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一种用于监测奥沙利铂诱导的周围神经病变进展的新工具CLIP试验:一项多中心前瞻性研究。

A new monitoring tool CLIP test for progression of oxaliplatin-induced peripheral neuropathy: A multicenter prospective study.

作者信息

Kamei Keiko, Ohnishi Tadashi, Nakata Ken, Danno Katsuki, Ohkawa Atsushi, Miyake Yasuhiro, Okazaki Satoshi, Fukunaga Mutsumi, Toyokawa Akihiro, Hamada Tetsuhiro, Shindoh Junichi, Kanazawa Akiyoshi

机构信息

Department of Surgery, Kindai University Faculty of Medicine, Osakasayama, Japan.

Department of Surgery, Nishinomiya Municipal Central Hospital, Nishinomiya, Japan.

出版信息

Asia Pac J Clin Oncol. 2020 Oct;16(5):e257-e262. doi: 10.1111/ajco.13404. Epub 2020 Sep 7.

DOI:10.1111/ajco.13404
PMID:32893979
Abstract

INTRODUCTION

Oxaliplatin-induced peripheral neuropathy (OIPN) is a common adverse events that can limit a patient's quality of life during/after chemotherapy. However, no appropriate methods have been established yet for monitoring the risk of progression of OIPN.

METHODS

A simple assessment tool using gem clips, the CLIP test, was established and its performance in predicting the risk of progression to ≥grade 2 peripheral sensory neuropathy (CTCAE ver. 4.0) was investigated in patients receiving chemotherapy with oxaliplatin.

RESULTS

Among 101 patients included in this study, 71 patients developed CTCAE ≥grade 1 peripheral neuropathy (grade 1, n = 67; grade 2, n = 4) at a median of 63 (range, 14-259) days after the start of treatment. Of the 67 patients with grade 1 peripheral neuropathy, 17 showed progression to ≥grade 2 neuropathy after a median interval of 84 (range, 21-246) days. Of these patients, 27 showed a positive result of the CLIP test at a median of 91 (range, 14-224) days, excluding one patient who already showed a positive result of the test at the baseline. Therefore, the risk ratio for the development of CTCAE ≥grade 2 peripheral neuropathy was 8.3 in the patients who showed a positive result on the CLIP test. Multivariate analysis confirmed that a positive results on the CLIP test was significantly correlated with the risk of future development of CTCAE ≥grade 2 peripheral neuropathy (odds ratio, 9.37; P = 0.002).

CONCLUSION

A positive result on the CLIP test predict is predictive of the risk of progression of OIPN during chemotherapy with oxaliplatin.

摘要

引言

奥沙利铂引起的周围神经病变(OIPN)是一种常见的不良事件,会限制患者化疗期间及化疗后的生活质量。然而,尚未建立监测OIPN进展风险的合适方法。

方法

建立了一种使用宝石夹的简单评估工具——CLIP试验,并在接受奥沙利铂化疗的患者中研究其预测进展为≥2级周围感觉神经病变(CTCAE 4.0版)风险的性能。

结果

本研究纳入的101例患者中,71例在治疗开始后中位63天(范围14 - 259天)出现CTCAE≥1级周围神经病变(1级,n = 67;2级,n = 4)。67例1级周围神经病变患者中,17例在中位84天(范围21 - 246天)后进展为≥2级神经病变。在这些患者中,27例在中位91天(范围14 - 224天)时CLIP试验呈阳性,排除1例基线时试验已呈阳性的患者。因此,CLIP试验呈阳性的患者发生CTCAE≥2级周围神经病变的风险比为8.3。多因素分析证实,CLIP试验阳性与未来发生CTCAE≥2级周围神经病变的风险显著相关(优势比,9.37;P = 0.002)。

结论

CLIP试验阳性可预测奥沙利铂化疗期间OIPN进展的风险。

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