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http://hdl.handle.net/2445/176420
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DC Field | Value | Language |
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dc.contributor.author | López Miranda, Elena | - |
dc.contributor.author | Pérez García, José Manuel | - |
dc.contributor.author | Cosimo, Serena Di | - |
dc.contributor.author | Brain, Etienne | - |
dc.contributor.author | Ravnik, Maja | - |
dc.contributor.author | Escrivá de Romaní, Santiago | - |
dc.contributor.author | Vidal Losada, Maria Jesús | - |
dc.contributor.author | Gligorov, Joseph | - |
dc.contributor.author | Borstnar, Simona | - |
dc.contributor.author | Calabuig, Laura | - |
dc.contributor.author | Sampayo-Cordero, Miguel | - |
dc.contributor.author | Malfettone, Andrea | - |
dc.contributor.author | Llombart Cussac, Antonio | - |
dc.contributor.author | Suter, Thomas M. | - |
dc.contributor.author | Cortés, Javier | - |
dc.date.accessioned | 2021-04-19T09:20:03Z | - |
dc.date.available | 2021-04-19T09:20:03Z | - |
dc.date.issued | 2020-12-01 | - |
dc.identifier.issn | 2072-6694 | - |
dc.identifier.uri | http://hdl.handle.net/2445/176420 | - |
dc.description.abstract | 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. | - |
dc.format.extent | 14 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | MDPI | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.3390/cancers12123509 | - |
dc.relation.ispartof | Cancers, 2020, vol. 12, num. 12 | - |
dc.relation.uri | https://doi.org/10.3390/cancers12123509 | - |
dc.rights | cc-by (c) López Miranda, Elena et al., 2020 | - |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/es | - |
dc.source | Articles publicats en revistes (Medicina) | - |
dc.subject.classification | Càncer de mama | - |
dc.subject.classification | Metàstasi | - |
dc.subject.other | Breast cancer | - |
dc.subject.other | Metastasis | - |
dc.title | Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib Trial | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 709546 | - |
dc.date.updated | 2021-04-19T09:20:04Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 33255658 | - |
Appears in Collections: | Articles publicats en revistes (Medicina) Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer) |
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709546.pdf | 1.05 MB | Adobe PDF | View/Open |
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