HspE7 treatment of pediatric recurrent respiratory papillomatosis: final results of an open-label trial

Craig S Derkay; Richard J H Smith; John McClay; Jo-Anne H van Burik; Brian J Wiatrak; James Arnold; Bruce Berger; John R Neefe

doi:10.1177/000348940511400913

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HspE7 treatment of pediatric recurrent respiratory papillomatosis: final results of an open-label trial

Journal article

Peer reviewed

HspE7 treatment of pediatric recurrent respiratory papillomatosis: final results of an open-label trial

Craig S Derkay, Richard J H Smith, John McClay, Jo-Anne H van Burik, Brian J Wiatrak, James Arnold, Bruce Berger and John R Neefe

Annals of otology, rhinology & laryngology, Vol.114(9), pp.730-737

09/2005

DOI: 10.1177/000348940511400913

PMID: 16240938

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Abstract

We sought to evaluate the effectiveness of HspE7, a recombinant fusion protein of Hsp65 from Mycobacterium bovis BCG and E7 protein from human papillomavirus 16, to improve the clinical course of pediatric patients with recurrent respiratory papillomatosis. An open-label, single-arm intervention study was conducted in 8 university-affiliated medical centers. Twenty-seven male and female patients with recurrent respiratory papillomatosis, ages 2 to 18 years, were enrolled and followed up to 60 weeks. Before enrollment, these patients required surgery on average every 55 days. After a baseline debulking surgery, the patients received HspE7 500 microg subcutaneously monthly, for 3 doses over 60 days. The primary end point was the length of the interval from the last surgery during the treatment period until the first debulking surgery in the posttreatment period, compared with the median intersurgical interval (ISI) of the 4 surgeries before the treatment. The mean of the first posttreatment ISI increased 93% (from 55 days to 106 days; p < .02). The median ISI for all surgeries after treatment was similarly prolonged (mean, 107 days; p < .02), indicating a sustained treatment effect, and was associated with a significant decrease in the number of required surgeries (p < .003). Unexpectedly, the treatment effect was most striking in the 13 female patients, who had statistically significant increases in both the first posttreatment ISI (142%; p < .03) and the median ISI (147%; p < .03). The most common adverse events were mild-to-moderate injection site reactions. Treatment with HspE7 appears to significantly improve the clinical course in pediatric patients with RRP insofar as it reduces the frequency of required surgeries. These results warrant a confirmatory phase III trial.

Respiratory Tract Neoplasms - drug therapy

Follow-Up Studies

Papillomaviridae - drug effects

Humans

Recombinant Fusion Proteins - therapeutic use

Bacterial Proteins - genetics

Child, Preschool

Neoplasm Recurrence, Local - drug therapy

Male

Oncogene Proteins, Viral - therapeutic use

Papillomavirus E7 Proteins

Treatment Outcome

Bacterial Proteins - therapeutic use

Chaperonin 60

Chaperonins - therapeutic use

Adolescent

Female

Oncogene Proteins, Viral - genetics

Chaperonins - genetics

Child

Papilloma - drug therapy

Details

Title: Subtitle: HspE7 treatment of pediatric recurrent respiratory papillomatosis: final results of an open-label trial
Creators: Craig S Derkay - Department of Otolaryngology-Head and Neck Surgery, Eastern Virginia Medical School, Norfolk, Virginia, USA
Richard J H Smith
John McClay
Jo-Anne H van Burik
Brian J Wiatrak
James Arnold
Bruce Berger
John R Neefe
Resource Type: Journal article
Publication Details: Annals of otology, rhinology & laryngology, Vol.114(9), pp.730-737
DOI: 10.1177/000348940511400913
PMID: 16240938
NLM abbreviation: Ann Otol Rhinol Laryngol
ISSN: 0003-4894
eISSN: 1943-572X
Publisher: United States
Language: English
Date published: 09/2005
Academic Unit: Roy J. Carver Department of Biomedical Engineering; Molecular Physiology and Biophysics; Anatomy and Cell Biology; Stead Family Department of Pediatrics; Iowa Neuroscience Institute; Otolaryngology; Internal Medicine
Record Identifier: 9984007182402771

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