Diagnosis and Treatment of Neuropathy Post Chemotherapy in Three Health Care Systems

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1 Diagnosis and Treatment of Neuropathy Post Chemotherapy in Three Health Care Systems HCSRN 2019 Conference April 10, 2019 Kaiser Permanente Research

2 Peripheral neuropathy is a common side effect of neurotoxic chemotherapies Chemo induced neuropathy affects anywhere from 11 to 80% of patients using select therapies (e.g., taxanes, platinums) CIPN can: Occur during or after treatment or both Be acute or chronic in nature Prevention and Treatment No recommend therapies for prevention Duloxetine; other agents used (gabapentin, tricyclic antidepressants) Limited evidence regarding how to prevent it, how to effectively treat it, and how patients in real world practice are being assessed and treated. Sources: Rivera et al 2018; Staff N, et al. Annals Neurology 2017; Hershmann D, et al. JCO 2016; Fontes et al. The Breast 2016; Serenty et al March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

3 Chemo-Induced Neuropathy: Patient Perspectives Since the chemotherapy, my fingers feel numb, as do my toes. When I get up in the morning, my fingers are all numb. when I sewed trousers, I could finish the task in 15 min in the past, but now I need an hour to finish it because my fingers feel numb (P4, 5 months after chemotherapy completion) I don't think my numbness will completely disappear I have gradually become clumsy. I have to get someone to help me go out. If I could go out on my own, I would be very happy. I would be just like normal people and wouldn't need the family to take care of me, but [I] still need people to help [me] to go out... [participant weeps] So I try to think happier thoughts. (P12, 23 months after chemotherapy completion) Chan et al. European Journal of Oncology Nursing, March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

4 Factors associated with CIPN Diagnosis Limitations of current studies: small sample size, lack of generalizability, inadequate patient follow up Sources: Rivera et al. 2018; Staff N, et al. 2017; Hershmann D, et al. 2016; Fontes et al. 2016; Serenty et al. 2014; Bao et al. 2016; Bulls et al March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

5 Study Aims & Team To examine factors associated with peripheral neuropathy (PN) diagnosis and treatment in a cohort of insured cancer patients in three integrated health systems using real world EHR data Research Team KP Washington: Jessica Chubak, Rebecca Ziebell, Laura Ichikawa HealthPartners: Pam Pawloski, Mary Becker NCI: Donna Rivera KP Northern California: Alyce Adams, Lin Ma, Tatjana Kolesvska Funder The NCI Cancer Research Network, Rapid Analysis pilot study 5 March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

6 Methods (1) Setting: 3 geographically diverse health systems (KPNC, KP Washington, HealthPartners) Data Source: VDW Study Sample Inclusions: 1 st observed (invasive) cancer diagnosis age ; prescribed neurotoxic chemotherapy within 12 months of diagnosis; enrolled at time of diagnosis, chemotherapy, and 12 months prior to chemotherapy with at least one clinic visit Exclusions: diagnosis of PN or use of PN study drug in 12 months before chemotherapy start; opted out of research studies 6 March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

7 Methods (2) Outcome Measures New Dx of Peripheral Neuropathy following chemo start Newly dispensed PN medication following PN Dx Covariates Patient demographics Tumor characteristics Class of chemotherapy received Comorbidities Use of non-cancer drugs with known neurotoxic risk Statistical Analysis Cox PH models 7 March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

8 Characteristics of patients initiating chemotherapies of interest (13,051) Age (15%) (29%) (33%) (19%) (4%) Sex Female 8260 (63%) Male 4791 (37%) Race White 9820 (75%) Black or African American 1015 (8%) Asian or Pacific Islander 2033 (16%) All Other/Unknown 173 (1%) Ethnicity Hispanic (89%) Non-Hispanic 1404 (11%) 8 March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

9 OTHER VINCA ALKALOID PLATINUM TAXANE First Chemotherapy Drug Used by Class* Paclitaxel Docetaxel Carboplatin Cisplatin paclitaxel 1699 docetaxel 689 Oxaliplatin Vincristine Vinorelbine Vinblastine Etoposide Ixabepilone Bortezomib Lenalidomide carboplatin 1147 oxaliplatin 802 cisplatin % of patients used a combination of drugs, mainly Taxane and Platinum * Drugs used by n 10 patients not shown Number of patients 9 March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

10 Cumulative Incidence Curve for PN Dx, accounting for competing risk 10 March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

11 Cumulative Incidence Curve for PN Treatment, accounting for competing risk 11 March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

12 Time to PN Diagnosis Post Chemotherapy Start Site A (ref) B C Age (ref) Sex Race Adjusted HR % CI p-value Female (ref) Male White, non-hispanic (ref) Black/AA, non-hispanic Hispanic Asian/PI Other/Unknown < < March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

13 Time to PN Diagnosis, cont Adjusted HR 95% CI p-value Seer Stage Diabetes Chronic Pain Other Comorbidities Other Neurotoxic Agents Local Regional (ref) Distant Unstaged yes no yes no yes no yes no < < < March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

14 Time to PN Diagnosis: Chemotherapy Class Drug Class Adjusted HR 95% CI p-value platinum only (ref) < No platinum platinum+taxane platinum+other platinum+taxane+ other March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

15 Time to New PN Treatment Post PN Dx Site A (ref) B C Age (ref) Sex Race Adjusted HR % CI p-value Female (ref) Male White, non-hispanic (ref) Black/AA, non-hispanic Hispanic Asian/PI Other < March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

16 Time to PN Treatment, cont Median Time to Dx (Days) Adjusted HR 95% CI p-value Seer Stage Local Regional (ref) Distant Unstaged 46 (0-270) 73 (1-288) 32 (0-147) 0 (0-180) Seizure Disorder yes no 26 (0-180) 50 (0-230) Chronic Pain yes no 61 (0-270) 41 (0-200) < March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

17 Conclusions Factors associated with elevated risk PN Dx Combination taxane and platinum treatment compared to platinum only (similar result compared to taxane only) Health care system Black/African American race Age Regional tumor Comorbid: diabetes, chronic pain Use of other neurotoxic agents PN Treatment Health care system Black/African American race Comorbid chronic pain 17 March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

18 Strengths and Limitations Strengths Sample size Data from multiple health systems Ability to control for multiple clinical risk factors Limitations Dx rather than assessment of CIPN Unmeasured confounders 18 March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

19 DISCUSSION 19 March 27, Kaiser Foundation Health Plan, Inc. For internal use only.

20 THANK YOU 20 March 27, Kaiser Foundation Health Plan, Inc. For internal use only.