Evidence map›Paper›PMID 28068178›Full record

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

Cetuximab Plus Chemoradiotherapy in Immunocompetent Patients With Anal Carcinoma: A Phase II Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group Trial (E3205).

Madhur K Garg, Fengmin Zhao, Joseph A Sparano, Joel Palefsky, Richard Whittington, Edith P Mitchell, Mary F Mulcahy, Karin I Armstrong, Nassim H Nabbout, Shalom Kalnicki and 5 more

Abstract 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. Cited by 41 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 3 pooled it
9.9field-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

41 citing papers in PubMed, 3 syntheses or guidelines pooled it, 81 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. Radiochemotherapy with or without cetuximab for unresectable esophageal cancer: final results of a randomized phase 2 trial (LEOPARD-2).Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2020
    Trial
  5. Trial
  6. Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Article
  14. Recent Advances in the Management of Anal Cancer.Healthcare (Basel, Switzerland) · 2023
    Review
  15. Article
  16. Review
  17. Review
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 1 institution in 1 country.

Madhur K GargMadhur K. Garg, Joseph A. Sparano, and Shalom Kalnicki, Montefiore Medical Center, Albert Einstein College of Medicine, Montefiore-Einstein Center for Cancer Care, Bronx, NY; Fengmin Zhao, Dana Farber Cancer Institute, Boston, MA; Joel Palefsky, University of California, San Francisco, CA; Richard Whittington, Philadelphia VA Medical Center; Edith P. Mitchell, Thomas Jefferson University, Philadelphia, PA; Mary F. Mulcahy and Al B. Benson III, Northwestern University, Chicago, IL; Karin I. Armstrong, United Hospital, Woodbury, MN; Nassim H. Nabbout, Cancer Center of Kansas, Wichita, KS; Bassel F. El-Rayes, Emory University, Atlanta, GA; Adedayo A. Onitilo, Marshfield Clinic, Marshfield, WI; Daniel J. Moriarty, Overlook Medical Center, Summit, NJ; and Thomas J. Fitzgerald, Imaging and Radiation Oncology Core, Quality Assurance Review Center, Providence, RI.
Fengmin ZhaoMadhur K. Garg, Joseph A. Sparano, and Shalom Kalnicki, Montefiore Medical Center, Albert Einstein College of Medicine, Montefiore-Einstein Center for Cancer Care, Bronx, NY; Fengmin Zhao, Dana Farber Cancer Institute, Boston, MA; Joel Palefsky, University of California, San Francisco, CA; Richard Whittington, Philadelphia VA Medical Center; Edith P. Mitchell, Thomas Jefferson University, Philadelphia, PA; Mary F. Mulcahy and Al B. Benson III, Northwestern University, Chicago, IL; Karin I. Armstrong, United Hospital, Woodbury, MN; Nassim H. Nabbout, Cancer Center of Kansas, Wichita, KS; Bassel F. El-Rayes, Emory University, Atlanta, GA; Adedayo A. Onitilo, Marshfield Clinic, Marshfield, WI; Daniel J. Moriarty, Overlook Medical Center, Summit, NJ; and Thomas J. Fitzgerald, Imaging and Radiation Oncology Core, Quality Assurance Review Center, Providence, RI.
Joseph A SparanoMadhur K. Garg, Joseph A. Sparano, and Shalom Kalnicki, Montefiore Medical Center, Albert Einstein College of Medicine, Montefiore-Einstein Center for Cancer Care, Bronx, NY; Fengmin Zhao, Dana Farber Cancer Institute, Boston, MA; Joel Palefsky, University of California, San Francisco, CA; Richard Whittington, Philadelphia VA Medical Center; Edith P. Mitchell, Thomas Jefferson University, Philadelphia, PA; Mary F. Mulcahy and Al B. Benson III, Northwestern University, Chicago, IL; Karin I. Armstrong, United Hospital, Woodbury, MN; Nassim H. Nabbout, Cancer Center of Kansas, Wichita, KS; Bassel F. El-Rayes, Emory University, Atlanta, GA; Adedayo A. Onitilo, Marshfield Clinic, Marshfield, WI; Daniel J. Moriarty, Overlook Medical Center, Summit, NJ; and Thomas J. Fitzgerald, Imaging and Radiation Oncology Core, Quality Assurance Review Center, Providence, RI.
Joel PalefskyMadhur K. Garg, Joseph A. Sparano, and Shalom Kalnicki, Montefiore Medical Center, Albert Einstein College of Medicine, Montefiore-Einstein Center for Cancer Care, Bronx, NY; Fengmin Zhao, Dana Farber Cancer Institute, Boston, MA; Joel Palefsky, University of California, San Francisco, CA; Richard Whittington, Philadelphia VA Medical Center; Edith P. Mitchell, Thomas Jefferson University, Philadelphia, PA; Mary F. Mulcahy and Al B. Benson III, Northwestern University, Chicago, IL; Karin I. Armstrong, United Hospital, Woodbury, MN; Nassim H. Nabbout, Cancer Center of Kansas, Wichita, KS; Bassel F. El-Rayes, Emory University, Atlanta, GA; Adedayo A. Onitilo, Marshfield Clinic, Marshfield, WI; Daniel J. Moriarty, Overlook Medical Center, Summit, NJ; and Thomas J. Fitzgerald, Imaging and Radiation Oncology Core, Quality Assurance Review Center, Providence, RI.
Richard WhittingtonMadhur K. Garg, Joseph A. Sparano, and Shalom Kalnicki, Montefiore Medical Center, Albert Einstein College of Medicine, Montefiore-Einstein Center for Cancer Care, Bronx, NY; Fengmin Zhao, Dana Farber Cancer Institute, Boston, MA; Joel Palefsky, University of California, San Francisco, CA; Richard Whittington, Philadelphia VA Medical Center; Edith P. Mitchell, Thomas Jefferson University, Philadelphia, PA; Mary F. Mulcahy and Al B. Benson III, Northwestern University, Chicago, IL; Karin I. Armstrong, United Hospital, Woodbury, MN; Nassim H. Nabbout, Cancer Center of Kansas, Wichita, KS; Bassel F. El-Rayes, Emory University, Atlanta, GA; Adedayo A. Onitilo, Marshfield Clinic, Marshfield, WI; Daniel J. Moriarty, Overlook Medical Center, Summit, NJ; and Thomas J. Fitzgerald, Imaging and Radiation Oncology Core, Quality Assurance Review Center, Providence, RI.
Edith P MitchellMadhur K. Garg, Joseph A. Sparano, and Shalom Kalnicki, Montefiore Medical Center, Albert Einstein College of Medicine, Montefiore-Einstein Center for Cancer Care, Bronx, NY; Fengmin Zhao, Dana Farber Cancer Institute, Boston, MA; Joel Palefsky, University of California, San Francisco, CA; Richard Whittington, Philadelphia VA Medical Center; Edith P. Mitchell, Thomas Jefferson University, Philadelphia, PA; Mary F. Mulcahy and Al B. Benson III, Northwestern University, Chicago, IL; Karin I. Armstrong, United Hospital, Woodbury, MN; Nassim H. Nabbout, Cancer Center of Kansas, Wichita, KS; Bassel F. El-Rayes, Emory University, Atlanta, GA; Adedayo A. Onitilo, Marshfield Clinic, Marshfield, WI; Daniel J. Moriarty, Overlook Medical Center, Summit, NJ; and Thomas J. Fitzgerald, Imaging and Radiation Oncology Core, Quality Assurance Review Center, Providence, RI.
Mary F MulcahyMadhur K. Garg, Joseph A. Sparano, and Shalom Kalnicki, Montefiore Medical Center, Albert Einstein College of Medicine, Montefiore-Einstein Center for Cancer Care, Bronx, NY; Fengmin Zhao, Dana Farber Cancer Institute, Boston, MA; Joel Palefsky, University of California, San Francisco, CA; Richard Whittington, Philadelphia VA Medical Center; Edith P. Mitchell, Thomas Jefferson University, Philadelphia, PA; Mary F. Mulcahy and Al B. Benson III, Northwestern University, Chicago, IL; Karin I. Armstrong, United Hospital, Woodbury, MN; Nassim H. Nabbout, Cancer Center of Kansas, Wichita, KS; Bassel F. El-Rayes, Emory University, Atlanta, GA; Adedayo A. Onitilo, Marshfield Clinic, Marshfield, WI; Daniel J. Moriarty, Overlook Medical Center, Summit, NJ; and Thomas J. Fitzgerald, Imaging and Radiation Oncology Core, Quality Assurance Review Center, Providence, RI.
Karin I ArmstrongMadhur K. Garg, Joseph A. Sparano, and Shalom Kalnicki, Montefiore Medical Center, Albert Einstein College of Medicine, Montefiore-Einstein Center for Cancer Care, Bronx, NY; Fengmin Zhao, Dana Farber Cancer Institute, Boston, MA; Joel Palefsky, University of California, San Francisco, CA; Richard Whittington, Philadelphia VA Medical Center; Edith P. Mitchell, Thomas Jefferson University, Philadelphia, PA; Mary F. Mulcahy and Al B. Benson III, Northwestern University, Chicago, IL; Karin I. Armstrong, United Hospital, Woodbury, MN; Nassim H. Nabbout, Cancer Center of Kansas, Wichita, KS; Bassel F. El-Rayes, Emory University, Atlanta, GA; Adedayo A. Onitilo, Marshfield Clinic, Marshfield, WI; Daniel J. Moriarty, Overlook Medical Center, Summit, NJ; and Thomas J. Fitzgerald, Imaging and Radiation Oncology Core, Quality Assurance Review Center, Providence, RI.
Nassim H NabboutMadhur K. Garg, Joseph A. Sparano, and Shalom Kalnicki, Montefiore Medical Center, Albert Einstein College of Medicine, Montefiore-Einstein Center for Cancer Care, Bronx, NY; Fengmin Zhao, Dana Farber Cancer Institute, Boston, MA; Joel Palefsky, University of California, San Francisco, CA; Richard Whittington, Philadelphia VA Medical Center; Edith P. Mitchell, Thomas Jefferson University, Philadelphia, PA; Mary F. Mulcahy and Al B. Benson III, Northwestern University, Chicago, IL; Karin I. Armstrong, United Hospital, Woodbury, MN; Nassim H. Nabbout, Cancer Center of Kansas, Wichita, KS; Bassel F. El-Rayes, Emory University, Atlanta, GA; Adedayo A. Onitilo, Marshfield Clinic, Marshfield, WI; Daniel J. Moriarty, Overlook Medical Center, Summit, NJ; and Thomas J. Fitzgerald, Imaging and Radiation Oncology Core, Quality Assurance Review Center, Providence, RI.
Shalom KalnickiMadhur K. Garg, Joseph A. Sparano, and Shalom Kalnicki, Montefiore Medical Center, Albert Einstein College of Medicine, Montefiore-Einstein Center for Cancer Care, Bronx, NY; Fengmin Zhao, Dana Farber Cancer Institute, Boston, MA; Joel Palefsky, University of California, San Francisco, CA; Richard Whittington, Philadelphia VA Medical Center; Edith P. Mitchell, Thomas Jefferson University, Philadelphia, PA; Mary F. Mulcahy and Al B. Benson III, Northwestern University, Chicago, IL; Karin I. Armstrong, United Hospital, Woodbury, MN; Nassim H. Nabbout, Cancer Center of Kansas, Wichita, KS; Bassel F. El-Rayes, Emory University, Atlanta, GA; Adedayo A. Onitilo, Marshfield Clinic, Marshfield, WI; Daniel J. Moriarty, Overlook Medical Center, Summit, NJ; and Thomas J. Fitzgerald, Imaging and Radiation Oncology Core, Quality Assurance Review Center, Providence, RI.
Bassel F El-RayesMadhur K. Garg, Joseph A. Sparano, and Shalom Kalnicki, Montefiore Medical Center, Albert Einstein College of Medicine, Montefiore-Einstein Center for Cancer Care, Bronx, NY; Fengmin Zhao, Dana Farber Cancer Institute, Boston, MA; Joel Palefsky, University of California, San Francisco, CA; Richard Whittington, Philadelphia VA Medical Center; Edith P. Mitchell, Thomas Jefferson University, Philadelphia, PA; Mary F. Mulcahy and Al B. Benson III, Northwestern University, Chicago, IL; Karin I. Armstrong, United Hospital, Woodbury, MN; Nassim H. Nabbout, Cancer Center of Kansas, Wichita, KS; Bassel F. El-Rayes, Emory University, Atlanta, GA; Adedayo A. Onitilo, Marshfield Clinic, Marshfield, WI; Daniel J. Moriarty, Overlook Medical Center, Summit, NJ; and Thomas J. Fitzgerald, Imaging and Radiation Oncology Core, Quality Assurance Review Center, Providence, RI.
Adedayo A OnitiloMadhur K. Garg, Joseph A. Sparano, and Shalom Kalnicki, Montefiore Medical Center, Albert Einstein College of Medicine, Montefiore-Einstein Center for Cancer Care, Bronx, NY; Fengmin Zhao, Dana Farber Cancer Institute, Boston, MA; Joel Palefsky, University of California, San Francisco, CA; Richard Whittington, Philadelphia VA Medical Center; Edith P. Mitchell, Thomas Jefferson University, Philadelphia, PA; Mary F. Mulcahy and Al B. Benson III, Northwestern University, Chicago, IL; Karin I. Armstrong, United Hospital, Woodbury, MN; Nassim H. Nabbout, Cancer Center of Kansas, Wichita, KS; Bassel F. El-Rayes, Emory University, Atlanta, GA; Adedayo A. Onitilo, Marshfield Clinic, Marshfield, WI; Daniel J. Moriarty, Overlook Medical Center, Summit, NJ; and Thomas J. Fitzgerald, Imaging and Radiation Oncology Core, Quality Assurance Review Center, Providence, RI.
Daniel J MoriartyMadhur K. Garg, Joseph A. Sparano, and Shalom Kalnicki, Montefiore Medical Center, Albert Einstein College of Medicine, Montefiore-Einstein Center for Cancer Care, Bronx, NY; Fengmin Zhao, Dana Farber Cancer Institute, Boston, MA; Joel Palefsky, University of California, San Francisco, CA; Richard Whittington, Philadelphia VA Medical Center; Edith P. Mitchell, Thomas Jefferson University, Philadelphia, PA; Mary F. Mulcahy and Al B. Benson III, Northwestern University, Chicago, IL; Karin I. Armstrong, United Hospital, Woodbury, MN; Nassim H. Nabbout, Cancer Center of Kansas, Wichita, KS; Bassel F. El-Rayes, Emory University, Atlanta, GA; Adedayo A. Onitilo, Marshfield Clinic, Marshfield, WI; Daniel J. Moriarty, Overlook Medical Center, Summit, NJ; and Thomas J. Fitzgerald, Imaging and Radiation Oncology Core, Quality Assurance Review Center, Providence, RI.
Thomas J FitzgeraldMadhur K. Garg, Joseph A. Sparano, and Shalom Kalnicki, Montefiore Medical Center, Albert Einstein College of Medicine, Montefiore-Einstein Center for Cancer Care, Bronx, NY; Fengmin Zhao, Dana Farber Cancer Institute, Boston, MA; Joel Palefsky, University of California, San Francisco, CA; Richard Whittington, Philadelphia VA Medical Center; Edith P. Mitchell, Thomas Jefferson University, Philadelphia, PA; Mary F. Mulcahy and Al B. Benson III, Northwestern University, Chicago, IL; Karin I. Armstrong, United Hospital, Woodbury, MN; Nassim H. Nabbout, Cancer Center of Kansas, Wichita, KS; Bassel F. El-Rayes, Emory University, Atlanta, GA; Adedayo A. Onitilo, Marshfield Clinic, Marshfield, WI; Daniel J. Moriarty, Overlook Medical Center, Summit, NJ; and Thomas J. Fitzgerald, Imaging and Radiation Oncology Core, Quality Assurance Review Center, Providence, RI.
Al B BensonMadhur K. Garg, Joseph A. Sparano, and Shalom Kalnicki, Montefiore Medical Center, Albert Einstein College of Medicine, Montefiore-Einstein Center for Cancer Care, Bronx, NY; Fengmin Zhao, Dana Farber Cancer Institute, Boston, MA; Joel Palefsky, University of California, San Francisco, CA; Richard Whittington, Philadelphia VA Medical Center; Edith P. Mitchell, Thomas Jefferson University, Philadelphia, PA; Mary F. Mulcahy and Al B. Benson III, Northwestern University, Chicago, IL; Karin I. Armstrong, United Hospital, Woodbury, MN; Nassim H. Nabbout, Cancer Center of Kansas, Wichita, KS; Bassel F. El-Rayes, Emory University, Atlanta, GA; Adedayo A. Onitilo, Marshfield Clinic, Marshfield, WI; Daniel J. Moriarty, Overlook Medical Center, Summit, NJ; and Thomas J. Fitzgerald, Imaging and Radiation Oncology Core, Quality Assurance Review Center, Providence, RI.
Montefiore Medical Center · US

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
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
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO · 2014 to 2026
$111.2M
Metro-Minnesota Community Oncology Research Consortium (MMCORC)UG1CA189863 · NCI · PARK NICOLLET INSTITUTE · PI JOLEEN M HUBBARD, Yan Ji · 2014 to 2026
$43.2M
ECOG-ACRIN Biospecimen Bank to Support NCTNU24CA196172 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI STANLEY R. HAMILTON, Scott D Jewell · 2015 to 2026
$41.1M
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
Wisconsin NCI Community Oncology Research Program (WiNCORP)UG1CA189956 · NCI · MARSHFIELD CLINIC RESEARCH FOUNDATION · PI ADEDAYO A ONITILO, Kurt Oettel · 2014 to 2026
$32.3M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
QUALITY ASSURANCE REVIEW CENTER (QARC)U10CA029511 · NCI · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI FITZGERALD, THOMAS J. · 1985 to 2013
$23.4M
W METRO-MINNEAPOLIS COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035267 · NCI · PARK NICOLLET INSTITUTE · PI LEACH, JOSEPH · 1985 to 2014
$23.2M
NCI NIH HHS N01 CA035431NCI NIH HHS U10 CA013650NCI NIH HHS U10 CA014958NCI NIH HHS U10 CA015488NCI NIH HHS U10 CA017145NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA029511NCI NIH HHS U10 CA035267NCI NIH HHS U10 CA035412NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA066636NCI NIH HHS U10 CA107868NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180864NCI NIH HHS U24 CA180803NCI NIH HHS U24 CA196172NCI NIH HHS UG1 CA189808NCI NIH HHS UG1 CA189859NCI NIH HHS UG1 CA189863NCI NIH HHS UG1 CA189956NCI NIH HHS UG1 CA233341
6 · The paper itself

Abstract

Purpose Squamous cell carcinoma of the anal canal (SCCAC) is characterized by high locoregional failure (LRF) rates after sphincter-preserving definitive chemoradiation (CRT) and is typically associated with anogenital human papilloma virus infection. Because cetuximab enhances the effect of radiation therapy in human papilloma virus-associated oropharyngeal squamous cell carcinoma, we hypothesized that adding cetuximab to CRT would reduce LRF in SCCAC. Methods Sixty-one patients with stage I to III SCCAC received CRT including cisplatin, fluorouracil, and radiation therapy to the primary tumor and regional lymph nodes (45 to 54 Gy) plus eight once-weekly doses of concurrent cetuximab. 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 Poor risk features included stage III disease in 64% and male sex in 20%. The 3-year LRF rate was 23% (95% CI, 13% to 36%; one-sided P = .03) by binomial proportional estimate using the prespecified end point and 21% (95% CI, 7% to 26%) by Kaplan-Meier estimate in a post hoc analysis using methods consistent with historical data. Three-year rates were 68% (95% CI, 55% to 79%) for progression-free survival and 83% (95% CI, 71% to 91%) for overall survival. Grade 4 toxicity occurred in 32%, and 5% had treatment-associated deaths. Conclusion Although the addition of cetuximab to chemoradiation for SCCAC was associated with lower LRF rates than historical data with CRT alone, toxicity was substantial, and LRF still occurs in approximately 20%, indicating the continued need for more effective and less toxic therapies.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsAnus NeoplasmsCarcinoma, Squamous CellCetuximabChemoradiotherapyCisplatinDisease-Free SurvivalFemaleFluorouracilHumansImmunocompetenceMaleMiddle AgedNeoplasm StagingCetuximabCisplatinFluorouracil

Identifiers

PMID28068178
PMCPMC5455423
OpenAlexW2579647781

What OpenQuestion holds

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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.