Evidence map›Paper›PMID 39319400›Full record

Trial reportThe British journal of surgery2024

Baseline MRI predictors of successful organ preservation in the Organ Preservation in Rectal Adenocarcinoma (OPRA) trial.

Hannah Williams, Jonathan B Yuval, Floris S Verheij, Joao Miranda, Sabrina T Lin, Dana M Omer, Li-Xuan Qin, Marc J Gollub, Tae-Hyung Kim, Julio Garcia-Aguilar and 1 more

Erratum issuedAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in The British journal of surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

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

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. Review
  7. Nonoperative management of rectal cancer.Frontiers in oncology · 2024
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Hannah WilliamsDepartment of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, New York, USA.ORCID 0000-0001-8928-4190
Jonathan B YuvalDepartment of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Floris S VerheijDepartment of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, New York, USA.ORCID 0000-0001-7834-7336
Joao MirandaDepartment of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Sabrina T LinDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Dana M OmerDepartment of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Li-Xuan QinDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.ORCID 0000-0002-9367-3807
Marc J GollubDepartment of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Tae-Hyung KimDepartment of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Julio Garcia-AguilarDepartment of Surgery, Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
OPRA Consortium

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
SURGICAL ONCOLOGY RESEARCH TRAINING PROGRAMT32CA009501 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Babak J Mehrara · 1985 to 2026
$7.7M
Organ Preservation in Rectal AdenocarcinomaR01CA182551 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI GARCIA-AGUILAR, JULIO · 2014 to 2018
$3.1M
NCI NIH HHS P30 CA008748NCI NIH HHS R01 CA182551NCI NIH HHS R01CA182551NCI NIH HHS T32 CA009501
6 · The paper itself

Abstract

backgroundProspective randomized trials have not yet identified baseline features predictive of organ preservation in locally advanced rectal cancers treated with total neoadjuvant therapy and a selective watch-and-wait strategy.

methodsThis was a secondary analysis of the OPRA trial, which randomized patients with stage II-III rectal adenocarcinoma to receive either induction or consolidation total neoadjuvant therapy. Patients were recommended for total mesorectal excision, or watch and wait based on clinical response at 8 ± 4 weeks after completing treatment. Standardized baseline clinical and radiological variables were collected prospectively. Survival outcomes, including total mesorectal excision-free survival, disease-free survival, and overall survival, were assessed by intention-to-treat analysis. Cox proportional hazards models were used to evaluate associations between baseline variables and survival outcomes.

resultsOf the 324 patients randomized for the OPRA trial, 38 (11.7%) had cT4 tumours, 230 (71.0%) cN-positive disease, 101 (32.5%) mesorectal fascia involvement, and 64 (19.8%) extramural venous invasion. Several baseline features were independently associated with recommendation for total mesorectal excision on multivariable analysis: nodal disease (HR 1.66, 95% c.i. 1.12 to 2.48), extramural venous invasion (HR 1.57, 1.07 to 2.29), mesorectal fascia involvement (HR 1.45, 1.01 to 2.09), and tumour length (HR 1.11, 1.00 to 1.22). Of these, nodal disease (HR 2.02, 1.15 to 3.53) and mesorectal fascia involvement (HR 2.02, 1.26 to 3.26) also predicted worse disease-free survival. Age (HR 1.03, 1.00 to 1.06) was associated with overall survival.

conclusionBaseline MRI features, including nodal disease, extramural venous invasion, mesorectal fascia involvement, and tumour length, independently predict the likelihood of organ preservation after completion of total neoadjuvant therapy. Mesorectal fascia involvement and nodal disease are associated with disease-free survival.

Indexed as

AdenocarcinomaMagnetic Resonance ImagingNeoadjuvant TherapyOrgan Sparing TreatmentsRectal NeoplasmsAdultAgedDisease-Free SurvivalFemaleHumansMaleMiddle AgedNeoplasm StagingProspective StudiesWatchful Waiting

Identifiers

PMID39319400
PMCPMC11422670

What OpenQuestion holds

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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.