Evidence map›Paper›PMID 40307073›Full record

ArticleJournal of voice : official journal of the Voice Foundation2025

Disease Control and Voice Outcomes Following Treatment With PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis.

Amir Kaskas, Janet Valdez, Scott Napier, Hyoyoung Choo-Wosoba, Scott M Norberg, Clint T Allen

Abstract read
In one paragraph

Article in Journal of voice : official journal of the Voice Foundation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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

6 authors.

Amir KaskasSurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Janet ValdezSurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Scott NapierCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Hyoyoung Choo-WosobaBiostatistics and Data Management Section, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Rockville, MD.
Scott M NorbergCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Clint T AllenSurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD; Center for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD. Electronic address: clint.allen@nih.gov.

Funding

Enhancing anti-tumor immunity in head and neck neoplasmsZIABC012131 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ALLEN, CLINT · 2023 to 2025
$13.4M
Intramural NIH HHS ZIA BC012131
6 · The paper itself

Abstract

objectiveMore than 50% of adult patients with recurrent respiratory papillomatosis that receive PRGN-2012 develop a protocol-defined complete response. The relationship between papilloma disease control and change in voice handicap following PRGN-2012 treatment requires clarity as patients and providers consider treatment. STUDY

designA post hoc study of pretreatment and post treatment Derkay and Voice Handicap Index-10 (VHI-10) data collected prospectively as predetermined exploratory outcome measures on a completed single-arm, single-cohort, phase 1/2 registration clinical trial of PRGN-2012 monotherapy. All patients (n = 38) that were enrolled and treated were included in this study. Patients underwent prospective collection of recorded clinical nasopharyngolaryngoscopy and were administered a VHI-10 questionnaire before, during, and after treatment with PRGN-2012. Fisher's exact test, Wilcoxon rank sum test, Spearman's correlation, and multiple linear regression analyses were used to associate demographic and clinical variables to clinical response (CR) to PRGN-2012 treatment. Wilcoxon rank sum and Spearman's correlation tests were performed to compare change in anatomic Derkay to reduction in clinically-indicated interventions and VHI-10 scores after PRGN-2012 treatment compared to before treatment.

resultsGreater reduction in anatomic Derkay score associated with greater percent reduction in clinically-indicated interventions after PRGN-2012 treatment (r = 0.68, P = 0.0001). Greater reduction in anatomic Derkay score significantly associated with greater reduction in VHI-10 score (r = 0.81, P < 0.0001). No association (r = 0.10, P = 0.5586) was observed between the number of clinically-indicated interventions required in the 12 months prior to treatment and CR. A reduced number of total lifetime clinically-indicated interventions associated with greater CR (r = 0.46, P = 0.0037) in univariate analysis, but the significance of this relationship was lost on multi-variate analysis (P = 0.184) adjusting for multiple co-variates.

conclusionsThese data link greater papilloma disease control with reduced need for clinically indicated procedures and reduced voice handicap after PRGN-2012 treatment independent of short- or long-term measures of disease severity.

Indexed as

Recurrent respiratory papillomatosis—Immunotherapy—Derkay score—VHI-10 score.

Identifiers

PMID40307073
PMCPMC12353205

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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.