Sacituzumab govitecan as second-line treatment for metastatic triple-negative breast cancer—phase 3 ASCENT study subanalysis

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作者
Lisa A. Carey
Delphine Loirat
Kevin Punie
Aditya Bardia
Véronique Diéras
Florence Dalenc
Jennifer R. Diamond
Christel Fontaine
Grace Wang
Hope S. Rugo
Sara A. Hurvitz
Kevin Kalinsky
Joyce O’Shaughnessy
Sibylle Loibl
Luca Gianni
Martine Piccart
Yanni Zhu
Rosemary Delaney
See Phan
Javier Cortés
机构
[1] University of North Carolina Lineberger Comprehensive Cancer Center,Department of General Medical Oncology and Multidisciplinary Breast Centre, Leuven Cancer Institute
[2] Medical Oncology Department and D3i,Department of Hematology/Oncology
[3] Institut Curie,Department of Medical Oncology
[4] University Hospitals Leuven,Division of Medical Oncology, Department of Medicine
[5] Massachusetts General Hospital Cancer Center,Medical Oncology Department
[6] Harvard Medical School,Department of Medicine
[7] Centre Eugène Marquis,Department of Medicine, Division of Hematology/Oncology, David Geffen School of Medicine
[8] Institut Claudius Regaud,Department of Medicine and Research
[9] IUCT-Oncopole,Medical Oncology
[10] University of Colorado Anschutz Medical Campus,Medical Oncology Department
[11] Oncologisch Centrum,Department of Biostatistics
[12] UZ Brussel,Department of Clinical Research
[13] Miami Cancer Institute,Department of Clinical Development
[14] University of California San Francisco Helen Diller Family Comprehensive Cancer Center,International Breast Cancer Center, Quirón Group, Barcelona
[15] University of California,undefined
[16] Los Angeles,undefined
[17] Jonsson Comprehensive Cancer Center,undefined
[18] Winship Cancer Institute,undefined
[19] Emory University,undefined
[20] Baylor University Medical Center,undefined
[21] Texas Oncology,undefined
[22] US Oncology,undefined
[23] Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus,undefined
[24] Gianni Bonadonna Foundation,undefined
[25] Institut Jules Bordet and l’Université Libre de Bruxelles,undefined
[26] Gilead Sciences,undefined
[27] Inc,undefined
[28] Gilead Sciences,undefined
[29] Inc,undefined
[30] Gilead Sciences Inc,undefined
[31] Universidad Europea de Madrid,undefined
[32] Faculty of Biomedical and Health Sciences,undefined
[33] Department of Medicine,undefined
[34] Madrid,undefined
[35] Vall d´Hebron Institute of Oncology (VHIO),undefined
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摘要
Patients with triple-negative breast cancer (TNBC) who relapse early after (neo)adjuvant chemotherapy have more aggressive disease. In the ASCENT trial, sacituzumab govitecan (SG), an antibody-drug conjugate composed of an anti-Trop–2 antibody coupled to SN-38 via a hydrolyzable linker, improved outcomes over single-agent chemotherapy of physician’s choice (TPC) in metastatic TNBC (mTNBC). Of 468 patients without known baseline brain metastases, 33/235 vs 32/233 patients (both 14%) in the SG vs TPC arms, respectively, received one line of therapy in the metastatic setting and experienced disease recurrence ≤12 months after (neo)adjuvant chemotherapy. SG prolonged progression-free survival (median 5.7 vs 1.5 months [HR, 0.41; 95% CI, 0.22–0.76]) and overall survival (median 10.9 vs 4.9 months [HR, 0.51; 95% CI, 0.28–0.91]) vs TPC, with a manageable safety profile in this subgroup consistent with the overall population. In this second-line setting, as with later-line therapy, SG improved survival over conventional chemotherapy for patients with mTNBC.
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