NPE®山茶提取物预防女性乳腺癌术后放疗患者急性辐射引起的皮肤反应:一项单中心、前瞻性、开放标签的试点研究

IF 1.6 Q4 ONCOLOGY
International Journal of Breast Cancer Pub Date : 2018-07-02 eCollection Date: 2018-01-01 DOI:10.1155/2018/2479274
Gabriela Näf, Urs E Gasser, Hans E Holzgang, Sandra Schafroth, Christoph Oehler, Daniel R Zwahlen
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引用次数: 4

摘要

研究背景:评价山茶(CSNF)提取物NPE对急性放射性皮肤反应(ARSR)的预防和恢复以及术后全乳放疗(RT)期间皮肤护理的效果。方法:20例患者被纳入这项单中心、前瞻性、开放标签的先导研究。将20个前瞻性数据集的结果与100个回顾性收集的来自医院记录的匹配数据集进行比较。预防性CSNF凝胶(2.5%)在每次照射前1至2小时施用于辐照场。护理CSNF洗剂(0.4%)在每次RT后进行7天预处理,在RT期间每天两次,之后4至8周。对照组按医院护理指南进行治疗。主要终点是达到ARSR≥2级的时间(CTCAE v4.03);次要终点是ARSR 1、2、3和4级的频率,ARSR的恢复,中断和RT停止的频率,并发症和所需的抢救干预,以及CSNF的耐受性。结果:CSNF组至ARSR≥G2(切除)的时间明显延长(p = 0.014)。风险比为2.33 (95% CI: 1.15-4.72),表明发生ARSR≥G2的风险降低了50%。在CSNF组中,ARSR G2的恢复速度更快(100% vs 47%;P = 0.078)。与CSNF组相比,对照组在RT和随访期间需要抢救治疗的患者比例明显高于CSNF组(1%至51%对0%至15%)。结论:本初步研究首次证明了CSNF提取物在预防RT诱导的ARSR和术后全乳RT患者皮肤刺激恢复方面的潜在药理作用,可能反映了一种预防RT诱导的ARSR和刺激皮肤护理的新概念。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Prevention of Acute Radiation-Induced Skin Reaction with NPE® Camellia Sinensis Nonfermentatum Extract in Female Breast Cancer Patients Undergoing Postoperative Radiotherapy: A Single Centre, Prospective, Open-Label Pilot Study.

Prevention of Acute Radiation-Induced Skin Reaction with NPE® Camellia Sinensis Nonfermentatum Extract in Female Breast Cancer Patients Undergoing Postoperative Radiotherapy: A Single Centre, Prospective, Open-Label Pilot Study.

Prevention of Acute Radiation-Induced Skin Reaction with NPE® Camellia Sinensis Nonfermentatum Extract in Female Breast Cancer Patients Undergoing Postoperative Radiotherapy: A Single Centre, Prospective, Open-Label Pilot Study.

Prevention of Acute Radiation-Induced Skin Reaction with NPE® Camellia Sinensis Nonfermentatum Extract in Female Breast Cancer Patients Undergoing Postoperative Radiotherapy: A Single Centre, Prospective, Open-Label Pilot Study.

Background: To assess effectiveness of NPE, a proprietary Camellia sinensis nonfermentatum (CSNF) extract, in prevention and recovery of acute radiation-induced skin reaction (ARSR) and skin care during postoperative whole breast radiotherapy (RT).

Methods: Twenty patients were enrolled in this single centre, prospective, open-label pilot study. The outcomes of 20 prospective data sets were compared with 100 retrospectively collected matched data sets derived from hospital records. The preventive CSNF gel (2.5%) was administered 1 to 2 hours before each session on the irradiated fields. The care CSNF lotion (0.4%) was administered as 7-day pretreatment after each RT session, twice daily between RT sessions, and 4 to 8 weeks thereafter. The control group was treated according to the hospital care guidelines. The primary endpoint was time to ARSR ≥ Grade 2 (CTCAE v4.03); secondary endpoints were frequencies of ARSR grades 1, 2, 3, and 4, recovery of ARSR, frequencies of interruption and RT stop, complications and required rescue interventions, and tolerability of CSNF.

Results: Time to ARSR ≥ G2 (censoring) was significantly longer (p = 0.014) in the CSNF group. The hazard ratio was 2.33 (95% CI: 1.15-4.72), demonstrating a 50% decrease in the risk of developing ARSR ≥ G2. There was a trend to faster recovery from ARSR G2 in the CSNF group (100% versus 47%; p = 0.078). The proportion of patients requiring rescue treatment during RT and follow-up was markedly higher in the control compared to the CSNF group (1% to 51% versus 0% to 15%). CSNF gel and lotion were well tolerated both during and after RT.

Conclusions: This pilot study provides the first evidence on the potential pharmacological effectiveness of CSNF extract in prevention of RT-induced ARSR and recovery of skin irritation in patients undergoing postoperative whole breast RT and may reflect a novel concept for prevention of RT-induced ARSR and care of irritated skin.

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来源期刊
CiteScore
3.40
自引率
0.00%
发文量
25
审稿时长
19 weeks
期刊介绍: International Journal of Breast Cancer is a peer-reviewed, Open Access journal that provides a forum for scientists, clinicians, and health care professionals working in breast cancer research and management. The journal publishes original research articles, review articles, and clinical studies related to molecular pathology, genomics, genetic predisposition, screening and diagnosis, disease markers, drug sensitivity and resistance, as well as novel therapies, with a specific focus on molecular targeted agents and immune therapies.
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