Evidence map›Paper›PMID 39886131›Full record

ArticleBMJ oncology2024

Postprogression therapy and confounding for the estimated treatment effect on overall survival in phase III oncology trials.

Alexander D Sherry, Pavlos Msaouel, Timothy A Lin, Joseph Abi Jaoude, Ramez Kouzy, Esther J Beck, Avital M Miller, Adina H Passy, Gabrielle S Kupferman, Eugene J Koay and 4 more

Abstract read
In one paragraph

Article in BMJ oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Beyond theJCO precision oncology · 2026
    Review
  3. Review
  4. Article
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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

14 authors.

Alexander D SherryDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID 0000-0001-5115-1691
Pavlos MsaouelDepartment of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Timothy A LinDepartment of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins Medicine, Baltimore, Maryland, USA.
Joseph Abi JaoudeDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Ramez KouzyDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Esther J BeckDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID 0009-0009-6821-8966
Avital M MillerDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Adina H PassyDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Gabrielle S KupfermanDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Eugene J KoayDepartment of Gastrointestinal Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Clifton David FullerDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Charles R ThomasDepartment of Radiation Oncology and Applied Sciences, Dartmouth College Geisel School of Medicine, Lebanon, New Hampshire, USA.
Zachary R McCawDepartment of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Ethan B LudmirDepartment of Gastrointestinal Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DIANE BODURKA · 1985 to 2026
$290.8M
Development of functional magnetic resonance imaging-guided adaptive radiotherapy for head and neck cancer patients using novel MR-Linac deviceR01DE028290 · NIDCR · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI CHRISTODOULEAS, JOHN PAUL, FULLER, CLIFTON DAVID · 2019 to 2023
$4.3M
Longitudinal Spatial-Nonspatial Decision Support for Competing Outcomes in Head and Neck Cancer TherapyR01CA258827 · NCI · UNIVERSITY OF ILLINOIS AT CHICAGO · PI CANAHUATE, GUADALUPE, FULLER, CLIFTON DAVID · 2021 to 2025
$2.9M
Fellow and Resident Radiation Oncology iNtensive Training in Imaging and Informatics to Empower Research Careers (FRONTI2ER)R25EB025787 · NIBIB · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DAS, PRAJNAN, FULLER, CLIFTON DAVID · 2018 to 2022
$535k
NCI NIH HHS P30 CA016672NCI NIH HHS R01 CA258827NIBIB NIH HHS R25 EB025787NIDCR NIH HHS R01 DE028290
6 · The paper itself

Abstract

Objective: Estimations of the treatment effect on overall survival (OS) may be influenced by post-progression therapies (PPTs). It is unclear how often OS analyses account for PPT effects. The purpose of this cross-sectional analysis was to determine the prevalence of OS analyses accounting for PPT effects in phase III oncology trials. Methods and analysis: We screened two-arm, superiority design, phase III, randomised, oncology trials reporting OS from ClinicalTrials.gov. The primary outcome was the frequency of OS analyses adjusting for PPT confounding. Logistic regressions computed ORs for the association between trial-level covariates and the outcome. Results: A total of 334 phase III trials enrolling 265 310 patients were included, with publications between 2004 and 2020. PPTs were reported in 47% of trials (157 of 334), and an analysis accounting for PPTs was performed in only 12% of trials (N=41). PPT adjustments were often prespecified (N=23, 56%), and appeared to be more likely in cross-over studies (OR 5.04, 95% CI 2.42 to 10.38) and studies with discordant surrogate-OS findings (OR 2.26, 95% CI 1.16 to 4.38). In key subgroup analyses, PPT analyses were infrequent, including 8% of trials among those studying locoregional/first-line therapy and 11% of trials among those powered for OS. Conclusions: Although time on PPTs is an important component of OS, PPTs are rarely considered in OS analyses, which may introduce confounding on estimates of the treatment effect on OS. PPTs and methods to account for their effects on OS estimates should be considered at the time of trial design and reporting.

Indexed as

EpidemiologyMetastatic cancerMortality

Identifiers

PMID39886131
PMCPMC11234993

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.