Evidence map›Paper›PMID 37756580›Full record

ArticleCancer prevention research (Philadelphia, Pa.)2023

Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial.

Vinicius F Calsavara, Norah L Henry, Ron D Hays, Sungjin Kim, Michael Luu, Márcio A Diniz, Gillian Gresham, Reena S Cecchini, Greg Yothers, Patricia A Ganz and 2 more

Abstract read
In one paragraph

Article in Cancer prevention research (Philadelphia, Pa.), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
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

12 authors.

Vinicius F CalsavaraCedars-Sinai Cancer Center, Cedars-Sinai Medical Center, Los Angeles, California.ORCID 0000-0003-2332-5863
Norah L HenryUniversity of Michigan Rogel Cancer Center, Ann Arbor, Michigan.ORCID 0000-0002-4771-5930
Ron D HaysUniversity of California Los Angeles, Department of Medicine, Los Angeles, California.ORCID 0000-0001-6697-907X
Sungjin KimCedars-Sinai Cancer Center, Cedars-Sinai Medical Center, Los Angeles, California.ORCID 0000-0002-1150-703X
Michael LuuCedars-Sinai Cancer Center, Cedars-Sinai Medical Center, Los Angeles, California.ORCID 0000-0002-7968-7313
Márcio A DinizCedars-Sinai Cancer Center, Cedars-Sinai Medical Center, Los Angeles, California.ORCID 0000-0002-2427-7843
Gillian GreshamCedars-Sinai Cancer Center, Cedars-Sinai Medical Center, Los Angeles, California.ORCID 0000-0001-7142-1230
Reena S CecchiniUniversity of Pittsburgh, Pittsburgh, Pennsylvania.ORCID 0000-0002-9075-9357
Greg YothersUniversity of Pittsburgh, Pittsburgh, Pennsylvania.ORCID 0000-0002-7965-7333
Patricia A GanzUniversity of California Los Angeles Jonsson Comprehensive Cancer Center, Los Angeles, California.ORCID 0000-0002-1841-4143
André RogatkoCedars-Sinai Cancer Center, Cedars-Sinai Medical Center, Los Angeles, California.ORCID 0000-0001-8935-8890
Mourad TighiouartCedars-Sinai Cancer Center, Cedars-Sinai Medical Center, Los Angeles, California.ORCID 0000-0001-8021-5690

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Elaina Harper · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
UCLA Clinical Translational Science InstituteUL1TR001881 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ARLEEN F. BROWN, ARASH NAEIM · 2016 to 2026
$118.1M
The paradoxical roles of beta hydroxy butyrate in the liver pro-metastatic nicheP01CA233452 · NCI · CEDARS-SINAI MEDICAL CENTER · PI BHOWMICK, NEIL A., LU, SHELLY CHI-LOO · 2020 to 2024
$9.5M
Advancing Analysis and Interpretation ofAdverse Events and PROs in Cancer Clinical TrialsU01CA232859 · NCI · CEDARS-SINAI MEDICAL CENTER · PI GANZ, PATRICIA A., TIGHIOUART, MOURAD · 2018 to 2023
$3.7M
NCATS NIH HHS UL1 TR001881NCI NIH HHS P01 CA233452NCI NIH HHS U01 CA232859NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

Predicting an individual's risk of treatment discontinuation is critical for the implementation of precision chemoprevention. We developed partly conditional survival models to predict discontinuation of tamoxifen or anastrozole using patient-reported outcome (PRO) data from postmenopausal women with ductal carcinoma in situ enrolled in the NSABP B-35 clinical trial. In a secondary analysis of the NSABP B-35 clinical trial PRO data, we proposed two models for treatment discontinuation within each treatment arm (anastrozole or tamoxifen treated patients) using partly conditional Cox-type models with time-dependent covariates. A 70/30 split of the sample was used for the training and validation datasets. The predictive performance of the models was evaluated using calibration and discrimination measures based on the Brier score and AUC from time-dependent ROC curves. The predictive models stratified high-risk versus low-risk early discontinuation at a 6-month horizon. For anastrozole-treated patients, predictive factors included baseline body mass index (BMI) and longitudinal patient-reported symptoms such as insomnia, joint pain, hot flashes, headaches, gynecologic symptoms, and vaginal discharge, all collected up to 12 months [Brier score, 0.039; AUC, 0.76; 95% confidence interval (CI), 0.57-0.95]. As for tamoxifen-treated patients, predictive factors included baseline BMI, and time-dependent covariates: cognitive problems, feelings of happiness, calmness, weight problems, and pain (Brier score, 0.032; AUC, 0.78; 95% CI, 0.65-0.91). A real-time calculator based on these models was developed in Shiny to create a web-based application with a future goal to aid healthcare professionals in decision-making. PREVENTION RELEVANCE: The dynamic prediction provided by partly conditional models offers valuable insights into the treatment discontinuation risks using PRO data collected over time from clinical trial participants. This tool may benefit healthcare professionals in identifying patients at high risk of premature treatment discontinuation and support interventions to prevent potential discontinuation.

Indexed as

Breast NeoplasmsAnastrozoleClinical Trials, Phase III as TopicFemaleHumansPatient Reported Outcome MeasuresTamoxifenAnastrozoleTamoxifen

Identifiers

PMID37756580
PMCPMC10618646

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.