KEY TAKEAWAYS
- The phase 3 MONARCH-3 trial compared the QoL reported by patients who received ribociclib + AI and abemaciclib + AI treatments for advanced breast cancer (ABC).
- The study primarily used the MAIC method to compare the QoL of patients treated with ribociclib + AI versus abemaciclib + AI.
- The study used a MAIC with anchoring to evaluate the relative effectiveness between different studies.
- Researchers found that the combination of ribociclib and AI exhibited superior quality of life outcomes related to symptoms, including appetite loss, diarrhea, and fatigue.
- The TTSD was computed as the duration from randomization to a decline of ⩾10 points with no subsequent improvement beyond this threshold.
- The study highlights the significance of QoL assessment in determining treatment options for HR+/HER2- ABC patients.
The recommended initial treatment for advanced breast cancer (ABC) that is hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) is a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with endocrine therapy. Quality of Life (QoL) assessment is a crucial endpoint that significantly influences the determination of treatment options. The significance of CDK4/6 inhibitor treatment on QoL is becoming increasingly important, particularly its utilization in earlier treatment regimens for advanced breast cancer (ABC) and its emerging role in managing early breast cancer, where QoL may have a more pronounced impact. A matching-adjusted indirect comparison (MAIC) without direct comparative clinical trials evaluates the relative effectiveness between different studies. This study aimed to compare the quality of life (QoL) reported by patients who received MONALEESA-2 [ribociclib + aromatase inhibitor (AI)] and MONARCH-3 (abemaciclib + AI) treatments. The analysis used the matching-adjusted indirect comparison (MAIC) method, particularly on individual domains. A MAIC with anchoring was conducted to compare the QoL of patients treated with ribociclib + AI versus abemaciclib + AI. The data for this analysis was obtained from the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (QLQ)-C30 and BR-23 questionnaires.
The analysis incorporated individual patient data from MONALEESA-2 and published aggregated data from MONARCH-3. The TTSD was computed as the duration from randomization to a decline of ⩾10 points with no subsequent improvement beyond this threshold. The individuals who received ribociclib (n = 205) and placebo (n = 149) in MONALEESA-2 were paired with those who received abemaciclib (n = 328) and placebo (n = 165) in MONARCH-3. Following weight assessment, the fundamental characteristics of the patients were adequately equilibrated. The hazard ratio (HR) for appetite loss was significantly lower for ribociclib than abemaciclib (HR 0.46, 95% CI 0.27-0.81). Similarly, the HR for diarrhea was lower for ribociclib (HR 0.42, 95% CI 0.23-0.79), as was the HR for fatigue (HR 0.63, 95% CI 0.41-0.96) and arm symptoms (HR 0.49, 95% CI 0.30-0.79) in patients with TTSD. The results indicated no significant difference in the functional or symptom scale of the QLQ-C30 or BR-23 questionnaires between abemaciclib and ribociclib for TTSD. According to the MAIC, the combination of ribociclib and AI exhibits a superior quality of life outcomes related to symptoms compared to the combination of abemaciclib and AI for postmenopausal patients diagnosed with HR+/HER2- advanced breast cancer and treated in the first-line setting.
Source:https://pubmed.ncbi.nlm.nih.gov/36861085/
Clinical Trail:https://clinicaltrials.gov/ct2/show/NCT02246621
Rugo HS, Harmer V, O’Shaughnessy J, Jhaveri K, Tolaney SM, Cardoso F, Bardia A, Maheshwari VK, Tripathi S, Haftchenary S, Pathak P, Fasching PA. Quality of life with ribociclib versus abemaciclib as first-line treatment of HR+/HER2- advanced breast cancer: a matching-adjusted indirect comparison. Ther Adv Med Oncol. 2023 Feb 24;15:17588359231152843. doi: 10.1177/17588359231152843. PMID: 36861085; PMCID: PMC9969464.
