β-羟-β-甲基丁酸、精氨酸和谷氨酰胺预防头颈部癌铂类放化疗所致黏膜炎的疗效：一项 II 期研究。

Efficacy of beta-hydroxy-beta-methylbutyrate, arginine, and glutamine for the prevention of mucositis induced by platinum-based chemoradiation in head and neck cancer: A phase II study.

机构信息

Department of Head and Neck Surgery, National Hospital Organization Kyushu Cancer Center, Notame 3-1-1, Minami-ku, Fukuoka, 811-1395, Japan.

Department of Radiology, National Hospital Organization Kyushu Cancer Center, Notame 3-1-1, Minami-ku, Fukuoka, 811-1395, Japan.

出版信息

Clin Nutr ESPEN. 2023 Oct;57:730-734. doi: 10.1016/j.clnesp.2023.08.027. Epub 2023 Aug 28.

DOI:10.1016/j.clnesp.2023.08.027

PMID:37739730

Abstract

BACKGROUND & AIMS: The current standard treatment modality for advanced head and neck squamous cell carcinoma (HNSCC), namely platinum-based (PB) concurrent chemoradiotherapy (CRT), is associated with frequent severe mucositis which is responsible for the multiple acute and late adverse events. So far, effective preventive methods for this CRT-induced mucositis are not identified. In the current study, we examined the prophylactic effects of beta-hydroxy-beta-methylbutyrate (HMB), arginine (Arg), and glutamine (Gln) (HMB/Arg/Gln) mixture.

METHODS

Patients with HNSCC who were subject to PBCRT were randomly assigned to HMB/Arg/Gln intervention (Group I) and non-intervention (Group NI) cohort. The incidences of ≧ grade 3 mucositis (primary endpoint), ≧ grade 2 mucositis, and opioid usage and the degree of body weight loss (secondary endpoints) were compared between Group I and Group NI.

RESULTS

A total of 75 patients were enrolled to this study and 38 patients were assigned to Group I, while 37 patients were to Group NI. After excluding patients who failed to complete CRT (3 in Group I and 2 in Group NI) or withdrew consents (11 in Group I and 1 in Group NI), 24 patients in Group I and 34 patients in Group NI were evaluated. HMB/Arg/Gln failed to reduce the incidences of ≧ grade 2 mucositis, but significantly (p = 0.0003) inhibited grade 3 mucositis in the late phase CRT, reducing the incidence from 64.6% (Group NI) to 25% (Group I) at 70Gy. The degree of body weight loss was significantly (p = 0.0038) lower in Group I (5.6%) compared to Group NI (8.9%), preventing the progression of PBCRT-induced cachexia.

CONCLUSIONS

HMB/Arg/Gln administration demonstrated inhibitory effects on the progression of grade 3 mucositis and cancer cachexia in HNSCC patients treated with PBCRT. A larger scale phase III study is encouraged.

CLINICAL TRIAL REGISTRATION

This study is registered to the UMIN Clinical Trial Registry: UMIN000050011.

摘要

背景与目的

目前，铂类药物联合放化疗（CRT）是治疗晚期头颈部鳞状细胞癌（HNSCC）的标准治疗方法，但该治疗方法常导致严重的黏膜炎，从而引起多种急性和迟发性不良事件。迄今为止，尚无有效的 CRT 诱导性黏膜炎预防方法。本研究旨在评估β-羟基-β-甲基丁酸（HMB）、精氨酸（Arg）和谷氨酰胺（Gln）（HMB/Arg/Gln）混合物的预防作用。

方法

将接受 PBCRT 的 HNSCC 患者随机分为 HMB/Arg/Gln 干预（I 组）和非干预（NI 组）队列。比较两组≧3 级黏膜炎（主要终点）、≧2 级黏膜炎、阿片类药物使用和体重减轻程度（次要终点）的发生率。

结果

本研究共纳入 75 例患者，其中 38 例患者被分配到 I 组，37 例患者被分配到 NI 组。在排除未完成 CRT（I 组 3 例，NI 组 2 例）或退出同意（I 组 11 例，NI 组 1 例）的患者后，共有 24 例 I 组患者和 34 例 NI 组患者纳入评估。HMB/Arg/Gln 未能降低≧2 级黏膜炎的发生率，但显著（p=0.0003）抑制了 CRT 晚期 3 级黏膜炎的发生，使 70Gy 时 3 级黏膜炎的发生率从 64.6%（NI 组）降至 25%（I 组）。I 组的体重减轻程度显著低于 NI 组（p=0.0038，5.6%比 8.9%），从而预防了 PBCRT 诱导的恶病质进展。