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Article: Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer

TitleTrastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer
Authors
Keywordsadult
adverse outcome
aged
alanine aminotransferase blood level
anemia
Issue Date2019
PublisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
Citation
New England Journal of Medicine, 2019, v. 380, p. 617-628 How to Cite?
AbstractBACKGROUND: Patients who have residual invasive breast cancer after receiving neoadjuvant chemotherapy plus human epidermal growth factor receptor 2 (HER2)-targeted therapy have a worse prognosis than those who have no residual cancer. Trastuzumab emtansine (T-DM1), an antibody-drug conjugate of trastuzumab and the cytotoxic agent emtansine (DM1), a maytansine derivative and microtubule inhibitor, provides benefit in patients with metastatic breast cancer that was previously treated with chemotherapy plus HER2-targeted therapy. METHODS: We conducted a phase 3, open-label trial involving patients with HER2-positive early breast cancer who were found to have residual invasive disease in the breast or axilla at surgery after receiving neoadjuvant therapy containing a taxane (with or without anthracycline) and trastuzumab. Patients were randomly assigned to receive adjuvant T-DM1 or trastuzumab for 14 cycles. The primary end point was invasive disease-free survival (defined as freedom from ipsilateral invasive breast tumor recurrence, ipsilateral locoregional invasive breast cancer recurrence, contralateral invasive breast cancer, distant recurrence, or death from any cause). RESULTS: At the interim analysis, among 1486 randomly assigned patients (743 in the T-DM1 group and 743 in the trastuzumab group), invasive disease or death had occurred in 91 patients in the T-DM1 group (12.2%) and 165 patients in the trastuzumab group (22.2%). The estimated percentage of patients who were free of invasive disease at 3 years was 88.3% in the T-DM1 group and 77.0% in the trastuzumab group. Invasive disease-free survival was significantly higher in the T-DM1 group than in the trastuzumab group (hazard ratio for invasive disease or death, 0.50; 95% confidence interval, 0.39 to 0.64; P<0.001). Distant recurrence as the first invasive-disease event occurred in 10.5% of patients in the T-DM1 group and 15.9% of those in the trastuzumab group. The safety data were consistent with the known safety profile of T-DM1, with more adverse events associated with T-DM1 than with trastuzumab alone. CONCLUSIONS: Among patients with HER2-positive early breast cancer who had residual invasive disease after completion of neoadjuvant therapy, the risk of recurrence of invasive breast cancer or death was 50% lower with adjuvant T-DM1 than with trastuzumab alone. (Funded by F. Hoffmann-La Roche/Genentech; KATHERINE ClinicalTrials.gov number, NCT01772472 .).
Persistent Identifierhttp://hdl.handle.net/10722/272354
ISSN
2017 Impact Factor: 79.26
2015 SCImago Journal Rankings: 14.619

 

DC FieldValueLanguage
dc.contributor.authorvon Minckwitz, G-
dc.contributor.authorHuang, CS-
dc.contributor.authorMano, MS-
dc.contributor.authorLoibl, S-
dc.contributor.authorMamounas, EP-
dc.contributor.authorUntch, M-
dc.contributor.authorWolmark, N-
dc.contributor.authorRastogi, P-
dc.contributor.authorSchneeweiss, A-
dc.contributor.authorRedondo, A-
dc.contributor.authorFischer, HH-
dc.contributor.authorJacot, W-
dc.contributor.authorConlin, AK-
dc.contributor.authorArce-Salinas, C-
dc.contributor.authorWapnir, IL-
dc.contributor.authorJackisch, C-
dc.contributor.authorDiGiovanna, MP-
dc.contributor.authorFasching, PA-
dc.contributor.authorCrown, JP-
dc.contributor.authorWülfing, P-
dc.contributor.authorShao, Z-
dc.contributor.authorRota Caremoli, E-
dc.contributor.authorWu, H-
dc.contributor.authorLam, LH-
dc.contributor.authorTesarowski, D-
dc.contributor.authorSmitt, M-
dc.contributor.authorDouthwaite, H-
dc.contributor.authorSingel, SM-
dc.contributor.authorGeyer, CE-
dc.contributor.authorThe KATHERINE Investigators-
dc.contributor.authorKwong, A-
dc.date.accessioned2019-07-20T10:40:40Z-
dc.date.available2019-07-20T10:40:40Z-
dc.date.issued2019-
dc.identifier.citationNew England Journal of Medicine, 2019, v. 380, p. 617-628-
dc.identifier.issn0028-4793-
dc.identifier.urihttp://hdl.handle.net/10722/272354-
dc.description.abstractBACKGROUND: Patients who have residual invasive breast cancer after receiving neoadjuvant chemotherapy plus human epidermal growth factor receptor 2 (HER2)-targeted therapy have a worse prognosis than those who have no residual cancer. Trastuzumab emtansine (T-DM1), an antibody-drug conjugate of trastuzumab and the cytotoxic agent emtansine (DM1), a maytansine derivative and microtubule inhibitor, provides benefit in patients with metastatic breast cancer that was previously treated with chemotherapy plus HER2-targeted therapy. METHODS: We conducted a phase 3, open-label trial involving patients with HER2-positive early breast cancer who were found to have residual invasive disease in the breast or axilla at surgery after receiving neoadjuvant therapy containing a taxane (with or without anthracycline) and trastuzumab. Patients were randomly assigned to receive adjuvant T-DM1 or trastuzumab for 14 cycles. The primary end point was invasive disease-free survival (defined as freedom from ipsilateral invasive breast tumor recurrence, ipsilateral locoregional invasive breast cancer recurrence, contralateral invasive breast cancer, distant recurrence, or death from any cause). RESULTS: At the interim analysis, among 1486 randomly assigned patients (743 in the T-DM1 group and 743 in the trastuzumab group), invasive disease or death had occurred in 91 patients in the T-DM1 group (12.2%) and 165 patients in the trastuzumab group (22.2%). The estimated percentage of patients who were free of invasive disease at 3 years was 88.3% in the T-DM1 group and 77.0% in the trastuzumab group. Invasive disease-free survival was significantly higher in the T-DM1 group than in the trastuzumab group (hazard ratio for invasive disease or death, 0.50; 95% confidence interval, 0.39 to 0.64; P<0.001). Distant recurrence as the first invasive-disease event occurred in 10.5% of patients in the T-DM1 group and 15.9% of those in the trastuzumab group. The safety data were consistent with the known safety profile of T-DM1, with more adverse events associated with T-DM1 than with trastuzumab alone. CONCLUSIONS: Among patients with HER2-positive early breast cancer who had residual invasive disease after completion of neoadjuvant therapy, the risk of recurrence of invasive breast cancer or death was 50% lower with adjuvant T-DM1 than with trastuzumab alone. (Funded by F. Hoffmann-La Roche/Genentech; KATHERINE ClinicalTrials.gov number, NCT01772472 .).-
dc.languageeng-
dc.publisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/-
dc.relation.ispartofNew England Journal of Medicine-
dc.rightsNew England Journal of Medicine. Copyright © Massachusetts Medical Society.-
dc.subjectadult-
dc.subjectadverse outcome-
dc.subjectaged-
dc.subjectalanine aminotransferase blood level-
dc.subjectanemia-
dc.titleTrastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer-
dc.typeArticle-
dc.identifier.emailKwong, A: avakwong@hku.hk-
dc.identifier.authorityKwong, A=rp01734-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1056/NEJMoa1814017-
dc.identifier.pmid30516102-
dc.identifier.scopuseid_2-s2.0-85059540229-
dc.identifier.hkuros298826-
dc.identifier.volume380-
dc.identifier.spage617-
dc.identifier.epage628-
dc.publisher.placeUnited States-
dc.identifier.f1000734556957-

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