Evidence map›Paper›PMID 24035327›Full record

Trial reportInternational journal of radiation oncology, biology, physics2013

Anal carcinoma: impact of TN category of disease on survival, disease relapse, and colostomy failure in US Gastrointestinal Intergroup RTOG 98-11 phase 3 trial.

Leonard L Gunderson, Jennifer Moughan, Jaffer A Ajani, John E Pedersen, Kathryn A Winter, Al B Benson, Charles R Thomas, Robert J Mayer, Michael G Haddock, Tyvin A Rich and 1 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05374252 (A Phase 3, Multicenter, Double-Blind Randomized Study of Mitomycin, 5-Fluorouracil and IMRT Combined With or Without Anti-PD-1 in Patients With Locally Advanced Anal Canal Squamous Carcinoma), which is not on this map. Cited by 47 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 2 pooled it
7.6field-weighted citation impact, top 2% of its field
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.

NCT05374252 phase3unknown statusnot on this mapstarted 2022, after this paper: background citation

A Phase 3, Multicenter, Double-Blind Randomized Study of Mitomycin, 5-Fluorouracil and IMRT Combined With or Without Anti-PD-1 in Patients With Locally Advanced Anal Canal Squamous Carcinoma

TypeinterventionalSponsorSixth Affiliated Hospital, Sun Yat-sen UniversityRan2022 to 2025Enrolled102ConditionsAnal Canal Cancer Stage III, Anal Squamous Cell Carcinoma, Anal Canal Cancer, Anal CancerArmsPD-1 inhibitor, concurrent chemoradiotherapy
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 2 syntheses or guidelines pooled it, 136 citations in OpenAlex.

  1. Executive Summary of the American Radium Society Appropriate Use Criteria for Treatment of Anal Cancer.International journal of radiation oncology, biology, physics · 2019
    Pooled it
  2. Systematic review of outcome measures following chemoradiotherapy for the treatment of anal cancer (CORMAC).Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2018
    Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Interstitial HDR brachytherapy for anal cancer-results and quality of life.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2025
    Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
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

11 authors at 10 institutions in 3 countries.

Leonard L GundersonMayo Clinic Cancer Center, Scottsdale, Arizona. Electronic address: gunderson.leonard@mayo.edu.
Jennifer Moughan
Jaffer A Ajani
John E Pedersen
Kathryn A Winter
Al B Benson
Charles R Thomas
Robert J Mayer
Michael G Haddock
Tyvin A Rich
Christopher G Willett
RTOG Foundation · USCancer Institute (WIA) · INDana-Farber Cancer Institute · USDuke University · USMayo Clinic · USMayo Clinic in Arizona · USNorthwestern University · USOregon Health & Science University · USThe University of Texas Health Science Center at Houston · USUniversity of Virginia · US

Funding

RTOG Foreign AccrualU10CA021661 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI CURRAN, WALTER J. · 1985 to 2013
$150.3M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
RTOG Foreign AccrualsU10CA037422 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI BRUNER, DEBORAH WATKINS · 1985 to 2013
$30.4M
Multidisciplinary Clinical and Translational Science (MCTS) Program (UL1)UL1TR000150 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI LLOYD-JONES, DONALD M · 2012 to 2013
$10.1M
NCATS NIH HHS UL1 TR000150NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA021661NCI NIH HHS U10 CA037422NCI NIH HHS U10 CA21661NCI NIH HHS U10 CA37422
6 · The paper itself

Abstract

purposeThe long-term update of US GI Intergroup RTOG 98-11 anal cancer trial found that concurrent chemoradiation (CCRT) with fluorouracil (5-FU) plus mitomycin had a significant impact on disease-free survival (DFS) and overall survival (OS) compared with induction plus concurrent 5-FU plus cisplatin. The intent of the current analysis was to determine the impact of tumor node (TN) category of disease on survival (DFS and OS), colostomy failure (CF), and relapse (local-regional failure [LRF] and distant metastases [DM]) in this patient group. METHODS AND MATERIALS: DFS and OS were estimated univariately by using the Kaplan-Meier method, and 6 TN categories were compared by the log-rank test (T2N0, T3N0, T4N0, T2N1-3, T3N1-3, and T4N1-3). Time to relapse and colostomy were estimated by the cumulative incidence method, and TN categories were compared using Gray's test.

resultsOf 682 patients, 620 were analyzable for outcomes by TN category. All endpoints showed statistically significant differences among the TN categories of disease (OS, P<.0001; DFS, P<.0001; LRF, P<.0001; DM, P=.0011; CF, P=.01). Patients with the poorest OS, DFS, and LRF outcomes were those with T3-4N-positive (+) disease. CF was lowest for T2N0 and T2N+ (11%, 11%, respectively) and worst for the T4N0, T3N+, and T4N+ categories (26%, 27%, 24%, respectively).

conclusionsTN category of disease has a statistically significant impact on OS, DFS, LRF, DM, and CF in patients treated with CCRT and provides excellent prognostic information for outcomes in patients with anal carcinoma. Significant challenges remain for patients with T4N0 and T3-4N+ categories of disease with regard to survival, relapse, and CF and lesser challenges for T2-3N0/T2N+ categories.

Indexed as

ChemoradiotherapyColostomyAnalysis of VarianceAntineoplastic Combined Chemotherapy ProtocolsAnus NeoplasmsCarcinoma, Squamous CellCarcinoma, Transitional CellCisplatinFluorouracilHumansLymph NodesMitomycinNeoplasm Recurrence, LocalNeoplasm StagingSurvival AnalysisTreatment FailureCisplatinFluorouracilMitomycin

Identifiers

PMID24035327
PMCPMC3938865
OpenAlexW2066861752

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.