MONALEESA-7 Trial Follow-Up Shows Maintained, Improved Quality of Life, Work Productivity

Premenopausal women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer experienced substantial clinical benefit, while maintaining or improving work productivity with greater maintenance of quality of life, according to study findings presented at the 37^th Annual Miami Breast Cancer Conference^®.

“It is particularly important to understand survival benefits in the context of treatment impact on quality of life in premenopausal patients with (advanced breast cancer),” the researchers wrote. “It is also important to assess the impact of treatment on (quality of life) in a subset of the (intent-to-treat) population with only patients who received (Kisqali or placebo) plus a (nonsteroidal aromatase inhibitor), to reflect the indicated use of (Kisqali).”

The phase 3 MONALEESA-7 trial, a first-of-its-kind, evaluated the addition of Kisqali (ribociclib) to treatment with Zoladex (goserelin) and endocrine therapy (either a nonsteroidal aromatase inhibitor or tamoxifen) in premenopausal women with HR-positive, HER2-negative advanced breast cancer.

The combination demonstrated a statistically significant improvement in progression-free survival (the time from treatment to disease worsening or progression) and overall survival, compared with placebo. Median progression-free survival in the treatment group was 23.8 months compared with 13 months in the placebo group. Median overall survival was not reached in the treatment group and was 40.9 months in the placebo group.

In this follow-up, the researchers evaluated quality of life and work productivity in the MONALEESA-7 trial. Quality of life was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ), while impact on work productivity was determined using patient responses to the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH), which evaluated hours of paid work missed in the last seven days due to inability to work or perform regular activities or health problems.

The researchers found that global and social functioning scores were generally maintained throughout treatment and changes from the start of treatment were comparable between treatment groups. In addition, scores following the conclusion of treatment decreased compared with scores given during treatment.

When evaluating those who received a nonsteroidal aromatase inhibitor, changes in quality of life from start of treatment to after, as well as differences between treatment groups, were small, according to the researchers.

The four key work impairment measures included the average percent of work time missed, impairment in a patient’s ability to perform work duties both during work hours and overall and percent of activity impairment — all of which decreased from start of treatment to cycle 31 of treatment among those who experienced impairment measures. The average decrease in all four impairment measures was larger in the treatment group compared with placebo, and also in the nonsteroidal aromatase inhibitor group.

“Treatment with (Kisqali) has demonstrated improved (progression-free survival) and (overall survival), maintenance or improvement in work productivity, and greater maintenance of (quality of life versus placebo), indicating a substantial clinical benefit with (Kisqali) treatment in premenopausal women with HR-positive/HER2-negative (advanced breast cancer),” the researchers concluded.