دورية أكاديمية
Efficacy of Margetuximab vs Trastuzumab in Patients with Pretreated ERBB2-Positive Advanced Breast Cancer: A Phase 3 Randomized Clinical Trial
| العنوان: | Efficacy of Margetuximab vs Trastuzumab in Patients with Pretreated ERBB2-Positive Advanced Breast Cancer: A Phase 3 Randomized Clinical Trial |
|---|---|
| المؤلفون: | Rugo H. S., Im S. -A., Cardoso F., Cortes J., Curigliano G., Musolino A., Pegram M. D., Wright G. S., Saura C., Escriva-De-Romani S., De Laurentiis M., Levy C., Brown-Glaberman U., Ferrero J. -M., De Boer M., Kim S. -B., Petrakova K., Yardley D. A., Freedman O., Jakobsen E. H., Kaufman B., Yerushalmi R., Fasching P. A., Nordstrom J. L., Bonvini E., Koenig S., Edlich S., Hong S., Rock E. P., Gradishar W. J. |
| المساهمون: | H.S. Rugo, S.-. Im, F. Cardoso, J. Corte, G. Curigliano, A. Musolino, M.D. Pegram, G.S. Wright, C. Saura, S. Escriva-De-Romani, M. De Laurentii, C. Levy, U. Brown-Glaberman, J.-. Ferrero, M. De Boer, S.-. Kim, K. Petrakova, D.A. Yardley, O. Freedman, E.H. Jakobsen, B. Kaufman, R. Yerushalmi, P.A. Fasching, J.L. Nordstrom, E. Bonvini, S. Koenig, S. Edlich, S. Hong, E.P. Rock, W.J. Gradishar |
| بيانات النشر: | American Medical Association |
| سنة النشر: | 2021 |
| المجموعة: | The University of Milan: Archivio Istituzionale della Ricerca (AIR) |
| مصطلحات موضوعية: | Settore MED/06 - Oncologia Medica |
| الوصف: | Importance: ERRB2 (formerly HER2)-positive advanced breast cancer (ABC) remains typically incurable with optimal treatment undefined in later lines of therapy. The chimeric antibody margetuximab shares ERBB2 specificity with trastuzumab but incorporates an engineered Fc region to increase immune activation. Objective: To compare the clinical efficacy of margetuximab vs trastuzumab, each with chemotherapy, in patients with pretreated ERBB2-positive ABC. Design, Setting, and Participants: The SOPHIA phase 3 randomized open-label trial of margetuximab plus chemotherapy vs trastuzumab plus chemotherapy enrolled 536 patients from August 26, 2015, to October 10, 2018, at 166 sites in 17 countries. Eligible patients had disease progression on 2 or more prior anti-ERBB2 therapies and 1 to 3 lines of therapy for metastatic disease. Data were analyzed from February 2019 to October 2019. Interventions: Investigators selected chemotherapy before 1:1 randomization to margetuximab, 15 mg/kg, or trastuzumab, 6 mg/kg (loading dose, 8 mg/kg), each in 3-week cycles. Stratification factors were metastatic sites (≤2, >2), lines of therapy (≤2, >2), and chemotherapy choice. Main Outcomes and Measures: Sequential primary end points were progression-free survival (PFS) by central blinded analysis and overall survival (OS). All α was allocated to PFS, followed by OS. Secondary end points were investigator-assessed PFS and objective response rate by central blinded analysis. Results: A total of 536 patients were randomized to receive margetuximab (n = 266) or trastuzumab (n = 270). The median age was 56 (27-86) years; 266 (100%) women were in the margetuximab group, while 267 (98.9%) women were in the trastuzumab group. Groups were balanced. All but 1 patient had received prior pertuzumab, and 489 (91.2%) had received prior ado-trastuzumab emtansine. Margetuximab improved primary PFS over trastuzumab with 24% relative risk reduction (hazard ratio [HR], 0.76; 95% CI, 0.59-0.98; P =.03; median, 5.8 [95% CI, 5.5-7.0] months vs 4.9 ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/33480963; info:eu-repo/semantics/altIdentifier/wos/WOS:000609546400001; volume:7; issue:4; firstpage:573; lastpage:584; numberofpages:12; journal:JAMA ONCOLOGY; http://hdl.handle.net/2434/825172Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85099823030 |
| DOI: | 10.1001/jamaoncol.2020.7932 |
| الإتاحة: | https://doi.org/10.1001/jamaoncol.2020.7932Test http://hdl.handle.net/2434/825172Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.1472199F |
| قاعدة البيانات: | BASE |
| DOI: | 10.1001/jamaoncol.2020.7932 |
|---|