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Chemotherapy-induced peripheral neuropathy (CIPN) and its treatment: an NIH Collaboratory study of claims data

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Abstract

Purpose

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.

Methods

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).

Results

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.

Conclusions

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.

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Acknowledgments

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.

Data sharing

Comprehensive aggregate data tables will be shared upon request.

Funding

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).

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Authors and Affiliations

  1. Department of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, NY, USA

    Jennifer S. Gewandter & Robert H. Dworkin

  2. Cancer Control, Department of Surgery, University of Rochester Medical Center, Rochester, NY, USA

    Amber S. Kleckner, Javier Bautista, Ian R. Kleckner & Karen M. Mustian

  3. Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, USA

    James H. Marshall & Jeffrey S. Brown

  4. Department of Population Health Sciences and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA

    Lesley H. Curtis

  5. The University of Vermont Medical Center, Burlington, VT, USA

    Noah Kolb

  6. Department of Medicine, Hematology/Oncology, University of Rochester Medical Center, Rochester, NY, USA

    Supriya G. Mohile

Authors
  1. Jennifer S. Gewandter
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  2. Amber S. Kleckner
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  3. James H. Marshall
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  4. Jeffrey S. Brown
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  5. Lesley H. Curtis
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  6. Javier Bautista
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  7. Robert H. Dworkin
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  8. Ian R. Kleckner
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  9. Noah Kolb
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  10. Supriya G. Mohile
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  11. Karen M. Mustian
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Contributions

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

Corresponding author

Correspondence to Jennifer S. Gewandter.

Ethics declarations

Competing interests

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.

Ethics approval

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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Gewandter, J.S., Kleckner, A.S., Marshall, J.H. et al. Chemotherapy-induced peripheral neuropathy (CIPN) and its treatment: an NIH Collaboratory study of claims data. Support Care Cancer 28, 2553–2562 (2020). https://doi.org/10.1007/s00520-019-05063-x

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  • DOI: https://doi.org/10.1007/s00520-019-05063-x

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