ArticleCancers2024
Tolerability and Preliminary Outcomes of Adjuvant T-DM1 in HER2-Positive Breast Cancer After Neoadjuvant Therapy: The ATD Study.
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Article in Cancers, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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3 citing papers in PubMed.
- Comparative safety of concurrent adjuvant trastuzumab emtansine vs trastuzumab with radiotherapy in HER2-positive early breast cancer.The oncologist · 2026Observational
- Integration of L1CAM and β-catenin immunohistochemistry for prognostic risk stratification of endometrial carcinoma: a practical approach for resource-limited settings.Medical molecular morphology · 2026Article
- Neoadjuvant Regimens and Their Impact on Adjuvant T-DM1 Outcomes in HER2-Positive Early Breast Cancer.Medicina (Kaunas, Lithuania) · 2025Article
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Authors and funding
68 authors.
Eriseld KrasniqiPhase IV Clinical Studies Unit, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.ORCID 0000-0002-6702-0087
Lorena FilomenoPhase IV Clinical Studies Unit, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Teresa ArcuriPhase IV Clinical Studies Unit, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Francesca Sofia Di LisaMedical Oncology Unit, San Giovanni Evangelista Hospital, ASL RM5, 00019 Tivoli, Italy.
Antonio AstoneOncology Division, San Pietro Fatebenefratelli Hospital, 00189 Rome, Italy.
Claudia CutigniOncology Division, San Pietro Fatebenefratelli Hospital, 00189 Rome, Italy.
Jennifer FogliettaOncology Unit, Ospedale Santa Maria, 05100 Terni, Italy.
Martina NunziOncology Unit, Ospedale Santa Maria, 05100 Terni, Italy.
Rosalinda RossiDivision of Oncology, San Giovanni Addolorata Hospital, 00184 Rome, Italy.
Mauro MinelliDivision of Oncology, San Giovanni Addolorata Hospital, 00184 Rome, Italy.
Icro MeattiniDepartment of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, 50134 Florence, Italy.ORCID 0000-0002-1861-2895
Luca VisaniRadiation Oncology Unit, Oncology Department, Azienda Ospedaliero-Universitaria Careggi, 50134 Florence, Italy.
Jacopo ScialinoRadiation Oncology Unit, Oncology Department, Azienda Ospedaliero-Universitaria Careggi, 50134 Florence, Italy.
Lorenzo LiviDepartment of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, 50134 Florence, Italy.
Luca MoscettiOncology and Hemathology Department, Azienda Ospedaliero-Universitaria Policlinico di Modena, 41125 Modena, Italy.
Paolo MarchettiIstituto Dermatopatico dell'Immacolata IRCCS, 00167 Rome, Italy.
Andrea BotticelliDepartment of Radiological, Oncological and Pathological Science, Policlinico Umberto I, "Sapienza" University of Rome, 00161 Rome, Italy.
Ida ParisDivision of Gynecologic Oncology, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00136 Rome, Italy.ORCID 0000-0002-7445-3366
Francesco PaveseDivision of Gynecologic Oncology, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00136 Rome, Italy.
Tatiana D'AngeloDivision of Gynecologic Oncology, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00136 Rome, Italy.
Valentina SiniMedical Oncology, Santo Spirito Hospital, 00193 Rome, Italy.
Simonetta StaniMedical Oncology, Santo Spirito Hospital, 00193 Rome, Italy.
Maria Rosaria ValerioMedical Oncology, AOU Policlinico Paolo Giaccone, 90127 Palermo, Italy.
Antonino GrassadoniaDepartment of Innovative Technologies in Medicine and Dentistry, Centre for Advanced Studies and Technology (CAST), G. D'Annunzio University Chieti-Pescara, 66100 Chieti, Italy.ORCID 0000-0002-2459-0661
Nicola TinariDepartment of Medical, Oral and Biotechnological Sciences, Center for Advanced Studies and Technology (CAST), G. D'Annunzio University Chieti-Pescara, 66100 Chieti, Italy.ORCID 0000-0001-8449-5407
Marco MazzottaMedical Oncology Unit, Department of Medical Oncology, Sandro Pertini Hospital, 00157 Rome, Italy.
Matteo VergatiMedical Oncology Unit, Department of Medical Oncology, Sandro Pertini Hospital, 00157 Rome, Italy.
Giuliana D'AuriaMedical Oncology Unit, Department of Medical Oncology, Sandro Pertini Hospital, 00157 Rome, Italy.
Teresa GamucciMedical Oncology Unit, Department of Medical Oncology, Sandro Pertini Hospital, 00157 Rome, Italy.
Loretta D'OnofrioDivision of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Simona GasparroDivision of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Arianna RoselliDivision of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Alberto FulviDivision of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Gianluigi FerrettiDivision of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.ORCID 0000-0002-2271-6427
Andrea TorchiaDivision of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.ORCID 0000-0002-4020-6893
Monica GiordanoMedical Oncology Department, Azienda Socio Sanitaria Lariana, 22100 Como, Italy.
Filippo GrecoMedical Oncology Unit, Mater Salutis Hospital, Ulss 9 Veneto Region, 37045 Legnago, Italy.ORCID 0009-0004-9568-5029
Francesco PantanoDepartment of Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico, 00128 Rome, Italy.
Giuseppe ToniniDepartment of Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico, 00128 Rome, Italy.
Agnese FabbriMedical Oncology Unit, Belcolle Hospital, 01100 Viterbo, Italy.ORCID 0000-0002-3357-6343
Emilio BriaUniversità Cattolica del Sacro Cuore, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, 00136 Rome, Italy.
Giovanna GarufiUniversità Cattolica del Sacro Cuore, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, 00136 Rome, Italy.
Elena FiorioSection of Oncology, Department of Medicine, University of Verona School of Medicine and Verona University Hospital Trust, 37126 Verona, Italy.ORCID 0000-0002-1354-4600
Mimma RaffaelePresidio Cassia Sant'andrea, Dipartimento Oncologico, Asl Roma 1, 00189 Rome, Italy.
Mirco PistelliDepartment of Medical Oncology, Università Politecnica delle Marche, AOU delle Marche, 60126 Ancona, Italy.
Rossana BerardiDepartment of Medical Oncology, Università Politecnica delle Marche, AOU delle Marche, 60126 Ancona, Italy.ORCID 0000-0002-9529-2960
Rosa SaltarelliMedical Oncology Unit, San Giovanni Evangelista Hospital, ASL RM5, 00019 Tivoli, Italy.
Ramy KayalRadiology Unit, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Francesca Romana FerrantiRadiology Unit, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Katia CannitaMedical Oncology Unit, Department of Oncology, "Giuseppe Mazzini" Hospital, AUSL Teramo, 64100 Teramo, Italy.
Azzurra IrelliMedical Oncology Unit, Department of Oncology, "Giuseppe Mazzini" Hospital, AUSL Teramo, 64100 Teramo, Italy.ORCID 0000-0003-4724-6297
Nicola D'OstilioMedical Oncology, ASL 2 Abruzzo, Ospedale Floraspe Renzetti, 66034 Lanciano, Italy.
Costanza De RossiMedical Oncology Unit, AULSS 3 Serenissima, 30174 Mestre-Venice, Italy.ORCID 0000-0002-2020-1032
Raffaella PalumboMedical Oncology Unit, Istituti Clinici Scientifici Maugeri IRCCS, 27100 Pavia, Italy.
Anna CarielloOncology Department, AUSL Romagna, 48100 Ravenna, Italy.ORCID 0000-0002-2579-6661
Giuseppe SanguinetiRadiation Oncology Department, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Fabio CalabròDivision of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.ORCID 0000-0002-7863-3540
Laura PizzutiDivision of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Maddalena BarbaDivision of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Claudio BottiBreast Surgery Department, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Fabio PelleBreast Surgery Department, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Sonia CappelliBreast Surgery Department, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Flavia CavicchiBreast Surgery Department, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.ORCID 0009-0008-2656-8143
Ilaria PuccicaBreast Surgery Department, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Amedeo VillanucciBreast Surgery Department, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Isabella SperdutiBiostatistics Unit, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Gennaro CilibertoScientific Direction, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Patrizia ViciPhase IV Clinical Studies Unit, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Funding
Ministero della Salute NAThis work was financially supported through funding from the institutional "Ricerca Corrente" granted by the Italian Ministry of Health NA
Abstract
BACKGROUND/
objectivesHER2-positive breast cancer (HER2
methodsThis was a multicenter, retrospective study across 24 Italian oncology centers, including 410 patients with HER2
resultsOverall, 228 patients (55.6%) experienced at least one AE related to T-DM1, with 4.9% experiencing grade 3 or higher AEs. The most common AEs were hepatotoxicity (18.5%) and thrombocytopenia (17.6%). T-DM1 was discontinued in 10.0% of patients due to toxicity. After a median follow-up of 25 months, 31 relapse events (7.6%) and 22 deaths (5.4%) were reported. The preliminary incidence of RFS and OS events was similar between patients who completed the T-DM1 course and those who discontinued it early.
conclusionsT-DM1 demonstrated a manageable safety profile, and the adverse events were consistent with those reported in randomized trials. The data are not yet sufficient to allow for a formal analysis of RFS and OS, and long-term follow-up is required.
Indexed as
adjuvant T-DM1adverse eventsbreast cancerHER2-positive subtypereal-world evidence
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