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NSABP B-47/NRG Oncology Phase III Randomized Trial Comparing Adjuvant Chemotherapy With or Without Trastuzumab in High-Risk Invasive Breast Cancer Negative for HER2 by FISH and With IHC 1+ or 2+

 Louis Fehrenbacher  ;  Reena S Cecchini  ;  Charles E Geyer Jr  ;  Priya Rastogi  ;  Joseph P Costantino  ;  James N Atkins  ;  John P Crown  ;  Jonathan Polikoff  ;  Jean-Francois Boileau  ;  Louise Provencher  ;  Christopher Stokoe  ;  Timothy D Moore  ;  André Robidoux  ;  Patrick J Flynn  ;  Virginia F Borges  ;  Kathy S Albain  ;  Sandra M Swain  ;  Soonmyung Paik  ;  Eleftherios P Mamounas  ;  Norman Wolmark 
 JOURNAL OF CLINICAL ONCOLOGY, Vol.38(5) : 444-453, 2020-02 
Journal Title
Issue Date
Antineoplastic Agents, Immunological / administration & dosage ; Antineoplastic Combined Chemotherapy Protocols / therapeutic use* ; Breast Neoplasms / drug therapy* ; Breast Neoplasms / enzymology ; Breast Neoplasms / genetics ; Breast Neoplasms / pathology ; Chemotherapy, Adjuvant ; Cyclophosphamide / administration & dosage ; Disease-Free Survival ; Docetaxel / administration & dosage ; Doxorubicin / administration & dosage ; Female ; Humans ; Immunohistochemistry ; In Situ Hybridization, Fluorescence ; Middle Aged ; Neoplasm Invasiveness ; Receptor, ErbB-2 / biosynthesis* ; Receptor, ErbB-2 / genetics ; Risk Factors ; Trastuzumab / administration & dosage
PURPOSE Adjuvant trastuzumab reduces invasive breast cancer (IBC) recurrence and risk for death in patients with HER2-amplified or overexpressing IBC. A subset of patients in the landmark trastuzumab adjuvant trials who originally tested HER2-positive but were HER2-negative by central HER2 testing appeared to possibly benefit from trastuzumab. The objective for the NSABP B-47 trial was to determine whether the addition of trastuzumab to adjuvant chemotherapy (CRx) would improve invasive disease-free survival (IDFS) in patients with HER2-negative breast cancer. PATIENTS AND METHODS A total of 3,270 women with high-risk primary IBC were randomly assigned to CRx with or without 1 year of trastuzumab. Eligibility criteria included immunohistochemistry (IHC) score 1+ or 2+ with fluorescence in situ hybridization ratio (FISH) < 2.0 or, if ratio was not performed, HER2 gene copy number < 4.0. CRx was either docetaxel plus cyclophosphamide or doxorubicin and cyclophosphamide followed by weekly paclitaxel for 12 weeks. RESULTS At a median follow-up of 46 months, the addition of trastuzumab to CRx did not improve IDFS (5-year IDFS: 89.8% with CRx plus trastuzumab [CRxT] v 89.2% with CRx alone; hazard ratio [HR], 0.98; 95% CI, 0.76 to 1.25; P = .85). These findings did not differ by level of HER2 IHC expression, lymph node involvement, or hormone-receptor status. For distant recurrence-free interval, 5-year estimates were 92.7% with CRxT compared with 93.6% for CRx alone (HR, 1.10; 95% CI, 0.81 to 1.50; P = .55) and for overall survival (OS) were 94.8% with CRxT and 96.3% in CRx alone (HR, 1.33; 95% CI, 0.90 to 1.95; P = .15). There were no unexpected toxicities from the addition of trastuzumab to CRx. CONCLUSION The addition of trastuzumab to CRx did not improve IDFS, distant recurrence-free interval, or OS in women with non-HER2-overexpressing IBC. Trastuzumab does not benefit women without IHC 3+ or FISH ratio-amplified breast cancer. (C) 2019 by American Society of Clinical Oncology
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1. College of Medicine (의과대학) > BioMedical Science Institute (의생명과학부) > 1. Journal Papers
Yonsei Authors
Paik, Soon Myung(백순명) ORCID logo https://orcid.org/0000-0001-9688-6480
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