Across the MONALEESA-2, -3, and -7 clinical trials, first-line treatment with endocrine therapy and ribociclib mitigated negative effects on quality of life, global health scores, pain, and emotional functioning.
Peter A. Fasching, MD, Head, Clinical Trial Unit, and Coordinator, Breast Cancer Center and Gynecologic Oncology Center, University Hospital Erlangen, Germany, provided his expert insight on a pooled analysis of the MONALEESA-2, -3, and -7 clinical trials. These trials included patient-reported quality of life (QOL) that was in conjunction with the efficacy and safety of ribociclib combined with various endocrine therapeutic options as first- or second-line therapy for hormone receptor–positive, HER2-negative advanced breast cancer. This pooled data analysis of the MONALEESA trials provided a more robust analysis of the impact of treatment on QOL based on both pre- and postmenopausal patients receiving various endocrine therapy combinations.
A total of 1528 patients from the MONALEESA trials were assessed in this study, in which the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 was used to evaluate health-related QOL and pain. QOL was also assessed for all patients in MONALEESA-2, in patients receiving endocrine therapy as initial treatment in MONALEESA-3, and in patients receiving ribociclib or placebo plus a nonsteroidal aromatase inhibitor as endocrine therapy in MONALEESA-7.
When treated with ribociclib, time to definitive deterioration ≥10% for global health status, pain, and emotional functioning were extended. The pooled analysis showed that median time to definitive deterioration ≥10% for global health status was 39.6 months for the group treated with ribociclib versus 33.1 months for the group administered placebo (hazard ratio [HR], 0.79; 95% confidence interval [CI], 0.66-0.94). However, median time to definitive deterioration ≥10% for pain was not reached for either the ribociclib or placebo cohorts (HR, 0.77; 95% CI, 0.61-0.97).
The median time to definitive deterioration ≥10% for emotional functioning was 46.9 months for the group treated with ribociclib and compared with 35.9 months in the group administered placebo (HR, 0.71; 95% CI, 0.59-0.85).
While the HRs for time to definitive deterioration ≥10% for social and physical functioning and fatigue favored ribociclib, the investigators noted there were wide CIs.
Global health status and QOL were maintained from baseline throughout treatment in both arms; however, at the end of treatment, it diminished. Similarly, pain management was improved from baseline and maintained during treatment but worsened at end of treatment.
Patients receiving first-line endocrine therapy plus ribociclib delayed worsening of QOL. In addition, ribociclib treatment positively affected time to definite deterioration for global health status, emotional function scores, and pain in patients with hormone receptor–positive, HER2-negative advanced breast cancer.
Source: Fasching PA, Bardia A, Nusch A, et al. Pooled analysis of patient (pt)-reported quality of life (QOL) in the MONALEESA (ML)-2, -3, and -7 trials of ribociclib (RIB) plus endocrine therapy (ET) to treat hormone receptor–positive, HER2-negative (HR+/HER2−) advanced breast cancer (ABC). Ann Oncol. 2020;31(4_suppl). Abstract 2760.