The monarchE study added the CDK4/6 inhibitor abemaciclib to the care of women with oestrogen-positive (ER+) breast cancers. Eligibility required meeting monarchE criteria—either >3 positive axillary nodes, or 1–3 positive sentinel nodes (SNB+) with tumour size >50 mm or grade 3 cancers. Women were advised to proceed to completion axillary node clearance (cANC) if size/grade criteria were not fulfilled for >3 positive nodes to be identified. However, cANC is associated with significant morbidity, conflicting with the potential benefits of abemaciclib. We analysed data of 229 consecutive women (2016-2022) with ER+ breast cancer and SNB+ who proceeded to cANC, keeping with contemporary treatment guidelines. We used this cohort to assess numbers that, under national guidance in place currently, would be advised to undergo cANC solely to check eligibility for abemaciclib treatment. Using monarchE criteria, 90 women (39%) would have accessed abemaciclib based on SNB+ and size/grade, without cANC. In total, 139 women would have been advised to proceed to cANC to check eligibility, with only 15/139 (11%) having >3 positive nodes after sentinel node biopsy and cANC. The remaining 124 (89%) would have undergone cANC but remained ineligible for abemaciclib. Size, age, grade, and Ki67 did not predict >3 nodes at cANC. Following cANC, a large majority of women with ER+, <50 mm, and grade 1–2 tumours remain ineligible for abemaciclib yet are subject to significant morbidity including lifelong lymphoedema risk. The monarchE authors state that 15 women need abemaciclib therapy for 1 to clinically benefit. Thus, in our cohort, 139 women undergoing cANC would lead to one woman benefitting.
monarchE研究将CDK4/6抑制剂阿贝西利纳入雌激素受体阳性（ER+）乳腺癌患者的治疗方案。入组标准需满足monarchE研究条件——即腋窝淋巴结阳性数>3个，或前哨淋巴结阳性数1-3个（SNB+）且肿瘤尺寸>50毫米或为3级癌症。若患者腋窝淋巴结阳性数未达>3个标准但符合尺寸/分级条件，则建议进行全腋窝淋巴结清扫术（cANC）。然而，cANC与显著的并发症相关，这与阿贝西利的潜在获益相矛盾。我们分析了2016年至2022年间连续229例ER+乳腺癌且SNB+并接受cANC的女性患者数据，这些治疗均符合当代临床指南。我们利用该队列评估了在当前国家指导原则下，仅为了确认是否符合阿贝西利治疗资格而被建议接受cANC的患者数量。根据monarchE标准，90例患者（39%）仅基于SNB+及肿瘤尺寸/分级即可获得阿贝西利治疗，无需cANC。总体而言，139例患者被建议通过cANC确认治疗资格，但其中仅15/139例（11%）在前哨淋巴结活检及cANC后显示淋巴结阳性数>3个。其余124例（89%）虽接受了cANC却仍不符合阿贝西利治疗条件。肿瘤尺寸、年龄、分级及Ki67指数均无法预测cANC后淋巴结阳性数>3个的情况。对于ER+、肿瘤<50毫米、1-2级的患者，绝大多数在接受cANC后仍不符合阿贝西利治疗条件，却需承担包括终身淋巴水肿风险在内的显著并发症。monarchE研究者指出，需要15例患者接受阿贝西利治疗才能使1例患者获得临床获益。因此在本队列中，139例接受cANC的患者中仅1例能最终获益。
肿瘤(癌症)患者之家