Research in context
Evidence before this study
Vasomotor symptoms, which are highly prevalent in patients who have had breast cancer, negatively affect physical and psychological wellbeing and overall quality of life. Furthermore, vasomotor symptoms might 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. Oestrogen therapy is generally contraindicated after breast cancer and non-hormonal treatment options for vasomotor symptoms are limited. Consequently, the negative effect of vasomotor symptoms is a common cause of non-adherence to, and discontinuation of, oral adjuvant endocrine therapy. A PubMed search through to June 30, 2022, using the keywords “breast cancer”, “oral adjuvant endocrine therapy”, “vasomotor symptoms”, “hot flash”, and “hot flushes” without restrictions on language or publication date was conducted to identify articles that investigated non-hormonal treatments of adverse symptoms, including vasomotor symptoms, associated with oral adjuvant endocrine therapy. The identified studies of non-hormonal pharmacological, non-pharmacological, and complementary and alternative medicines for vasomotor symptoms report varying efficacy and tolerability. Our search found that the availability of safe and efficacious treatments of vasomotor symptoms for women taking oral adjuvant endocrine therapy for breast cancer remains a substantial unmet medical need.
Added value of this study
This is the first randomised, double-blind, placebo-controlled clinical trial of the efficacy and safety of oral Q-122 for the alleviation of moderate and severe vasomotor symptoms in women taking oral adjuvant endocrine therapy after breast cancer. Oral Q-122 significantly reduced the frequency and severity of moderate and severe vasomotor symptoms, with associated improvement in quality of life. Thus, Q-122 shows promise as a differentiated and novel non-hormonal treatment of vasomotor symptoms.
Implications of all the available evidence
The results of our study support the conduct of larger and longer studies of Q-122, with potential use extending to postmenopausal women who require an alternative to oestrogen therapy for vasomotor symptoms.