A health-related quality of life analysis of the phase 3 NATALEE trial supports the risk/benefit profile of adding ribociclib to nonsteroidal aromatase inhibitors in patients with hormone receptor–positive, HER2-negative early breast cancer.
Treatment with ribociclib (Kisqali) plus nonsteroidal aromatase inhibitors (NSAIs) led to sustained health-reality quality of life (HRQOL) compared with NSAI alone in patients with hormone receptor (HR)–positive, HER2-negative early breast cancer, according to findings from a prespecified analysis of the phase 3 NATALEE trial (NCT03701334).
Investigators presented these data as part of a European Society of Medical Oncology (ESMO) Virtual Plenary session.
In the ribociclib plus NSAI and NSAI alone arms, respectively, investigators reported a change in physical functioning scores of –1.12 vs –1.35 points at 1 year, –1.62 vs –1.10 points at 2 years, and –1.50 vs –1.34 points at 3 years in the descriptive analysis. According to model-based analysis, each respective treatment group experienced score changes of –1.85 (95% CI, –2.38 to –1.32) vs –2.39 (95% CI, –2.98 to –1.80) points at 1 year, –2.30 (95% CI, –2.85 to –1.76) vs –2.84 (95% CI, –3.49 to –2.19) points at 2 years, and –2.75 (95% CI, –3.35 to –2.15) vs –3.29 (95% CI, –4.03 to –2.56) points at 3 years.
Investigators highlighted that physical functioning scores appeared to be higher in premenopausal women and men compared with postmenopausal women; the same was true for patients who received prior neoadjuvant chemotherapy compared with those who did not. These findings were not affected based on treatment arm.
In the phase 3 NATALEE trial, investigators assessed ribociclib plus NSAI vs NSAI on its own among adult patients with HR-positive HER2-negative early breast cancer. Patients were randomly assigned to receive NSAI with or without 400 mg of ribociclib per day as part of a 3 weeks on, 1 week off schedule for 3 years. Treatment with NSAI consisted of letrozole or anastrozole for at least 5 years plus goserelin for male patients and premenopausal women.
The NATALEE trial’s primary end point was invasive disease-free survival based on Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials criteria. Secondary end points included recurrence-free survival, distant disease-free survival, overall survival, HRQOL, and safety.
As part of the trial’s prespecified HRQOL analysis, the physical functioning scale—the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30—was the primary measure of interest. Other HRQOL end points included social functioning and emotional functioning according to the EORTC QLQ-C30, EORTC-QLQ-BR23, visual analog scale scores (EQ-VAS), and anxiety and depression based on the Hospital Anxiety and Depression Scale (HADS).
The trial population consisted of 5101 patients, including 2549 who were assigned to the ribociclib plus NSAI arm and 2552 to the NSAI alone arm. The median patient age in the overall population was 52 years (range, 24-90). In the combination treatment and NSAI alone arms, respectively, most patients were postmenopausal women (56% vs 56%), had stage III disease (60% vs 59%), received prior endocrine therapy (72% vs 71%), and received prior neoadjuvant chemotherapy (88% vs 88%).
Per the EORTC QLQ-C30, investigators reported no impact on global health status in either the ribociclib plus NSAI or NSAI alone arms. Additionally, there were no differences in changes of social functioning scores from baseline in either arm. Investigators highlighted a small deterioration in emotional functioning from baseline between both arms, although there was no difference in this deterioration depending on treatment.
Study treatment appeared to quickly reduce breast cancer symptoms before producing improvements at a slower rate. Additionally, the analysis indicated that there was no impact on EQ-VAS in either treatment arm over time. With respect to HADS, depression and anxiety scores did not meaningfully change throughout the study in both treatment arms.
Fasching PA, Slamon D, Nowecki Z, et al. Health-related quality of life (HRQoL) in the phase III NATALEE study of adjuvant ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) vs NSAI alone in patients (pts) with HR+/HER2- early breast cancer (EBC). Ann Oncol. Published online September 14, 2023. doi:10.1016/j.annonc.2023.08.007