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Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer
DC Field | Value | Language |
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dc.contributor.author | 손주혁 | - |
dc.date.accessioned | 2022-12-22T02:50:19Z | - |
dc.date.available | 2022-12-22T02:50:19Z | - |
dc.date.issued | 2022-07 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/191707 | - |
dc.description.abstract | Background: Among breast cancers without human epidermal growth factor receptor 2 (HER2) amplification, overexpression, or both, a large proportion express low levels of HER2 that may be targetable. Currently available HER2-directed therapies have been ineffective in patients with these "HER2-low" cancers. Methods: We conducted a phase 3 trial involving patients with HER2-low metastatic breast cancer who had received one or two previous lines of chemotherapy. (Low expression of HER2 was defined as a score of 1+ on immunohistochemical [IHC] analysis or as an IHC score of 2+ and negative results on in situ hybridization.) Patients were randomly assigned in a 2:1 ratio to receive trastuzumab deruxtecan or the physician's choice of chemotherapy. The primary end point was progression-free survival in the hormone receptor-positive cohort. The key secondary end points were progression-free survival among all patients and overall survival in the hormone receptor-positive cohort and among all patients. Results: Of 557 patients who underwent randomization, 494 (88.7%) had hormone receptor-positive disease and 63 (11.3%) had hormone receptor-negative disease. In the hormone receptor-positive cohort, the median progression-free survival was 10.1 months in the trastuzumab deruxtecan group and 5.4 months in the physician's choice group (hazard ratio for disease progression or death, 0.51; P<0.001), and overall survival was 23.9 months and 17.5 months, respectively (hazard ratio for death, 0.64; P = 0.003). Among all patients, the median progression-free survival was 9.9 months in the trastuzumab deruxtecan group and 5.1 months in the physician's choice group (hazard ratio for disease progression or death, 0.50; P<0.001), and overall survival was 23.4 months and 16.8 months, respectively (hazard ratio for death, 0.64; P = 0.001). Adverse events of grade 3 or higher occurred in 52.6% of the patients who received trastuzumab deruxtecan and 67.4% of those who received the physician's choice of chemotherapy. Adjudicated, drug-related interstitial lung disease or pneumonitis occurred in 12.1% of the patients who received trastuzumab deruxtecan; 0.8% had grade 5 events. Conclusions: In this trial involving patients with HER2-low metastatic breast cancer, trastuzumab deruxtecan resulted in significantly longer progression-free and overall survival than the physician's choice of chemotherapy. (Funded by Daiichi Sankyo and AstraZeneca; DESTINY-Breast04 ClinicalTrials.gov number, NCT03734029.). | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isPartOf | NEW ENGLAND JOURNAL OF MEDICINE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antibodies, Monoclonal, Humanized / adverse effects | - |
dc.subject.MESH | Antibodies, Monoclonal, Humanized / therapeutic use | - |
dc.subject.MESH | Antineoplastic Agents, Immunological* / adverse effects | - |
dc.subject.MESH | Antineoplastic Agents, Immunological* / therapeutic use | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / adverse effects | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / therapeutic use | - |
dc.subject.MESH | Breast Neoplasms* / drug therapy | - |
dc.subject.MESH | Breast Neoplasms* / genetics | - |
dc.subject.MESH | Breast Neoplasms* / metabolism | - |
dc.subject.MESH | Breast Neoplasms* / secondary | - |
dc.subject.MESH | Camptothecin / analogs & derivatives | - |
dc.subject.MESH | Disease Progression | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Immunoconjugates / adverse effects | - |
dc.subject.MESH | Immunoconjugates / therapeutic use | - |
dc.subject.MESH | Immunohistochemistry | - |
dc.subject.MESH | Receptor, ErbB-2* / analysis | - |
dc.subject.MESH | Receptor, ErbB-2* / biosynthesis | - |
dc.subject.MESH | Receptor, ErbB-2* / genetics | - |
dc.subject.MESH | Trastuzumab* / adverse effects | - |
dc.subject.MESH | Trastuzumab* / therapeutic use | - |
dc.title | Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Shanu Modi | - |
dc.contributor.googleauthor | William Jacot | - |
dc.contributor.googleauthor | Toshinari Yamashita | - |
dc.contributor.googleauthor | Joohyuk Sohn | - |
dc.contributor.googleauthor | Maria Vidal | - |
dc.contributor.googleauthor | Eriko Tokunaga | - |
dc.contributor.googleauthor | Junji Tsurutani | - |
dc.contributor.googleauthor | Naoto T Ueno | - |
dc.contributor.googleauthor | Aleix Prat | - |
dc.contributor.googleauthor | Yee Soo Chae | - |
dc.contributor.googleauthor | Keun Seok Lee | - |
dc.contributor.googleauthor | Naoki Niikura | - |
dc.contributor.googleauthor | Yeon Hee Park | - |
dc.contributor.googleauthor | Binghe Xu | - |
dc.contributor.googleauthor | Xiaojia Wang | - |
dc.contributor.googleauthor | Miguel Gil-Gil | - |
dc.contributor.googleauthor | Wei Li | - |
dc.contributor.googleauthor | Jean-Yves Pierga | - |
dc.contributor.googleauthor | Seock-Ah Im | - |
dc.contributor.googleauthor | Halle C F Moore | - |
dc.contributor.googleauthor | Hope S Rugo | - |
dc.contributor.googleauthor | Rinat Yerushalmi | - |
dc.contributor.googleauthor | Flora Zagouri | - |
dc.contributor.googleauthor | Andrea Gombos | - |
dc.contributor.googleauthor | Sung-Bae Kim | - |
dc.contributor.googleauthor | Qiang Liu | - |
dc.contributor.googleauthor | Ting Luo | - |
dc.contributor.googleauthor | Cristina Saura | - |
dc.contributor.googleauthor | Peter Schmid | - |
dc.contributor.googleauthor | Tao Sun | - |
dc.contributor.googleauthor | Dhiraj Gambhire | - |
dc.contributor.googleauthor | Lotus Yung | - |
dc.contributor.googleauthor | Yibin Wang | - |
dc.contributor.googleauthor | Jasmeet Singh | - |
dc.contributor.googleauthor | Patrik Vitazka | - |
dc.contributor.googleauthor | Gerold Meinhardt | - |
dc.contributor.googleauthor | Nadia Harbeck | - |
dc.contributor.googleauthor | David A Cameron | - |
dc.contributor.googleauthor | DESTINY-Breast04 Trial Investigators | - |
dc.identifier.doi | 10.1056/NEJMoa2203690 | - |
dc.contributor.localId | A01995 | - |
dc.relation.journalcode | J02371 | - |
dc.identifier.eissn | 1533-4406 | - |
dc.identifier.pmid | 35665782 | - |
dc.identifier.url | https://www.nejm.org/doi/10.1056/NEJMoa2203690 | - |
dc.contributor.alternativeName | Sohn, Joo Hyuk | - |
dc.contributor.affiliatedAuthor | 손주혁 | - |
dc.citation.volume | 387 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 9 | - |
dc.citation.endPage | 20 | - |
dc.identifier.bibliographicCitation | NEW ENGLAND JOURNAL OF MEDICINE, Vol.387(1) : 9-20, 2022-07 | - |
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