Evidence map›Paper›PMID 37902752›Full record

Trial reportJAMA network open2023

Overall Survival After Treatment Failure Among Patients With Rectal Cancer.

Markus Diefenhardt, Daniel Martin, Maximilian Fleischmann, Ralf-Dieter Hofheinz, Michael Ghadimi, Claus Rödel, Emmanouil Fokas

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in JAMA network open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07651007 (A Phase II Clinical Study of Short-course Radiotherapy Followed by NALIRIFOX Plus Pemolivimab as Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer With MSS/pMMR), which is not on this 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.

NCT07651007 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Phase II Clinical Study of Short-course Radiotherapy Followed by NALIRIFOX Plus Pemolivimab as Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer With MSS/pMMR

TypeinterventionalSponsorWang XinRan2026 to 2029Enrolled29ConditionsAdvanced Rectal CancerArmsiTNT-HX02
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Targeting metabolic dependencies to reverse chemoradiotherapy resistance in colorectal cancer.Journal of experimental & clinical cancer research : CR · 2026
    Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Markus DiefenhardtDepartment of Radiotherapy and Oncology, University Hospital, Goethe University Frankfurt, Frankfurt, Germany.
Daniel MartinDepartment of Radiotherapy and Oncology, University Hospital, Goethe University Frankfurt, Frankfurt, Germany.
Maximilian FleischmannDepartment of Radiotherapy and Oncology, University Hospital, Goethe University Frankfurt, Frankfurt, Germany.
Ralf-Dieter HofheinzDepartment of Medical Oncology, University Hospital Mannheim, University Heidelberg, Heidelberg, Germany.
Michael GhadimiDepartment of General, Visceral, and Paediatric Surgery, University Medical Center Göttingen, University Göttingen, Göttingen, Germany.
Claus RödelDepartment of Radiotherapy and Oncology, University Hospital, Goethe University Frankfurt, Frankfurt, Germany.
Emmanouil FokasDepartment of Radiotherapy and Oncology, University Hospital, Goethe University Frankfurt, Frankfurt, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: Oncologic outcomes among patients with rectal cancer after developing local recurrence and/or distant metastases remain poorly studied. Objective: To analyze the trend of overall survival after treatment failure for patients with rectal cancer within three consecutive phase 2 or 3 trials of the German Rectal Cancer Study Group. Design, Setting, and Participants: This cohort study is a post hoc analysis of 3 randomized phase 2 or 3 trials (CAO/ARO/AIO-94, -04, and -12 trials, conducted in Germany) that included 1948 patients with locally advanced rectal adenocarcinoma. The CAO/ARO/AIO-94 trial recruited patients between February 1995 and September 2002, the CAO/ARO/AIO-04 trial recruited patients between July 2006 and February 2010, and the CAO/ARO/AIO-12 trial recruited patients between June 2015 and January 2018. Statistical analysis was conducted between September 2022 and March 2023. Exposures: A total of 119 of 391 patients in the CAO/ARO/AIO-94 trial group A, 295 of 1236 patients in the CAO/ARO/AIO-04 trial, and 69 of 306 in the CAO/ARO/AIO-12 trial experienced treatment failure (R2 resection or local recurrence or distant metastases) and were included in further analyses. Main Outcomes and Measures: Characteristics of treatment failure and overall survival were assessed in all 3 trial cohorts. Results: Of the 1948 patients treated in the 3 trials, 15 were excluded because of missing data. Of the remaining 1933 patients (median age, 62.5 years [range, 19-84 years]; 1363 men [71%] and 570 women [29%]) with locally advanced rectal adenocarcinoma (cT3 or 4 or cN+) treated within 3 consecutive clinical trials, 483 experienced treatment failure and were analyzed. After a median follow-up of 36 months (IQR, 24-51 months) for all patients, overall survival after treatment failure was significantly improved in the CAO/ARO/AIO-04 trial (at 3 years, 44% [IQR, 37%-51%]; hazard ratio [HR], 0.61 [95% CI, 0.47-0.79]) and further improved in the CAO/ARO/AIO-12 trial (at 3 years, 73% [IQR, 60%-87%]; HR, 0.32 [95% CI, 0.18-0.54]) compared with the CAO/ARO/AIO-94 trial (at 3 years, 30% [IQR, 22%-39%]) (both P < .001). Distant metastasis was the main reason for treatment failure throughout a 5-year follow-up (range, 67%-87%), and the relative risk for treatment failure was highest in the first 18 months in all 3 trials. ypTNM stage was significantly associated with the risk and time interval to treatment failure. Improvement in overall survival after treatment failure was independent of sex. Conclusions and Relevance: This cohort study suggests that advancements in salvage strategies during the past decades have likely improved overall survival among patients with rectal cancer who experienced treatment failure.

Indexed as

AdenocarcinomaRectal NeoplasmsCohort StudiesFemaleGermanyHumansMaleMiddle AgedTreatment Failure

Identifiers

PMID37902752
PMCPMC10616722

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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.