Evidence map›Paper›PMID 30913305›Full record

Trial reportCancer2019

Validation of NRG oncology/RTOG-0129 risk groups for HPV-positive and HPV-negative oropharyngeal squamous cell cancer: Implications for risk-based therapeutic intensity trials.

Carole Fakhry, Qiang Zhang, Maura L Gillison, Phuc Felix Nguyen-Tân, David I Rosenthal, Randal S Weber, Louise Lambert, Andy M Trotti, William L Barrett, Wade L Thorstad and 9 more

Open access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled TrialValidation Study
In one paragraph

Trial report in Cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 1 pooled it
8.7field-weighted citation impact, top 1% 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.

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

43 citing papers in PubMed, 1 synthesis or guideline pooled it, 79 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Does Smoking Influence Outcomes in Human Papillomavirus-Associated Oropharyngeal Cancer Treated with Transoral Robotic Surgery?Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2026
    Article
  4. Article
  5. Automated Lymph Node and Extranodal Extension Assessment Improves Risk Stratification in Oropharyngeal Carcinoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
    Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. Oropharyngeal cancer outcomes correlate with p16 status, multinucleation and immune infiltration.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2022
    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

19 authors at 15 institutions in 2 countries.

Carole FakhryDepartment of Otolaryngology-Head and Neck Surgery, Johns Hopkins University, School of Medicine, Baltimore, Maryland.ORCID 0000-0002-5251-6178
Qiang ZhangNRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, Pennsylvania.
Maura L GillisonThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Phuc Felix Nguyen-TânUniversity Hospital of Montreal, Montreal, Quebec, Canada.
David I RosenthalThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Randal S WeberThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Louise LambertUniversity Hospital of Montreal, Montreal, Quebec, Canada.
Andy M TrottiH. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
William L BarrettUniversity of Cincinnati Cancer Institute, Cincinnati, Ohio.
Wade L ThorstadWashington University, St. Louis, Missouri.
Sue S YomUniversity of California at San Francisco, San Francisco, California.ORCID 0000-0002-0779-7476
Stuart J WongMedical College of Wisconsin, Milwaukee, Wisconsin.
John A RidgeFox Chase Cancer Center, Philadelphia, Pennsylvania.
Shyam S D RaoUniversity of California at Davis, Davis, California.
Sharon SpencerUniversity of Alabama at Birmingham Medical Center, Birmingham, Alabama.
Andre FortinL'Hotel-Dieu de Quebec, Quebec City, Quebec, Canada.
David RabenUniversity of Colorado, Aurora, Colorado.
Jonathan HarrisNRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, Pennsylvania.
Quynh-Thu LeStanford University, Stanford, California.
The University of Texas MD Anderson Cancer Center · USAmerican College of Radiology · USMontreal General Hospital · CAFox Chase Cancer Center · USHôtel-Dieu de Québec · CAJohns Hopkins University · USMedical College of Wisconsin · USMoffitt Cancer Center · USStanford University · USUniversity of Alabama at Birmingham · USUniversity of California, Davis · USUniversity of California, San Francisco · USUniversity of Cincinnati · USUniversity of Colorado Anschutz Medical Campus · USWashington University in St. Louis · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
RTOG Foreign AccrualU10CA021661 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI CURRAN, WALTER J. · 1985 to 2013
$150.3M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Mei-Yin C Polley · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
Impacting the oral HPV continuum: prevention, screening, and early detectionR35DE026631 · NIDCR · JOHNS HOPKINS UNIVERSITY · PI D'SOUZA, GYPSYAMBER · 2016 to 2023
$8.4M
NCI National Clinical Trials Network - Lead Academic Participating SiteUG1CA233324 · NCI · UNIVERSITY OF COLORADO DENVER · PI ANTHONY D ELIAS · 2019 to 2026
$5.2M
NCTN Deep South Research ConsortiumUG1CA233330 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Charles A. Leath, Andrew M McDonald · 2019 to 2026
$3.7M
UCDCCC NCTN UG1 PROGRAMUG1CA233340 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI GANDARA, DAVID R, VALICENTI, RICHARD · 2019 to 2025
$3.7M
UCDCCC NCTN U10 ProgramU10CA180846 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI GANDARA, DAVID R, VALICENTI, RICHARD · 2014 to 2018
$3.3M
NCI NIH HHS U10 CA021661NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180846NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA233324NCI NIH HHS UG1 CA233330NCI NIH HHS UG1 CA233340NIDCR NIH HHS R35 DE026631
6 · The paper itself

Abstract

backgroundRadiation Therapy Oncology Group (RTOG)-0129 recursive partitioning analysis was the basis for risk-based therapeutic intensification trials for oropharyngeal cancer (OPC). To the authors' knowledge, the question of whether RTOG-0129 overall survival (OS) estimates for low-risk, intermediate-risk, and high-risk groups are similar in other data sets or applicable to progression-free survival (PFS) is unknown. Therefore, the authors evaluated whether survival differences between RTOG-0129 risk groups persist at 5 years, are reproducible in an independent clinical trial, and are applicable to PFS, and whether toxicities differ across risk groups.

methodsProspective randomized clinical trials were analyzed retrospectively. RTOG-0129 evaluated standard versus accelerated fractionation radiotherapy concurrent with cisplatin. RTOG-0522 compared the combination of cisplatin and accelerated fractionation with or without cetuximab. Patients with OPC with available p16 status and tobacco history were eligible.

resultsThere was a total of 260 patients and 287 patients, respectively, from RTOG-0129 and RTOG-0522, with median follow-ups for surviving patients of 7.9 years (range, 1.7-9.9 years) and 4.7 years (range, 0.1-7.0 years), respectively. Previous OS differences in RTOG-0129 persisted at 5 years. In RTOG-0522, the 5-year OS rates for the low-risk, intermediate-risk, and high-risk groups were 88.1%, 69.9%, and 45.1%, respectively (P for trend, <.001). The 5-year PFS rates for the same 3 groups were 72.9%, 56.1%, and 42.2%, respectively. In RTOG-0522 among a subgroup of patients considered to be at very good risk (p16-positive disease, smoking history of ≤10 pack-years, and classified with T1-T2 disease with ipsilateral lymph nodes measuring ≤6 cm or T3 disease without contralateral or >6 cm lymph nodes), the 5-year OS and PFS rates were 93.8% and 82.2%, respectively. Overall rates of acute and late toxicities were similar by risk group.

conclusionsRTOG-0129 risk groups persisted at 5 years and were reproducible in RTOG-0522. However, there was variability in the estimates. These data underscore the importance of long-term follow-up and appropriate patient selection in therapeutic deintensification trials.

Indexed as

Patient SelectionAdultAgedCarcinoma, Squamous CellChemoradiotherapyClinical Trials as TopicFemaleFollow-Up StudiesHumansMaleMiddle AgedOropharyngeal NeoplasmsPapillomaviridaePapillomavirus InfectionsPrognosisProspective Studieshead and neck cancerhuman papillomavirus (HPV)oropharyngeal canceroverall survivalprogression-free survivalRadiation Therapy Oncology Group (RTOG)recursive partititioning analysisrisk stratificationtherapeutic deescalationtherapeutic deintensification

Identifiers

PMID30913305
PMCPMC6594017
OpenAlexW2924642225

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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.