Eriseld Krasniqi, Lorena Filomeno, Teresa Arcuri, Francesca Sofia Di Lisa, Antonio Astone, Claudia Cutigni, Jennifer Foglietta, Martina Nunzi, Rosalinda Rossi, Mauro Minelli, Icro Meattini, Luca Visani, Jacopo Scialino, Lorenzo Livi, Luca Moscetti, Paolo Marchetti, Andrea Botticelli, Ida Paris, Francesco Pavese, Tatiana D'Angelo, Valentina Sini, Simonetta Stani, Maria Rosaria Valerio, Antonino Grassadonia, Nicola Tinari, Marco Mazzotta, Matteo Vergati, Giuliana D'Auria, Teresa Gamucci, Loretta D'Onofrio, Simona Gasparro, Arianna Roselli, Alberto Fulvi, Gianluigi Ferretti, Andrea Torchia, Monica Giordano, Filippo Greco, Francesco Pantano, Giuseppe Tonini, Agnese Fabbri, Emilio Bria, Giovanna Garufi, Elena Fiorio, Mimma Raffaele, Mirco Pistelli, Rossana Berardi, Rosa Saltarelli, Ramy Kayal, Francesca Romana Ferranti, Katia Cannita, Azzurra Irelli, Nicola D'Ostilio, Costanza De Rossi, Raffaella Palumbo, Anna Cariello, Giuseppe Sanguineti, Fabio Calabrò, Laura Pizzuti, Maddalena Barba, Claudio Botti, Fabio Pelle, Sonia Cappelli, Flavia Cavicchi, Ilaria Puccica, Amedeo Villanucci, Isabella Sperduti, Gennaro Ciliberto, Patrizia Vici
{"title":"Tolerability and Preliminary Outcomes of Adjuvant T-DM1 in HER2-Positive Breast Cancer After Neoadjuvant Therapy: The ATD Study.","authors":"Eriseld Krasniqi, Lorena Filomeno, Teresa Arcuri, Francesca Sofia Di Lisa, Antonio Astone, Claudia Cutigni, Jennifer Foglietta, Martina Nunzi, Rosalinda Rossi, Mauro Minelli, Icro Meattini, Luca Visani, Jacopo Scialino, Lorenzo Livi, Luca Moscetti, Paolo Marchetti, Andrea Botticelli, Ida Paris, Francesco Pavese, Tatiana D'Angelo, Valentina Sini, Simonetta Stani, Maria Rosaria Valerio, Antonino Grassadonia, Nicola Tinari, Marco Mazzotta, Matteo Vergati, Giuliana D'Auria, Teresa Gamucci, Loretta D'Onofrio, Simona Gasparro, Arianna Roselli, Alberto Fulvi, Gianluigi Ferretti, Andrea Torchia, Monica Giordano, Filippo Greco, Francesco Pantano, Giuseppe Tonini, Agnese Fabbri, Emilio Bria, Giovanna Garufi, Elena Fiorio, Mimma Raffaele, Mirco Pistelli, Rossana Berardi, Rosa Saltarelli, Ramy Kayal, Francesca Romana Ferranti, Katia Cannita, Azzurra Irelli, Nicola D'Ostilio, Costanza De Rossi, Raffaella Palumbo, Anna Cariello, Giuseppe Sanguineti, Fabio Calabrò, Laura Pizzuti, Maddalena Barba, Claudio Botti, Fabio Pelle, Sonia Cappelli, Flavia Cavicchi, Ilaria Puccica, Amedeo Villanucci, Isabella Sperduti, Gennaro Ciliberto, Patrizia Vici","doi":"10.3390/cancers16234104","DOIUrl":null,"url":null,"abstract":"<p><strong>Background/objectives: </strong>HER2-positive breast cancer (HER2<sup>+</sup>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<sup>+</sup>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.</p><p><strong>Methods: </strong>This was a multicenter, retrospective study across 24 Italian oncology centers, including 410 patients with HER2<sup>+</sup>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":9681,"journal":{"name":"Cancers","volume":"16 23","pages":""},"PeriodicalIF":4.5000,"publicationDate":"2024-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancers","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3390/cancers16234104","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍：
Cancers (ISSN 2072-6694) is an international, peer-reviewed open access journal on oncology. It publishes reviews, regular research papers and short communications. Our aim is to encourage scientists to publish their experimental and theoretical results in as much detail as possible. There is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced.
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