Key result
Among 585 women receiving adjuvant trastuzumab for ≥90 days, only 15.9% were fully compliant with standard left ventricular testing protocols, and 7 developed new-onset heart failure.
Why the study?
Do clinicians routinely follow standard left ventricular testing protocols for women receiving adjuvant trastuzumab therapy in a real-world setting?
Observational (n=631)
Do clinicians routinely follow standard left ventricular testing protocols for women receiving adjuvant trastuzumab therapy in a real-world setting?
Real-world compliance with recommended left ventricular monitoring during cardiotoxic trastuzumab therapy is poor, highlighting a significant gap in cardio-oncology care.
Answers are grounded in this paper and cite their sources.
Suboptimal real-world LV monitoring during trastuzumab should not yet change practice; leaves open impact of adherence interventions on HF.
Adjuvant therapy with trastuzumab is standard in women with early stage HER-2-positive breast cancer. Following reports of left ventricular (LV) dysfunction with trastuzumab in metastatic disease, trials of adjuvant trastuzumab specified LV monitoring schedules. This study analyzes the pattern of cardiac testing and the incidence of heart failure (HF) in women treated with adjuvant trastuzumab in a real-world setting. De-identified medical and pharmacy claims data for women <65 years of age who began trastuzumab therapy between January 1, 2007 and December 31, 2007 were obtained from an integrated database at Medco Health Solutions, Inc. Patients receiving trastuzumab for ≥90 days were assessed for compliance with standard LV testing, defined as testing at baseline, at 4-month intervals, and at the end of trastuzumab therapy. Cardiac risk factors and HF were identified by ICD-9-CM diagnosis codes, by medical claims, and by pharmacy claims for drugs used to treat diabetes, hypercholesterolemia, or HF. A total of 631 women received trastuzumab ≥30 days, and 585 continued for ≥90 days (median duration 356 days [±1Q = 322-378]). Seventy nine patients had no LV tests. Ninety three were fully compliant with baseline, interval, and final testing. Seven women were identified as having new-onset HF. In this retrospective analysis, clinicians did not routinely follow LV testing protocols used in clinical trials or published recommendations. As breast cancer specific survival rates improve, the long-term contribution of cardiotoxic therapies to cardiac morbidity and mortality in survivors will gain attention. Early efforts to ensure compliance with testing could contribute to use of preventive therapies to mitigate future long-term consequences.
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Subar et al. (2011) conducted an observational in early stage HER-2-positive breast cancer (n=631). Adjuvant trastuzumab therapy was evaluated on compliance with standard LV testing (baseline, 4-month intervals, and end of therapy). Among 585 women receiving adjuvant trastuzumab for ≥90 days, only 15.9% were fully compliant with standard left ventricular testing protocols, and 7 developed new-onset heart failure.
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