dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | López-Miranda, Elena |
dc.contributor.author | Perez-Garcia, Jose Manuel |
dc.contributor.author | Brain, Etienne |
dc.contributor.author | Ravnik, Maja |
dc.contributor.author | Escriva de Romaní Muñoz, Santiago Ignacio |
dc.contributor.author | Cortés Castan, Javier |
dc.contributor.author | Di Cosimo, Serena |
dc.date.accessioned | 2021-09-01T10:16:22Z |
dc.date.available | 2021-09-01T10:16:22Z |
dc.date.issued | 2020-11-25 |
dc.identifier.citation | López-Miranda E, Pérez-García JM, Di Cosimo S, Brain E, Ravnik M, Escrivá-de-Romaní S, et al. Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib Trial. Cancers. 2020 Nov 25;12(12):3509. |
dc.identifier.issn | 2072-6694 |
dc.identifier.uri | https://hdl.handle.net/11351/6248 |
dc.description | HER2-positive; Metastatic breast cancer; Trastuzumab emtansine |
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.language.iso | eng |
dc.publisher | MDPI |
dc.relation.ispartofseries | Cancers;12(12) |
dc.rights | Attribution 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ |
dc.source | Scientia |
dc.subject | Mama - Càncer |
dc.subject | Medicaments antineoplàstics - Efectes secundaris |
dc.subject.mesh | Breast Neoplasms |
dc.subject.mesh | Antineoplastic Combined Chemotherapy Protocols |
dc.subject.mesh | /adverse effects |
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.identifier.doi | 10.3390/cancers12123509 |
dc.subject.decs | neoplasias de la mama |
dc.subject.decs | protocolos de quimioterapia antineoplásica combinada |
dc.subject.decs | /efectos adversos |
dc.relation.publishversion | https://www.mdpi.com/2072-6694/12/12/3509 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut Català de la Salut |
dc.contributor.authoraffiliation | [López-Miranda E] Department of Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid, Spain. Medical Department, Medica Scientia Innovation Research (MedSIR), Ridgewood, NJ, USA. Medical Department, Medica Scientia Innovation Research (MedSIR), Barcelona, Spain. [Pérez-García JM] Medical Department, Medica Scientia Innovation Research (MedSIR), Ridgewood, NJ, USA. Medical Department, Medica Scientia Innovation Research (MedSIR), Barcelona, Spain. International Breast Cancer Center (IBCC), Quiron Group, Medical Oncology Department, Barcelona, Spain. [Di Cosimo S] Medical Department, Medica Scientia Innovation Research (MedSIR), Ridgewood, NJ, USA. Medical Department, Medica Scientia Innovation Research (MedSIR), 08018 Barcelona, Spain. Biomarkers Unit, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy. [Brain E] Department of Medical Oncology, Institut Curie, St. Cloud, France. [Ravnik M] Department of Oncology, University Medical Centre Maribor, Maribor, Slovenia. [Escrivá-de-Romaní S] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Cortés J] Medical Department, Medica Scientia Innovation Research (MedSIR), Ridgewood, NJ, USA. Medical Department, Medica Scientia Innovation Research (MedSIR), Barcelona, Spain. International Breast Cancer Center (IBCC), Quiron Group, Medical Oncology Department, Barcelona, Spain. Servei d’Oncologia Mèdica, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain |
dc.identifier.pmid | 33255658 |
dc.identifier.wos | 000601788300001 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |