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Dr Cardoso on the Effect of Elinzanetant on Vasomotor Symptoms in HR+ Breast Cancer

Fatima Cardoso, MD, MSc, FESMO, discusses the use of elinzanetant for vasomotor symptoms in women receiving endocrine therapy for HR+ breast cancer.

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    "In the OASIS 4 trial, [regarding] the primary end point, which was change in the frequency of moderate-to-severe vasomotor symptoms from baseline to weeks 4 and 12, we saw a statistically significant and clinically meaningful reduction in symptom frequency with elinzanetant compared with placebo."

    Fatima Cardoso, MD, MSc, FESMO, director of the Breast Unit at the Champalimaud Clinical Center in Lisbon, Portugal, discussed findings from the phase 3 OASIS 4 trial (NCT05587296), which evaluated the effect of elinzanetant on vasomotor symptoms and overall quality of life (QOL) in women undergoing adjuvant endocrine therapy for hormone receptor–positive breast cancer.

    The trial assessed the efficacy of elinzanetant—a selective neurokinin-1,3 receptor antagonist—in reducing moderate-to-severe vasomotor symptoms associated with endocrine therapy. Findings presented at the 2025 ASCO Annual Meeting showed that patients treated with elinzanetant(n = 316) experienced a statistically significant reduction in vasomotor symptom frequency and severity from baseline to week 4 and week 12 compared with those receiving placebo (n = 158). Among patients initially randomly assigned to receive placebo, symptom burden decreased rapidly following crossover to the elinzanetant arm at week 12, confirming a consistent and durable treatment effect.

    Elinzanetant demonstrated a rapid onset of action, with measurable symptom improvement observed by week 1. This benefit was maintained through the 12-week core treatment period and extended across the 40-week continuation phase, totaling 52 weeks of therapy. Additionally, an optional 2-year extension period is ongoing to assess the long-term safety and efficacy of the intervention.

    Vasomotor symptoms remain a leading cause of nonadherence to endocrine therapy, and agents like elinzanetant may offer a nonhormonal strategy to enhance tolerability. Improvements in sleep quality, a secondary concern often linked to nocturnal hot flashes, were also observed. These findings underscore the clinical utility of elinzanetant in addressing key QOL issues without compromising the oncologic benefit of endocrine therapy.

    Cardoso noted that the early and sustained symptom control with elinzanetant supports its role as a viable supportive care option for women with breast cancer receiving endocrine therapy. The agent’s nonhormonal mechanism is particularly relevant for this population, where hormone modulation is a cornerstone of systemic treatment.


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