Evidence map›Paper›PMID 35119908›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

Sex Differences in Risk of Severe Adverse Events in Patients Receiving Immunotherapy, Targeted Therapy, or Chemotherapy in Cancer Clinical Trials.

Joseph M Unger, Riha Vaidya, Kathy S Albain, Michael LeBlanc, Lori M Minasian, Carolyn C Gotay, N Lynn Henry, Michael J Fisch, Shing M Lee, Charles D Blanke and 1 more

Registry-linked trialOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07249060 (Interferon Signature in Cancer Patients Treated With Anti-CTLA-4 and Anti-PD-1/PD-L1 Therapies), which is not on this map. Cited by 195 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
195citing papers in PubMed, 7 pooled it
29.6field-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.

NCT07249060 recruitingnot on this mapstarted 2024, after this paper: background citation

Interferon Signature in Cancer Patients Treated With Anti-CTLA-4 and Anti-PD-1/PD-L1 Therapies: A Multicenter, Prospective, Observational Cohort Study Comparing Cancer Patients and Non-Cancer Patients With Systemic Autoimmune Diseases

Typeobservational_patient_registrySponsorHospital Universitario ArabaRan2024 to 2026Enrolled300ConditionsImmune-Related Adverse Events, Lupus Erythematosus, Systemic, Sjogren Syndrome, Systemic Sclerosis (SSc)ArmsImmune Checkpoint Inhibitors
3 · Its place in the literature

Who cites it

195 citing papers in PubMed, 7 syntheses or guidelines pooled it, 293 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Article
  15. Sex-Biased Immunity: The Hidden Variable in Immuno-oncology.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Review
  16. Sex Steroid Hormone Regulation of T-Cell Function and Antitumor Immunity.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Review
  17. Article
  18. Review
  19. Review
  20. Article

135 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 2 countries.

Joseph M UngerSWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA.ORCID 0000-0002-5191-0317
Riha VaidyaSWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA.ORCID 0000-0001-5316-6352
Kathy S AlbainLoyola University Chicago Stritch School of Medicine, Maywood, IL.ORCID 0000-0002-2899-2473
Michael LeBlancSWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA.
Lori M MinasianNational Cancer Institute, Division of Cancer Prevention, Rockville, MD.ORCID 0000-0002-0472-4079
Carolyn C GotayUniversity of British Columbia, Vancouver, British Columbia, Canada.
N Lynn HenryUniversity of Michigan, Ann Arbor, MI.ORCID 0000-0002-4771-5930
Michael J FischAIM Specialty Health, Chicago, IL.ORCID 0000-0001-5312-403X
Shing M LeeColumbia University, New York, NY.
Charles D BlankeSWOG Group Chair's Office/Knight Cancer Institute, Oregon Health & Science University, Portland, OR.
Dawn L HershmanColumbia University, New York, NY.ORCID 0000-0001-8807-153X
Fred Hutch Cancer Center · USColumbia University · USLoyola University Chicago · USNational Cancer Institute · USOregon Health & Science University · USUniversity of British Columbia · CAUniversity of Michigan · US

Funding

SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Michael L. LeBlanc · 2014 to 2026
$115.2M
SWOG NCORP Research BaseUG1CA189974 · NCI · THE HOPE FOUNDATION · PI CHARLES D. BLANKE, DAWN HERSHMAN · 2014 to 2026
$80.6M
NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189974
6 · The paper itself

Abstract

purposeWomen have more adverse events (AEs) from chemotherapy than men, but few studies have investigated sex differences in immune or targeted therapies. We examined AEs by sex across different treatment domains.

methodsWe analyzed treatment-related AEs by sex in SWOG phase II and III clinical trials conducted between 1980 and 2019, excluding sex-specific cancers. AE codes and grade were categorized using the Common Terminology Criteria for Adverse Events. Symptomatic AEs were defined as those aligned with the National Cancer Institute's Patient-Reported Outcome-Common Terminology Criteria for Adverse Events; laboratory-based or observable/measurable AEs were designated as objective (hematologic

resultsIn total, N = 23,296 patients (women, 8,838 [37.9%]; men, 14,458 [62.1%]) from 202 trials experiencing 274,688 AEs were analyzed; 17,417 received chemotherapy, 2,319 received immunotherapy, and 3,560 received targeted therapy. Overall, 64.6% (n = 15,051) experienced one or more severe (grade ≥ 3) AEs. Women had a 34% increased risk of severe AEs compared with men (odds ratio [OR] = 1.34; 95% CI, 1.27 to 1.42;

conclusionThe greater severity of both symptomatic AEs and hematologic AEs in women across multiple treatment modalities indicates that broad-based sex differences exist. This could be due to differences in AE reported, pharmacogenomics of drug metabolism/disposition, total dose received, and/or adherence to therapy. Particularly large sex differences were observed for patients receiving immunotherapy, suggesting that studying AEs from these agents is a priority.

Indexed as

NeoplasmsSex CharacteristicsClinical Trials as TopicFemaleHumansImmunologic FactorsImmunotherapyMalePatient Reported Outcome MeasuresImmunologic Factors

Identifiers

PMID35119908
PMCPMC9061143
OpenAlexW4210620015

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.