Abstract

BackgroundOlder patients with HER2-positive metastatic breast (HER2 + MBC) cancer are underrepresented in clinical trials. We aim to describe the treatment patterns and overall survival (OS) for older women receiving trastuzumab for HER2 + MBC.MethodsRetrospective, whole-of-population cohort study using demographic, dispensing, and medical services data for Australian women ≥ 65 years initiating trastuzumab for HER2 + MBC between 2003 and 2015. We describe time-on-trastuzumab; type and timing of other cancer treatments; rates of cardiac monitoring; and OS from trastuzumab initiation for HER2 + MBC.ResultsOf 5404 women initiating trastuzumab for HER2 + MBC, 1583 (29%) were ≥ 65 years old, and the proportion of older patients increased from 20% in 2003 to 38% in 2015. The median age for older women was 73 years and 516 (33%) were ≥ 75 years. Most older patients (92%) received ≥3medicines for comorbidities other than cancer. Median (IQR) time on trastuzumab was 14.1 months (5.9–32.1) and on all chemotherapy was 5.6 months (3.3–10.8). 74% received ≥1 chemotherapy agent and 56% received endocrine therapy. Half (49%) of patients had a cardiac assessment prior to initiating trastuzumab and overall 1228 (76%) had ≥1 cardiac assessment during the study period. At a median follow-up of 6 years, 73% of patients had died and the median OS was 25.6 months (IQR 10.7–58.7).ConclusionsOlder patients comprise a growing proportion of patients treated with HER2-targeted therapies in the real-world but they remain underrepresented in trials of these agents. Few trials report duration or OS estimates for older patients but our estimates are similar to those from trials that have. Although cardiac monitoring was a requirement of accessing trastuzumab during our study period, many patients did not undergo a cardiac assessment.

Highlights

  • Older patients with HER2-positive metastatic breast (HER2 + MBC) cancer are underrepresented in clinical trials

  • Median survival at initiation was 29.9 months (IQR: 13.3–69.4) for patients aged 65–74 and 19.6 months (IQR: 7.4–47.4) for patients ≥ 75 at initiation (Additional file 1: Figure S1D). In this population-based cohort study we described the largest cohort of older patients with HER2 + MBC, treated with trastuzumab, in the literature to date

  • HER2 + MBC patients are living longer, and it is reassuring that approximately 25% of older patients starting trastuzumab for HER2+ MBC are living longer than 5 years

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Summary

Introduction

Older patients with HER2-positive metastatic breast (HER2 + MBC) cancer are underrepresented in clinical trials. We aim to describe the treatment patterns and overall survival (OS) for older women receiving trastuzumab for HER2 + MBC. Evidence around the efficacy and safety of new treatments is, largely absent for a substantial proportion of patients undergoing breast cancer treatment. In the case of HER2-positive metastatic breast cancer (HER2 + MBC), treatment patterns and survival outcomes are not well understood in older patients. Pivotal trials of HER2-targeted agents indicate that survival estimates have been increasing over time [7,8,9], the trend in survival over time for older patients is unknown [9, 10], with most RCTs including only a small number of participants ≥65. Sub-group analysis of these patients found that they received benefit in terms of overall survival (OS) from the addition of trastuzumab to chemotherapy, but rates of cardiotoxicity were double those reported in patients ≤ 60 [10]

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