KEY TAKEAWAYS
- The phase 3 MONALEESA-2 (NCT01958021) trial compared two first-line treatments for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) ABC.
- The study’s primary aim was to assess the patient-reported QoL using the MAIC in the two treatment groups.
- The study used an anchored MAIC of individual patient data from MONALEESA-2 and previously published aggregated data from MONARCH 3.
- TTSD was determined as the time it took to fall ten points or more after randomization without recovering.
- The European Organization for Research and Treatment of Cancer QLQ-C30 and BR-23 were used to collect patient-reported QoL data.
- The study showed that Ribociclib + AI improves the symptom-related quality of life in postmenopausal HR+/HER2- advanced breast cancer patients.
For hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC), a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) + endocrine therapy is recommended as first-line treatment. QoL is a crucial treatment consideration, and CDK4/6 inhibitors’ impact on QoL is significant in advanced and early breast cancer. MAIC enables comparative efficacy when direct comparisons are lacking, which is why this study used the Multidimensional Efficacy Comparison Instrument (MAIC) to assess patient-reported QoL between MONARCH 3 (abemaciclib + aromatase inhibitor) and MONALEESA-2 (ribociclib + aromatase inhibitor).
Data from the European Organization for Research and Treatment of Cancer quality of life questionnaire (QLQ)-C30 and BR-23 were used to conduct an anchored MIA of QoL comparing ribociclib + AI to abemaciclib + AI. The study incorporated individual patient data from MONALEESA-2 and previously published aggregated data from MONARCH 3. Time to sustained decline (TTSD) was determined as the time it took to fall ten points or more after randomization without recovering.
Abemaciclib (n = 328) and placebo (n = 165) patients from MONARCH 3 were paired with ribociclib (n = 205) and placebo (n = 149) patients from MONALEESA-2. Baseline patient characteristics were relatively evenly distributed after weighing. Appetite loss [hazard ratio (HR), 0.46; 95% CI, 0.27-0.81], diarrhea [HR, 0.42; 95% CI, 0.23-0.79], weariness [HR, 0.63; 95% CI, 0.41-0.96], and arm symptoms [HR, 0.49; 95% CI, 0.30-0.79] all preferred ribociclib over abemaciclib in TTSD. Neither the QLQ-C30 nor the BR-23 questionnaires’ functional or symptom scales substantially favored abemaciclib over ribociclib at TTSD. Based on the results of this MAIC, postmenopausal individuals with HR+/HER2- ABC treated in the first-line scenario who choose ribociclib + AI have a higher quality of life than those who decide abemaciclib + AI.
Source:https://pubmed.ncbi.nlm.nih.gov/36861085/
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT01958021
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 HR+/HER2- advanced breast cancer treatment: a matching-adjusted indirect comparison. Ther Adv Med Oncol. 2023 Feb 24;15:17588359231152843. Doi: 10.1177/17588359231152843. PMID: 36861085; PMCID: PMC9969464.
