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. 2025 May 8;30(5):oyaf088.
doi: 10.1093/oncolo/oyaf088.

Delphi consensus on the management of adverse events in patients with metastatic triple-negative breast cancer treated with sacituzumab govitecan

Anna Amela Valsecchi  1 , Simona Pisegna  2   3 , Andrea Antonuzzo  4 , Grazia Arpino  5 , Giampaolo Bianchini  6   7 , Laura Biganzoli  8 , Giuseppe Ferdinando Colloca  9 , Carmen Criscitiello  10   11 , Romano Danesi  12 , Alessandra Fabi  13 , Raffaele Giusti  14 , Loredana Pau  15 , Massimo Di Maio  1 , Daniele Santini  16   17
Affiliations

Delphi consensus on the management of adverse events in patients with metastatic triple-negative breast cancer treated with sacituzumab govitecan

Anna Amela Valsecchi et al. Oncologist. .

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.

Keywords: Delphi; adverse events; breast cancer; consensus; guidelines; mTNBC; management; sacituzumab govitecan.

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Conflict of interest statement

The authors A.A.V., A.A., R.G., L.P., and D.S., declare no conflicts of interest; S.P.: Daichii, AstraZeneca, Eli Lilly, Pfizer, Gentili, Sophos, Seagen, Novartis, Roche (speaker), Gilead, AstraZeneca (investigator); G.A.: Novartis, Lilly (personal fees), Roche (grants and personal fees), Pfizer, AstraZeneca (personal fees, and nonfinancial support), Daichi (personal fees); G.B.: AstraZeneca, Daiichi Sankyo, Eli Lilly, Novartis, Pfizer, Roche, MSD, EISAI, Gilead, Menarini/Stemline, Exact Science, Seagen, Helsinn, Takeda (consultancy/honorarium/advisory role), Gilead (Institutional fee for research grant); L.B.: Amgen, AstraZeneca, Boehringer-Ingelheim, Daiichi-Sankyo, Eisai, Exact Sciences, Gilead, Lilly, Menarini, Novartis, Pfizer, Pierre Fabre, Roche, Sanofi, SeaGen (honoraria, consultancy or advisory role), Celgene, Genomic Health, Novartis (Institutional financial interests), AstraZeneca, Daiichi-Sankyo (travel grant); G.F.C.: C.C.: AstraZeneca, Daichii Sankyo, Gilead, Lilly, MSD, Novartis, Pfizer, Roche, Seagen (Consulting/Advisory role/speaker); A.F.: Astra Zeneca, Dompè Biotech, Eisai, Exact Science, Gilead, Lilly, MSD, Novartis, Pfizer, Pierre Fabre, Roche, Sophos, Seagen; R.D.: Roche, Ipsen, Novartis, Pfizer, Sanofi Genzyme, AstraZeneca, Janssen, Gilead, Lilly, Gilead, EUSA Pharma (scientific advisory board, consulting relationship), Ipsen, Sanofi Genzyme (travel, accommodation, expenses); A.F.: M.D.M.: AstraZeneca, Boehringer Ingelheim, Janssen, Merck Sharp & Dohme (MSD), Novartis, Pfizer, Roche, GlaxoSmithKline, Amgen, Merck, Takeda, Viatris, Ipsen, Astellas (consultancy or participation to advisory boards).

Figures

Figure 1.
Figure 1.
Flowchart of the methodology design including editorial project, data collection, and final consensus paper definition; * Statements that did not reach 75% in the first round were subjected to a second round of voting.
See this image and copyright information in PMC

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