Evidence map›Paper›PMID 27937092›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2017

Cetuximab Plus Chemoradiotherapy for HIV-Associated Anal Carcinoma: A Phase II AIDS Malignancy Consortium Trial.

Joseph A Sparano, Jeannette Y Lee, Joel Palefsky, David H Henry, William Wachsman, Lakshmi Rajdev, David Aboulafia, Lee Ratner, Thomas J Fitzgerald, Lisa Kachnic and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00324415 (Phase II Trial of Combined Modality Therapy Plus Cetuximab in HIV-Associated Anal Carcinoma), which is not on this map. Cited by 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 pooled it
9.7field-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.

NCT00324415 phase2completednot on this map

Phase II Trial of Combined Modality Therapy Plus Cetuximab in HIV-Associated Anal Carcinoma

TypeinterventionalSponsorAIDS Malignancy ConsortiumRan2006 to 2016Enrolled45ConditionsAnal CancerArmscetuximab, cisplatin, fluorouracil, radiation therapy
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. 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
  3. Anal Carcinoma, Version 2.2018, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2018
    Guideline
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Recent Advances in the Management of Anal Cancer.Healthcare (Basel, Switzerland) · 2023
    Review
  11. Review
  12. Anal Cancer: The Past, Present and Future.Current oncology (Toronto, Ont.) · 2023
    Review
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  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 1 institution in 1 country.

Joseph A SparanoJoseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA.
Jeannette Y LeeJoseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA.
Joel PalefskyJoseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA.
David H HenryJoseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA.
William WachsmanJoseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA.
Lakshmi RajdevJoseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA.
David AboulafiaJoseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA.
Lee RatnerJoseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA.
Thomas J FitzgeraldJoseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA.
Lisa KachnicJoseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA.
Ronald MitsuyasuJoseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA.
Montefiore Medical Center · US

Funding

Consortium for Advancing Management and Prevention of Cancer in People with HIVUM1CA121947 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Joseph A. Sparano · 2015 to 2026
$253.7M
IROC: Enhancing local enrolling site radiological data capture capabilities for NCTN trialsU24CA180803 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI Thomas J. FitzGerald, MICHAEL V KNOPP · 2014 to 2026
$116.2M
QUALITY ASSURANCE REVIEW CENTER (QARC)U10CA029511 · NCI · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI FITZGERALD, THOMAS J. · 1985 to 2013
$23.4M
NCI NIH HHS U10 CA029511NCI NIH HHS U24 CA180803NCI NIH HHS UM1 CA121947
6 · The paper itself

Abstract

Purpose Squamous cell carcinoma of the anal canal (SCCAC) is characterized by high locoregional failure (LRF) rates after definitive chemoradiation (CRT), associated with anogenital human papilloma virus, and often appears in HIV infection. Because cetuximab enhances the effect of radiation therapy in human papilloma virus-associated oropharyngeal SCC, we hypothesized that adding cetuximab to CRT would reduce LRF in SCCAC. Methods Forty-five patients with stage I to III SCCAC and HIV infection received CRT: 45 to 54 Gy radiation therapy to the primary tumor and regional lymph nodes plus eight once-weekly doses of concurrent cetuximab and two cycles of cisplatin and fluorouracil. The study was designed to detect at least a 50% reduction in 3-year LRF rate (one-sided α, 0.10; power, 90%), assuming a 35% LRF rate from historical data. Results The 3-year LRF rate was 42% (95% CI, 28% to 56%; one-sided P = .9) by binomial proportional estimate using the prespecified end point (LRF or alive without LRF and followed < 3 years), and 20% (95% CI, 10% to 37%) by Kaplan-Meier estimate in post hoc analysis using definitions and methods consistent with historical data. Three-year rates by Kaplan-Meier estimate were 72% (95% CI, 56% to 84%) for progression-free survival and 79% (95% CI, 63% to 89%) for overall survival. Grade 4 toxicity occurred in 26%, and 4% had treatment-associated deaths. Conclusion HIV-associated SCCAC is potentially curable with definitive CRT. Although addition of cetuximab may result in less LRF, the 20% recurrence and 26% grade 4 toxicity rates indicate the continued need for more-effective and less-toxic therapies.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsAnus NeoplasmsCarcinoma, Squamous CellCetuximabChemoradiotherapyCisplatinDisease-Free SurvivalFemaleFluorouracilHIV InfectionsHumansMaleMiddle AgedProspective StudiesCetuximabCisplatinFluorouracil

Identifiers

PMID27937092
PMCPMC5455422
OpenAlexW2565526207

What OpenQuestion holds

Textmetadata
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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.