Program

In-person AND virtual! – We are pioneering a new conference format that will connect in-person and virtual audiences to create a unique experience. Matching the innovation that comes through our members’ work, ISPOR is pushing the boundaries of innovation to design an event that works in today’s quickly changing environment. 

In-person registration included the full virtual experience, and virtual-only attendees will be able to tune into live in-person sessions and/or watch captured in-person sessions on-demand in addition to having a variety of virtual-only sessions to attend.

Real-World Cardiac Safety of Anti-HER2 Therapies in Elderly Patients with HER2+/HR-Metastatic Breast Cancer: A Retrospective Cohort Study Using SEER-Medicare DATA 2012-2016

Speaker(s)

Ou Z1, Nohria A2, Spring LM3, Seeger JD4, Doucette J5, Murimi-Worstell IB5
1MCPHS University, Belmont, MA, USA, 2Brigham and Women's Hospital, Boston, MA, USA, 3Massachusetts General Hospital Cancer Center, Boston, MA, USA, 4Optum, Boston, MA, USA, 5MCPHS University, Boston, MA, USA

Presentation Documents

OBJECTIVES: Anti-HER2 therapies have significantly improved survival in human epidermal growth factor 2 (HER2)-positive metastatic breast cancer (mBC). However, clinical trials have identified increased cardiac risk with trastuzumab-based therapies. The purpose of our study was to assess the incidence of cardiac safety events after trastuzumab initiation among elderly HER2+ mBC patients in the real-world setting.

METHODS: We identified 73 eligible HER2+/ hormone receptor-negative mBC patients diagnosed between February 2013 and December 2015 (mean age at diagnosis, 75.0±7.7 years) from SEER and followed their MEDICARE records through December 2016. Fifty-six patients were treated with trastuzumab, and among them, five received ado-trastuzumab emtansine (T-DM1) as second-line therapy during the study period. We identified the occurrence of cardiac safety events 12 months before diagnosis through patient death or the end of observation. We defined a cardiac safety event as inpatient or outpatient cardiomyopathy (CM) or heart failure (HF).

RESULTS: There were no significant baseline differences between patients treated with trastuzumab or not, except that the non-trastuzumab group had a higher proportion of patients with a prior history of CM/HF. Eight of the 56 patients (14.3%) developed CM/HF during or following trastuzumab treatment, including one HF hospitalization. Three of the 8 patients (37.5%) who developed CM/HF had pre-existing cardiac conditions. Four of the 8 patients (50%) died within one month of developing CM/HF. The average number of cardiac events per trastuzumab-treated patient was 2.9. Excluding patients with a history of CM/HF before mBC diagnosis, the incidence of CM/HF was 9.6% in patients treated with trastuzumab and 6.7% in patients without trastuzumab treatment (OR, 1.49; 95%CI, 0.16-13.83).

CONCLUSIONS: Our results suggest that elderly patients treated with trastuzumab-based therapies do not have an increased cardiac safety risk compared with patients with no trastuzumab-based treatment. However, our results are limited by the small size of our cohort.

Code

SA33

Topic

Epidemiology & Public Health, Study Approaches

Topic Subcategory

Registries, Safety & Pharmacoepidemiology

Disease

Biologics and Biosimilars