Abstract 324P
Background
CDK4/6i use in HR+, HER2- ABC has led to significant improvements in clinical outcomes, however, there is a paucity of data on the cardiovascular (CV) health of pts prescribed CDK4/6i in a non-clinical trial setting. The aim of this cohort study was to explore CV risk factors, CVD, cardiac medications, ECG monitoring, comorbidities, and HCU in ABC pts treated with endocrine therapy (ET) or ET + CDK4/6i.
Methods
We retrospectively evaluated records for pts (post-menopausal women, pre-menopausal women on ovarian suppression, and men) with HR+, HER2- ABC who were receiving first line ET at a single institution. Two cohorts were defined: ET alone (2012-2104, prior to approval of CDK 4/6i) and ET+ CDK 4/6i (2015-2017). Data was extracted from the electronic medical record (EPIC) and entered into a REDCap database: demographics, CVD, comorbidities, cardiac medication/procedures, and HCU. Summary statistics include medians and interquartile ranges for continuous variables and frequencies and percentages for categorial variables.
Results
The study population included 108 patients: 62 on ET alone and 46 on ET+CDK4/6i. Median age was 61.5 and 63.5 years, respectively. Baseline characteristics were similar between groups (data not shown). CVD and HCU are presented in the table. Table: 324P
CVD and HCU in pts treated with ET or ET + CDK4/6i
| ET (n=62) | ET+ CDK4/6i (n=46) | |
| Age in yrs, median (range) | 61.5 (27-84) | 63.5 (29-82) |
| CVD (at baseline), n (%) CVA MI Angina CAD* | 9 (14.5) 2 (3.2) 3 (4.8) 1 (1.6) 3 (4.8) | 4 (8.7) 1 (2.2) 0 (0) 2 (4.3) 1 (2.2) |
| CV medications (at baseline), n (%) 0 1-3 4+ | 25 (40.3) 28 (45.2) 9 (14.5) | 17 (37.0) 22 (47.8) 7(15.2) |
| Inpatient visits, n (%) 0 1 2+ | 41 (66.1) 17 (27.4) 4 (6.5) | 30 (65.2) 11 (23.9) 5 (10.9) |
| ICU admission, n (%) | 2 (3.2) | 2 (4.3) |
| CP during hospitalization, n(%) Outpatient visits within 6 months of diagnosis, n (%) 0-1 2 3+ | 2 (3.2) 53 (85.5) 7 (11.3) 2 (3.2) | 4 (8.7) 42 (91.3) 2 (4.3) 2 (4.3) |
| ECG (at baseline), n (%) Prolonged QTc | 26 (41.9) 4 (6.5) | 10 (21.7) 3 (6.5) |
| ECG (during therapy), n (%) Prolonged QTc | 18 (29.0) 5 (8.1) | 5 (11.9) 2 (4.8) |
CVA: cerebral vascular accident; MI: myocardial infarction; CAD: coronary artery disease; CAD* includes prior to and during treatment; CP: cardiac procedures; ECG: electrocardiogram
Conclusions
In this retrospective single institution cohort study, baseline CVD and HCU during treatment was similar in pts prescribed ET alone and ET + CDK4/6i. Presence of CVD did not seem to dissuade practitioners from prescribing ET + CDK4/6i. Further research is needed to understand the impact of CDK4/6i on CV health and HCU in a larger cohort of pts.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Novartis Pharmaceuticals Corporation.
Funding
Novartis Pharmaceuticals Corporation.
Disclosure
S. Dent, L. Alder, G. Broadwater, T. Hyslop, K. Oeffinger, M. Khouri G. Kimmick: Other, Institutional, This study was funded by Novartis Pharmaceuticals Corporation. S. Balu: Financial Interests, Institutional, Stocks/Shares, Employee: Novartis Pharmaceuticals Corporation.