Chemotherapy-induced peripheral neuropathy (CIPN) and its treatment: an NIH Collaboratory study of claims data
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Chemotherapy-induced peripheral neuropathy (CIPN) is a disabling complication of many chemotherapies. We investigated the feasibility of using health plan claims and administrative data to identify CIPN occurrence by comparing patients who received neurotoxic and non-neurotoxic chemotherapies.
The sample included over 53,000,000 patients from two regional and one national insurer in the USA (> 400,000 exposed to chemotherapy). Peripheral neuropathy was identified using a broad definition (definition 1) and a specific definition (i.e., drug-induced polyneuropathy code) (definition 2).
CIPN incidence as measured by definition 1 within 6 months of chemotherapy initiation was 18.1% and 6.2% for patients who received neurotoxic and non-neurotoxic chemotherapy, respectively (relative risk neurotoxic vs. non-neurotoxic (RR), 2.93 (95% CI, 2.87–2.98)). For definition 2, these incidences were 3.6% and 0.1% (RR, 25.2 (95% CI, 22.8–27.8)). The incidences of new analgesic prescriptions for neurotoxic and non-neurotoxic groups were as follows: gabapentin, 7.1%/1.7%; pregabalin, 0.69%/0.31%; and duloxetine, 0.78%/0.76%. The incidence of CIPN as defined by definitions 1 and 2 was low compared with that of published research studies, but the relative risk of CIPN among patients who received neurotoxic chemotherapies compared with those who received non-neurotoxic chemotherapies was high using definition 2.
These data suggest that as used currently by clinicians, administrative codes likely underestimate CIPN incidence. Thus, studies using administrative data to estimate CIPN incidence are not currently feasible. However, the drug-induced polyneuropathy code is a specific indicator of CIPN in administrative data and may be useful for investigating predictors or potentially preventive therapies of CIPN.
KeywordsChemotherapy-induced peripheral neuropathy CIPN Neuropathy Claims data Incidence
The authors would like to thank Dr. Cheryl McMahill-Walraven of Aetna, a CVS Health company, and Dr. Kevin Haynes of Healthcore, Inc., for their contributions to this project.
Comprehensive aggregate data tables will be shared upon request.
Study concept and design: JSG, JSB, LHC, RHD, SGM, and KMM
Acquisition, analysis, or interpretation of data: JSG, ASK, JHM, LHC, JSB, JB, and RHD
Drafting of the manuscript: JSG and ASK
Critical revision of the manuscript for important intellectual content: all authors
Statistical analysis: JHM and JB
Obtained funding: LHC, JSB, and KMM
Study supervision: JSG
This study was funded by the NIH U24AT009676 (The Collaboratory) and NIH/NCI UG1CA189961 (University of Rochester Cancer Center NCORP Research Base to KMM and G. Morrow).
Compliance with ethical standards
Jennifer S. Gewandter has received consulting income in the past 36 months from MundiPharma, Disarm Therapeutics, Asahi Kasei Pharma, and SK Life Science. Ian R. Kleckner has received funding from the National Institutes of Health (K07CA221931). Robert H. Dworkin has received in the past 36 months research grants and contracts from US Food and Drug Administration and US National Institutes of Health, and compensation for consulting on clinical trial methods from Abide, Adynxx, Analgesic Solutions, Aptinyx, Asahi Kasei, Astellas, AstraZeneca, Biogen, Biohaven, Boston Scientific, Braeburn, Celgene, Centrexion, Chromocell, Clexio, Concert, Decibel, Dong-A, Eli Lilly, Eupraxia, Glenmark, Grace, Hope, Immune, Lotus Clinical Research, Mainstay, Neumentum, NeuroBo, Novaremed, Novartis, Pfizer, Phosphagenics, Quark, Reckitt Benckiser, Regenacy (also equity), Relmada, Sandoz, Scilex, Semnur, Sollis, Teva, Theranexus, Trevena, and Vertex.
The Harvard Pilgrim Health Care Institutional Review Board (IRB) determined that the project does not meet the definition of human subject research under the purview of the IRB according to federal regulations.
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