Details

Autor(en) / Beteiligte

• Fehrenbacher, Louis
• Cecchini, Reena S
• Geyer, Jr, Charles E
• Rastogi, Priya
• Costantino, Joseph P
• Atkins, James N
• Crown, John P
• Polikoff, Jonathan
• Boileau, Jean-Francois
• Provencher, Louise
• Stokoe, Christopher
• Moore, Timothy D
• Robidoux, André
• Flynn, Patrick J
• Borges, Virginia F
• Albain, Kathy S
• Swain, Sandra M
• Paik, Soonmyung
• Mamounas, Eleftherios P
• Wolmark, Norman

Titel

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

Ist Teil von

• Journal of clinical oncology, 2020-02, Vol.38 (5), p.444-453

Ort / Verlag

United States: American Society of Clinical Oncology

Erscheinungsjahr

2020

Link zum Volltext

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• 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. 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. 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] 89.2% with CRx alone; hazard ratio [HR], 0.98; 95% CI, 0.76 to 1.25; = .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; = .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; = .15). There were no unexpected toxicities from the addition of trastuzumab to CRx. 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.