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胱氨酸和茶氨酸治疗非小细胞肺癌放化疗相关性食管炎的前瞻性观察研究。

Cystine and theanine for chemoradiotherapy-induced esophagitis in non-small cell lung cancer: a prospective observational study.

机构信息

Department of Nutrition Support Team, Kobe Minimally Invasive Cancer, Kobe, Japan.

Department of Pharmacy, Kobe Minimally Invasive Cancer Center, Kobe, Japan.

出版信息

Support Care Cancer. 2024 Jun 3;32(6):400. doi: 10.1007/s00520-024-08613-0.

Abstract

PURPOSE

Although several potential radioprotectants have been explored, radiation esophagitis is still difficult to control. Further development of supportive therapies is required. Our purpose was to investigate the efficacy and safety of cystine and theanine for esophagitis in non-small cell lung cancer (NSCLC) patients undergoing chemoradiotherapy (CRT).

METHODS

This study is a prospective observational study. The participants were recruited from unresectable locally advanced NSCLC who had scheduled to receive weekly paclitaxel or nab-paclitaxel/carboplatin plus radiation therapy (60 Gy in 30 fractions) for 6 weeks. They took an oral amino acid supplement containing 700 mg cystine and 280 mg theanine once daily regardless of CRT timing from the start of CRT until completion. The primary endpoint was the incidence of any grade esophagitis. The secondary endpoints were quality of life (QoL) and adverse events (AEs).

RESULTS

A total of 26 patients were evaluated. All participants completed 60 Gy of RT in 30 fractions. The overall incidence of esophagitis was 73%; however, no ≥ grade 3 was reported. There were no AEs likely to be related to cystine and theanine. The mean EuroQoL 5-Dimension 5-Level health index score before and after chemoradiotherapy was 0.952 ± 0.0591 and 0.952 ± 0.0515 (P = 0.89), and the mean Visual Analogue Scale scores before and after treatment were 67.9 ± 15.4 and 79.4 ± 13.2 (P = 0.0047), respectively.

CONCLUSION

Our study showed no severe esophagitis, any AEs, nor QoL decrease in NSCLC patients receiving CRT. Cystine and theanine are potentially effective to reduce severe CRT-induced esophagitis.

TRIAL REGISTRATION

UMIN000052622, 26 October 2023, retrospectively registered.

摘要

目的

尽管已经探索了几种潜在的辐射防护剂,但放射性食管炎仍然难以控制。需要进一步开发支持性治疗方法。我们的目的是研究胱氨酸和茶氨酸对接受放化疗(CRT)的非小细胞肺癌(NSCLC)患者食管炎的疗效和安全性。

方法

这是一项前瞻性观察性研究。参与者从无法手术的局部晚期 NSCLC 患者中招募,这些患者计划接受每周紫杉醇或 nab-紫杉醇/卡铂加放疗(60Gy 分 30 次),共 6 周。他们从 CRT 开始到完成,每天服用一次含有 700mg 胱氨酸和 280mg 茶氨酸的口服氨基酸补充剂。主要终点是任何级别的食管炎发生率。次要终点是生活质量(QoL)和不良事件(AEs)。

结果

共评估了 26 名患者。所有患者均完成了 30 次 60Gy 的放疗。食管炎总发生率为 73%;然而,未报告任何≥3 级的食管炎。没有可能与胱氨酸和茶氨酸有关的 AE。放化疗前后的 EuroQoL 5 维 5 级健康指数评分分别为 0.952±0.0591 和 0.952±0.0515(P=0.89),治疗前后的视觉模拟量表评分分别为 67.9±15.4 和 79.4±13.2(P=0.0047)。

结论

我们的研究表明,接受 CRT 的 NSCLC 患者没有严重的食管炎、任何 AE 或 QoL 下降。胱氨酸和茶氨酸可能有效减少严重 CRT 诱导的食管炎。

试验注册

UMIN000052622,2023 年 10 月 26 日,回顾性注册。

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