KEY TAKEAWAYS
- Phase III trials MONALEESA-2 and MONARCH-3 evaluated the first-line treatment for hormone receptor-positive, HER2-negative advanced breast cancer.
- ML-2 showed a significant benefit in overall survival with RIB and AI, while the final OS outcomes for MON-3 are pending.
- A MAIC comparative analysis was conducted to evaluate the patient-reported QoL between ML-2 and MON-3.
- RIB was significantly more effective than ABE in reducing appetite loss, diarrhea, fatigue, and arm symptoms as measured by QLQ-C30 and BR-23 assessments.
- Patient characteristics were adequately balanced following weight adjustments, and the study found no notable preference for ABE over RIB in functional.
- The combination of RIB and AI is linked to an improved quality of life in terms of symptoms compared to ABE and AI for postmenopausal patients.
The prescribed first-line treatment for hormone receptor-positive, HER2-negative advanced breast cancer is a regimen consisting of a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with endocrine therapy. The MONALEESA-2 (ML-2) study has reported a significant benefit in overall survival (OS) with RIB and AI. The final OS outcomes for the MONARCH 3 (MON-3) trial of ABE and AI are currently pending. Quality of life (QoL) is a crucial endpoint significantly impacting treatment decisions. The significance of comprehending the effects of CDK4/6 inhibitors on the quality of life is progressively crucial, particularly with their administration in earlier treatment lines for advanced breast cancer and their emerging role in managing early-stage breast cancer, where the quality of life considerations may hold more relevance. The utilization of MAIC analysis permits for comparative efficacy in the absence of head-to-head clinical trial information. The present study conducted a comparison of patient-reported quality of life (QoL) between Phase III ML-2 (RIB + AI) and MON-3 (ABE + AI) trials, with a specific emphasis on individual domains, using MAIC. Notably, the PALOMA-2 trial was not included in this analysis due to the distinct patient-reported outcome measures assessed in the trial compared to ML-2 and MON-3.
The study utilized data from EORTC QLQ-C30 and BR-23 questionnaires, individual participant data from ML-2 (data cutoff: 6/10/2021), and published data from MON-3 (data cutoff: 11/3/2017). All quality of life (QoL) data that were accessible were utilized in this analysis. The median follow-up duration for ML-2 was 79.7 months, while the median follow-up duration at which QoL data were reported for MON-3 was 26.73 months. The criteria for inclusion and exclusion exhibited a general similarity. Patients in both upper extremities of Medical Trial 2 were subjected to weight adjustments to ensure similarity with the baseline characteristics observed in the respective upper extremities of Medical Observation Note 3. The Cox proportional hazards model was employed to produce hazard ratios (HRs), while anchored HRs were computed using the Bucher method. The TTSD was computed as the duration between randomization and a decline of ≥ 10 points, with no subsequent improvement surpassing this threshold. A total of 205 and 149 patients from the ML-2 arms of RIB/PBO were paired with 328 and 165 patients from the ABE/PBO arms of MON-3.
Following weight measurement, patient characteristics were found to be adequately balanced. The study found that RIB was significantly more effective than ABE in reducing appetite loss (HR, 0.46; 95% CI, 0.27-0.81), diarrhea (HR, 0.42; 95% CI, 0.23-0.79), and fatigue (HR, 0.63; 95% CI, 0.41-0.96) as measured by QLQ-C30. Additionally, the BR-23 assessment showed that RIB was more effective in reducing arm symptoms (HR, 0.49; 95% CI, 0.30-0.79). The study found no notable preference for ABE over RIB regarding functional or symptomatic scales of the QLQ-C30 or BR-23. According to this medical analysis, the combination of RIB and AI appears to be linked to an improved quality of life in terms of symptoms compared to ABE and AI for postmenopausal patients with HR+/HER2- advanced breast cancer in the first-line treatment setting. The disparities in quality of life outcomes between CDK4/6 inhibitors and their corresponding adverse event profiles may impact clinical determinations in hormone receptor-positive, and HER2-negative advanced breast cancer.
Source:https://meetings.asco.org/abstracts-presentations/208059
Clinical Trail:https://clinicaltrials.gov/ct2/show/NCT02246621
Hope S. Rugo, Joyce O’Shaughnessy, Komal L. Jhaveri, Sara M. Tolaney, Fatima Cardoso, Aditya Bardia, Vikalp Kumar Maheshwari, Sandeep Tripathi, Purnima Pathak, Sina Haftchenary, Peter A. Fasching/Quality of life (QOL) with ribociclib (RIB) plus aromatase inhibitor (AI) versus abemaciclib (ABE) plus AI as first-line (1L) treatment (tx) of hormone receptor-positive/human epidermal growth factor receptor–negative (HR+/HER2−) advanced breast cancer (ABC), assessed via matching-adjusted indirect comparison (MAIC)/J Clin Oncol 40, 2022 (suppl 16; abstr 1015) DOI10.1200/JCO.2022.40.16_suppl.1015
