1. Real-world survival outcomes of heavily pretreated patients with refractory HR+, HER2-metastatic breast cancer receiving single-agent chemotherapy-a comparison with MONARCH 1
- Author
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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 AM, Li, Xiaohong I, Frenzel, Martin, Huang, Yu-Jing, Dickler, Maura N, and Tolaney, Sara M
- Subjects
Real-world evidence ,Real-world control arm ,Clinical Sciences ,Oncology and Carcinogenesis ,Evaluation of treatments and therapeutic interventions ,Breast Neoplasms ,Vinorelbine ,Metastatic breast cancer ,Abemaciclib ,Retrospective study ,Single-arm trial ,ErbB-2 ,6.1 Pharmaceuticals ,Antineoplastic Combined Chemotherapy Protocols ,Breast Cancer ,Humans ,Electronic health records ,Female ,Overall survival ,Oncology & Carcinogenesis ,Capecitabine ,Receptor ,Proportional Hazards Models ,Cancer - Abstract
PurposeIn 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.MethodsThe 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.ResultsA 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 22.3months in the abemaciclib arm versus 13.6months in the matched real-world chemotherapy cohort with an estimated hazard ratio (HR) of 0.54. The median DoT was 4.1months in MONARCH 1 compared to 2.9months in the real-world chemotherapy cohort with HR of 0.76.ConclusionsThis 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.
- Published
- 2020