化疗诱导周围神经毒性的医疗保健提供者和患者评估的前瞻性评估。
Prospective Evaluation of Health Care Provider and Patient Assessments in Chemotherapy-Induced Peripheral Neurotoxicity.
机构信息
From Experimental Neurology Unit (P.A., G.C.) and Bicocca Bioinformatics Biostatistics and Bioimaging Centre-B4 (D.P.B., M.G.V.), School of Medicine and Surgery, University of Milano-Bicocca, Monza; NeuroMI (Milan Center for Neuroscience) (P.A., G.C.), Milan, Italy; Johns Hopkins University School of Medicine (D.R.C.), Baltimore, MD; Department of Neurology (I.S.J.M., C.G.F.), Maastricht University Medical Centre, the Netherlands; Department of Neurology (I.S.J.M.), St Elisabeth Hospital, Willemstad, Curaçao; University of New South Wales (S.B.P.), Sydney, Australia; Unit of Neuro-Oncology, Neurology Department (R.V., J.B.), Hospital Universitari de Bellvitge-ICO l'Hospitalet, IDIBELL, L'Hospitalet de Llobregat, Barcelona; Institute of Neurosciences and Department of Cell Biology, Physiology and Immunology (R.V., J.B.), Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Bellaterra, Spain; Service de Neurologie Mazarin (D.P.), Hôpital de la Pitié-Salpêtrière, Université Paris Sorbonne, Paris, France; Department of Neurology and West German Cancer Center (S.K.), University of Essen, Germany; IRCCS Regina Elena Cancer Institute (A.P.), Neuro-Oncology Unit, Rome, Italy; Department of Pain & Translational Symptom Science (S.G.D.), University of Maryland Baltimore; Neurological Department (A.A.A.), Saint Andrew's General Hospital of Patras; Department of Medicine, Division of Oncology (A.A.A., H.P.K.), Medical School, University of Patras, Greece; Department of Neurosciences (C.B.), University of Padova; Department of Neurosciences, Rehabilitation, Ophthalmology, Genetic and Maternal and Infantile Sciences (DINOGMI) (A.S.), University of Genova; Unit of Neurology and Neuromuscular Diseases (A.M.), Department of Clinical and Experimental Medicine, University of Messina, Italy; and Ludwig Boltzmann Institute for Experimental und Clinical Traumatology (W.G.), Vienna, Austria.
出版信息
Neurology. 2021 Aug 17;97(7):e660-e672. doi: 10.1212/WNL.0000000000012300. Epub 2021 Jun 2.
BACKGROUND AND OBJECTIVE
There is no agreement on the gold standard for detection and grading of chemotherapy-induced peripheral neurotoxicity (CIPN) in clinical trials. The objective is to perform an observational prospective study to assess and compare patient-based and physician-based methods for detection and grading of CIPN.
METHODS
Consecutive patients, aged 18 years or older, candidates for neurotoxic chemotherapy, were enrolled in the United States, European Union, or Australia. A trained investigator performed physician-based scales (Total Neuropathy Score-clinical [TNSc], used to calculate Total Neuropathy Score-nurse [TNSn]) and supervised the patient-completed questionnaire (Functional Assessment of Cancer Treatment/Gynecologic Oncology Group-Neurotoxicity [FACT/GOG-NTX]). Evaluations were performed before and at the end of chemotherapy. On participants without neuropathy at baseline, we assessed the association between TNSc, TNSn, and FACT/GOG-NTX. Considering a previously established minimal clinically important difference (MCID) for FACT/GOG-NTX, we identified participants with and without a clinically important deterioration according to this scale. Then, we calculated the MCID for TNSc and TNSn as the difference in the mean change score of these scales between the 2 groups.
RESULTS
Data from 254 participants were available: 180 (71%) had normal neurologic status at baseline. At the end of the study, 88% of participants developed any grade of neuropathy. TNSc, TNSn, and FACT/GOG-NTX showed good responsiveness (standardized mean change from baseline to end of chemotherapy >1 for all scales). On the 153 participants without neuropathy at baseline and treated with a known neurotoxic chemotherapy regimen, we verified a moderate correlation in both TNSc and TNSn scores with FACT/GOG-NTX (Spearman correlation index = 0.6). On the same sample, considering as clinically important a change in the FACT/GOG-NTX score of at least 3.3 points, the MCID was 3.7 for TNSc and 2.8 for the TNSn.
CONCLUSIONS
MCID for TNSc and TNSn were calculated and the TNSn can be considered a reliable alternative objective clinical assessment if a more extended neurologic examination is not possible. The FACT/GOG-NTX score can be reduced to 7 items and these items correlate well with the TNSc and TNSn.
CLASSIFICATION OF EVIDENCE
This study provides Class III evidence that a patient-completed questionnaire and nurse-assessed scale correlate with a physician-assessed scale.
背景与目的
目前，对于临床试验中化疗诱导的周围神经毒性（CIPN）的检测和分级，尚无金标准。本研究旨在进行一项观察性前瞻性研究，以评估和比较基于患者和基于医生的 CIPN 检测和分级方法。
方法
本研究在美国、欧盟或澳大利亚招募了年龄在 18 岁及以上、符合神经毒性化疗条件的连续患者。一名经过培训的调查员进行了基于医生的量表（总神经病变评分-临床量表[TNSc]，用于计算总神经病变评分-护士量表[TNSn]）评估，并监督了患者完成的问卷（癌症治疗功能评估/妇科肿瘤学组神经毒性量表[FACT/GOG-NTX]）。在化疗前和化疗结束时进行评估。在基线时无神经病变的参与者中，我们评估了 TNSc、TNSn 和 FACT/GOG-NTX 之间的相关性。考虑到 FACT/GOG-NTX 的先前建立的最小临床重要差异（MCID），我们根据该量表确定了具有和不具有临床显著恶化的参与者。然后，我们计算了 TNSc 和 TNSn 的 MCID，即这两个量表在两组之间的平均变化评分差值。
结果
共有 254 名参与者的数据可用：180 名（71%）在基线时神经状态正常。研究结束时，88%的参与者出现任何级别的神经病变。TNSc、TNSn 和 FACT/GOG-NTX 均表现出良好的反应性（所有量表从基线到化疗结束时的标准化平均变化均大于 1）。在基线时无神经病变且接受已知神经毒性化疗方案治疗的 153 名参与者中，我们验证了 TNSc 和 TNSn 评分与 FACT/GOG-NTX 之间存在中度相关性（Spearman 相关系数=0.6）。在同一样本中，考虑到 FACT/GOG-NTX 评分至少变化 3.3 分具有临床意义，TNSc 的 MCID 为 3.7，TNSn 的 MCID 为 2.8。
结论
计算了 TNSc 和 TNSn 的 MCID，如果不可能进行更广泛的神经检查，则 TNSn 可被视为可靠的替代客观临床评估方法。FACT/GOG-NTX 评分可以简化为 7 项，这些项目与 TNSc 和 TNSn 相关性良好。
证据分类
本研究提供了 III 级证据，表明患者完成的问卷和护士评估的量表与医生评估的量表相关。
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