Evidence map›Paper›PMID 30996010›Full record

ArticleThe oncologist2019

Sicca Syndrome Associated with Immune Checkpoint Inhibitor Therapy.

Blake M Warner, Alan N Baer, Evan J Lipson, Clint Allen, Christian Hinrichs, Arun Rajan, Eileen Pelayo, Margaret Beach, James L Gulley, Ravi A Madan and 7 more

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in The oncologist, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06465628 (Effect of Self-administered Acupressure for Improving Xerostomia in Head and Neck Cancer Patients), which is not on this map. Cited by 96 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
96citing papers in PubMed, 5 pooled it
9.1field-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.

NCT06465628 narecruitingnot on this mapstarted 2024, after this paper: background citation

Effect of Self-administered Acupressure for Improving Xerostomia in Head and Neck Cancer Patients: a Randomized Controlled Trial

TypeinterventionalSponsorThe University of Hong KongRan2024 to 2027Enrolled126ConditionsHead and Neck Cancer, XerostomiaArmsSelf-administered acupressure, Oral health education
3 · Its place in the literature

Who cites it

96 citing papers in PubMed, 5 syntheses or guidelines pooled it, 173 citations in OpenAlex.

  1. Pooled it
  2. Diagnosis and management of immune checkpoint inhibitor-induced dry mouth and salivary gland dysfunction in oncology patients: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Pooled it
  3. MASCC/ISOO Clinical Practice Statement: management of oral complications of immunotherapy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Guideline
  4. Pooled it
  5. Guideline
  6. Trial
  7. Trial
  8. The Immune Checkpoint Inhibitors Journey: From Early Promise to Lasting Impact.Journal of immunotherapy and precision oncology · 2026
    Review
  9. Immune Checkpoint Inhibitor-Associated Inflammatory Arthritis.Arthritis & rheumatology (Hoboken, N.J.) · 2026
    Review
  10. Article
  11. Prevalence and characteristics of persistent taste and smell dysfunction after immune checkpoint inhibitor therapy for cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Observational
  12. Review
  13. Article
  14. The management of rheumatic immune related adverse events.Best practice & research. Clinical rheumatology · 2026
    Review
  15. ICI-induced Granulomatous Sialadenitis is Responsive to Prednisone.medRxiv : the preprint server for health sciences · 2026
    Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Taste disorders in cancer patients and current therapeutic approaches: a narrative review of an understudied topic in supportive care.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 7 institutions in 1 country.

Blake M WarnerSjögren's Syndrome and Salivary Gland Dysfunction Unit, National Institutes of Health, Baltimore, Maryland, USA blake.warner@nih.gov.ORCID 0000-0002-4961-018X
Alan N BaerSjögren's Syndrome and Salivary Gland Dysfunction Unit, National Institutes of Health, Baltimore, Maryland, USA.
Evan J LipsonDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center and Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Clint AllenTranslational Tumor Immunology Program, National Institute on Deafness and Other Communication Disorders, National Institutes of Health, Baltimore, Maryland, USA.
Christian HinrichsCenter for Cancer Research, National Cancer Institute, National Institutes of Health, Baltimore, Maryland, USA.
Arun RajanCenter for Cancer Research, National Cancer Institute, National Institutes of Health, Baltimore, Maryland, USA.
Eileen PelayoSjögren's Syndrome and Salivary Gland Dysfunction Unit, National Institutes of Health, Baltimore, Maryland, USA.
Margaret BeachSjögren's Syndrome and Salivary Gland Dysfunction Unit, National Institutes of Health, Baltimore, Maryland, USA.
James L GulleyCenter for Cancer Research, National Cancer Institute, National Institutes of Health, Baltimore, Maryland, USA.
Ravi A MadanCenter for Cancer Research, National Cancer Institute, National Institutes of Health, Baltimore, Maryland, USA.
Josephine FelicianoDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center and Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Margaret GrisiusSjögren's Syndrome and Salivary Gland Dysfunction Unit, National Institutes of Health, Baltimore, Maryland, USA.
Lauren LongSjögren's Syndrome and Salivary Gland Dysfunction Unit, National Institutes of Health, Baltimore, Maryland, USA.
Astin PowersLaboratory of Pathology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Baltimore, Maryland, USA.
David E KleinerLaboratory of Pathology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Baltimore, Maryland, USA.
Laura CappelliDivision of Rheumatology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Ilias AlevizosSjögren's Syndrome and Salivary Gland Dysfunction Unit, National Institutes of Health, Baltimore, Maryland, USA.
National Institutes of Health · USNational Cancer Institute · USJohns Hopkins University · USBloomberg (United States) · USJohns Hopkins Medicine · USNational Institute of Dental and Craniofacial Research · USNational Institute on Deafness and Other Communication Disorders · US

Funding

Clinical Investigations of Sjogren's SyndromeZIADE000704 · NIDCR · NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH · PI WARNER, BLAKE · 2009 to 2025
$22.3M
Postmortem PathologyZICBC010685 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI KLEINER, DAVID ERWIN · 2009 to 2025
$14.3M
Characterization and Enhancement of Anti-Tumor Immune Responses in Head and Neck CancerZIADC000087 · NIDCD · NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS · PI ALLEN, CLINT · 2015 to 2022
$13.5M
NIDCR DIR Clinical TrainingZIEDE000727 · NIDCR · NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH · PI MAYS, JACQUELINE · 2009 to 2025
$6.8M
DEVELOPMENT OF SYNAPTIC PATHWAYS IN RETINAR01EY012345 · NEI · YALE UNIVERSITY · PI TIAN, NING · 1999 to 2015
$5.1M
Intramural NIH HHS ZIA DE000704Intramural NIH HHS ZIE DE000727NEI NIH HHS R01 EY012345
6 · The paper itself

Abstract

backgroundThe objective of this study was to characterize the clinicopathologic features of sicca syndrome associated with immune checkpoint inhibitor (ICI) therapy. SUBJECTS, MATERIALS, AND

methodsConsecutive patients with new or worsening xerostomia in the setting of ICI treatment for benign or malignant neoplastic disease were evaluated, including labial salivary gland biopsy (LSGB).

resultsTwenty patients (14 male; median age 57 years) had metastatic melanoma (

conclusionICI therapy is associated with an autoimmune-induced sicca syndrome distinct from Sjögren's syndrome, often abrupt in onset, usually developing within the first 3 months of treatment, and associated with sialadenitis and glandular injury. Improvement can be achieved with a graded approach depending on severity, including withholding the ICI and initiating corticosteroids. However, profound salivary flow deficits may be long term. IMPLICATIONS FOR PRACTICE: Sicca syndrome has been reported as an immune-related adverse event (irAE) of immune checkpoint inhibitor therapy (ICI) for neoplastic diseases. Severe dry mouth (interfering with eating or sleeping) developed abruptly, typically within 90 days, after initiation of ICI therapy. Salivary gland biopsies demonstrated mild-to-severe sialadenitis distinct from Sjögren's syndrome, with diffuse T-cell lymphocytic infiltration and acinar injury. Recognition of the cardinal features of ICI-induced sicca will spur appropriate clinical evaluation and management, including withholding of the ICI and corticosteroid, initiation. This characterization should help oncologists, rheumatologists, and oral medicine specialists better identify patients that develop ICI-induced sicca to initiate appropriate clinical evaluation and therapy to reduce the likelihood of permanent salivary gland dysfunction.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCohort StudiesFemaleHumansMaleMiddle AgedNeoplasmsNivolumabPapillomavirus InfectionsRespiratory Tract InfectionsSjogren's SyndromeAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalavelumabNivolumabpembrolizumabImmune checkpoint inhibitorImmune‐related adverse eventProgrammed cell death 1/programmed cell death ligand 1 pathwaySialadenitisSicca syndromeSjögren's syndromeXerostomia

Identifiers

PMID30996010
PMCPMC6738284
OpenAlexW2939131851

What OpenQuestion holds

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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.