Evidence map›Paper›PMID 35954320›Full record

ArticleCancers2022

Total Neoadjuvant Therapy for Rectal Cancer in the CAO/ARO/AIO-12 Randomized Phase 2 Trial: Early Surrogate Endpoints Revisited.

Markus Diefenhardt, Anke Schlenska-Lange, Thomas Kuhnt, Simon Kirste, Pompiliu Piso, Wolf O Bechstein, Guido Hildebrandt, Michael Ghadimi, Ralf-Dieter Hofheinz, Claus Rödel and 2 more

Abstract read
In one paragraph

Article in Cancers, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Trial
  2. Targeting metabolic dependencies to reverse chemoradiotherapy resistance in colorectal cancer.Journal of experimental & clinical cancer research : CR · 2026
    Article
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  5. Review
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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

12 authors.

Markus DiefenhardtDepartment of Radiotherapy and Oncology, University of Frankfurt, 60596 Frankfurt, Germany.ORCID 0000-0002-9042-9729
Anke Schlenska-LangeDepartment of Haematology and Oncology, Barmherzige Brüder Hospital Regensburg, 93049 Regensburg, Germany.
Thomas KuhntDepartment of Radiation Oncology, University Hospital Leipzig, 04103 Leipzig, Germany.
Simon KirsteDepartment of Radiation Oncology, Faculty of Medicine, Medical Center University of Freiburg, 79098 Freiburg, Germany.
Pompiliu PisoDepartment of General and Visceral Surgery, Barmherzige Brüder Hospital, 93049 Regensburg, Germany.
Wolf O BechsteinDepartment of General and Visceral Surgery, University of Frankfurt, 60596 Frankfurt, Germany.
Guido HildebrandtDepartment of Radiotherapy, University of Rostock, 18051 Rostock, Germany.ORCID 0000-0002-0498-2692
Michael GhadimiDepartment of General and Visceral Surgery, University Medical Center Göttingen, 37075 Göttingen, Germany.
Ralf-Dieter HofheinzDepartment of Medical Oncology, University Hospital Mannheim, 68167 Mannheim, Germany.
Claus RödelDepartment of Radiotherapy and Oncology, University of Frankfurt, 60596 Frankfurt, Germany.
Emmanouil FokasDepartment of Radiotherapy and Oncology, University of Frankfurt, 60596 Frankfurt, Germany.
German Rectal Cancer Study Group

Funding

German Cancer Aid 110-460
6 · The paper itself

Abstract

backgroundEarly efficacy outcome measures in rectal cancer after total neoadjuvant treatment are increasingly investigated. We examined the prognostic role of pathological complete response (pCR), tumor regression grading (TRG) and neoadjuvant rectal (NAR) score for disease-free survival (DFS) in patients with rectal carcinoma treated within the CAO/ARO/AIO-12 randomized phase 2 trial.

methodsDistribution of pCR, TRG and NAR score was analyzed using the Pearson's chi-squared test. Univariable analyses were performed using the log-rank test, stratified by treatment arm. Discrimination ability of non-pCR for DFS was assessed by analyzing the ROC curve as a function of time.

resultsOf the 311 patients enrolled, 306 patients were evaluable (Arm A:156, Arm B:150). After a median follow-up of 43 months, the 3-year DFS was 73% in both groups (HR, 0.95, 95% CI, 0.63-1.45,

conclusionAlthough pCR, TRG and NAR were strong prognostic factors for DFS in the CAO/ARO/AIO-12 trial, their value in selecting one TNT approach over another could not be confirmed. Hence, the conclusion of a long-term survival benefit of one treatment arm based on early surrogate endpoints should be stated with caution.

Indexed as

clinical trialdisease-free survivalearly surrogate endpointslocally advanced rectal cancertumor regression

Identifiers

PMID35954320
PMCPMC9367426

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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.