在2026年ESMO乳腺癌年会（ESMO BC）的“激素受体阳性早期乳腺癌辅助治疗”专场中，韩国蔚山大学医学院峨山医学中心Sung-Bae Kim教授以“Adjuvant CDK 4/6 inhibitors: Could they replace chemotherapy for intermediate risk ER+eBC（CDK4/6抑制剂辅助治疗：能否取代中危ER+ eBC的化疗？）”为题作了精彩报告。报告结束后，Sung-Bae Kim教授接受了肿瘤瞭望的专访，并就主要观点进行了深入介绍。
编者按：在2026年ESMO乳腺癌年会（ESMO BC）的“激素受体阳性早期乳腺癌辅助治疗”专场中，韩国蔚山大学医学院峨山医学中心Sung-Bae Kim教授以“Adjuvant CDK 4/6 inhibitors: Could they replace chemotherapy for intermediate risk ER+eBC（CDK4/6抑制剂辅助治疗：能否取代中危ER+ eBC的化疗？）”为题作了精彩报告。报告结束后，Sung-Bae Kim教授接受了肿瘤瞭望的专访，并就主要观点进行了深入介绍。
△Sung-Bae Kim教授报告要点内容
Sung-Bae Kim 教授：我是韩国首尔峨山医疗中心的肿瘤内科医生Sung-Bae Kim。很高兴以线上方式与大家见面，我是一名乳腺肿瘤内科医生，曾于2021年至2023年担任ESMO BC的科学委员会联合主席，因此对这个会议有着特殊的感情，也很欣喜地看到它的逐渐壮大。ESMO BC不仅是获取新知的优秀平台，也是同行间建立联系的重要平台。
今年，我以讲者身份参与了早期乳腺癌患者治疗相关的环节，讲题与HR+/HER2-且伴有中危风险特征的早期乳腺癌有关。当前，新的数据不断涌现，辅助治疗中CDK4/6抑制剂证明了其疗效，不仅在改善无浸润性疾病生存期（iDFS）方面（如monarchE研究和NATALEE研究的数据）展示了较好数据，而且在总生存期（OS）数据方面也显示出强劲的疗效。但在NATALEE研究提供的数据中，有约12%的患者没有接受新辅助化疗。基于此，我的演讲重点探讨了一个问题：CDK4/6抑制剂联合内分泌治疗是否能够替代新辅助化疗？
目前尚无成熟的III期临床数据来回答这一问题，相关研究正在进行中。但从已有的循证依据（如TAILORx和RxPONDER试验）我们可以看到，化疗在中等风险组中的获益其实是有限的。虽然在绝经前亚组中观察到一定疗效，但这究竟来自化疗本身，还是由化疗引起的闭经（卵巢功能抑制）所驱动，尚不十分明确。
在此背景下，借助基因表达检测，我们已能够筛选出对内分泌治疗敏感、可以安全豁免化疗的患者群体。尽管缺乏III期研究的确定性证据，但相关的证据越来越有说服力，而且这个问题值得进一步探讨。所以在此次会议上我的主题报告，想传达的核心结论是：目前谈完全CDK4/6抑制剂替代化疗还为时过早，但对于经过选择的、中等风险的HR+/HER2-早期乳腺癌患者，不含化疗的辅助CDK4/6抑制剂方案可以作为一种选项，而这一决策必须建立在医患共同决策的基础上。
展望未来，基于循环肿瘤DNA（ctDNA）指导的升降阶梯治疗以及整合新型口服选择性雌激素受体下调剂（SERD）等手段，必将为HR+早期乳腺癌的治疗优化带来真正的变革，这也是我们今后应不断努力探索的方向。
I'm Sung-Bae Kim, a medical oncologist from Asan Medical Center, Seoul, Korea. Very glad to see you virtually. I am a breast medical oncologist. I actually was the scientific co-chair of this meeting from 2021 to 2023. So I have a very special affinity to this meeting and also very happy to see the growth of this meeting and how this meeting was a very good, not only to get the new information, but also a very good platform for networking people.
This year I participated in this as a speaker in the early breast cancer session. My talk was related to the hormone receptor-positive HER2-negative high intermediate risk. The new data is coming, the adjuvant CDK4/6 inhibitor proved that efficacy, robust efficacy in terms of overall survival data, not only invasive disease-free survival improvement, like monarchE data and NATALEE data.
But NATALEE data, 12% of patients did not receive neoadjuvant chemotherapy, so my talk was that is there any role the CDK4/6 inhibitor plus endocrine therapy can replace neoadjuvant chemotherapy. At the moment there's no robust data because Phase 3 data is running, but evidence from the previous data, TAILORx and also the RxPONDER trial, that the chemo effect is modest, especially in the intermediate group. Although there was an efficacy in the premenopausal subgroup, but the addition of chemotherapy was not clear whether it is coming from the chemo-induced amenorrhea effect or chemotherapy effect.
So with that background and with the gene expression assay, we can select the endocrine response, we can select those patients who does not need chemotherapy, who can avoid chemotherapy. So we don't have the Phase 3 robust data, but that question, emerging evidences are compelling and also that question deserves further research, so I talked about that issue. My conclusion is that this is too early but adjuvant CDK4/6 inhibitor without chemo can be an option in intermediate-risk patients, but that decision should be made as a shared decision. That is my message. So the future will be the ctDNA-guided treatment, escalated treatment or de-escalated treatment or incorporation of SERD, that will make a difference. That will be the future of how to optimize, how to better provide better treatment in early breast hormone receptor-positive early breast cancer space. Thank you.
Sung-Bae Kim
韩国蔚山大学医学院峨山医学中心
ESMO BC科学委员会联合主席（2021-2023）
多项国际临床试验的指导委员会成员
其主要研究方向包括肿瘤免疫治疗、分子影像、早期新药研发，以及头颈癌、食管癌和乳腺癌的临床诊疗。参与撰写多部学术专著章节，并在肿瘤学同行评审期刊上发表论文逾400篇，同时是多篇高影响力期刊论文的作者或合著者。