麻豆传媒

A novel, non-hormonal oral drug was effective in reducing hot flashes and night sweats in women taking oral adjuvant endocrine therapy after breast cancer, according to results from a .

After 28 days of treatment, patients taking the investigational therapy, Q-122, had a significantly greater mean percentage change from baseline in the Vasomotor Symptom Severity Score of moderate and severe hot flashes and night sweats than those on placebo (-39% vs -26% for placebo, P=0.018), reported Amanda Vrselja, PhD, of QUE Oncology in Melbourne, Australia, and colleagues.

In addition, treatment-emergent adverse events (TEAEs) were "generally mild to moderate" and similar between the groups, the team said.

"Our results support the conduct of larger and longer studies of Q-122, with potential use extending to postmenopausal women who require an alternative to menopausal hormone therapy," the researchers wrote in .

The authors also assessed the effect of vasomotor symptoms on work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, and enjoyment of life, and here found a non-significant advantage at 28 days with Q-122 on the 10-item Hot Flash Related Daily Interference Scale (-36% vs -21%, P=0.054). Significant differences were seen when it came to social activities, leisure activities, and sleep.

TEAEs occurred in 17% of patients in the Q-122 group and 14% in the placebo group, with hot flashes, diarrhea, and urinary tract infections most commonly reported. TEAEs that led to Q-122 discontinuation included hot flashes, which were considered mild and related to Q-122 and remained ongoing 2 weeks after treatment discontinuation, and a case of pancreatitis, which was also considered mild but not related to Q-122 and resolved while the patient was off the drug in the follow-up period.

Vrselja and co-authors noted that not only are hot flashes and night sweats prevalent in patients who have had breast cancer, but the symptoms can also be exacerbated by oral adjuvant endocrine therapy -- including tamoxifen and aromatase inhibitors -- which is recommended for women with hormone receptor-positive disease to improve disease-free and overall survival.

Moreover, menopausal hormone therapy, "the most effective treatment for vasomotor symptoms, is contraindicated for women with hormone receptor-positive breast cancer," the researchers pointed out. "Consequently, the negative effect of vasomotor symptoms is a common cause of non-adherence to, and discontinuation of, oral adjuvant endocrine therapy."

Thus, the need for an "effective and safe therapy for women with hormone receptor-positive breast cancer with bothersome vasomotor symptoms, notably those taking oral adjuvant endocrine therapy," the team said, adding that Q-122 has demonstrated promise for reducing these symptoms by modulating estrogen-responsive neurons in the hypothalamus.

In a , however, Carolyn J. Crandall, MD, and Patricia A. Ganz, MD, both of the David Geffen School of Medicine at the University of California Los Angeles, had some concerns. For example, the study's relatively short follow-up means that it doesn't provide enough information about the drug's potential toxicity.

Additionally, Crandall and Ganz said, since the trial required that participants have at least 50 self-reported moderate-to-severe hot flashes and sweats per week, it isn't possible to know whether patients with fewer than 50 moderate-to-severe vasomotor symptoms per week would benefit from the tested dose of Q-122.

The commentators also pointed out that the patients in the study were mostly white, and that vasomotor symptom patterns vary by race and ethnicity.

"In summary, one must view this study as preliminary, with future evaluation necessary before adoption in the clinic," Crandall and Ganz wrote. "In the meantime, the use of venlafaxine or other selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors is likely to remain the first-line pharmacological option to treat vasomotor symptoms in women with breast cancer."

The study included 131 patients from 18 hospitals and research sites in Australia, New Zealand, and the U.S. Eligible patients were ages 18-70, 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.

Patients were randomly assigned 1:1 to either oral Q-122 100 mg or placebo, twice daily for 28 days. Randomization was stratified by body mass index (≤30 or >30), and use of any selective serotonin reuptake inhibitor, selective norepinephrine reuptake inhibitor, gabapentin, or pregabalin.

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