{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T03:36:37Z","timestamp":1792985797173,"version":"4.5.0"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2023,11,23]],"date-time":"2023-11-23T00:00:00Z","timestamp":1700697600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,4,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Trastuzumab deruxtecan (T-DXd) demonstrated unprecedented efficacy in patients with pretreated HER2+ metastatic breast cancer (mBC). However, few data are available about its efficacy in routine clinical practice. In this multicenter retrospective study, we examined effectiveness and safety of T-DXd in a real-world population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Clinico-pathological information about patients with HER2+ mBC who received T-DXd were collected from 12 Italian hospitals. HER2 status was determined locally. Patients who received at least one administration of T-DXd, as any therapy line for advanced disease were included in the analysis. The primary endpoint was real-word PFS (rwPFS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>One hundred and forty-three patients were included. Median age was 66 (range: 37-90), and 4 men were included. Hormone receptor (HR) status was positive in 108 (75%) patients and negative in 35(25%). T-DXd was administered as first, second, third, or subsequent lines in 4 (3%), 16 (11%), 42 (29%), and 81 (57%) patients, respectively. Among 123 patients with measurable disease, the ORR was 68%, and the DCR was 93% (9 CRs, 74 PRs, and 30 SD). Nine (7%) patients had a primary resistance to T-DXd. With a median follow-up of 12 months, the median rwPFS was 16 months. RwPFS was 84%, 59%, and 39% at 6, 12, and 18 months, respectively. A favorable trend in rwPFS was reported in patients receiving T-DXd as I\/II line versus further lines (17 vs. 15 months; P\u2005=\u2005.098). Any-grade toxicity was registered in 84 patients (59%). Most common adverse events (AEs) reported were nausea (33%), neutropenia (21%), and asthenia (21%). Liver toxicity and diarrhea were uncommon (5% and 1%). Severe toxicities was registered in 18% of patients, and the most frequent were neutropenia, nausea\/vomiting, and ILD observed in 15, 2, and 3 patients. AEs led to dose reduction in 37 patients (26%). Dose reduction and AEs do not affect patients\u2019 response and survival outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Efficacy and safety of T-DXd were confirmed in an unselected real-world population of HER2+ mBC. These results are consistent with the results of known findings, and no new safety concerns were reported.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/oncolo\/oyad308","type":"journal-article","created":{"date-parts":[[2023,11,6]],"date-time":"2023-11-06T00:27:09Z","timestamp":1699230429000},"page":"303-310","source":"Crossref","is-referenced-by-count":44,"title":["Real-World Outcomes of Trastuzumab Deruxtecan in Patients With HER2+ Metastatic Breast Cancer: The DE-REAL Study"],"prefix":"10.1093","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6425-9893","authenticated-orcid":false,"given":"Andrea","family":"Botticelli","sequence":"first","affiliation":[{"name":"Department of Radiological, Oncological and Pathological Science, Sapienza University of Rome , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberta","family":"Caputo","sequence":"additional","affiliation":[{"name":"Department of Breast and Thoracic Oncology, Division of Breast Medical Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Pascale , Naples , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4943-5622","authenticated-orcid":false,"given":"Simone","family":"Scagnoli","sequence":"additional","affiliation":[{"name":"Department of Radiological, Oncological and Pathological Science, Sapienza University of Rome , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simona","family":"Pisegna","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, Sapienza University of Rome , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelino","family":"De Laurentiis","sequence":"additional","affiliation":[{"name":"Department of Breast and Thoracic Oncology, Division of Breast Medical Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Pascale , Naples , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1781-2518","authenticated-orcid":false,"given":"Giuseppe","family":"Curigliano","sequence":"additional","affiliation":[{"name":"Department of Oncology and Hematology, University of Milan , Milan , Italy"},{"name":"Division of New Drugs and Early Drug Development for Innovative Therapies, European Institute of Oncology, IRCCS , Milan , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1797-5296","authenticated-orcid":false,"given":"Matteo","family":"Lambertini","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova , Genova , Italy"},{"name":"Department of Medical Oncology, UOC Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino , Genova , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Pantano","sequence":"additional","affiliation":[{"name":"Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonella","family":"Palazzo","sequence":"additional","affiliation":[{"name":"Depatment of Medical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ida","family":"Paris","sequence":"additional","affiliation":[{"name":"Department of Woman and Child Health, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudio","family":"Vernieri","sequence":"additional","affiliation":[{"name":"Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori , Milan , Italy"},{"name":"IFOM ETS, the AIRC Institute of Molecular Oncology , Milan , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beatrice","family":"Tedesco","sequence":"additional","affiliation":[{"name":"Medical Oncology Unit, \u201cS. Carlo\u201d Hospital , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marianna","family":"Giampaglia","sequence":"additional","affiliation":[{"name":"Medical Oncology Unit, \u201cS. Carlo\u201d Hospital , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michela","family":"Palleschi","sequence":"additional","affiliation":[{"name":"IRCCS Istituto Romagnolo per lo Studio dei Tumori \u201cDino Amadori\u201d IRST , Meldola , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zelmira","family":"Ballatore","sequence":"additional","affiliation":[{"name":"Clinical Oncology, Universit\u00e0 Politecnica delle Marche, AOU Ospedali Riuniti , Ancona , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniele","family":"Alesini","sequence":"additional","affiliation":[{"name":"UOSD Centro Oncologico S. Spirito e Nuovo Regina Margherita , Ospedale Santo Spirito in Sassia, Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuliana","family":"D\u2019Auria","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Sandro Pertini Hospital , Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agnese","family":"Fabbri","sequence":"additional","affiliation":[{"name":"Department of Oncology and Hematology, Medical Oncology and Breast Unit, Central Hospital of Belcolle , Viterbo , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luigi","family":"Rossi","sequence":"additional","affiliation":[{"name":"Multispeciality Department of Oncology, ASL Latina, \u201cSapienza\u201d University of Rome , Aprilia , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annarita","family":"Verrazzo","sequence":"additional","affiliation":[{"name":"Department of Breast and Thoracic Oncology, Division of Breast Medical Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Pascale , Naples , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberta","family":"Scafetta","sequence":"additional","affiliation":[{"name":"Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniele","family":"Marinelli","sequence":"additional","affiliation":[{"name":"Department of Radiological, Oncological and Pathological Science, Sapienza University of Rome , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caterina","family":"Sposetti","sequence":"additional","affiliation":[{"name":"Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori , Milan , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vittoria","family":"Barberi","sequence":"additional","affiliation":[{"name":"Sapienza Universit\u00e0 di Roma - IRCCS Istituto Nazionale Tumori Regina Elena , Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lidia","family":"Strigari","sequence":"additional","affiliation":[{"name":"Department of Medical Physics, IRCCS Azienda Ospedaliero-Universitaria di Bologna , Bologna , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Marchetti","sequence":"additional","affiliation":[{"name":"Department of Oncology and Dermatological Oncology, Istituto Dermopatico dell\u2019Immacolata IDI IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniele","family":"Santini","sequence":"additional","affiliation":[{"name":"Department of Medico-Surgical Sciences and Biotechnology, Polo Pontino, Sapienza University of Rome , Rome , Italy"},{"name":"Medical Oncology A, AOU Policlinico Umberto I , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Fabi","sequence":"additional","affiliation":[{"name":"Precision Medicine in Senology, Scientific Directorate - Department of Women and Child Health, Fondazione Policlinico Universitario \u201cA. 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