Valsecchi Anna Amela, Pisegna Simona, Antonuzzo Andrea, Arpino Grazia, Bianchini Giampaolo, Biganzoli Laura, Colloca Giuseppe Ferdinando, Criscitiello Carmen, Danesi Romano, Fabi Alessandra, Giusti Raffaele, Pau Loredana, Di Maio Massimo, Santini Daniele
Department of Oncology, University of Turin, A.O.U. Città della Salute e della Scienza di Torino, Ospedale Molinette, Turin, Italy.
Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
Oncologist. 2025 May 8;30(5). doi: 10.1093/oncolo/oyaf088.
Metastatic triple-negative breast cancer (BC; mTNBC) is one of the most aggressive cancers, difficult to treat due to the absence of hormone target receptors. Sacituzumab govitecan (SG) is a new therapeutic approach that exploits the combination of an antibody directed against the Trop-2 antigen expressed in solid epithelial tumors and the active metabolite SN-38, to precisely target cancer cells. The development of consensus recommendations requires synthesizing expert opinions, especially when direct evidence is limited.
This study aimed to create a Delphi process to gather the perspectives of a panel of BC and supportive specialists on the use of SG in clinical practice. A scientific board discussed and defined a series of statements that were submitted to the panel through 2 rounds of voting. The process was designed to collect expert opinions to achieve consensus on key points regarding the safety, dosing regimens, and patient management for SG. Each round of the survey included targeted questions informed by current literature. Predefined criteria for consensus were set at ≥75% agreement.
In October 2024, 29 experts' opinions were collected by voting on 40 statements and reaching a 67% agreement. The reduction of the initial SG dose and the management of prophylaxis for patients with the UGT1A1 *28/*28 genotype were the most discussed topics.
The results provide a foundational framework for clinical decision-making, and highlight the importance of collaborative expert synthesis in forming practice guidelines. Future studies should focus on prospective SG trials to address the identified areas of uncertainty.
转移性三阴性乳腺癌（mTNBC）是最具侵袭性的癌症之一，由于缺乏激素靶受体而难以治疗。戈沙妥珠单抗（SG）是一种新的治疗方法，它利用针对实体上皮肿瘤中表达的Trop-2抗原的抗体与活性代谢物SN-38的组合，精确靶向癌细胞。制定共识性建议需要综合专家意见，尤其是在直接证据有限的情况下。
本研究旨在创建一个德尔菲法流程，以收集一组乳腺癌和支持治疗专家对SG在临床实践中应用的观点。一个科学委员会讨论并确定了一系列陈述，并通过两轮投票提交给专家小组。该流程旨在收集专家意见，以就SG的安全性、给药方案和患者管理等关键点达成共识。每轮调查都包括根据当前文献提出的针对性问题。共识的预定义标准设定为≥75%的一致同意率。
2024年10月，通过对40项陈述进行投票收集了29位专家的意见，达成了67%的一致同意率。初始SG剂量的降低以及UGT1A1 *28/*28基因型患者的预防管理是讨论最多的话题。
研究结果为临床决策提供了一个基础框架，并强调了专家协作综合在形成实践指南中的重要性。未来的研究应专注于SG的前瞻性试验，以解决已确定的不确定性领域。
