Dr Cardoso on Outcomes With Elinzanetant for Hot Flashes in HR+ Breast Cancer

“In terms of safety, the elinzanetant was very well tolerated, with no major [adverse] effects.”

Fatima Cardoso, MD, MSc, FESMO, director of the Breast Unit of the Champalimaud Clinical Center in Lisbon, discussed safety and quality-of-life (QOL) outcomes with elinzanetant given for the treatment of hot flashes in women undergoing adjuvant endocrine therapy for hormone receptor–positive breast cancer.

Findings from the phase 3 OASIS-4 trial (NCT05587296) demonstrated that the neurokinin-1/3 receptor antagonist was well tolerated and provided meaningful improvements in vasomotor symptoms and menopause-related quality of life.

The safety profile of elinzanetant was favorable, with no major adverse effects reported. The most frequent toxicities were mild to moderate in severity, including somnolence, fatigue, and diarrhea. Importantly, more than 90% of patients chose to continue therapy in the optional 2-year extension study, underscoring the agent’s tolerability and patient acceptance.

Beyond safety, secondary end points evaluated the impact of elinzanetant on vasomotor symptoms, sleep disturbances, and menopause-related QOL. Treatment was associated with clinically meaningful improvements across all QOL domains, suggesting that elinzanetant may represent an effective nonhormonal strategy for managing treatment-related toxicities in this population.

According to Cardoso, these results highlight the potential of elinzanetant to improve adherence to adjuvant endocrine therapy by reducing symptom burden without introducing significant toxicity. Vasomotor symptoms remain a leading cause of treatment discontinuation, which can negatively affect long-term outcomes in patients with hormone receptor–positive breast cancer. By addressing this challenge, elinzanetant could serve as an important supportive care intervention to optimize the patient experience and sustain therapy adherence.

Future efforts will focus on further characterizing the long-term safety and efficacy of elinzanetant in the extended treatment setting. Cardoso emphasized that the consistency of findings across safety and QOL measures supports elinzanetant as a promising option for women receiving adjuvant endocrine therapy, and she expressed optimism that regulatory approval could soon provide patients with timely access to this therapy.