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bardia-et-al-2024-datopotamab-deruxtecan-versus-chemotherapy-in-previously-treated-inoperable-metastatic-hormone.pdf (1.13 MB)

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2025-01-20

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cc-by-nc-nd (c) Bardia, Aditya, et al. 2025
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/218878

Datopotamab Deruxtecan Versus Chemotherapy in Previously Treated Inoperable/Metastatic Hormone Receptor–Positive Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer: Primary Results From TROPION-Breast01

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https://doi.org/10.1200/JCO.24.00920

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PURPOSE The global, phase 3, open-label, randomized TROPION-Breast01 study assessed the trophoblast cell surface antigen 2-directed antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) versus investigator's choice of chemotherapy (ICC) in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. METHODS Adult patients with inoperable/metastatic HR+/HER2- breast cancer, who had disease progression on endocrine therapy, for whom endocrine therapy was unsuitable, and had received one to two previous lines of chemotherapy in the inoperable/metastatic setting, were randomly assigned 1:1 to Dato-DXd (6 mg/kg once every 3 weeks) or ICC (eribulin/vinorelbine/capecitabine/gemcitabine). Dual primary end points were progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS). RESULTS Patients were randomly assigned to Dato-DXd (n = 365) or ICC (n = 367). Dato-DXd significantly reduced the risk of progression or death versus ICC (PFS by BICR hazard ratio [HR], 0.63 [95% CI, 0.52 to 0.76]; P < .0001). Consistent PFS benefit was observed across subgroups. Although OS data were not mature, a trend favoring Dato-DXd was observed (HR, 0.84 [95% CI, 0.62 to 1.14]). The rate of grade >= 3 treatment-related adverse events (TRAEs) with Dato-DXd was lower than ICC (20.8% v 44.7%). The most common TRAEs (any grade; grade >= 3) were nausea (51.1%; 1.4%) and stomatitis (50%; 6.4%) with Dato-DXd and neutropenia (grouped term, 42.5%; 30.8%) with ICC. CONCLUSION Patients receiving Dato-DXd had statistically significant and clinically meaningful improvement in PFS and a favorable and manageable safety profile, compared with ICC. Results support Dato-DXd as a novel treatment option for patients with inoperable/metastatic HR+/HER2- breast cancer who have received one to two previous lines of chemotherapy in this setting.

Matèries

Càncer de mama, Immunoteràpia, Quimioteràpia del càncer

Matèries (anglès)

Breast cancer, Immunotheraphy, Cancer chemotherapy

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Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

Citació

BARDIA, Aditya, JHAVERI, Komal, IM, Seock-ah, PERNAS, Sònia, DE LAURENTIIS, Michelino, WANG, Shusen, MARTÍNEZ JAÑEZ, Noelia, BORGES, Giuliano, CESCON, David w., HATTORI, Masaya, LU, Yen-shen, HAMILTON, Erika, ZHANG, Qingyuan, TSURUTANI, Junji, KALINSKY, Kevin, RUBINI LIEDKE, Pedro emanuel, XU, Lu, FAIRHURST, Rick m., KHAN, Sabrina, DENDULURI, Neelima, RUGO, Hope s., XU, Binghe, PISTILLI, Barbara, The TROPION-Breast01 Investigators. Datopotamab Deruxtecan Versus Chemotherapy in Previously Treated Inoperable/Metastatic Hormone Receptor–Positive Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer: Primary Results From TROPION-Breast01. _Journal of Clinical Oncology_. 2025. Vol. 43, núm. 3, pàgs. 285-296. [consulta: 25 de gener de 2026]. ISSN: 1527-7755. [Disponible a: https://hdl.handle.net/2445/218878]

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