Imlunestrant

编者按：在乳腺癌领域的国际舞台上，奥地利维也纳医科大学综合癌症中心Michael Gnant教授以其深厚的学术造诣和卓越的领导力，成为了备受尊敬的权威专家。他不仅在学术研究中取得了显著成就，还积极投身于国际交流与合作，为全球乳腺癌的发展做出了重要贡献。在2024年SABCS大会上，Michael Gnant教授不仅主持了会议重要环节，还在会上点评了多项前沿研究成果，为乳腺癌的治疗带来了新的启示。肿瘤瞭望在SABCS大会现场特邀采访了Michael Gnant教授，请他分享SABCS大会的最新进展及未来发展趋势。 01 《肿瘤瞭望》：您和邵志敏教授共同主持了此次大会的General Session 2环节，作为该环节的主持人，能否请您为我们概述一下该环节的主要内容与亮点？ Michael Gnant教授：首先，我非常高兴能与我的同道、朋友——复旦大学附属肿瘤医院邵志敏教授共同主持圣安东尼奥乳腺癌研讨会上这一重要且具有突破性意义的环节。会议内容非常精彩，首先介绍了EUROPA研究的中期分析（GS2-01）结果。该研究探讨了低风险Luminal型乳腺癌患者接受放疗或内分泌治疗的效果，尽管两年的随访时间相对较短，但这项研究仍具有重要意义，并且特别关注了患者的生活质量。结果表明，当前接受放疗患者的耐受性非常好。此项研究成果同期已在《柳叶刀》杂志上发表，进一步证明了其学术价值。 随后，我们讨论了另外两项关于低风险乳腺导管内原位癌（DCIS）的研究（GS2-05/GS2-06），比较了传统治疗（手术联合放疗）与积极监测的效果，这是一项具有创新性的临床试验。我个人认为，这些研究表明治疗方案正在逐步降级，因为我们已经为DCIS建立了成熟的治疗体系。实际上，超过30%的患者从原先分配的治疗组转至其他治疗组，这表明两种治疗之间差异并不显著，我认为这些结果尚不成熟，不能立即纳入常规临床实践。此外，我们还看到了SUPREMO研究（GS2-03）的10年分析，该研究探讨了在乳房切除术后，对于1至3个淋巴结受累的患者是否需要放疗。简而言之，结果显示，两组在总体生存率上没有差异，这在一定程度上与之前的研究结果相矛盾。关于乳房切除术后的放疗相信之后会有很多讨论。 我认为本环节最重要的内容可能是INSEMA研究（GS2-07）结果的公布。这项试验比较了前哨淋巴结活检与完全不进行腋窝手术的随机分配方案。至少目前来看，我们可以说，如果仔细筛选患者——如年龄较大的患者、低分级患者和低风险的DCIS患者，那么部分患者可以考虑不进行前哨淋巴结活检。这与2023年St. Gallen会议上Gentilini博士展示的SOUND试验非常相似。不过，INSEMA研究的规模要大得多，数据质量也令人印象深刻。因此，我认为这项研究可能会改变临床实践，对于风险非常低的患者，省略腋窝清扫手术可能是安全的。这篇文章同期发表在《新英格兰医学杂志》上，显然也体现了INSEMA研究的重要性。 Oncology Frontier: You and Professor Zhimin Shao jointly presided over the General Session 2 of this conference. As the moderator of this session, could you please give us an overview of the main content and highlights of this segment? Prof. Michael Gnant: First of all, I was delighted and honored for the opportunity to moderate this important and breakthrough session at the San Antonio Breast Cancer Symposium together with my friend Professor Zhimin Shao from Fudan. It was a great session. It started with an interim analysis of the EUROPA trial, which is a trial of radiotherapy or endocrine treatment for low-risk patients. Two-year follow-up is not too long, but this is a significant trial, also looking at quality of life and indicating that modern radiotherapy is actually very well tolerated. This paper is also published in the Lancet today, so that also indicates the importance. We then had two other trials looking at low-risk DCIS, doing the traditional treatment, surgery plus radiotherapy versus active monitoring. Now, this is a very innovative trial. Personally, I find it's a lot of de-escalation because we obviously have established treatment for DCIS. As a matter of fact, more than 30% of patients actually switched from the arm they have been assigned to. It indicates that there is not too much difference, but I don't think that that is mature for routine clinical practice. Also, we saw a very provocative 10-year analysis of the SUPREMO trial, radiotherapy after mastectomy for patients with 1, 2, 3 involved lymph nodes. In short, it showed that there is no overall survival difference there, which is somewhat in contrast with previous reports. There will be a lot of discussion about post-mastectomy radiotherapy. Probably most important was the presentation of the INSEMA trial. This randomized sentinel node biopsy versus no axillary surgery whatsoever. At least for now, we can say, not very surprisingly, that if you select your patients carefully, older patients, low-grade patients, low-risk DCIS, that this is something that we can consider leaving out even the sentinel node biopsy. Very similar to the SOUND trial that has been presented in last year's St. Gallen meeting by Dr. Gentilini. But INSEMA is much larger and the quality of the data is impressive. So I think this is practice changing in a way that for very low-risk patients, it's probably safe to leave the axilla alone. This paper is today published in the New England Journal of Medicine, which is obviously also appreciating the importance of this work.  02 《肿瘤瞭望》：您多次莅临中国参与乳腺癌领域的学术交流，能否分享一下您观察到的中国与您所在国家在乳腺癌患者治疗上的主要差异？同时，您认为这些差异背后的原因是什么？ Michael Gnant教授：我热爱中国，并且经常去中国。几个月前我刚去过中国的几个城市，我在中国也有很多朋友。我在中国几所机构担任客座教授，我看到近几年中国的进展非常迅速，虽然不同地区间也存在一些差异。例如，各地的早期筛查仍然是一个问题。在奥地利这样的国家，以人口为基础的筛查显然要容易得多，因为奥地利的居民比中国大多数大城市都少。但我认为，相对较晚的筛查仍然导致了乳房切除术的过度应用。全国范围内，中国的保乳率接近30%，虽然较几年前有所提高，但仍然没有达到应有的水平。而在奥地利，这一比例接近80%。不过我相信，在中国一些领先的科研机构正在开展许多令人印象深刻的研究。目前，中国在CSCO和CACA的支持下开展了多项临床试验，许多乳腺癌领域的杰出领导者也积极参与其中，我相信中国很快就会迎头赶上。希望未来中国能够更加开放，在全球及国际研究合作中做出更多贡献，不仅仅是与企业进行合作，还包括与其他学术团体的合作。总体而言，我认为中国正走在一条前景光明的发展道路，这条路将能够更好地服务于患者。 Oncology Frontier: You have visited China many times to participate in academic exchanges in the field of breast cancer. Can you share your observations on the main differences in the treatment of breast cancer patients between China and your country? At the same time, what do you think are the reasons behind these differences? Prof. Michael Gnant: I love China. I'm in China a lot. I visited just a couple of months ago quite a number of cities and I have many friends there. I hold visiting professorships in several institutions. China is progressing massively. However, there are differences. For example, early detection is still a problem. So population-based screening is obviously much easier in a country like Austria, where we have fewer inhabitants than most Chinese major cities. But I think the relatively later detection still also leads to an excess in mastectomy. Nationwide, the breast conservation rate in China is approaching 30%, which is up from a few years ago, but it's still not there where it should be. Like in my country, it's almost 80%. However, I believe there's a lot of really very impressive research going on at the leading Chinese institutions. And now, if also clinical trials that are currently developed by CSCO and by the CACA framework with many of very distinguished leaders in the field, China will catch up very soon. And also hopefully open up a little bit in a way that contribution to global and international research collaborations, not only with companies but also with other academic groups, will develop in the years to come. But in general, I think China is on a great way to even better serve the patients than they do now.  03 《肿瘤瞭望》：在本届SABCS大会上，最令您印象深刻研究有哪些？能否为我们简要介绍一下这些研究成果及其意义？ Michael Gnant教授：我认为昨天（12月11日）最令人印象深刻的是EMBER-3研究（GS1-01）的结果。该研究探索了一种新的SERD类药物Imlunestrant作为单药治疗或联合阿贝西利治疗的效果，并将其与标准内分泌单药治疗（如氟维司群或芳香化酶抑制剂）进行了比较。这个研究特别有趣，因为它涉及到SERD（选择性雌激素受体降解剂）这一药物治疗领域，Imlunestrant作为单药治疗在ESR1突变的疾病中显示出了很好的疗效。然而，在与阿贝西利联合使用时，疗效似乎与ESR1突变状态无关，这一点从科学角度来看非常有意思，并且为那些可能无法进行分子检测的患者提供了一个良好的治疗选择。 Oncology Frontier: What research has impressed you most in this SABCS conference? Could you give us a brief introduction of these research results and their significance? Prof. Michael Gnant: I think what was very impressive yesterday is the presentation of the EMBER-3 trial. That is a trial of a new SERD imlunestrant in combination with abemaciclib or as monotherapy. And very interesting in that developing field of selective estrogen receptor downgraders, imlunestrant appears to be very effective both as monotherapy, particularly in ESR1 mutated disease. However, in the combination with abemaciclib, the effect appears to be independent of the mutation status of ESR1, which is, number one, interesting from a scientific point of view and also offers an excellent treatment option for patients who might not have access to molecular testing.  04 《肿瘤瞭望》：第19届St.Gallen国际乳腺癌大会（SGBCC）即将于2025年3月在奥地利维也纳召开，作为备受尊敬的大会主席，能否提前为我们透露一些会议筹备工作的亮点与特色，让我们对这场盛会充满期待？ Michael Gnant教授：是的，圣加仑国际乳腺癌大会（SGBCC）无疑是乳腺癌领域最重要的会议之一，也是以共识投票形式召开的会议，投票将在周六进行。会议的结果定义了治疗标准，因为在会议期间发布的所有研究成果最终都会被纳入临床实践，并通过投票和随后公布的论文确定新的治疗标准。第19届SGBCC会议，我们预计将有来自100多个国家约5000名参与者，我非常乐观地认为，也将有许多中国医生参加。我们与CSCO建立了合作关系，届时将设置“中国之声”的特别环节，还将举行针对中国同道的专场活动。值得一提的是，本次大会首次邀请了四位来自中国的专家作为专题讨论的小组成员，这显然也传递出一个信号，即SGBCC会议上，与中国医生和科学家的合作交流对我们来说非常重要。 Oncology Frontier: The 19th St.Gallen International Breast Cancer Conference (SGBCC) will be held in Vienna, Austria in March 2025. As the highly respected president of the SGBCC, could you please tell us some highlights and features of the preparatory work in advance, so that we are full of expectations for this grand event? Prof. Michael Gnant: Yes, the St. Gallen International Breast Cancer Conference is probably the most important highlight meeting and also summit of the consensus conference on Saturday where the voting takes place. And it defines the standard of care because whatever has been published in between will be related into clinical practice, what is the new standard of care by these votings and by the subsequent manuscript. Now, next year we expect around 5,000 participants from more than 100 countries in the world and I'm very optimistic that also many Chinese physicians will have the ability to attend. We have a partnership with CSCO. There will be special programs like we call it the Voice of China session and there will be a China launch directed at our colleagues from China. For the first time we have four panelists from China which is obviously also a signal that interaction with physicians and scientists in China is very important for us in the St. Gallen conference in Vienna. Michael Gnant教授 奥地利维也纳医科大学综合癌症中心外科学教授 奥地利乳腺癌和结肠直肠癌研究小组主席 （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。