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Support Care Cancer. 2017 Nov;25(11):3537-3544. doi: 10.1007/s00520-017-3780-y. Epub 2017 Jun 20.

Patient-reported (EORTC QLQ-CIPN20) versus physician-reported (CTCAE) quantification of oxaliplatin- and paclitaxel/carboplatin-induced peripheral neuropathy in NCCTG/Alliance clinical trials.

Author information

1
Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
2
Mayo Clinic Cancer Center, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
3
Department of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
4
Regeneron Pharmaceuticals, Basking Ridge, NJ, USA.
5
Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, USA.
6
Pain and Translational Symptom Science Department, School of Nursing, University of Maryland, Baltimore, MD, USA.
7
Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.
8
Mayo Clinic Cancer Center, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. cloprinzi@mayo.edu.
9
Department of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. cloprinzi@mayo.edu.
10
Mayo Clinic Cancer Center, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. beutler.andreas@mayo.edu.
11
Department of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. beutler.andreas@mayo.edu.

Abstract

PURPOSE:

Clinical practice guidelines on chemotherapy-induced peripheral neuropathy (CIPN) use the NCI Common Terminology Criteria for Adverse Events (CTCAE), while recent clinical trials employ a potentially superior measure, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20), a patient-reported outcome (PRO). Practitioners and researchers lack guidance, regarding how QLQ-CIPN20 results relate to the traditional CTCAE during the serial assessment of patients undergoing chemotherapy.

METHODS:

Two large CIPN clinical trial datasets (538 patients) pairing QLQ-CIPN20 and CTCAE outcomes were analyzed using a multivariable linear mixed model with QLQ-CIPN20 score as the outcome variable, CTCAE grade as the main effect, and patient as random effect (accounting for internal correlation of serial measures).

RESULTS:

The association between QLQ-CIPN20 scores and CTCAE grades was strong (p < 0.0001), whereby patients with higher CTCAE grade had worse QLQ-CIPN20 scores. Some variation of QLQ-CIPN20 scores was observed based on drug, treatment, and cycle. While there was a marked difference in the mean QLQ-CIPN20 scores between CTCAE grades, the ranges of QLQ-CIPN20 scores within each CTCAE grade were large, leading to large overlap in CIPN20 scores across CTCAE grades.

CONCLUSIONS:

A strong positive association of QLQ-CIPN20 scores and CTCAE grade provides evidence of convergent validity as well as practical guidance, as to how to quantitatively interpret QLQ-CIPN20 scores at the study level in terms of the traditional CTCAE. The present results also highlight an important clinical caveat, specifically, that conversion of a specific QLQ-CIPN20 score to a specific CTCAE score may not be reliable at the level of an individual patient.

KEYWORDS:

CTCAE; EORTC QLQ-CIPN20; Patient-reported outcome; Peripheral neuropathy; Physician-reported outcome

PMID:
28634656
PMCID:
PMC5693734
DOI:
10.1007/s00520-017-3780-y
[Indexed for MEDLINE]
Free PMC Article

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