Chemotherapy-Induced Peripheral Neuropathy (CIPN) Measurement Approaches
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1 Chemotherapy-Induced Peripheral Neuropathy (CIPN) Measurement Approaches Ellen Lavoie Smith PhD, APRN, AOCN, FAAN Associate Professor PhD Program Director University of Michigan School of Nursing
2 Faculty Disclosure x No, nothing to disclose Yes, please specify: Company Name Honoraria/ Expenses Consulting/ Advisory Board Funded Research Royalties/ Patent Stock Options Ownership/ Equity Position Employee Other (please specify) Mundipharma x ASCO x Columbia University x
3 CIPN has been a difficult side effect to measure.
4 Measurement Challenges Don t tell, don t ask Lack skills No standardized approach Lack access to best measures Hardwired use of unreliable grading scales Under-es?mate severity Measurement error in clinical trials Hershman, et al., 2014; Gewandter, et al., 2017; Postma, et al., 1998; Griffith, et al., 2010; CavaleP, et al., 2010; Smith, et al., 2013; Albers, et al., 2011
5 Symmetrical Distal to Proximal Extension of Signs and Symptoms Stubblefield, et al., 2009
6 Adapted with permission from WebMD Scien?fic American Medicine. Neurotoxic Drugs & Our Nervous Systems Injury Brain Descending pathway Peripheral nerve DRG C-fiber A-beta fiber A-delta fiber Dorsal horn Spinal cord Ascending pathways
7 Measurement Approaches There is no gold standard approach for clinical and research sepngs. A comprehensive approach improves validity. Objec?ve measurement of large and small fibers Distal to proximal extension Pa?ent-reported outcomes (PRO) Func?on assessment Must have strong psychometric proper?es England, et al., 2005; EFNS/PNS, 2010; Alber?, et al., 2014; Griffith, et al., 2010; CavaleP, et al., 2010
8 ObjecGve Measures Clinical neurologic exam, quan?ta?ve sensory tes?ng (QST), nerve conduc?on studies (NCS), electromyography (EMG), skin biopsy Advantages Quan?fies actual nerve damage Assesses pre-clinical signs Useful in mechanis?c studies May be important for diagnosis in complex cases Disadvantages Require specialized training & equipment NCS & EMG - large fibers Skin biopsy small fibers QST, NCS, EMG & biopsy are costly, inconvenient, painful,?meconsuming, & may not be reimbursed QST? reliability Poor correla?on with pa?ent report England, et al., 2005, Ruppert, et al., 2003; EFNS/PNS, 2010; Smith, et al., 2008; Alber?, et al., 2014
9 Total Neuropathy Score (TNS) The only comprehensive composite tool to be extensively tested in pa?ents receiving neurotoxic chemotherapy Reliable, valid, sensi?ve, & responsive Mul?dimensional Symptoms - Proximal Extension Tingling, Numbness, Pain Signs e.g., Reflexes, Vibra?on & Pin Sensibility, Strength NCS and QST - Op?onal Abbreviated versions can be used in clinical prac?ce to assess adults and children. Griffith, et al., 2010; CavaleP, et al., 2007, 2010, 2013; Smith, et al., 2008, 2010, 2011, 2013; Wampler, et al., 2006; Gilchrist et al., 2009
10 5-itemTNS Scoring Smith, et al., 2013.
11 TNS-PV Responsiveness Sample: Children ages 1-18 receiving vincris?ne for ALL 6 TNS Versus Grading Scale Scores by Week N = 65 Mean Scores TNS Total (A) TNS Total (B) CTC Motor CTC Sensory Balis Motor Balis Sensory Month Smith, et al., 2013
12 TesGng VibraGon Sensibility Feasible to perform in individuals > 6 years of age Use weighted 128Hz Tuning Fork Smith, et al., 2013, Cancer Nursing; Smith et al., 2013, Clinical Journal of Oncology Nursing
13 Grading Scale Problems OK for screening but... Under-reports severity when compared to pa?ent report Poor sensi?vity & responsiveness No opera?onal defini?ons, poor reliability Imprecisely captures progression Preclinical and clinical signs/sx in same grade Distal to proximal extension What about pain? Postma, et al., 1998; Griffith, et al., 2010; CavaleP, et al., 2007, 2010, 2013; Smith, et al., 2010, 2011; Basch et al., 2006, 2009, 2010; Atkinson, et al., 2016
14 NaGonal Cancer InsGtute (NCI) CTCAE V. 4.0 Mandated in all NCI-Sponsored Trials Sensory Neuropathy Grade 0 Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 No signs or symptoms Asymptoma?c: loss of deep tendon reflexes or paresthesia Moderate symptoms: limi?ng instrumental ADL Severe symptoms: limi?ng self care ADL Lifethreatening consequences: urgent interven?on indicated Death Published: May 28, 2009 (v4.02: Sept. 15, 2009) Na?onal Ins?tutes of Health; Na?onal Cancer Ins?tute
15 PRO Measures Seven Measures: The most extensively tested are the FACT-GOG/ NTX & EORTC QLQ-CIPN20. Advantages Captures the pa?ent s experience berer than provider-rated scales Can be collected electronically Extensively tested, mul?ple transla?ons Doesn t require special training and ease of use in mul?site trials Some assess specific CIPN types (i.e., taxane, oxalipla?n) Curcio et al., 2017; Griffith, et al., 2010; CavaleP, et Disadvantages Doesn t capture pre-clinical signs Pa?ent burden,? Work flow Lack of systems to integrate & visualize scores within EMR systems No reimbursement incen?ve from payers despite survival benefit Sufficiently tested? Are all items good and necessary? No standard for use in prac?ce or
16 FACT GOG-NTX
17 QLQ CIPN20
18 QLQ CIPN20 (cont.)
19 Comparison of FACT GOG/NTX with CIPN20 FACT GOG/NTX/NTX12 QLQ-CIPN20 Number of Studies 10 9 Popula?ons N Range US, European, Asian, African Various Cancers Proper?es Tested ICR, Contras?ng Group, Content, Structural, Contras?ng Groups, & Convergent Validity, Sensi?vity & Specificity, Responsiveness N Range US, European, Asian Various Cancers ICR & Test-Retest Reliability; Content, Structural, Contras?ng Group, & Convergent Validity, Sensi?vity, Responsiveness, Mode Equivalence, Item Response Languages Numerous Numerous Neuropathy Types Strengths Weaknesses Taxanes, Pla?nums, Vinblas?ne, Bortezomib Feasible for mul?site trials Brief (11/12-items, 4-items) Some items may not be neuropathy-specific Taxanes, Pla?nums, Vincas, Bortezomib Feasible for mul?site trials Brief (20-items) but longer than FACT. Lack of Consensus About Autonomic & Driving items; Disordered response thresholds
20 Rasch Analysis-Response Ordering
21 Small Objects Foot Drop Pedals Erec?on
22 PRO-CTCAE - Neuropathy What was the SEVERITY of your NUMBNESS OR TINGLING IN YOUR HANDS OR FEET at its WORST in the past 7 days? How much did NUMBNESS OR TINGLING IN YOUR HANDS OR FEET INTERFERE with your usual or daily ac?vi?es in the past 7 days? 1 Not At All Very Much Concurrent validity when compared to QLQ CIPN20 Knoerl et al., 2017
23 Kennedy, et al., 2011; Stubblefield, et al., 2009; Mannil et al., 2014; Gilchrist, et al., 2016; Caronni, et al., 2016 FuncGon Measures Examples: Timed Up-and-Go (TUG), 9-Hole Peg Test, Bumps Test Advantages Assesses func?onal outcomes such as walking and balance, hand dexterity and sensory func?on. Useful for research sepngs Disadvantages Requires special training and equipment Time-consuming Limited psychometric tes?ng in CIPN
24 Summary No Consensus About Measurement Approaches But Many Good Op?ons Assess: At Baseline, During Rx, & In Survivors Prac?ce SePngs: CTCAE PRO-CTCAE 5-item TNS Research SePngs: Objec?ve Measures FACT GOG/NTX or QLQ-CIPN20 Func?onal Measures PRO-CTCAE
25 Thank you!
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