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- Title
Patient-reported (EORTC QLQ-CIPN20) versus physician-reported (CTCAE) quantification of oxaliplatin- and paclitaxel/carboplatin-induced peripheral neuropathy in NCCTG/Alliance clinical trials.
- Authors
Le-Rademacher, Jennifer; Pachman, Deirdre; Qin, Rui; Ruddy, Kathryn; Banck, Michaela; Sloan, Jeff; Loprinzi, Charles; Beutler, Andreas; Kanwar, Rahul; Seisler, Drew; Abyzov, Alexej; Lavoie Smith, Ellen; Dorsey, Susan; Aaronson, Neil; Pachman, Deirdre R; Ruddy, Kathryn J; Banck, Michaela S; Lavoie Smith, Ellen M; Dorsey, Susan G; Aaronson, Neil K
- Abstract
<bold>Purpose: </bold>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.<bold>Methods: </bold>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).<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Subjects
QUALITY of life; CANCER patients; OXALIPLATIN; CARBOPLATIN; PERIPHERAL neuropathy; PACLITAXEL; ANTINEOPLASTIC agents; ORGANOPLATINUM compounds; PHYSICIANS; QUESTIONNAIRES; RESEARCH funding; TUMORS
- Publication
Supportive Care in Cancer, 2017, Vol 25, Issue 11, p3537
- ISSN
0941-4355
- Publication type
journal article
- DOI
10.1007/s00520-017-3780-y