Tolerability and Preliminary Outcomes of Adjuvant T-DM1 in HER2-Positive Breast Cancer After Neoadjuvant Therapy: The ATD Study.

Autor:	Krasniqi E; Phase IV Clinical Studies Unit, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Filomeno L; Phase IV Clinical Studies Unit, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Arcuri T; Phase IV Clinical Studies Unit, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Di Lisa FS; Medical Oncology Unit, San Giovanni Evangelista Hospital, ASL RM5, 00019 Tivoli, Italy., Astone A; Oncology Division, San Pietro Fatebenefratelli Hospital, 00189 Rome, Italy., Cutigni C; Oncology Division, San Pietro Fatebenefratelli Hospital, 00189 Rome, Italy., Foglietta J; Oncology Unit, Ospedale Santa Maria, 05100 Terni, Italy., Nunzi M; Oncology Unit, Ospedale Santa Maria, 05100 Terni, Italy., Rossi R; Division of Oncology, San Giovanni Addolorata Hospital, 00184 Rome, Italy., Minelli M; Division of Oncology, San Giovanni Addolorata Hospital, 00184 Rome, Italy., Meattini I; Department of Experimental and Clinical Biomedical Sciences 'M. Serio', University of Florence, 50134 Florence, Italy.; Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero-Universitaria Careggi, 50134 Florence, Italy., Visani L; Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero-Universitaria Careggi, 50134 Florence, Italy., Scialino J; Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero-Universitaria Careggi, 50134 Florence, Italy., Livi L; Department of Experimental and Clinical Biomedical Sciences 'M. Serio', University of Florence, 50134 Florence, Italy.; Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero-Universitaria Careggi, 50134 Florence, Italy., Moscetti L; Oncology and Hemathology Department, Azienda Ospedaliero-Universitaria Policlinico di Modena, 41125 Modena, Italy., Marchetti P; Istituto Dermatopatico dell'Immacolata IRCCS, 00167 Rome, Italy., Botticelli A; Department of Radiological, Oncological and Pathological Science, Policlinico Umberto I, 'Sapienza' University of Rome, 00161 Rome, Italy., Paris I; Division of Gynecologic Oncology, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00136 Rome, Italy., Pavese F; Division of Gynecologic Oncology, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00136 Rome, Italy., D'Angelo T; Division of Gynecologic Oncology, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00136 Rome, Italy., Sini V; Medical Oncology, Santo Spirito Hospital, 00193 Rome, Italy., Stani S; Medical Oncology, Santo Spirito Hospital, 00193 Rome, Italy., Valerio MR; Medical Oncology, AOU Policlinico Paolo Giaccone, 90127 Palermo, Italy., Grassadonia A; Department of Innovative Technologies in Medicine and Dentistry, Centre for Advanced Studies and Technology (CAST), G. D'Annunzio University Chieti-Pescara, 66100 Chieti, Italy., Tinari N; Department of Medical, Oral and Biotechnological Sciences, Center for Advanced Studies and Technology (CAST), G. D'Annunzio University Chieti-Pescara, 66100 Chieti, Italy., Mazzotta M; Medical Oncology Unit, Department of Medical Oncology, Sandro Pertini Hospital, 00157 Rome, Italy., Vergati M; Medical Oncology Unit, Department of Medical Oncology, Sandro Pertini Hospital, 00157 Rome, Italy., D'Auria G; Medical Oncology Unit, Department of Medical Oncology, Sandro Pertini Hospital, 00157 Rome, Italy., Gamucci T; Medical Oncology Unit, Department of Medical Oncology, Sandro Pertini Hospital, 00157 Rome, Italy., D'Onofrio L; Division of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Gasparro S; Division of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Roselli A; Division of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Fulvi A; Division of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Ferretti G; Division of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Torchia A; Division of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.; Clinical and Molecular Medicine, Sapienza-Università di Roma, 00189 Rome, Italy., Giordano M; Medical Oncology Department, Azienda Socio Sanitaria Lariana, 22100 Como, Italy., Greco F; Medical Oncology Unit, Mater Salutis Hospital, Ulss 9 Veneto Region, 37045 Legnago, Italy., Pantano F; Department of Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico, 00128 Rome, Italy., Tonini G; Department of Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico, 00128 Rome, Italy., Fabbri A; Medical Oncology Unit, Belcolle Hospital, 01100 Viterbo, Italy., Bria E; Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, 00136 Rome, Italy.; Ospedale Isola Tiberina-Gemelli Isola, 00186 Rome, Italy., Garufi G; Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, 00136 Rome, Italy., Fiorio E; Section of Oncology, Department of Medicine, University of Verona School of Medicine and Verona University Hospital Trust, 37126 Verona, Italy., Raffaele M; Presidio Cassia Sant'andrea, Dipartimento Oncologico, Asl Roma 1, 00189 Rome, Italy., Pistelli M; Department of Medical Oncology, Università Politecnica delle Marche, AOU delle Marche, 60126 Ancona, Italy., Berardi R; Department of Medical Oncology, Università Politecnica delle Marche, AOU delle Marche, 60126 Ancona, Italy., Saltarelli R; Medical Oncology Unit, San Giovanni Evangelista Hospital, ASL RM5, 00019 Tivoli, Italy., Kayal R; Radiology Unit, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Ferranti FR; Radiology Unit, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Cannita K; Medical Oncology Unit, Department of Oncology, 'Giuseppe Mazzini' Hospital, AUSL Teramo, 64100 Teramo, Italy., Irelli A; Medical Oncology Unit, Department of Oncology, 'Giuseppe Mazzini' Hospital, AUSL Teramo, 64100 Teramo, Italy., D'Ostilio N; Medical Oncology, ASL 2 Abruzzo, Ospedale Floraspe Renzetti, 66034 Lanciano, Italy., De Rossi C; Medical Oncology Unit, AULSS 3 Serenissima, 30174 Mestre-Venice, Italy., Palumbo R; Medical Oncology Unit, Istituti Clinici Scientifici Maugeri IRCCS, 27100 Pavia, Italy., Cariello A; Oncology Department, AUSL Romagna, 48100 Ravenna, Italy., Sanguineti G; Radiation Oncology Department, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Calabrò F; Division of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Pizzuti L; Division of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Barba M; Division of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Botti C; Breast Surgery Department, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Pelle F; Breast Surgery Department, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Cappelli S; Breast Surgery Department, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Cavicchi F; Breast Surgery Department, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Puccica I; Breast Surgery Department, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Villanucci A; Breast Surgery Department, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Sperduti I; Biostatistics Unit, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Ciliberto G; Scientific Direction, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy., Vici P; Phase IV Clinical Studies Unit, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy.
Jazyk:	angličtina
Zdroj:	Cancers [Cancers (Basel)] 2024 Dec 07; Vol. 16 (23). Date of Electronic Publication: 2024 Dec 07.
DOI:	10.3390/cancers16234104
Abstrakt:	Background/objectives: HER2-positive breast cancer (HER2 + BC) is an aggressive subtype, with neoadjuvant treatment (NAT) aiming to achieve a pathological complete response (pCR) to improve long-term outcomes. Trastuzumab emtansine (T-DM1) has been established as the standard of care in the adjuvant setting for HER2 + BC patients who do not obtain pCR. The ATD study aimed to evaluate the real-world tolerability of T-DM1 in this setting. The secondary objective was to assess the effectiveness. Methods: This was a multicenter, retrospective study across 24 Italian oncology centers, including 410 patients with HER2 + BC treated with adjuvant T-DM1 following a lack of pCR after NAT. Patient characteristics, NAT regimens, and surgical outcomes were recorded. Tolerability was assessed by documenting adverse events (AEs) according to the CTCAE (v5.0). Preliminary effectiveness was evaluated in terms of relapse-free survival (RFS) and overall survival (OS). Results: Overall, 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. Conclusions: T-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.
Databáze:	MEDLINE
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