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Published on: July 22, 2015
Recommendations for cancer prevention trials using potentially ototoxic test agents
L I Shotland1, F G Ondrey, K A Mayo
1Hearing Section, Neuro-Otology Branch, National Institute on Deafness and Other Communication Disorders, National Institutes of Health, Bethesda, MD 20892, USA.
Purpose:
Preventive oncology applies pharmacologic agents to reverse, retard, or halt progression of neoplastic cells to invasive malignancy, a process that may require administration of agents over long periods of time. Although ototoxicity may be a tolerable side effect of anticancer or antimicrobial therapy, even modest ototoxicity may not be acceptable in agents developed for preventive oncology that are routinely administered to subjects who neither are, nor necessarily will become, clinically ill.
Materials And Methods:
Age-related shifts in hearing may occur over the course of longterm or open-ended therapy; consequently, age-adjusted norms enable researchers to better distinguish hearing loss caused by drugs from that caused by aging. Norms for hearing sensitivity are derived from the Baltimore Longitudinal Study of Aging and are the basis for the proposed audiologic monitoring recommendations.
Results:
Audiologic monitoring recommendations are presented that standardize patient selection, adverse event reporting, posttreatment follow-up, and audiologic testing for potentially ototoxic investigational agents.
Conclusion:
These recommendations are applicable to trials of investigational agents as well as various classes of drugs used in routine clinical care.
Insights
Preventive oncology agents require careful monitoring for hearing loss. New audiologic recommendations help distinguish drug-induced ototoxicity from age-related hearing changes.
Area of Science:
- Oncology
- Audiology
- Pharmacology
Background:
- Preventive oncology uses long-term pharmacologic agents to halt cancer progression.
- Ototoxicity is a potential side effect, but may be unacceptable in preventive therapies for asymptomatic individuals.
Purpose of the Study:
- To establish audiologic monitoring recommendations for potentially ototoxic agents in preventive oncology.
- To differentiate drug-induced hearing loss from age-related hearing shifts during long-term therapy.
Main Methods:
- Utilized age-adjusted hearing norms from the Baltimore Longitudinal Study of Aging.
- Developed recommendations for standardizing patient selection, adverse event reporting, and audiologic testing.
Main Results:
- Presented standardized audiologic monitoring recommendations for investigational agents.
- Recommendations cover patient selection, adverse event reporting, posttreatment follow-up, and testing protocols.
Conclusions:
- The recommendations are applicable to clinical trials of new agents.
- These guidelines also apply to drugs used in routine clinical practice for ototoxicity monitoring.
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