Mitigating Vasomotor Symptoms from Adjuvant Endocrine Therapy

Vasomotor symptoms — hot flashes and night sweats — are commonly reported by patients, both men and women, who receive adjuvant endocrine therapy for early-stage breast cancer. In many cases, these symptoms significantly impact quality of life, leading to nonadherence, noncompliance, and early discontinuation of therapy. Most of the numerous strategies for mitigating vasomotor symptoms, including low-dose antidepressants, acupuncture, and herbal products, have limited to no efficacy.

Q-122 is a nonhormonal, orally available compound that is postulated to affect activation of specific estrogen-responsive neurons in the hypothalamus responsible for vasomotor symptoms. Investigators conducted an industry-funded, multinational, double-blind, randomized, controlled phase 2 trial of Q-122 in women on adjuvant endocrine therapy who experienced 50 or more self-reported moderate-to-severe hot flashes and night sweats per week. Patients received Q-122 or placebo twice daily for 28 days.

Of 131 patients, median age was 54.9 years and mean body-mass index was 29.3 kg/m². The distribution of adjuvant endocrine therapy was similar between the two groups (~41% aromatase inhibitor; ~59% tamoxifen or toremifene). The primary outcome, mean percentage change from baseline in the number of vasomotor events, was greater in patients receiving Q-122 compared with placebo (−39% vs. −26%). The most frequent treatment-related adverse events were hot flashes, diarrhea, and urinary tract infection. Some quality-of-life domains, including sleep, leisure, and social activities, were improved in patients receiving Q-122.