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Chemotherapy-induced peripheral neuropathy: Identifying the research gaps and associated changes to clinical trial
Diane C St Germain1, Ann M O'Mara1, Jennifer L Robinson2
1Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland.
Background:
To the authors' knowledge, the empiric identification of agents and interventions to mitigate chemotherapy-induced peripheral neuropathy (CIPN) has resulted in only 1 agent that modestly mitigates it and no agents or interventions that prevent its development. This speaks to the need for a mechanistic understanding of CIPN to develop effective interventions.
Methods:
To understand the extent to which mechanistic understanding of CIPN is being translated into the development of interventions, the National Cancer Institute conducted a review of the National Institutes of Health (NIH)'s portfolio of investigator-initiated grants, the literature regarding CIPN mechanisms, and the clinical trials listed in the ClinicalTrials.gov database from January 1, 2011, to May 22, 2019.
Results:
A total of 69 NIH-supported grants and 95 published articles were identified that evaluated mechanistic pathways of 7 different chemotherapy agents that cause CIPN. The review also identified 35 clinical trials that investigated agents or devices with which to treat CIPN. Only 3 trials incorporated a mechanistic rationale to support the choice of the intervention.
Conclusions:
To the authors' knowledge, very little of the mechanistic understanding of the development of CIPN is being translated into intervention rationale in clinical trials that evaluate interventions to mitigate CIPN. Efforts to incentivize this translation are needed.
Insights
Developing effective treatments for chemotherapy-induced peripheral neuropathy (CIPN) requires a deeper mechanistic understanding. Current clinical trials show limited translation of this knowledge into novel interventions for CIPN.
Area of Science:
- Oncology
- Neuroscience
- Pharmacology
Background:
- Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of cancer treatment.
- Current interventions offer limited efficacy in mitigating or preventing CIPN, highlighting a critical need for mechanism-based treatments.
Purpose of the Study:
- To assess the translation of mechanistic understanding of CIPN into clinical trial interventions.
- To evaluate the National Cancer Institute's (NCI) portfolio of grants and clinical trial data for CIPN research.
Main Methods:
- A comprehensive review of NIH-supported investigator-initiated grants and published literature on CIPN mechanisms.
- Analysis of clinical trials registered in ClinicalTrials.gov (January 2011 to May 2019) for interventions targeting CIPN.
Main Results:
- Identified 69 NIH grants and 95 publications detailing CIPN mechanisms for 7 chemotherapy agents.
- Reviewed 35 clinical trials for CIPN interventions, with only 3 trials incorporating a mechanistic rationale.
Conclusions:
- A significant gap exists between understanding CIPN mechanisms and their application in clinical trial design.
- Incentives are needed to promote the translation of mechanistic insights into the development of effective CIPN interventions.
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