#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....

ESMO 2026
2026 年 10 月 23–27 日 · Madrid · 共 4873 条
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
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。
- 1.Rationale and trial design of NATALEE · Ther Adv Med Oncol 2023
- 2.Ribociclib plus Endocrine Therapy in Early Breast Cancer · N Engl J Med 2024
- 3.NATALEE final invasive disease-free survival · Ann Oncol 2025
Yakup Ergün@dr_yakupergun 引用@Timothée Olivier, MD@Timothee_MD Yakup Ergün@dr_yakupergun #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.
Elisa Agostinetto@ElisaAgostinett OncoAlert@OncoAlert Aya Mohamed | MSc, MD 🎗@Dr_Oncologista Sara Tolaney@stolaney1 Timothée Olivier, MD@Timothee_MD Mustafa Özdoğan, MD@ozdogan_md Hope Rugo@hoperugo 引用@Opening ceremony at #ESMO26 #ESMO26 #ESMOAmbassadors #ESMOcommunity @myESMO
Annals of Oncology@Annals_Oncology Oncology Brothers@OncBrothers Yakup Ergün@dr_yakupergun Evandro de Azambuja, MD, PhD@E_de_Azambuja Sherene Loi, MD@LoiSher Carlos Gonzalez@DrMedOnco 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
Timothée Olivier, MD@Timothee_MD Mitsuo Terada, MD, PhD@乳腺科医@MamMa_mimumemo 術後アジュバントのリボシクリブのNATALEE試験 6年OSデータ。
Matteo Lambertini, MD PhD@matteolambe #BreastCancer分会口头摘要(#ESMO26):NATALEE试验的更新数据已在@Annals_Oncology同步发表 @OncoAlert @myESMO
Aya Mohamed | MSc, MD 🎗@Dr_Oncologista 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
Stephanie Graff, MD, FACP, FASCO@DrSGraff NATALEE 6年OS分析显示OS改善幅度不大(早期……考虑到我们刚刚在NSABP42中看到的结果……)。 IDFS获益随时间持续存在。 #ESMO26 @OncoAlert
KOL Pulse AI@KolPulseAI ProfJohnCrown@ProfJohnCrown 好消息!NATALEE 在总生存期方面取得了积极结果。Slamon 医生的演讲非常精彩。衷心感谢所有患者,以及在新冠疫情期间冒着风险协助完成这项研究的科研护士。#ESMO26 #ESMO2026
Kazuki Nozawa, MD@kazuki_nozawa Kristina Jankovic, MD@JankovicK 引用@Oral abstract #BreastCancer session at #ESMO26: updated data from NATALEE trial simultaneously published in @Annals_Oncology @OncoAlert @myESMO
Kristina Jankovic, MD@JankovicK 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
Mirrors of Medicine@mirrorsmed Dra. María Natalia Gandur Quiroga@nataliagandur 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
Kristina Jankovic, MD@JankovicK 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
Elisabetta Bonzano MD, PhD@to_be_elizabeth 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