Efficacy of Margetuximab vs Trastuzumab in Patients With Pretreated ERBB2-Positive Advanced Breast Cancer
| العنوان: | Efficacy of Margetuximab vs Trastuzumab in Patients With Pretreated ERBB2-Positive Advanced Breast Cancer |
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| المؤلفون: | Ursa Brown-Glaberman, Maaike de Boer, Denise A. Yardley, Jeffrey L. Nordstrom, Sung Bae Kim, Erik Jakobsen, Jean Marc Ferrero, Scott Koenig, William J. Gradishar, Seock-Ah Im, Javier Cortes, Gail S. Wright, Ezio Bonvini, Cristina Saura, Michelino De Laurentiis, Bella Kaufman, Sutton Edlich, Hope S. Rugo, Christelle Levy, Fatima Cardoso, Antonino Musolino, Peter A. Fasching, Mark D. Pegram, Orit Freedman, Santiago Escrivá-de-Romaní, Shengyan Hong, Rinat Yerushalmi, Edwin P. Rock, Giuseppe Curigliano, Katarína Petráková |
| المساهمون: | RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, MUMC+: MA Medische Oncologie (9), 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., Institut Català de la Salut, [Rugo HS] University of California San Francisco Helen Diller Family Comprehensive Cancer Center. [Im SA] Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea. [Cardoso F] Champalimaud Clinical Center/Champalimaud Foundation, Breast Unit, Lisbon, Portugal. [Cortés J] IOB Institute of Oncology, Quironsalud Group, Madrid and Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Curigliano G] European Institute of Oncology, IRCCS, Division of Early Drug Development, University of Milano, Milan, Italy. [Musolino A] Department of Medicine and Surgery, University of Parma, Medical Oncology and Breast Unit, University Hospital of Parma, Parma, Italy. [Saura C] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus |
| المصدر: | SOPHIA Study Group 2021, ' Efficacy of Margetuximab vs Trastuzumab in Patients with Pretreated ERBB2-Positive Advanced Breast Cancer : A Phase 3 Randomized Clinical Trial ', JAMA Oncology, vol. 7, no. 4, pp. 573-584 . https://doi.org/10.1001/jamaoncol.2020.7932Test JAMA Oncology, 7(4), 573-584. American Medical Association JAMA Oncol Scientia |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Oncology, Relative risk reduction, Cancer Research, MONOCLONAL-ANTIBODY, Receptor, ErbB-2, Neoplasms::Neoplasms by Site::Breast Neoplasms [DISEASES], Other subheadings::Other subheadings::/drug therapy [Other subheadings], Ado-Trastuzumab Emtansine, RECOMMENDATIONS, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Trastuzumab, Antineoplastic Combined Chemotherapy Protocols, 030212 general & internal medicine, Original Investigation, Aged, 80 and over, neoplasias::neoplasias por localización::neoplasias de la mama [ENFERMEDADES], benefit, Hazard ratio, terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Antibodies, Monoclonal, Middle Aged, CHEMOTHERAPY, Chemotherapy regimen, 030220 oncology & carcinogenesis, Female, Pertuzumab, medicine.drug, Adult, medicine.medical_specialty, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Breast Neoplasms, IMMUNITY, survival, Quimioteràpia combinada, 03 medical and health sciences, Breast cancer, Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Internal medicine, medicine, Humans, Aged, C RECEPTOR POLYMORPHISMS, therapy, business.industry, association, diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], medicine.disease, Interim analysis, Mama - Càncer - Tractament, Avaluació de resultats (Assistència sanitària), business |
| الوصف: | Advanced Breast Cancer; Efficacy; Margetuximab Cáncer de mama avanzado; Eficacia; Margetuximab Càncer de mama avançat; Eficàcia; Margetuximab 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 [95% CI, 4.2-5.6] months; October 10, 2018). After the second planned interim analysis of 270 deaths, median OS was 21.6 months with margetuximab vs 19.8 months with trastuzumab (HR, 0.89; 95% CI, 0.69-1.13; P = .33; September 10, 2019), and investigator-assessed PFS showed 29% relative risk reduction favoring margetuximab (HR, 0.71; 95% CI, 0.58-0.86; P |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 2374-2437 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::beae17ac62d0e63c250dbce6359002edTest https://doi.org/10.1001/jamaoncol.2020.7932Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....beae17ac62d0e63c250dbce6359002ed |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 23742437 |
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