2026-04-17T06:28:44Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/62482024-12-13T10:22:22Zcom_2072_378070com_2072_378040col_2072_378092

2023-11-08T10:19:20Z urn:hdl:11351/6248 Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib Trial López-Miranda, Elena Perez-Garcia, Jose Manuel Brain, Etienne Ravnik, Maja Escriva de Romaní Muñoz, Santiago Ignacio Cortés Castan, Javier Di Cosimo, Serena Mama - Càncer Medicaments antineoplàstics - Efectes secundaris DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols Other subheadings::Other subheadings::Other subheadings::/adverse effects ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos HER2-positiu; Càncer de mama metastàsic; Trastuzumab emtansina HER2 positivo; Cáncer de mama metastásico; Trastuzumab emtansina HER2-positive; Metastatic breast cancer; Trastuzumab emtansine 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. Funding for this research was provided by F. Hoffmann-La Roche Ltd. 2023-11-08T10:19:20Z 2023-11-08T10:19:20Z 2021-09-01T10:16:22Z 2021-09-01T10:16:22Z 2020-11-25 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion http://hdl.handle.net/11351/6248 Cancers;12(12) https://www.mdpi.com/2072-6694/12/12/3509 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess MDPI Scientia