■化疗诱导的周围神经病变(CIPN)是抗癌治疗的实质性副作用。因此,CIPN的评估在研究和临床环境中仍然至关重要.
■比较各种患者报告的结果测量(PROMs)与神经生理学和感觉功能测量作为CIPN评估的最佳方法的有效性。
这项队列研究使用双重研究设计评估了2个队列中接受神经毒性化疗的参与者。开始治疗的参与者在神经毒性治疗开始时进行前瞻性评估,中期治疗,在治疗结束时。对在5年前完成治疗的参与者进行横断面评估,并完成一个评估时间点。参与者从2015年8月至2022年11月从澳大利亚的肿瘤中心招募。数据分析发生在2023年2月至11月。
■神经毒性癌症治疗,包括紫杉烷,铂族,长春花生物碱,蛋白酶体抑制剂,还有沙利度胺.
■CIPN通过PROMs(欧洲癌症研究和治疗组织生活质量问卷[EORTC-CIPN20],癌症治疗的功能评估/妇科癌症组神经毒性问卷(FACT/GOG-Ntx),和患者报告的结果版本的常见不良事件术语标准[PRO-CTCAE]),神经和神经生理学评估(总神经病变评分和腓肠和胫骨复合神经振幅),和感官措施(光栅方向,冯·弗雷单丝,和2点歧视任务)。评估了CIPN结局指标的核心测量特性。在治疗完成后,横向评估收敛和已知群体的有效性,在治疗期间前瞻性评估反应性。神经学,神经生理学,使用线性回归分析比较报告高和低水平CIPN症状的患者的感觉结果评分和感觉结果评分。
■共有1033名参与者(年龄中位数,61[50-59]岁;676名女性[65.4%])被招募到这项研究中,纳入1623评估。PROM表现出准确评估CIPN(收敛有效性)的最佳能力,尤其是PRO-CTCAE综合评分(r=0.85;P<.001)和EORTC-CIPN20(r=0.79;P<.001)。PROMS还证明了区分CIPN严重程度(已知组有效性)和检测CIPN发展开始时变化(反应性)的最佳能力,特别是EORTC-CIPN20(d=0.67;95%CI,0.52-0.83),FACT/GOG-Ntx(d=0.65;95%CI,0.49-0.81)和PRO-CTCAE(d=0.83;95%CI,0.64-1.02)。其他措施没有达到收敛有效性的阈值(α<0.7)。神经生理学和感觉测量未显示可接受的反应性。在回归模型中,神经学,神经生理学,与报告CIPN症状水平较低的参与者相比,报告CIPN症状水平较高的参与者的感觉结局指标明显受损。
■在这项1033名癌症患者的队列研究中,PROM是唯一满足所有3个核心测量属性标准(收敛有效性,已知群体有效性,和响应能力)。这些发现表明,在临床实践中采用PROM可以为临床医生提供评估CIPN发病率的有价值的信息。
UNASSIGNED: Chemotherapy-induced peripheral neuropathy (CIPN) is a substantial adverse effect of anticancer treatments. As such, the assessment of CIPN remains critically important in both research and clinic settings.
UNASSIGNED: To compare the validity of various patient-reported outcome measures (PROMs) with neurophysiological and sensory functional measures as the optimal method of CIPN assessment.
UNASSIGNED: This cohort study evaluated participants treated with neurotoxic chemotherapy across 2 cohorts using a dual-study design. Participants commencing treatment were assessed prospectively at beginning of neurotoxic treatment, midtreatment, and at the end of treatment. Participants who completed treatment up to 5 years prior were assessed cross-sectionally and completed a single assessment time point. Participants were recruited from oncology centers in Australia from August 2015 to November 2022. Data analysis occurred from February to November 2023.
UNASSIGNED: Neurotoxic cancer treatment including taxanes, platinums, vinca-alkaloids, proteasome inhibitors, and thalidomide.
UNASSIGNED: CIPN was assessed via PROMs (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-CIPN20], Functional Assessment of Cancer Therapy/Gynecological Cancer Group Neurotoxicity Questionnaire (FACT/GOG-Ntx), and the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events [PRO-CTCAE]), neurological and neurophysiological assessment (Total Neuropathy Score and sural and tibial compound nerve amplitudes), and sensory measures (Grating orientation, Von Frey monofilament, and 2-point discrimination tasks). Core measurement properties of CIPN outcome measures were evaluated. Convergent and known-groups validity was assessed cross-sectionally following treatment completion, and responsiveness was evaluated prospectively during treatment. Neurological, neurophysiological, and sensory outcome measure scores were compared between those who reported high and low levels of CIPN symptoms using linear regressions.
UNASSIGNED: A total of 1033 participants (median [IQR] age, 61 [50-59] years; 676 female [65.4%]) were recruited to this study, incorporating 1623 assessments. PROMs demonstrated best ability to accurately assess CIPN (convergent validity), especially the PRO-CTCAE composite score (r = 0.85; P < .001) and EORTC-CIPN20 (r = 0.79; P < .001). PROMS also demonstrated the best ability to discriminate between CIPN severity (known-groups validity) and to detect changes at onset of CIPN development (responsiveness), especially for EORTC-CIPN20 (d = 0.67; 95% CI, 0.52-0.83), FACT/GOG-Ntx (d = 0.65; 95% CI, 0.49-0.81) and the PRO-CTCAE (d = 0.83; 95% CI, 0.64-1.02). Other measures did not achieve threshold for convergent validity (α < 0.7). Neurophysiological and sensory measures did not demonstrate acceptable responsiveness. In regression models, neurological, neurophysiological, and sensory outcome measures were significantly impaired in participants who reported high levels of CIPN symptoms compared with those who reported low levels of CIPN symptoms.
UNASSIGNED: In this cohort study of 1033 cancer patients, PROMs were the only measures to satisfy all 3 core measurement property criteria (convergent validity, known-groups validity, and responsiveness). These findings suggest that adoption of PROMs in clinical practice can equip clinicians with valuable information in assessing CIPN morbidity.