dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Dieras, Veronique |
dc.contributor.author | Cortés Castan, Javier |
dc.contributor.author | Patt, Debra |
dc.contributor.author | Wildiers, Hans |
dc.contributor.author | O’Shaughnessy, Joyce |
dc.contributor.author | Zamora Adelantado, Esther |
dc.contributor.author | Rugo, Hope |
dc.date.accessioned | 2021-10-19T10:12:12Z |
dc.date.available | 2021-10-19T10:12:12Z |
dc.date.issued | 2020-11 |
dc.identifier.citation | Rugo HS, Dieras V, Cortes J, Patt D, Wildiers H, O’Shaughnessy J, et al. Real-world survival outcomes of heavily pretreated patients with refractory HR+, HER2−metastatic breast cancer receiving single-agent chemotherapy—a comparison with MONARCH 1. Breast Cancer Res Treat. 2020 Nov;184:161-72. |
dc.identifier.issn | 1573-7217 |
dc.identifier.uri | https://hdl.handle.net/11351/6406 |
dc.description | Abemaciclib; Metastatic breast cancer; Overall survival |
dc.description.abstract | 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. |
dc.language.iso | eng |
dc.publisher | Springer |
dc.relation.ispartofseries | Breast Cancer Research and Treatment;184 |
dc.rights | Attribution 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ |
dc.source | Scientia |
dc.subject | Mama - Càncer - Quimioteràpia |
dc.subject.mesh | Breast Neoplasms |
dc.subject.mesh | /drug therapy |
dc.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 |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1007/s10549-020-05838-5 |
dc.subject.decs | neoplasias de la mama |
dc.subject.decs | /farmacoterapia |
dc.relation.publishversion | https://doi.org/10.1007/s10549-020-05838-5 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut Català de la Salut |
dc.contributor.authoraffiliation | [Rugo HS] Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA. [Dieras V] Centre Eugene Marquis UNICANCER, Rennes Cedex, France. [Cortes J] 3 IOB Institute of Oncology, Quironsalud Group, Madrid, Spain. 4 IOB Institute of Oncology, Quironsalud Group, Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Patt D] Texas Oncology, Austin, TX, USA. US Oncology, Dallas, TX, USA. [Wildiers H] Department of General Medical Oncology, University Hospital Gasthuisberg, Leuven, Belgium. [O'Shaughnessy J] Texas Oncology, US Oncology, Baylor University Medical Center, Dallas, TX, USA. [Zamora E] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain |
dc.identifier.pmid | 32789591 |
dc.identifier.wos | 000559209800002 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |