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Real-world survival outcomes of heavily pretreated patients with refractory HR+, HER2−metastatic breast cancer receiving single-agent chemotherapy—a comparison with MONARCH 1
PURPOSE: In MONARCH 1 (NCT02102490), single-agent abemaciclib demonstrated promising efficacy activity and tolerability in a population of heavily pretreated women with refractory HR+, HER2− metastatic breast cancer (MBC). To help interpret these results and put in clinical context, we compared over...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer US
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7568708/ https://www.ncbi.nlm.nih.gov/pubmed/32789591 http://dx.doi.org/10.1007/s10549-020-05838-5 |
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author | Rugo, Hope S. Dieras, Veronique Cortes, Javier Patt, Debra Wildiers, Hans O’Shaughnessy, Joyce Zamora, Esther Yardley, Denise A. Carter, Gebra Cuyun Sheffield, Kristin M. Li, Li Andre, Valerie A. M. Li, Xiaohong I. Frenzel, Martin Huang, Yu-Jing Dickler, Maura N. Tolaney, Sara M. |
author_facet | Rugo, Hope S. Dieras, Veronique Cortes, Javier Patt, Debra Wildiers, Hans O’Shaughnessy, Joyce Zamora, Esther Yardley, Denise A. Carter, Gebra Cuyun Sheffield, Kristin M. Li, Li Andre, Valerie A. M. Li, Xiaohong I. Frenzel, Martin Huang, Yu-Jing Dickler, Maura N. Tolaney, Sara M. |
author_sort | Rugo, Hope S. |
collection | PubMed |
description | PURPOSE: In MONARCH 1 (NCT02102490), single-agent abemaciclib demonstrated promising efficacy activity and tolerability in a population of heavily pretreated women with refractory HR+, HER2− metastatic breast cancer (MBC). To help interpret these results and put in clinical context, we compared overall survival (OS) and duration of therapy (DoT) between MONARCH 1 and a real-world single-agent chemotherapy cohort. METHODS: The real-world chemotherapy cohort was created from a Flatiron Health electronic health records-derived database based on key eligibility criteria from MONARCH 1. The chemotherapies included in the cohort were single-agent capecitabine, gemcitabine, eribulin, or vinorelbine. Results were adjusted for baseline demographics and clinical differences using Mahalanobis distance matching (primary analysis) and entropy balancing (sensitivity analysis). OS and DoT were analyzed using the Kaplan–Meier method and Cox proportional hazards regression. RESULTS: A real-world single-agent chemotherapy cohort (n = 281) with eligibility criteria similar to the MONARCH 1 population (n = 132) was identified. The MONARCH 1 (n = 108) cohort was matched to the real-world chemotherapy cohort (n = 108). Median OS was 22.3 months in the abemaciclib arm versus 13.6 months in the matched real-world chemotherapy cohort with an estimated hazard ratio (HR) of 0.54. The median DoT was 4.1 months in MONARCH 1 compared to 2.9 months in the real-world chemotherapy cohort with HR of 0.76. CONCLUSIONS: This study demonstrates an approach to create a real-world chemotherapy cohort suitable to serve as a comparator for trial data. These exploratory results suggest a survival advantage and place the benefit of abemaciclib monotherapy in clinical context. |
format | Online Article Text |
id | pubmed-7568708 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Springer US |
record_format | MEDLINE/PubMed |
spelling | pubmed-75687082020-10-19 Real-world survival outcomes of heavily pretreated patients with refractory HR+, HER2−metastatic breast cancer receiving single-agent chemotherapy—a comparison with MONARCH 1 Rugo, Hope S. Dieras, Veronique Cortes, Javier Patt, Debra Wildiers, Hans O’Shaughnessy, Joyce Zamora, Esther Yardley, Denise A. Carter, Gebra Cuyun Sheffield, Kristin M. Li, Li Andre, Valerie A. M. Li, Xiaohong I. Frenzel, Martin Huang, Yu-Jing Dickler, Maura N. Tolaney, Sara M. Breast Cancer Res Treat Clinical Trial PURPOSE: In MONARCH 1 (NCT02102490), single-agent abemaciclib demonstrated promising efficacy activity and tolerability in a population of heavily pretreated women with refractory HR+, HER2− metastatic breast cancer (MBC). To help interpret these results and put in clinical context, we compared overall survival (OS) and duration of therapy (DoT) between MONARCH 1 and a real-world single-agent chemotherapy cohort. METHODS: The real-world chemotherapy cohort was created from a Flatiron Health electronic health records-derived database based on key eligibility criteria from MONARCH 1. The chemotherapies included in the cohort were single-agent capecitabine, gemcitabine, eribulin, or vinorelbine. Results were adjusted for baseline demographics and clinical differences using Mahalanobis distance matching (primary analysis) and entropy balancing (sensitivity analysis). OS and DoT were analyzed using the Kaplan–Meier method and Cox proportional hazards regression. RESULTS: A real-world single-agent chemotherapy cohort (n = 281) with eligibility criteria similar to the MONARCH 1 population (n = 132) was identified. The MONARCH 1 (n = 108) cohort was matched to the real-world chemotherapy cohort (n = 108). Median OS was 22.3 months in the abemaciclib arm versus 13.6 months in the matched real-world chemotherapy cohort with an estimated hazard ratio (HR) of 0.54. The median DoT was 4.1 months in MONARCH 1 compared to 2.9 months in the real-world chemotherapy cohort with HR of 0.76. CONCLUSIONS: This study demonstrates an approach to create a real-world chemotherapy cohort suitable to serve as a comparator for trial data. These exploratory results suggest a survival advantage and place the benefit of abemaciclib monotherapy in clinical context. Springer US 2020-08-12 2020 /pmc/articles/PMC7568708/ /pubmed/32789591 http://dx.doi.org/10.1007/s10549-020-05838-5 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits 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/4.0/. |
spellingShingle | Clinical Trial Rugo, Hope S. Dieras, Veronique Cortes, Javier Patt, Debra Wildiers, Hans O’Shaughnessy, Joyce Zamora, Esther Yardley, Denise A. Carter, Gebra Cuyun Sheffield, Kristin M. Li, Li Andre, Valerie A. M. Li, Xiaohong I. Frenzel, Martin Huang, Yu-Jing Dickler, Maura N. Tolaney, Sara M. Real-world survival outcomes of heavily pretreated patients with refractory HR+, HER2−metastatic breast cancer receiving single-agent chemotherapy—a comparison with MONARCH 1 |
title | Real-world survival outcomes of heavily pretreated patients with refractory HR+, HER2−metastatic breast cancer receiving single-agent chemotherapy—a comparison with MONARCH 1 |
title_full | Real-world survival outcomes of heavily pretreated patients with refractory HR+, HER2−metastatic breast cancer receiving single-agent chemotherapy—a comparison with MONARCH 1 |
title_fullStr | Real-world survival outcomes of heavily pretreated patients with refractory HR+, HER2−metastatic breast cancer receiving single-agent chemotherapy—a comparison with MONARCH 1 |
title_full_unstemmed | Real-world survival outcomes of heavily pretreated patients with refractory HR+, HER2−metastatic breast cancer receiving single-agent chemotherapy—a comparison with MONARCH 1 |
title_short | Real-world survival outcomes of heavily pretreated patients with refractory HR+, HER2−metastatic breast cancer receiving single-agent chemotherapy—a comparison with MONARCH 1 |
title_sort | real-world survival outcomes of heavily pretreated patients with refractory hr+, her2−metastatic breast cancer receiving single-agent chemotherapy—a comparison with monarch 1 |
topic | Clinical Trial |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7568708/ https://www.ncbi.nlm.nih.gov/pubmed/32789591 http://dx.doi.org/10.1007/s10549-020-05838-5 |
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