KEY TAKEAWAYS
- A Phase III MONALEESA-7 trial investigated ribociclib in combination with endocrine therapy in premenopausal women.
- The study investigated the correlation between work productivity loss (WPL) and the domains of the EORTC QLQ-C30 and QLQ-BR23.
- Univariable mixed-model repeated measures regression models were used to evaluate the association between WPL and EORTC domains.
- Higher levels of WPL were associated with a lower overall quality of life and other functional domains.
- The study identified the quality of life domains correlating with whole-body progression-free survival in premenopausal women.
- The study’s findings could aid in developing prognostic instruments for identifying and characterizing patients at higher risk for WPL.
The MONALEESA-7 phase III trial investigated the efficacy of ribociclib in combination with endocrine therapy (ET) compared to ET premenopausal women with HR+/HER2- advanced breast cancer (ABC). The correlation between work productivity loss (WPL) and the domains of the European Organisation for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) and the breast cancer (BC)-specific module (QLQ-BR23) has yet to be investigated in ABC. In this retrospective analysis with a data cutoff of November 30, 2018, the investigators evaluated the association between the WPL component of the Work Productivity and Activity Impairment: General Health (WPAI: GH) questionnaire and EORTC QLQ-C30/BR23 domains.
The EORTC and WPAI: GH data of 329 patients employed during the MONALEESA-7 trial were analyzed in both treatment arms. Individual univariable mixed-model repeated measures (MMRM) regression models were employed for each domain. The dependent variable was WPL; each EORTC domain score was considered a solitary fixed-effect covariate. Linear and quadratic associations were evaluated using the Akaike information criterion. Subsequently, two distinct multivariable mixed-effects models with repeated measures (MMRM) were employed, wherein the dependent variable was WPL, and all QLQ-C30/BR23 domain scores were considered fixed-effects covariates. The correlation strength between WPL and EORTC domains was assessed with regard to the minimally important differences for the QLQ-C30/BR23 modules.
According to our univariable analysis, there was a statistically significant association that existed between higher levels of WPL and lower levels of overall quality of life (QoL) and other functional domains. Additionally, higher levels of WPL were associated with increased levels of all symptomatic domains of the QLQ-C30/BR23 modules. Based on the multivariable analysis, it has been determined that alterations mainly influenced the correlation in the quality of life, including physical, role, social, and future perspective domains, as well as BC-specific symptomatic domains. The present study identified the quality of life domains that correlate with whole-body progression-free survival in premenopausal individuals diagnosed with hormone receptor-positive and HER2-negative advanced breast cancer. The findings mentioned above could potentially aid in developing prognostic instruments for identifying and characterizing patients at a higher risk for WPL. Additionally, these results may assist in creating intervention plans aimed at reducing the occurrence of WPL.
Source: https://pubmed.ncbi.nlm.nih.gov/35251320/
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT02278120
Tripathy D, Curteis T, Hurvitz S, Yardley D, Franke F, Babu KG, Wheatley-Price P, Im YH, Pencheva R, Eddowes LA, Dionne PA, Chandiwana D, Pathak P, Lanoue B, Harbeck N. Correlation between work productivity loss and EORTC QLQ-C30 and -BR23 domains from the MONALEESA-7 trial of premenopausal women with HR+/HER2- advanced breast cancer. Ther Adv Med Oncol. 2022 Feb 28;14:17588359221081203. doi: 10.1177/17588359221081203. PMID: 35251320; PMCID: PMC8891884.
