Abstract
Purpose
Little data exist for comparing cardiac safety and survival outcomes of trastuzumab/pertuzumab or ado-T emtansine (TDM1) in metastatic breast cancer (MBC) patients enrolled in randomized clinical trial (RCT) vs the real-world.
Methods
This was a retrospective population-based cohort of all patients with MBC treated with trastuzumab/pertuzumab or TDM1 (2012–2017) in Ontario, Canada. Outcomes were incident heart failure (HF) and overall survival (OS). RCT data were obtained from digitizing survival curves and compared with cohort data using Kaplan–Meier analysis. Age-based comparison of outcomes was conducted for patients ≥ 65 years old vs younger than 65.
Results
The two cohorts composed of 833 and 397 patients treated with trastuzumab/pertuzumab and TDM1, of whom 5.5% and 7.6% had baseline HF, respectively. Incident HF following trastuzumab/pertuzumab or TDM1 was low (trastuzumab/pertuzumab 1.8 events/100 person years; TDM1 0.02 events/100 person years). The median OS was 39.2 and 56.4 months in the trastuzumab/pertuzumab population-based cohort and CLEOPATRA, respectively. The median OS was 15.4 and 30.9 months in the TDM1 population-based cohort and EMILIA, respectively. Cohort OS was significantly worse than RCT OS (trastuzumab/pertuzumab HR 1.67, 95% CI 1.37–2.03, p < 0.0001; TDM1 HR 2.80, 95% CI 2.27–3.44, p < 0.0001). Older patients had worse OS than younger patients for trastuzumab/pertuzumab (HR 1.60, 95% CI 1.19–2.16, p = 0.0018), but not for TDM1 (HR 1.16, 95% CI 0.81–1.66, p = 0.43).
Conclusion
HF incidence during trastuzumab/pertuzumab or TDM1 therapy in this real-world cohort was low. Survival in this cohort was worse compared to RCT, suggesting that recruitment of patients similar to the real-world population is required.
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This research was supported through provision of data by Institute of Institute for Clinical Evaluative Sciences (ICES) and Cancer Care Ontario (CCO) and through funding support to ICES from an annual grant by the Ministry of Health and Long-Term Care (MOHLTC) and the Ontario Institute for Cancer Research (OICR). The opinions, results and conclusions reported in this paper are those of the authors and are independent from the funding sources. No endorsement by ICES, CCO, OICR or the Government of Ontario is intended or should be inferred.
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Gong, I.Y., Yan, A.T., Earle, C.C. et al. Comparison of outcomes in a population-based cohort of metastatic breast cancer patients receiving anti-HER2 therapy with clinical trial outcomes. Breast Cancer Res Treat 181, 155–165 (2020). https://doi.org/10.1007/s10549-020-05614-5
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DOI: https://doi.org/10.1007/s10549-020-05614-5