- For postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer (ABC), adding ribociclib or placebo to fulvestrant resulted in maintenance or improvement of global health status/quality of life scale score of the EORTC QLQ-C30 questionnaire in all treatment cycles. Ribociclib is unlikely to cause additional negative effects at the end of treatment.
Why this matters
- While the efficacy results of the MONALEESA-3 trial have been reported at ASCO 2018, it has not been clear if, or to what extent, improved PFS in this trial has come at the expense of health-related quality of life (HRQoL).
- More than 90% of patients completed the questionnaire at baseline, approximately 80% at the end of treatment.
- A numerical trend favored ribociclib over placebo for time to definite deterioration of ≥10% in global HRQoL.
- Global HRQoL was maintained in both arms while on treatment. Median in both arms at baseline was 66.7. Mean change up to cycle 19: ribociclib + fulvestrant 3.6–4.9; placebo + fulvestrant 1.3–4.3.
- During treatment, impact on fatigue, diarrhea and nausea/vomiting, pain score, and pain severity was similar in both groups.
- HRQoL worsened at end of treatment by 5.4 (1.9–9.1) points for ribociclib versus 4.3 (0.4–8.2) points for placebo.
- Questionnaires for HRQoL, pain, and patient-reported outcomes (PROs) were completed every 8 weeks for the first 18 months, then every 12 weeks, and at the end of treatment.
- Median time to definite deterioration of ≥10% in HRQoL scores was estimated using the Kaplan-Meier method.
- Underreporting of complaints towards end of study seems possible, as the sickest women might be less prone to fill out the questionnaire.
- “This supports the importance of delaying disease progression to maintain patients’ quality of life.” First author Peter A. Fasching, University Hospital Erlangen, Germany.
- Novartis Pharmaceuticals Corporation.