Cargando…

Retrospective Observational Study of Outcomes in HER2-Positive Metastatic Breast Cancer (mBC) Patients Treated with Ado-Trastuzumab Emtansine (T-DM1) and Subsequent Treatments After T-DM1 in the United States

BACKGROUND: Limited evidence exists on real-world outcomes with ado-trastuzumab emtansine (T-DM1) treatment and the effectiveness of subsequent therapies. OBJECTIVE: This study evaluated treatment patterns and outcomes of patients treated with T-DM1 and post-T-DM1 therapy in the United States. PATIE...

Descripción completa

Detalles Bibliográficos
Autores principales: Denduluri, Neelima, Espirito, Janet L., Hackshaw, Michelle D., Wentworth, Chuck, Recchia, Tamy, Kwong, Winghan J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10232689/
https://www.ncbi.nlm.nih.gov/pubmed/36539672
http://dx.doi.org/10.1007/s40801-022-00340-4
_version_ 1785052041592176640
author Denduluri, Neelima
Espirito, Janet L.
Hackshaw, Michelle D.
Wentworth, Chuck
Recchia, Tamy
Kwong, Winghan J.
author_facet Denduluri, Neelima
Espirito, Janet L.
Hackshaw, Michelle D.
Wentworth, Chuck
Recchia, Tamy
Kwong, Winghan J.
author_sort Denduluri, Neelima
collection PubMed
description BACKGROUND: Limited evidence exists on real-world outcomes with ado-trastuzumab emtansine (T-DM1) treatment and the effectiveness of subsequent therapies. OBJECTIVE: This study evaluated treatment patterns and outcomes of patients treated with T-DM1 and post-T-DM1 therapy in the United States. PATIENTS AND METHODS: Adult patients with HER2-positive (HER2+) metastatic breast cancer (mBC) initiating treatment with T-DM1 between 1/1/2013 and 9/30/2018 were included and followed through 12/31/2018. Data were obtained from the iKnowMed electronic health record. Demographic, clinical, and pre- and post-T-DM1 treatment characteristics were described. The Kaplan-Meier method was used to estimate time to treatment discontinuation (TTD) and overall survival (OS). RESULTS: Of 318 patients treated with T-DM1, 184 (57.9%) had prior treatment with pertuzumab. The median age was 58 years. Most patients had visceral disease (93.4%), and 62.3% had two or more prior treatments for mBC before T-DM1 (range 0–9). The most common subsequent regimens were trastuzumab + vinorelbine (22.5%), HER2-targeted monotherapy (22.5%), and trastuzumab + other chemotherapy (19.6%). Median TTD with T-DM1 was 5.9 months (95% confidence interval [CI] 4.6–6.9); median OS from the start of T-DM1 therapy was 19.2 months (95% CI 16.8–24.5). CONCLUSIONS: Patients treated with T-DM1 in this study appeared to have more advanced disease than patients in clinical trials and were treated in later lines of therapy. Variability was observed across subsequent therapy selections. Treatment patterns and outcomes appeared comparable for patients who received prior pertuzumab. The short treatment durations and survival with T-DM1 therapy in the real-world setting underscore the need for effective post-trastuzumab therapies. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40801-022-00340-4.
format Online
Article
Text
id pubmed-10232689
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Springer International Publishing
record_format MEDLINE/PubMed
spelling pubmed-102326892023-06-02 Retrospective Observational Study of Outcomes in HER2-Positive Metastatic Breast Cancer (mBC) Patients Treated with Ado-Trastuzumab Emtansine (T-DM1) and Subsequent Treatments After T-DM1 in the United States Denduluri, Neelima Espirito, Janet L. Hackshaw, Michelle D. Wentworth, Chuck Recchia, Tamy Kwong, Winghan J. Drugs Real World Outcomes Original Research Article BACKGROUND: Limited evidence exists on real-world outcomes with ado-trastuzumab emtansine (T-DM1) treatment and the effectiveness of subsequent therapies. OBJECTIVE: This study evaluated treatment patterns and outcomes of patients treated with T-DM1 and post-T-DM1 therapy in the United States. PATIENTS AND METHODS: Adult patients with HER2-positive (HER2+) metastatic breast cancer (mBC) initiating treatment with T-DM1 between 1/1/2013 and 9/30/2018 were included and followed through 12/31/2018. Data were obtained from the iKnowMed electronic health record. Demographic, clinical, and pre- and post-T-DM1 treatment characteristics were described. The Kaplan-Meier method was used to estimate time to treatment discontinuation (TTD) and overall survival (OS). RESULTS: Of 318 patients treated with T-DM1, 184 (57.9%) had prior treatment with pertuzumab. The median age was 58 years. Most patients had visceral disease (93.4%), and 62.3% had two or more prior treatments for mBC before T-DM1 (range 0–9). The most common subsequent regimens were trastuzumab + vinorelbine (22.5%), HER2-targeted monotherapy (22.5%), and trastuzumab + other chemotherapy (19.6%). Median TTD with T-DM1 was 5.9 months (95% confidence interval [CI] 4.6–6.9); median OS from the start of T-DM1 therapy was 19.2 months (95% CI 16.8–24.5). CONCLUSIONS: Patients treated with T-DM1 in this study appeared to have more advanced disease than patients in clinical trials and were treated in later lines of therapy. Variability was observed across subsequent therapy selections. Treatment patterns and outcomes appeared comparable for patients who received prior pertuzumab. The short treatment durations and survival with T-DM1 therapy in the real-world setting underscore the need for effective post-trastuzumab therapies. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40801-022-00340-4. Springer International Publishing 2022-12-20 /pmc/articles/PMC10232689/ /pubmed/36539672 http://dx.doi.org/10.1007/s40801-022-00340-4 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research Article
Denduluri, Neelima
Espirito, Janet L.
Hackshaw, Michelle D.
Wentworth, Chuck
Recchia, Tamy
Kwong, Winghan J.
Retrospective Observational Study of Outcomes in HER2-Positive Metastatic Breast Cancer (mBC) Patients Treated with Ado-Trastuzumab Emtansine (T-DM1) and Subsequent Treatments After T-DM1 in the United States
title Retrospective Observational Study of Outcomes in HER2-Positive Metastatic Breast Cancer (mBC) Patients Treated with Ado-Trastuzumab Emtansine (T-DM1) and Subsequent Treatments After T-DM1 in the United States
title_full Retrospective Observational Study of Outcomes in HER2-Positive Metastatic Breast Cancer (mBC) Patients Treated with Ado-Trastuzumab Emtansine (T-DM1) and Subsequent Treatments After T-DM1 in the United States
title_fullStr Retrospective Observational Study of Outcomes in HER2-Positive Metastatic Breast Cancer (mBC) Patients Treated with Ado-Trastuzumab Emtansine (T-DM1) and Subsequent Treatments After T-DM1 in the United States
title_full_unstemmed Retrospective Observational Study of Outcomes in HER2-Positive Metastatic Breast Cancer (mBC) Patients Treated with Ado-Trastuzumab Emtansine (T-DM1) and Subsequent Treatments After T-DM1 in the United States
title_short Retrospective Observational Study of Outcomes in HER2-Positive Metastatic Breast Cancer (mBC) Patients Treated with Ado-Trastuzumab Emtansine (T-DM1) and Subsequent Treatments After T-DM1 in the United States
title_sort retrospective observational study of outcomes in her2-positive metastatic breast cancer (mbc) patients treated with ado-trastuzumab emtansine (t-dm1) and subsequent treatments after t-dm1 in the united states
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10232689/
https://www.ncbi.nlm.nih.gov/pubmed/36539672
http://dx.doi.org/10.1007/s40801-022-00340-4
work_keys_str_mv AT dendulurineelima retrospectiveobservationalstudyofoutcomesinher2positivemetastaticbreastcancermbcpatientstreatedwithadotrastuzumabemtansinetdm1andsubsequenttreatmentsaftertdm1intheunitedstates
AT espiritojanetl retrospectiveobservationalstudyofoutcomesinher2positivemetastaticbreastcancermbcpatientstreatedwithadotrastuzumabemtansinetdm1andsubsequenttreatmentsaftertdm1intheunitedstates
AT hackshawmichelled retrospectiveobservationalstudyofoutcomesinher2positivemetastaticbreastcancermbcpatientstreatedwithadotrastuzumabemtansinetdm1andsubsequenttreatmentsaftertdm1intheunitedstates
AT wentworthchuck retrospectiveobservationalstudyofoutcomesinher2positivemetastaticbreastcancermbcpatientstreatedwithadotrastuzumabemtansinetdm1andsubsequenttreatmentsaftertdm1intheunitedstates
AT recchiatamy retrospectiveobservationalstudyofoutcomesinher2positivemetastaticbreastcancermbcpatientstreatedwithadotrastuzumabemtansinetdm1andsubsequenttreatmentsaftertdm1intheunitedstates
AT kwongwinghanj retrospectiveobservationalstudyofoutcomesinher2positivemetastaticbreastcancermbcpatientstreatedwithadotrastuzumabemtansinetdm1andsubsequenttreatmentsaftertdm1intheunitedstates