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Nonhormonal Treatment With Q-122 for Vasomotor Symptoms of Tamoxifen or Aromatase Inhibitors

Results of a phase 2 trial support the conduct of larger and longer studies of Q-122 in women with vasomotor symptoms following treatment for breast cancer with oral adjuvant endocrine therapy, researchers report. Q-122 works by modulation of estrogen-responsive neurons in the hypothalamus.

The multicenter trial conducted at 18 sites in Australia, New Zealand, and the U.S. included 131 women aged 18–70 years of age who were taking a stable dose of tamoxifen or an aromatase inhibitor following breast cancer and experiencing at least 50 self-reported moderate-to-severe vasomotor symptoms per week. Participants were randomized to oral Q-122 100 mg or identical placebo twice daily for 28 days.

Based on a primary outcome of mean percentage change from baseline in the Vasomotor Symptom Severity Score of moderate and severe hot flushes and night sweats (msVMS-SS), the results showed the following: “Q-122 resulted in a significantly greater mean percentage change in msVMS-SS from baseline over 28 days of treatment compared with placebo (least squares mean: Q-122 –39% [95% CI –46 to –31] vs placebo –26% [–33 to –18]; P = 0.018). Treatment-emergent adverse events were generally mild to moderate and similar between the two groups (treatment-related treatment-emergent adverse events in 11 [17%] of 65 patients in the Q-122 group vs nine [14%] of 66 in the placebo group); zero patients in the Q-122 group and two (3%) patients in the placebo group had serious adverse events.”

Source: Lancet, Lancet