One-year incidence of chemotherapy-induced peripheral neuropathy in oxaliplatin- or taxane-based chemotherapy: a multicenter, prospective registry study (MiroCIP study).

IF 2.5 3区 医学 Q3 PHARMACOLOGY & PHARMACY Expert Opinion on Pharmacotherapy Pub Date : 2025-01-22 DOI:10.1080/14656566.2025.2455445
Sonoko Misawa, Tadamichi Denda, Sho Kodama, Takuji Suzuki, Yoichi Naito, Takahiro Kogawa, Mamoru Takada, Aoi Hino, Kazuhito Shiosakai, Satoshi Kuwabara
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Abstract

Background: Chemotherapy-induced peripheral neuropathy (CIPN) and its associated pain negatively affect patient outcomes and quality of life (QoL). The two-part MiroCIP study included interventional and prospective observational studies. Here, we report the latter, describing CIPN incidence, risk factors, and outcomes.

Research design and methods: This 1-year, multicenter, prospective registry study (May 2021-April 2023) included patients aged ≥20 years with colorectal, gastric, non-small cell lung, or breast cancer who were scheduled to undergo chemotherapy with oxaliplatin or taxane. The primary endpoint was Grade ≥ 2 sensory CIPN incidence within 12 months after chemotherapy initiation. Subjective and objective symptoms, QoL, and pain were evaluated.

Results: Overall, 216 patients (female, 64.4%; mean age, 60.3 years) were included. Ninety-one (42.1%) and 131 (60.6%) patients received oxaliplatin- and taxane-based chemotherapy, respectively (six received both and were included in both groups). Grade ≥ 2 CIPN occurred in 96 patients (44.4%; 72.8/100 person-years), with 70.8% (68/96 patients) developing symptoms within 90 days. The most prominent CIPN symptoms were limb numbness/tingling and decreased vibration sensibility. No clinically meaningful risk factors were identified.

Conclusions: We clarified CIPN incidence in cancer patients. Subjective symptoms (limb numbness/tingling, decreased vibration sensibility) and pain are important CIPN symptoms requiring careful monitoring.

Trial registration: jRCTs031210101.

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以奥沙利铂或紫杉烷为基础的化疗中化疗引起的周围神经病变的一年发生率:一项多中心、前瞻性登记研究(MiroCIP研究)。
背景:化疗引起的周围神经病变(CIPN)及其相关的疼痛会对患者的预后和生活质量(QoL)产生负面影响。两部分的MiroCIP研究包括干预性和前瞻性观察性研究。在这里,我们报告后者,描述CIPN的发病率、危险因素和结局。研究设计和方法:这项为期1年的多中心前瞻性登记研究(2021年5月至2023年4月)纳入年龄≥20岁的结直肠癌、胃癌、非小细胞肺癌或乳腺癌患者,这些患者计划接受奥沙利铂或紫杉烷化疗。主要终点是化疗开始后12个月内感觉CIPN发生率≥2级。评估主客观症状、生活质量和疼痛。结果:共216例患者(女性,64.4%;平均年龄60.3岁)。分别有91名(42.1%)和131名(60.6%)患者接受了奥沙利铂和紫杉烷为基础的化疗(6名患者同时接受了两种化疗,并被纳入两组)。96例患者发生≥2级CIPN (44.4%;72.8/100人年),其中70.8%(68/96例)在90天内出现症状。最突出的CIPN症状是肢体麻木/刺痛和振动敏感性下降。未发现有临床意义的危险因素。结论:我们明确了CIPN在癌症患者中的发病率。主观症状(肢体麻木/刺痛,振动敏感性下降)和疼痛是重要的CIPN症状,需要仔细监测。试验注册:jRCTs031210101。
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来源期刊
CiteScore
5.60
自引率
3.10%
发文量
163
审稿时长
4-8 weeks
期刊介绍: Expert Opinion on Pharmacotherapy is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles and original papers on newly approved/near to launch compounds mainly of chemical/synthetic origin, providing expert opinion on the likely impact of these new agents on existing pharmacotherapy of specific diseases.
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