| Autor: |
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 |
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| Zdroj: |
Supportive Care in Cancer; Nov2017, Vol. 25 Issue 11, p3537-3544, 8p |
| Abstrakt: |
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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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