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Estimating global treatment toxicity burden from adverse‐event data
Author(s) -
Lee Shing M.,
Hershman Dawn L.,
Miao Jieling,
Zhong Xiaobo,
Unger Joseph M.,
Cheung Ying Kuen Ken
Publication year - 2018
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.31107
Subject(s) - medicine , adverse effect , toxicity , event (particle physics) , intensive care medicine , quantum mechanics , physics
BACKGROUND A summary measure that reflects the global toxicity burden of a treatment is essential for comparing therapies. Current toxicity summaries are ad hoc and do not distinguish among the severities and types of toxicities. Here a clinically feasible method for estimating the toxicity burden, based on a prospective evaluation of the toxicity profile of a randomized clinical trial of 746 prostate cancer patients conducted by SWOG, is proposed. METHODS For 308 patients who experienced severe toxicities, 2 physicians randomly selected from 14 physicians evaluated each toxicity profile and assigned a visual analogue scale score (0‐10) based on their impression of the global burden of toxicities. With mixed‐effects models, severity scores and a 10‐point toxicity burden score (TBS) were derived from 27 predictors accounting for severe (grade 3) and life‐threatening (grade 4) toxicities for each organ class of the Common Terminology Criteria for Adverse Events. RESULTS For most organ classes, grade 3 toxicities had a TBS of 4.14 (95% confidence interval [CI], 3.65‐4.63), but infections, cardiovascular events, and pulmonary events had a higher TBS with differences of 0.87 (95% CI, 0.53‐1.21), 0.88 (95% CI, 0.51‐1.25), and 0.73 (95% CI, 0.22‐1.24), respectively. Moreover, most grade 4 events had a higher TBS than grade 3 events, except for hemorrhaging, pain, metabolic events, and musculoskeletal events. The intrarater and interrater correlations were 0.91 and 0.59, respectively. CONCLUSIONS The burden of toxicity grades differs with toxicity types. A TBS provides a toxicity burden summary that incorporates physicians' perspectives and differentiates between severe and life‐threatening toxicities and organ classes. Cancer 2018;124:858‐64 . © 2017 American Cancer Society .