Department of Pharmacy, Houston Methodist Hospital, Houston, TX, USA.
Department of Pharmacy Practice, College of Pharmacy and Health Sciences, Texas Southern University, Houston, TX, USA.
Support Care Cancer. 2020 Apr;28(4):1901-1912. doi: 10.1007/s00520-019-05006-6. Epub 2019 Jul 29.
Chemotherapy-induced peripheral neuropathy (CIPN) may necessitate chemotherapy dose reduction, delay, or discontinuation. This pilot study tested feasibility of patient enrollment, CIPN screening, and data collection in cancer patients for a future clinical study that will assess the safety and efficacy of an intervention that may prevent CIPN.
This prospective, observational, single-center, pilot study included adults with newly diagnosed lymphoma or multiple myeloma receiving neurotoxic chemotherapy. Patients were enrolled between September 2016 and February 2017. The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire was completed by patients at 3 time points: baseline, week 6, and week 12. The primary outcome was change in the neurotoxicity score between these time points.
Of 33 patients approached for consent, 28 (85%) provided consent and were enrolled. The FACT/GOG-Ntx questionnaire was completed by 28 (100%) at baseline, 25 (89%) at week 6, and 24 (86%) at week 12. Average (standard deviation) neurotoxicity scores were 36.5 (6.6) at baseline, 34.0 (8.3) at week 6, and 30.6 (7.6) at week 12. Neurotoxicity scores changed from baseline by - 2.7 points (95% CI - 5.5 to 0.1; p = 0.061) at week 6 and - 6.0 points (95% CI - 5.6 to - 0.8; p = 0.012) at week 12. Clinically meaningful declines (decrease of > 10% from baseline) in neurotoxicity score were detected in 36% (9 of 25) at week 6 and in 67% (16 of 24) at week 12.
Sixty-seven percent of patients experienced clinically significant CIPN within 12 weeks of starting chemotherapy. Feasibility metrics for enrollment, consent, CIPN assessment, and follow-up were met.
化疗引起的周围神经病(CIPN)可能需要减少、延迟或停止化疗剂量。这项试点研究旨在测试在癌症患者中进行未来临床研究的可行性,该研究将评估一种可能预防 CIPN 的干预措施的安全性和疗效。
这是一项前瞻性、观察性、单中心的试点研究,纳入了新诊断为淋巴瘤或多发性骨髓瘤并接受神经毒性化疗的成年人。患者于 2016 年 9 月至 2017 年 2 月期间入组。患者在 3 个时间点完成功能性评估癌症治疗/妇科肿瘤组神经毒性(FACT/GOG-Ntx)问卷:基线、第 6 周和第 12 周。主要结局是这些时间点之间的神经毒性评分变化。
在 33 名接受同意征询的患者中,有 28 名(85%)提供了同意并被纳入研究。28 名(100%)患者在基线时完成了 FACT/GOG-Ntx 问卷,25 名(89%)在第 6 周,24 名(86%)在第 12 周。平均(标准差)神经毒性评分分别为基线时 36.5(6.6)、第 6 周时 34.0(8.3)和第 12 周时 30.6(7.6)。第 6 周时,神经毒性评分从基线下降了 2.7 分(95%置信区间:-5.5 至 0.1;p=0.061),第 12 周时下降了 6.0 分(95%置信区间:-5.6 至-0.8;p=0.012)。第 6 周时,神经毒性评分下降超过基线的 10%(9/25)的患者占 36%,第 12 周时占 67%(16/24)。
67%的患者在开始化疗后 12 周内出现了有临床意义的 CIPN。入组、同意、CIPN 评估和随访的可行性指标均得到满足。