 http://OncoAlert360.com @cdanicas @hoperugo @DrChoueiri @TiansterZhang @matteolambe @NiuSanford @stolaney1 @christine_lovly @amerseburger @GlopesMd @tompowles1 @montypal @Icro_Meattini @PGrivasMDPhD @brian_rini @CathyEngMD @apolo_andrea @AndreaNecchi @DrSGraff @BenWestphalen @graokane @to_be_elizabeth @ElisaAgostinett @nataliagandur @UOzkerim @DrMirallas @DrYukselUrun @Lucarecco @mzugman @HHorinouchi @p_ciracimd @DraMartinezLago @DrVilmaPBarcia @GIMedOnc @MarioBalsaMD @scocmem @AmandaNizamMD @GaiaGriguolo @JankovicK @Dr_Oncologista @Erman_Akkus @WeOncologists @niklas_kluemper @Markuseckstein3

    ★★★同题 NATALEE · 47 人PANKU-BREAST01KEYNOTE-866HERIZON-GEA2035 浏览18 赞12 转发1 回复
  4. Carlos Gonzalez

    NATALEE OS:未达到正式统计学显著性;该分析为描述性分析(名义 P,无 alpha)。相比之下,monarchE 进行了预先设定的 alpha 控制 OS 分析,并达到了标准。NATALEE:HR 稳定在约 0.80,Δ2.1%,BCSS 提供支持。具有临床意义,但并非确证性结果。#ESMO26 #NATALEE #MonarchE

    引用@

    NATALEE at 6 years: Ribociclib + NSAI vs NSAI alone in HR+/HER2− early breast cancer: • 6-year OS: 91.86% vs 89.73% • OS HR 0.809 (95% CI 0.661–0.989); nominal 1-sided P=0.019 • Absolute OS benefit: 2.1% • 6-year iDFS: 83.23% vs 77.92% • iDFS HR 0.741 (95% CI 0.646–0.849) • Absolute iDFS benefit: 5.3% Is OS significant? Looking forward to full data .@Timothee_MD @myESMO @OncBrothers @OncoAlert #ESMO26 #BreastCancer #NATALEE

    ★★★同题 NATALEE · 47 人MET#NATALEE#MONARCHE415 浏览9 赞6 转发0 回复
  5. Aya Mohamed | MSc, MD 🎗

    很荣幸与 OncoDaily 和各位杰出同仁参与这场关于 6 年 NATALEE 数据及其对乳腺癌诊疗影响的讨论。 #ESMO26 #BreastCancer @OncoAlert #ESMOAmbassadors #ESMOcommunity @myESMO

    引用@

    Oncologists Discuss NATALEE Trial The six-year #NATALEE trial results presented at #ESMO2026 showed an overall survival benefit and sustained improvements in invasive disease-free survival with adjuvant ribociclib plus endocrine therapy in patients with HR+/HER2− early breast cancer. https://oncodaily.com/science/natalee-esmo-26-615553 @KefahMokbel @SuyogCancer @emadshash @Timothee_MD @DrBarbiOnc @HundalJasmin @Aydah_AlAwadhi @DrSGraff @dr_yakupergun @kazuki_nozawa @sara_soliman7 @stolaney1 @Dr_Oncologista @DrHBurstein

    同题 NATALEE · 47 人#BREASTCANCER265 浏览11 赞3 转发3 回复
  6. KOL Pulse AI

    “还不能将 NATALEE 称为 OS 方面的胜利。” @nlindenberg NATALEE 6 年 OS,#ESMO26 LBA25 摘要:91.86% vs 89.73%(HR 0.809,95% CI 0.661–0.989;名义单侧 P=.019)。6 年 iDFS 83.23% vs 77.92%(HR 0.741)。 “具有临床意义,但并非确证性结果。” @DrMedOnco 辅助治疗 ribociclib 已获 FDA 批准;这不是一项新的批准。7 条医生评论 + 数据: https://hubs.ly/Q04C78R10 @Novartis @Timothee_MD @SuyogCancer

    同题 NATALEE · 47 人LBA25ribociclib749 浏览9 赞4 转发2 回复
  7. Kristina Jankovic, MD

    🚨 #ESMO26 第1天的精彩看点来了! 免费订阅 👉 https://buff.ly/N5gYtAc 从 NATALIE 和 PANKU-Breast01 到 KEYNOTE-866、ENERGIZE & HERIZON-GEA-01——关注 @OncoAlert,每天早晨将最新资讯直接送至您的收件箱!📩

    引用@

    🚨 The daily OncoAlert Newsletter is LIVE from Madrid 🇪🇸 #ESMO26 REGISTER for Free 👉 https://buff.ly/N5gYtAc DELIVER STRAIGHT TO YOUR INBOX EVERY MORNING Day One #ESMO26 is in: 📌 NATALEE 6-yr OS 📌 PANKU-Breast01 + Lancet pub 📌 KEYNOTE-866 & ENERGIZE, both negative in MIBC 📌 HERIZON-GEA-01 3-yr OS For colleagues… by colleagues 🤝 Subscribe 👉 http://OncoAlert360.com @cdanicas @hoperugo @DrChoueiri @TiansterZhang @matteolambe @NiuSanford @stolaney1 @christine_lovly @amerseburger @GlopesMd @tompowles1 @montypal @Icro_Meattini @PGrivasMDPhD @brian_rini @CathyEngMD @apolo_andrea @AndreaNecchi @DrSGraff @BenWestphalen @graokane @to_be_elizabeth @ElisaAgostinett @nataliagandur @UOzkerim @DrMirallas @DrYukselUrun @Lucarecco @mzugman @HHorinouchi @p_ciracimd @DraMartinezLago @DrVilmaPBarcia @GIMedOnc @MarioBalsaMD @scocmem @AmandaNizamMD @GaiaGriguolo @JankovicK @Dr_Oncologista @Erman_Akkus @WeOncologists @niklas_kluemper @Markuseckstein3

  8. Mirrors of Medicine

    📍 来自马德里 #ESMO26 的现场报道! NATALEE 3 期试验的最新 6 年结果显示,辅助治疗 ribociclib + NSAI 可让高危 II/III 期 HR+/HER2− 早期乳腺癌患者持续获益。 6 年时,与单用 NSAI 相比,ribociclib + NSAI 显示出总生存期获益,绝对差异为 2.1%(91.86% vs 89.73%)。iDFS 的绝对获益也增加至 5.3%(83.23% vs 77.92%)。 重要的是,在患者停用 ribociclib 后中位约 3 年的时间里,这些获益仍得以维持,且未观察到新的安全性信号。 NATALEE 的长期结果令人鼓舞。 https://www.annalsofoncology.org/article/S0923-7534(26)08640-0/fulltext #ESMO26 #NATALEE #BreastCancer #EarlyBreastCancer #Ribociclib

  9. Dra. María Natalia Gandur Quiroga

    🎥 #OAOnTheGO | #ESMO26 Madrid @OncoAlert 6年 NATALEE 更新中最有趣的部分不仅在于获益持续存在 —— 而是在 ribociclib 停药后,侵袭性无病生存(iDFS)的差距仍在持续扩大。 Dr. Gil Morgan @OncoAlert 解读最新数据: 📊 OS:HR 0.81 ➡️ 6年时绝对获益 2.1% 📊 iDFS:绝对获益现为 5.3% ✅ 无新的安全性信号 ⏳ 患者现已停用 ribociclib 超过 3 年 🎯 这为何重要:辅助治疗要求患者今天接受治疗和毒性,而获益可能要数年后才能完全显现。 对我来说,关键问题是复发风险的持续降低最终是否会在更长随访下转化为持久的生存获益。 OS 分析仍属描述性,绝对差异仍然适度——但这正是成熟随访至关重要的原因。 🎬 在 @OncoAlert 最新的 #OAOnTheGO 中观看 Dr. Gil Morgan 的临床解读。 @matteolambe @DrSGraff @ErikaHamilton9 @hoperugo @stolaney1 @BianchiniGP @kevinpunie @GaiaGriguolo @JankovicK @LoiSher #BreastCancer #NATALEE #Ribociclib #CDK46 #AdjuvantTherapy #OncoAlert

    引用@

    🎥 #OAOnTheGO Series in| #ESMO26 Madrid Dr. Gil Morgan (@OncoAlert) breaks down the 6-year NATALEE update! In this episode of #OAOnTheGO, Dr. Gil Morgan, OncoAlert representative, breaks down the 6-year NATALEE update, simultaneously published in Annals of Oncology. 🔬 Key takeaways: 📊 Overall survival: HR 0.81, with a 2.1% absolute benefit at 6 years. 📊 Invasive disease-free survival: Absolute benefit has widened to 5.3%. 📊 No new safety signals, with patients now more than 3 years off ribociclib. These findings strengthen the role of adjuvant ribociclib for eligible patients with high-risk, HR-positive, HER2-negative early breast cancer. While the overall survival analysis remains descriptive and the absolute benefit is modest, the results bring an important question into focus: Can preventing more recurrences ultimately help more patients live longer? 🎬 Watch Dr. Gil Morgan's clinical take in the latest #OAOnTheGO by OncoAlert. Pinging OncoAlert Breast Cancer Faculty @matteolambe @aftimosp @E_de_Azambuja @DrSGraff @ErikaHamilton9 @hoperugo @stolaney1 @BianchiniGP @aftimosp @kevinpunie @ElisaAgostinett @to_be_elizabeth @GaiaGriguolo @JankovicK @raalbany @JavierCortesMD @JaniceTNBCmets @Prof_Nadia_H @LoiSher @jamecancerdoc @Lucarecco @Dr_Oncologista @guiandri76

  10. Kristina Jankovic, MD

    🎥 #OAOnTheGO 来自 #ESMO26 🇪🇸 Dr. Gil Morgan @weoncologists 对 6 年 NATALEE 更新进行了精彩解读。 @OncoAlert @myESMO #BreastCancer

    引用@

    🎥 #OAOnTheGO Series in| #ESMO26 Madrid Dr. Gil Morgan (@OncoAlert) breaks down the 6-year NATALEE update! In this episode of #OAOnTheGO, Dr. Gil Morgan, OncoAlert representative, breaks down the 6-year NATALEE update, simultaneously published in Annals of Oncology. 🔬 Key takeaways: 📊 Overall survival: HR 0.81, with a 2.1% absolute benefit at 6 years. 📊 Invasive disease-free survival: Absolute benefit has widened to 5.3%. 📊 No new safety signals, with patients now more than 3 years off ribociclib. These findings strengthen the role of adjuvant ribociclib for eligible patients with high-risk, HR-positive, HER2-negative early breast cancer. While the overall survival analysis remains descriptive and the absolute benefit is modest, the results bring an important question into focus: Can preventing more recurrences ultimately help more patients live longer? 🎬 Watch Dr. Gil Morgan's clinical take in the latest #OAOnTheGO by OncoAlert. Pinging OncoAlert Breast Cancer Faculty @matteolambe @aftimosp @E_de_Azambuja @DrSGraff @ErikaHamilton9 @hoperugo @stolaney1 @BianchiniGP @aftimosp @kevinpunie @ElisaAgostinett @to_be_elizabeth @GaiaGriguolo @JankovicK @raalbany @JavierCortesMD @JaniceTNBCmets @Prof_Nadia_H @LoiSher @jamecancerdoc @Lucarecco @Dr_Oncologista @guiandri76

  11. Elisabetta Bonzano MD, PhD

    📌 #OAOnTheGO 系列 🎥 在| #ESMO26 马德里 Dr. Gil Morgan (@OncoAlert) 解读 6 年 NATALEE 更新! 在 #OAOnTheGO 的这一期中,Dr. Gil Morgan,OncoAlert 代表,解读 6 年 NATALEE 更新,同时发表于《Annals of Oncology》。

    引用@

    🎥 #OAOnTheGO Series in| #ESMO26 Madrid Dr. Gil Morgan (@OncoAlert) breaks down the 6-year NATALEE update! In this episode of #OAOnTheGO, Dr. Gil Morgan, OncoAlert representative, breaks down the 6-year NATALEE update, simultaneously published in Annals of Oncology. 🔬 Key takeaways: 📊 Overall survival: HR 0.81, with a 2.1% absolute benefit at 6 years. 📊 Invasive disease-free survival: Absolute benefit has widened to 5.3%. 📊 No new safety signals, with patients now more than 3 years off ribociclib. These findings strengthen the role of adjuvant ribociclib for eligible patients with high-risk, HR-positive, HER2-negative early breast cancer. While the overall survival analysis remains descriptive and the absolute benefit is modest, the results bring an important question into focus: Can preventing more recurrences ultimately help more patients live longer? 🎬 Watch Dr. Gil Morgan's clinical take in the latest #OAOnTheGO by OncoAlert. Pinging OncoAlert Breast Cancer Faculty @matteolambe @aftimosp @E_de_Azambuja @DrSGraff @ErikaHamilton9 @hoperugo @stolaney1 @BianchiniGP @aftimosp @kevinpunie @ElisaAgostinett @to_be_elizabeth @GaiaGriguolo @JankovicK @raalbany @JavierCortesMD @JaniceTNBCmets @Prof_Nadia_H @LoiSher @jamecancerdoc @Lucarecco @Dr_Oncologista @guiandri76

    同题 NATALEE · 47 人#OAONTHEGO38 浏览3 赞2 转发0 回复
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