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+
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| Title: | 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+ |
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| Authors: | Sandra M. Swain, Soonmyung Paik, Joseph P. Costantino, Kathy S. Albain, Jonathan Polikoff, Louis Fehrenbacher, Eleftherios P. Mamounas, James N. Atkins, Louise Provencher, Timothy David Moore, Priya Rastogi, Patrick J. Flynn, Christopher Stokoe, Charles E. Geyer, Jean Francois Boileau, Reena S. Cecchini, Norman Wolmark, John Crown, Virginia F. Borges, André Robidoux |
| Contributors: | 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, Paik, Soon Myung |
| Source: | Journal of Clinical Oncology. 38:444-453 |
| Publisher Information: | American Society of Clinical Oncology (ASCO), 2020. |
| Publication Year: | 2020 |
| Subject Terms: | Breast Neoplasms / drug therapy, Receptor, ErbB-2, Antineoplastic Agents, Breast Neoplasms, Docetaxel, Cyclophosphamide / administration & dosage, Fluorescence, Disease-Free Survival, 03 medical and health sciences, Antineoplastic Agents, Immunological, 0302 clinical medicine, Risk Factors, Antineoplastic Combined Chemotherapy Protocols, Immunological / administration & dosage, Chemotherapy, Humans, Trastuzumab / administration & dosage, Neoplasm Invasiveness, Cyclophosphamide, Adjuvant, In Situ Hybridization, In Situ Hybridization, Fluorescence, Antineoplastic Combined Chemotherapy Protocols / therapeutic use, Doxorubicin / administration & dosage, Middle Aged, Trastuzumab, ErbB-2 / biosynthesis, ErbB-2 / genetics, Immunohistochemistry, 3. Good health, Docetaxel / administration & dosage, Breast Neoplasms / genetics, Chemotherapy, Adjuvant, Doxorubicin, Breast Neoplasms / pathology, Female, Breast Neoplasms / enzymology, Receptor |
| Description: | 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. |
| Document Type: | Article |
| Language: | English |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.19.01455 |
| Access URL: | https://europepmc.org/articles/pmc7007289?pdf=render https://pubmed.ncbi.nlm.nih.gov/31821109 https://ascopubs.org/doi/pdf/10.1200/JCO.19.01455 https://pubmed.ncbi.nlm.nih.gov/31821109/ https://ascopubs.org/doi/10.1200/JCO.19.01455 https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/31821109/ https://scholars.houstonmethodist.org/en/publications/nsabp-b-47nrg-oncology-phase-iii-randomized-trial-comparing-adjuv https://scholars.houstonmethodist.org/en/publications/nsabp-b47nrg-oncology-phase-iii-randomized-trial-comparing-adjuvant-chemotherapy-with-or-without-trastuzumab-in-highrisk-invasive-breast-cancer-negative-for-her2-by-fish-and-with-ihc-1-or-2(bbc17b96-d858-489d-a4a1-4816df3a83b8).html |
| Rights: | CC BY NC ND |
| Accession Number: | edsair.doi.dedup.....2d4eed27d1d24ec4faa3c2d9ccb0df08 |
| Database: | OpenAIRE |
Nájsť tento článok vo Web of Science | Abstract: | 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. |
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| ISSN: | 15277755 0732183X |
| DOI: | 10.1200/jco.19.01455 |