Evidence map›Paper›PMID 35251320›Full record

ArticleTherapeutic advances in medical oncology2022

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.

Debu Tripathy, Tristan Curteis, Sara Hurvitz, Denise Yardley, Fabio Franke, K Govind Babu, Paul Wheatley-Price, Young-Hyuck Im, Radost Pencheva, Lucy A Eddowes and 5 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Therapeutic advances in medical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02278120 (A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02278120 phase3completednot on this map

A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

TypeinterventionalSponsorNovartis PharmaceuticalsRan2014 to 2023Enrolled672ConditionsAdvanced Metastatic Breast CancerArmsRibociclib, Tamoxifen, Letrozole, Anastrozole, Goserelin
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 10 institutions in 7 countries.

Debu TripathyDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe, Unit 1354, Houston, TX 77030, USA.
Tristan CurteisCostello Medical, Cambridge, UK.
Sara HurvitzUCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.
Denise YardleySarah Cannon Research Institute, Nashville, TN, USA; Tennessee Oncology, PLLC, Nashville, TN, USA.
Fabio FrankeHospital de Caridade de Ijuí, CACON, Ijuí, Brazil.
K Govind BabuHCG Curie Centre of Oncology and Kidwai Memorial Institute of Oncology, Bangalore, India.
Paul Wheatley-PriceUniversity of Ottawa, Ottawa, ON, Canada.
Young-Hyuck ImSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Radost PenchevaCostello Medical, Cambridge, UK.
Lucy A EddowesCostello Medical, Cambridge, UK.
Pierre-Alexandre DionneNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
David ChandiwanaNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Purnima PathakNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Brad LanoueNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Nadia HarbeckBreast Center, Department OB&GYN, LMU University Hospital, Munich, Germany.ORCID https://orcid.org/0000-0002-9744-7372
Novartis (United States) · USCostello Medical Consulting (United Kingdom) · GBHospital Universitário Cajuru · BRKidwai Memorial Institute of Oncology · INLudwig-Maximilians-Universität München · DESamsung Medical Center · KRSarah Cannon · USThe University of Texas MD Anderson Cancer Center · USUCLA Jonsson Comprehensive Cancer CenterUniversity of Ottawa · CA

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundThe phase III MONALEESA-7 trial (NCT02278120) assessed ribociclib + endocrine therapy (ET)

methodsWe analyzed EORTC and WPAI:GH data from 329 patients in both treatment arms of MONALEESA-7 who were employed during the trial. Separate univariable mixed-model repeated measures (MMRM) regression models were fitted for each domain, with WPL as dependent variable and each EORTC domain score as a single fixed-effect covariate. Linear and quadratic relationships were considered based on the Akaike information criterion. Next, two separate multivariable MMRM regression models were fitted with WPL a dependent variable and all QLQ-C30/BR23 domain scores as fixed-effect covariates. The strength of correlation between WPL and EORTC domains was assessed in terms of minimally important differences for the QLQ-C30/BR23 modules.

resultsOur univariable analysis showed that greater WPL was statistically significantly associated with lower levels of overall quality of life (QoL) and other functional domains and with higher levels of all symptomatic domains of the QLQ-C30/BR23 modules. Our multivariable analysis determined that this correlation was primarily driven by changes in QoL; physical, role, social, and future perspective domains; and BC-specific symptomatic domains.

conclusionThis analysis determined the QoL domains that correlate with WPL in premenopausal patients with HR+/HER2- ABC. These results may inform prognostic tools to identify and characterize patients with greater risk for WPL and help design interventional strategies to minimize WPL.

Indexed as

advanced breast cancerbreast cancerpremenopausal womenquality of liferibociclibwork productivity loss

Identifiers

PMID35251320
PMCPMC8891884
OpenAlexW4214529556

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.