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Journal Article Ahead of print 1 citation

PubMed: 42413328 DOI: 10.1016/j.esmoop.2026.108251

Real-world evidence of sacituzumab govitecan in metastatic triple-negative breast cancer: an updated multicenter analysis.

ESMO Open 11(7):108251

Authors: R Caputo, G Buono, C Martinelli, A Botticelli, A Caltavituro, F Pantano, A Guarino, M V Bonomo, A Diana, F Carlino, A Rizzo, F Giotta, L Orlando, M V SanĂ², N Staropoli, C Von Arx, G Pernice, S Stucci, E A Bajardi, G R Ricciardi, S Turano, F B Poggio, S Cinieri, M Orditura, G Arpino, M Giuliano, A Fabi, M Piezzo, L Del Mastro, M De Laurentiis

Affiliations

  • Department of Breast and Thoracic Oncology, Istituto Nazionale Tumori, IRCCS "Fondazione G. Pascale", Naples, Italy.
  • Department of Breast and Thoracic Oncology, Istituto Nazionale Tumori, IRCCS "Fondazione G. Pascale", Naples, Italy.
  • Department of Breast and Thoracic Oncology, Istituto Nazionale Tumori, IRCCS "Fondazione G. Pascale", Naples, Italy; Clinical and Translational Oncology, Scientific-Technological Interdisciplinary Area, Scuola Superiore Meridionale (SSM), Naples, Italy.
  • Department of Radiological, Oncological and Pathological Sciences, AOU Policlinico Umberto I, La Sapienza University of Rome, Rome, Italy.
  • Clinical and Translational Oncology, Scientific-Technological Interdisciplinary Area, Scuola Superiore Meridionale (SSM), Naples, Italy; Oncology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; Medical Oncology Department, Translational Genomics and Targeted Therapies in Solid Tumors, August Pi I Sunyer Biomedical Research Institute (IDIPAS), Barcelona, Spain.
  • Department of Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy.
  • Department of Medical Science, Oncology Unit, Ospedale del Mare, Napoli, Italy.
  • Oncology and Hematology Department, UOC Oncologia Medica a Direzione Universitaria AORN Sant'Anna e San Sebastiano, Caserta, Italy.
  • Clinical-Management Oncology Department, S.S.D. C.O.r.O. Bed Management Presa in Carico, TDM, IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy.
  • Department of Medical Area, Struttura Complessa Oncologia Medica, IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy.
  • Department of Medical Oncology, Oncologia Medica and Breast Unit, Ospedale "Antonio Perrino", Brindisi, Italy.
  • Oncology Department, UO Oncologia Medica e Oncoematologia, Humanitas Istituto Clinico Catanese, Catania, Italy.
  • Medical Oncology and Translational Medical Oncology Units, Department of Experimental and Clinical Medicine, Magna Graecia University, AOU R. Dulbecco Catanzaro, Catanzaro, Italy.
  • Oncology Department, UOC Oncologia Medica Fondazione Istituto Giglio, CefalĂ¹, Italy.
  • Division of Medical Oncology, Interdisciplinary Department of Medicine, AOU Consorziale Policlinico di Bari, Bari, Italy.
  • Level III Oncology Department, UO Oncologia Medica Clinica La Maddalena, Palermo, Italy.
  • Department of Onco-Hematology, AO Papardo, Messina, Italy.
  • Department of Onco-Hematology, UO Oncologia Azienda Ospedaliera di Cosenza, Cosenza, Italy.
  • Department of Medical Oncology, U.O.C. Clinica di Oncologia Medica, Azienda Ospedaliera Metropolitana, Genova, Italy.
  • Oncology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.
  • Precision Medicine in Senology, Scientific Directorate-Department of Woman and Child Health, IRCCS Fondazione Policlinico Universitario A. Gemelli, Rome, Italy.
  • Department of Breast and Thoracic Oncology, Istituto Nazionale Tumori, IRCCS "Fondazione G. Pascale", Naples, Italy.
  • Department of Internal Medicine and Medical Specialties (DIMI), School of Medicine, University of Genova, Genova, Italy; Department of Medical Oncology, Clinica di Oncologia Medica, IRCCS Ospedale San Martino, Genova, Italy.

Abstract

BACKGROUND

The Trop-2-directed antibody-drug conjugate sacituzumab govitecan (SG) has shown significant benefit in metastatic triple-negative breast cancer (mTNBC) in clinical trials. However, evidence about its effectiveness and safety in real-world heterogeneous patient populations is limited. This multicenter study, including the largest European and second-largest worldwide real-world cohort of SG-treated patients with mTNBC, offers valuable insights for its use in routine clinical practice.

MATERIALS AND METHODS

This analysis included 256 women with mTNBC treated with SG across 17 Italian oncology centers, consisting of 217 retrospectively identified patients and 39 prospectively enrolled patients. Treatment activity and safety were assessed according to RECIST v1.1 and Common Terminology Criteria for Adverse Events del National Cancer Institute (NCI-CTCAE) v5.0 criteria.

RESULTS

Median patient age was 54 years (range 26-80), and 70.7% had TNBC at initial diagnosis. The median interval from metastatic diagnosis to SG initiation was 16 months (range 0-115), with a median of two prior treatment lines (range 0-7). Frequent metastatic sites were lymph nodes (60.9%), bone (43.0%), lung (42.6%), liver (33.2%), and brain (26.2%). Overall, 37.5% achieved complete or partial response, 27.7% had stable disease, and 31.2% experienced progression. At a median follow-up of 17.4 months, 202 patients had progressed, and 139 had died. Median real-world progression-free survival was 6.4 months [95% confidence interval (CI) 5.3-7.3] and median real-world overall survival was 13.6 months (95% CI 11.5-15.5). The most common treatment-related adverse events were alopecia (69.1%), neutropenia (57.0%), nausea (49.6%), anemia (46.9%), and diarrhea (36.7%). Grade 3-4 neutropenia occurred in 18.0% and 5.9%, respectively. Dose reductions were required in 36.5%, and 2.7% discontinued treatment.

CONCLUSIONS

SG demonstrated durable clinical benefit and manageable toxicity in patients with mTNBC, highlighting the importance of optimized adverse-event management. The size and heterogeneity of the study population, including the largest reported cohort of patients with central nervous system metastases, support the robustness of these findings.

MeSH

Triple Negative Breast Neoplasms, Safety, Breast Neoplasms, Neutropenia, Neoplasms, Drug-Related Side Effects And Adverse Reactions, Breast, Diagnosis, Therapeutics