Delphi Consensus on the Management of Adverse Events in Patients with Metastatic Triple-Negative Breast Cancer Treated with Sacituzumab Govitecan

Sep 23, 2026

Uploaded by Connor

Metastatic triple-negative breast cancer is an aggressive disease with limited treatment options due to the absence of hormone target receptors. Sacituzumab govitecan combines an antibody to Trop-2 with the active metabolite SN-38 to target cancer cells. A Delphi process was created to synthesize expert opinions when direct evidence is limited, gathering specialist perspectives via two voting rounds. Consensus was predefined as ≥75% agreement, producing 67% agreement across 40 statements and informing safety, dosing regimens, and patient management.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages10

Reading Time25 min

AccessFree to download

Abstract

Background

Methods

Results

Conclusions

Implications for Practice

Received and Accepted

Introduction

Delphi consensus on the management of adverse events in patients with metastatic triple-negative breast cancer treated with sacituzumab govitecan Anna AmelaValsecchi1, Simona Pisegna2,3, Andrea Antonuzzo4, Grazia Arpino5, Giampaolo Bianchini6,7,, Laura Biganzoli8, Giuseppe Ferdinando Colloca9, Carmen Criscitiello10, 11,, Romano Danesi12,, Alessandra Fabi13, Raffaele Giusti14,, Loredana Pau15, Massimo Di Maio1,*,‡,, Daniele Santini16, 17,‡ 1Department of Oncology, University of Turin, A. O. U. Città della Salute e della Scienza di Torino, Ospedale Molinette, Turin, Italy 2Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy 3Medical Oncology Unit, Sant’Andrea Hospital of Rome, Rome, Italy 4 Internistic and Geriatric Supportive Care, Fondazione IRCCS-National Cancer Institute, Milan, Italy 5Oncology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy 6Department of Medical Oncology, IRCCS Ospedale San Raffaele, Milano, Italy 7School of Medicine, Vita-Salute San Raffaele University, Milano, Italy 8Department of Oncology, Hospital of Prato, Azienda USL Toscana Centro, Italy 9Department of Imaging Diagnostic, Oncologic Radiotherapy and Haematology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy 10Division of New Drugs and Early Drug Development for Innovative Therapies, European Institute of Oncology, IRCCS, Milan, Italy 11Department of Oncology and Hematology-Oncology (DIPO), University of Milan, Milan, Italy 12Department of Oncology and Hemato-Oncology, University of Milano “La Statale,” Milan, Italy 13 Precision Medicine Unit in Senology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy 14Medical Oncology Unit, Sant’Andrea Hospital, Rome, Italy 15Europa Donna Italia, Milan, Italy 16Medical-Surgical Sciences and Biotechnology, La Sapienza University of Rome, Rome, Italy 17Medical Oncology A, Policlinico Umberto 1, Rome, Italy * Corresponding author. Massimo Di Maio, Department of Oncology, University of Turin, A. O. U. Città della Salute e della Scienza di Torino, Ospedale Molinette, Turin, Italy. E-mail address: massimo. dimaio@unito. it ‡These authors contributed equally to this work. Abstract Background: 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. Methods: 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. Results: 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. Conclusions: 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. Key words: breast cancer; mTNBC; guidelin

FAQs

What is the Delphi consensus study focused on?

It focuses on building consensus recommendations for managing adverse events in metastatic triple-negative breast cancer patients treated with sacituzumab govitecan, using expert input when direct evidence is limited.

How was consensus defined and reached in the study?

Consensus criteria were predefined as at least 75% agreement. The panel voted on 40 statements across two rounds, achieving 67% agreement.

Which topics were most discussed among the experts?

The reduction of the initial sacituzumab govitecan dose and prophylaxis management for patients with the UGT1A1 *28/*28 genotype were the most discussed issues.

Sep 23, 2026

Uploaded by Connor