Analysis of chemotherapy-induced peripheral neuropathy using the Japanese Adverse Drug Event Report database

Abstract Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse event associated with several antineoplastic drugs; however, the precise risks and time course of reactions of particular drugs are not clearly understood. The aim of this study was to evaluate the relationship between an...

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Autores principales: Misaki Inoue, Kiyoka Matsumoto, Mizuki Tanaka, Yu Yoshida, Riko Satake, Fumiya Goto, Kazuyo Shimada, Ririka Mukai, Shiori Hasegawa, Takaaki Suzuki, Hiroaki Ikesue, Jun Liao, Tohru Hashida, Mitsuhiro Nakamura
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Publicado: Nature Portfolio 2021
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spelling oai:doaj.org-article:7796571f8629437685d0a677a289afe92021-12-02T18:24:55ZAnalysis of chemotherapy-induced peripheral neuropathy using the Japanese Adverse Drug Event Report database10.1038/s41598-021-90848-62045-2322https://doaj.org/article/7796571f8629437685d0a677a289afe92021-05-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-90848-6https://doaj.org/toc/2045-2322Abstract Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse event associated with several antineoplastic drugs; however, the precise risks and time course of reactions of particular drugs are not clearly understood. The aim of this study was to evaluate the relationship between anticancer agents and CIPN development using data from the Japanese Adverse Drug Event Report (JADER) database and to characterize the time-to-onset and outcomes of CIPN. Chemotherapy-induced peripheral neuropathy was defined using the Medical Dictionary for Regulatory Activities preferred terms. Disproportionality analysis was performed by calculating the reporting odds ratio (ROR) with 95% confidence interval for signal detection. Data of nine Anatomical Therapeutic Chemical (ATC) drug categories correlated with CIPN development, in addition to the data of the time-to-onset and outcomes. Among 622,289 reports in the JADER database from April 2004 to March 2020, there were 1883 reports of adverse events corresponding to peripheral neuropathy. The ROR (95% confidence interval) for vinblastine, sorbent-based paclitaxel (sb-PTX), oxaliplatin, and bortezomib was 20.4 (12.5–33.4), 13.6 (11.9–15.7), 26.2 (23.6–29.1), and 30.8 (26.6–35.8), respectively. The median duration (interquartile range) to CIPN development after the administration of vinca alkaloids and analogues, taxanes, platinum compounds, and monoclonal antibodies was 11.0 (5.0–46.5), 22.5 (6.0–82.5), 22.0 (6.0–68.5), and 32.5 (11.3–73.8) days, respectively. The median duration (interquartile range) of sb-PTX and nanoparticle albumin-bound (nab)-PTX was 35.0 (7.0–94.0) and 5.5 (3.0–29.3) days, respectively. Our analysis of records in the JADER database revealed several drugs associated with a high risk for CIPN development. In particular, the development of CIPN after vinca alkaloid administration should be closely monitored for 2 weeks after administration. CIPN caused by nab-PTX showed significantly faster onset than that by sb-PTX. Patients who receive taxanes or monoclonal antibodies often do not show an improvement; accordingly, early treatment is required.Misaki InoueKiyoka MatsumotoMizuki TanakaYu YoshidaRiko SatakeFumiya GotoKazuyo ShimadaRirika MukaiShiori HasegawaTakaaki SuzukiHiroaki IkesueJun LiaoTohru HashidaMitsuhiro NakamuraNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-11 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Misaki Inoue
Kiyoka Matsumoto
Mizuki Tanaka
Yu Yoshida
Riko Satake
Fumiya Goto
Kazuyo Shimada
Ririka Mukai
Shiori Hasegawa
Takaaki Suzuki
Hiroaki Ikesue
Jun Liao
Tohru Hashida
Mitsuhiro Nakamura
Analysis of chemotherapy-induced peripheral neuropathy using the Japanese Adverse Drug Event Report database
description Abstract Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse event associated with several antineoplastic drugs; however, the precise risks and time course of reactions of particular drugs are not clearly understood. The aim of this study was to evaluate the relationship between anticancer agents and CIPN development using data from the Japanese Adverse Drug Event Report (JADER) database and to characterize the time-to-onset and outcomes of CIPN. Chemotherapy-induced peripheral neuropathy was defined using the Medical Dictionary for Regulatory Activities preferred terms. Disproportionality analysis was performed by calculating the reporting odds ratio (ROR) with 95% confidence interval for signal detection. Data of nine Anatomical Therapeutic Chemical (ATC) drug categories correlated with CIPN development, in addition to the data of the time-to-onset and outcomes. Among 622,289 reports in the JADER database from April 2004 to March 2020, there were 1883 reports of adverse events corresponding to peripheral neuropathy. The ROR (95% confidence interval) for vinblastine, sorbent-based paclitaxel (sb-PTX), oxaliplatin, and bortezomib was 20.4 (12.5–33.4), 13.6 (11.9–15.7), 26.2 (23.6–29.1), and 30.8 (26.6–35.8), respectively. The median duration (interquartile range) to CIPN development after the administration of vinca alkaloids and analogues, taxanes, platinum compounds, and monoclonal antibodies was 11.0 (5.0–46.5), 22.5 (6.0–82.5), 22.0 (6.0–68.5), and 32.5 (11.3–73.8) days, respectively. The median duration (interquartile range) of sb-PTX and nanoparticle albumin-bound (nab)-PTX was 35.0 (7.0–94.0) and 5.5 (3.0–29.3) days, respectively. Our analysis of records in the JADER database revealed several drugs associated with a high risk for CIPN development. In particular, the development of CIPN after vinca alkaloid administration should be closely monitored for 2 weeks after administration. CIPN caused by nab-PTX showed significantly faster onset than that by sb-PTX. Patients who receive taxanes or monoclonal antibodies often do not show an improvement; accordingly, early treatment is required.
format article
author Misaki Inoue
Kiyoka Matsumoto
Mizuki Tanaka
Yu Yoshida
Riko Satake
Fumiya Goto
Kazuyo Shimada
Ririka Mukai
Shiori Hasegawa
Takaaki Suzuki
Hiroaki Ikesue
Jun Liao
Tohru Hashida
Mitsuhiro Nakamura
author_facet Misaki Inoue
Kiyoka Matsumoto
Mizuki Tanaka
Yu Yoshida
Riko Satake
Fumiya Goto
Kazuyo Shimada
Ririka Mukai
Shiori Hasegawa
Takaaki Suzuki
Hiroaki Ikesue
Jun Liao
Tohru Hashida
Mitsuhiro Nakamura
author_sort Misaki Inoue
title Analysis of chemotherapy-induced peripheral neuropathy using the Japanese Adverse Drug Event Report database
title_short Analysis of chemotherapy-induced peripheral neuropathy using the Japanese Adverse Drug Event Report database
title_full Analysis of chemotherapy-induced peripheral neuropathy using the Japanese Adverse Drug Event Report database
title_fullStr Analysis of chemotherapy-induced peripheral neuropathy using the Japanese Adverse Drug Event Report database
title_full_unstemmed Analysis of chemotherapy-induced peripheral neuropathy using the Japanese Adverse Drug Event Report database
title_sort analysis of chemotherapy-induced peripheral neuropathy using the japanese adverse drug event report database
publisher Nature Portfolio
publishDate 2021
url https://doaj.org/article/7796571f8629437685d0a677a289afe9
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