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2020-12-01

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cc-by (c) López Miranda, Elena et al., 2020
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/176420

Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib Trial

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https://doi.org/10.3390/cancers12123509

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The paper assesses the dose-limiting toxicities and the maximum tolerated dose (MTD) of trastuzumab emtansine (T-DM1) combined with non-pegylated liposomal doxorubicin (NPLD) in HER2-positive (HER2+) metastatic breast cancer (MBC). This single-arm, open-label, phase Ib trial (NCT02562378) enrolled anthracycline-naïve HER2+ MBC patients who had progressed on trastuzumab and taxanes. Patients received a maximum of 6 cycles of NPLD intravenously (IV) at various dose levels (45, 50, and 60 mg/m2) in the "3 plus 3" dose-escalation part. During expansion, they received 60 mg/m2 of NPLD every 3 weeks (Q3W) plus standard doses of T-DM1. The MTD was T-DM1 3.6 mg/kg plus NPLD 60 mg/m2 administered IV Q3W. No clinically relevant worsening of cardiac function was observed. Among all evaluable patients, the overall response rate was 40.0% (95%CI, 16.3-67.7) with a median duration of response of 6.9 months (95%CI, 4.8-9.1). Clinical benefit rate was 66.7% (95%CI, 38.4-88.2) and median progression-free survival was 7.2 months (95%CI, 4.5-9.6). No significant influence of NPLD on T-DM1 pharmacokinetics was observed. The addition of NPLD to T-DM1 is feasible but does not seem to improve the antitumor efficacy of T-DM1 in HER2+ MBC patients.

Matèries

Càncer de mama, Metàstasi

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Breast cancer, Metastasis

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Articles publicats en revistes (Medicina)
Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)

Citació

LÓPEZ MIRANDA, Elena, PÉREZ GARCÍA, José manuel, DI COSIMO, Serena, BRAIN, Etienne, RAVNIK, Maja, ESCRIVÁ DE ROMANÍ, Santiago, VIDAL LOSADA, Maria jesús, GLIGOROV, Joseph, BORSTNAR, Simona, CALABUIG, Laura, SAMPAYO CORDERO, Miguel, MALFETTONE, Andrea, LLOMBART CUSSAC, Antonio, SUTER, Thomas m., CORTÉS, Javier. Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib Trial. _Cancers_. 2020. Vol. 12, núm. 12. [consulta: 13 de febrer de 2026]. ISSN: 2072-6694. [Disponible a: https://hdl.handle.net/2445/176420]

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