Correlation between work productivity loss (WPL) and European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) domains from the MONALEESA-7 (ML-7) trial of premenopausal women with HR+/HER2- advanced breast cancer (ABC).

Authors

null

Debu Tripathy

The University of Texas MD Anderson Cancer Center, Houston, TX

Debu Tripathy , Tristan Curteis , Sara A. Hurvitz , Denise A. Yardley , Fabio Franke , Govind Babu Kanakasetty , Paul Wheatley-Price , Young-Hyuck Im , Radost Pencheva , David Chandiwana , Purnima Pathak , Brad Lanoue , Nadia Harbeck

Organizations

The University of Texas MD Anderson Cancer Center, Houston, TX, Costello Medical, Cambridge, MA, David Geffen School of Medicine, University of California, Los Angeles/ Jonsson Comprehensive Cancer Center, Los Angeles, CA, Sarah Cannon Research Institute and Tennessee Oncology, Nashville, TN, Oncosite/Hospital Unimed Noroeste, Ijuí, Brazil, Kidwai Memorial Institute of Oncology, Bangalore, India, Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, ON, Canada, Samsung Medical Center, Seoul, South Korea, Novartis Pharmaceuticals Corporation, East Hanover, NJ, Novartis Ireland Ltd, Dublin, Ireland, Novartis Pharmaceuticals Corporation, Florham Park, NJ, Brustzentrum der Universität München (LMU), Munich, Germany

Research Funding

Pharmaceutical/Biotech Company
Novartis Pharmaceuticals Corporation

Background: The international, randomized, double-blind, placebo-controlled, Phase III ML-7 trial (NCT02278120) assessed ribociclib + endocrine therapy (ET) vs ET alone in premenopausal women with HR+/HER2– ABC. To our knowledge, the relationship between WPL and domains of the EORTC QLQ-C30 and the tumor-specific module for breast cancer (QLQ-BR23) has not been explored in ABC. In this post hoc analysis (data cutoff, November 30, 2018) of all patients (pts) enrolled in ML-7, we assessed the correlation between the WPL component of the Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire and domains of the EORTC QLQ-C30/BR23. Methods: We analyzed EORTC and WPAI:GH data from all pts enrolled in ML-7 who were employed at any point during the trial (N = 329 of 672 total pts). Domains of the EORTC QLQ-C30 and QLQ-BR23 that had the greatest correlation (pairwise Pearson correlation) with WPL were prioritized for analysis. Separate univariable mixed-model repeated-measures regression models were fitted for each domain, with WPL as the dependent variable and each EORTC domain as a single fixed-effect covariate. Linear and quadratic relationships were considered. Model selection was based on the Akaike information criterion (AIC). Results: Linear models were favored over quadratic models. WPL was negatively correlated with global health status (GHS) and the physical, role, social, and emotional functioning domains and was positively correlated with the fatigue and pain domains of the QLQ-C30 (P<.001; Table). The coefficients indicated the estimated mean change in WPL was associated with a 1-unit increase in each QLQ-C30 domain. For example, a 10-point increase in GHS was associated with an estimated mean decrease of 7.8% (95% CI, 7.1%-8.5%) in WPL. Conclusions: Greater WPL was associated with higher levels of fatigue and pain and with lower levels of overall quality of life and physical, role, social, and emotional functioning among pts with HR+/HER2− ABC in ML-7. Further investigation of the correlation with QLQ-BR23 and multivariable analysis could determine which EORTC domains and items independently drive these findings. Clinical trial information: NCT02278120.

Domain
AIC (Linear)
AIC (Quadratic)
Regression Coefficient

(Linear Model)

(95% CI)
P Value
Fatigue
19,475.96
19,486.02
0.61 (0.54 to 0.67)
<.001
Pain
19,469.70
19,470.45
0.53 (0.47 to 0.59)
<.001
Physical functioning
19,383.55
19,389.79
−0.98 (−1.07 to −0.88)
<.001
Global health status
19,291.10
19,303.40
−0.78 (−0.85 to −0.71)
<.001
Role functioning
19,359.71
19,373.50
−0.65 (−0.71 to −0.60)
<.001
Social functioning
19,443.55
19,457.02
−0.59 (−0.65 to −0.53)
<.001
Emotional functioning
19,557.42
19,570.86
−0.49 (−0.56 to −0.42)
<.001

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Breast Cancer—Metastatic

Track

Breast Cancer

Sub Track

Hormone Receptor-Positive

Clinical Trial Registration Number

NCT02278120

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr 1051)

DOI

10.1200/JCO.2021.39.15_suppl.1051

Abstract #

1051

Poster Bd #

Online Only

Abstract Disclosures

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