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Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer

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dc.description.abstractBackground: 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.publisherMassachusetts Medical Society-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAntibodies, Monoclonal, Humanized / adverse effects-
dc.subject.MESHAntibodies, Monoclonal, Humanized / therapeutic use-
dc.subject.MESHAntineoplastic Agents, Immunological* / adverse effects-
dc.subject.MESHAntineoplastic Agents, Immunological* / therapeutic use-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols / adverse effects-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols / therapeutic use-
dc.subject.MESHBreast Neoplasms* / drug therapy-
dc.subject.MESHBreast Neoplasms* / genetics-
dc.subject.MESHBreast Neoplasms* / metabolism-
dc.subject.MESHBreast Neoplasms* / secondary-
dc.subject.MESHCamptothecin / analogs & derivatives-
dc.subject.MESHDisease Progression-
dc.subject.MESHImmunoconjugates / adverse effects-
dc.subject.MESHImmunoconjugates / therapeutic use-
dc.subject.MESHReceptor, ErbB-2* / analysis-
dc.subject.MESHReceptor, ErbB-2* / biosynthesis-
dc.subject.MESHReceptor, ErbB-2* / genetics-
dc.subject.MESHTrastuzumab* / adverse effects-
dc.subject.MESHTrastuzumab* / therapeutic use-
dc.titleTrastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorShanu Modi-
dc.contributor.googleauthorWilliam Jacot-
dc.contributor.googleauthorToshinari Yamashita-
dc.contributor.googleauthorJoohyuk Sohn-
dc.contributor.googleauthorMaria Vidal-
dc.contributor.googleauthorEriko Tokunaga-
dc.contributor.googleauthorJunji Tsurutani-
dc.contributor.googleauthorNaoto T Ueno-
dc.contributor.googleauthorAleix Prat-
dc.contributor.googleauthorYee Soo Chae-
dc.contributor.googleauthorKeun Seok Lee-
dc.contributor.googleauthorNaoki Niikura-
dc.contributor.googleauthorYeon Hee Park-
dc.contributor.googleauthorBinghe Xu-
dc.contributor.googleauthorXiaojia Wang-
dc.contributor.googleauthorMiguel Gil-Gil-
dc.contributor.googleauthorWei Li-
dc.contributor.googleauthorJean-Yves Pierga-
dc.contributor.googleauthorSeock-Ah Im-
dc.contributor.googleauthorHalle C F Moore-
dc.contributor.googleauthorHope S Rugo-
dc.contributor.googleauthorRinat Yerushalmi-
dc.contributor.googleauthorFlora Zagouri-
dc.contributor.googleauthorAndrea Gombos-
dc.contributor.googleauthorSung-Bae Kim-
dc.contributor.googleauthorQiang Liu-
dc.contributor.googleauthorTing Luo-
dc.contributor.googleauthorCristina Saura-
dc.contributor.googleauthorPeter Schmid-
dc.contributor.googleauthorTao Sun-
dc.contributor.googleauthorDhiraj Gambhire-
dc.contributor.googleauthorLotus Yung-
dc.contributor.googleauthorYibin Wang-
dc.contributor.googleauthorJasmeet Singh-
dc.contributor.googleauthorPatrik Vitazka-
dc.contributor.googleauthorGerold Meinhardt-
dc.contributor.googleauthorNadia Harbeck-
dc.contributor.googleauthorDavid A Cameron-
dc.contributor.googleauthorDESTINY-Breast04 Trial Investigators-
dc.contributor.alternativeNameSohn, Joo Hyuk-
dc.identifier.bibliographicCitationNEW ENGLAND JOURNAL OF MEDICINE, Vol.387(1) : 9-20, 2022-07-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers


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