What is the clinical evidence from this study?

Study design: Observational. Population: HER-2-positive metastatic breast cancer (n=48). Intervention: Long-term trastuzumab therapy vs. Baseline (beginning of treatment). Primary outcome: Left ventricular ejection fraction (LVEF) (p=0.019).

What does this research mean for the field?

Long-term trastuzumab therapy in patients with HER-2-positive metastatic breast cancer has a good safety profile, causing statistically significant but clinically benign reductions in left ventricular ejection fraction that remain within normal limits. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

December 16, 2022Open Access

Real-world data of cardiotoxicity during long-term therapy with trastuzumab in human epidermal growth factor receptor-2-positive metastatic breast cancer

MIMarina IljovskaUniversity Clinic of Traumatology ELEmilija LazarevaUniversity Clinic of Traumatology SSSnezhana SmichkoskaSaints Cyril and Methodius University of Skopje

Key Result

Long-term trastuzumab therapy in HER-2-positive metastatic breast cancer significantly reduced mean LVEF from 66.73% to 63.44% (p=0.019), though values remained within the normal range.

Study Design

Type

Observational (n=48)

Structured PICO

Does long-term trastuzumab therapy cause significant cardiotoxicity in patients with HER-2-positive metastatic breast cancer?

Population

48 patients with metastatic HER-2-positive breast cancer receiving long-term trastuzumab therapy for an average of 52.2 months.

Exposure

Long-term trastuzumab therapy (duration > 20 months)

Outcome

Cardiac toxicity assessed by left ventricular ejection fraction (LVEF) at the beginning, middle, and end of treatmentsafety

Main Result

Absolute Event Rate: 63.44% vs 66.73%

p-value: p=0.019

Abstract

Introduction/Objective. This study aims to investigate the cardiotoxicity of long-term therapy with trastuzumab in patients with HER-2-positive metastatic breast cancer. Methods. A total of 48 patients with metastatic HER-2-positive breast cancer were analyzed. The patients received long-term trastuzumab (time of application was longer than 20 months). The analyzed characteristics of the patients were the following: age, initial stage of the disease, application of anti-HER-2 therapy and anthracyclines in the adjuvant setting, the number and type of applied systemic therapies concomitant with trastuzumab in the metastatic setting. Cardiac toxicity was assessed using left ventricular ejection fraction (LVEF) values at three time-points: at the beginning, in the middle, and at the end of treatment period for each patient separately. Results. In 17 (35.4%) patients the trastuzumab treatment was temporary discontinued. The average time of trastuzumab therapy interval was 52.2 ? 23.5 months. The mean LVEF values were 66.73 ? 7.02%, 64.62 ? 5.7%, and 63.44 ? 6.1%, respectively. The mean values of LVEF differed significantly in the three observed time-points (F = 4.9 p = 0.009). Post hoc pairwise comparison, using Bonferroni correction, confirmed significantly lower mean LVEF values at the end point (at the end of treatment) compared with the mean LVEF values at the beginning of anti-HER-2 treatment (p = 0.019), but within the reference range of LVEF ? 50%. Conclusion. The data confirm good safety profile of long-term trastuzumab therapy in HER-2 positive metastatic breast cancer patients considering cardiotoxicity.

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