Abstract：
OBJECTIVE: 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.
CONCLUSIONS: 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.
BACKGROUND: UMIN000052622, 26 October 2023, retrospectively registered.
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.
CONCLUSIONS: 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.
BACKGROUND: 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，放射性食管炎仍难以控制。需要进一步发展支持疗法。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：本研究为前瞻性观察性研究。参与者来自不可切除的局部晚期NSCLC，他们计划每周接受紫杉醇或nab-紫杉醇/卡铂加放射治疗（60Gy，30个部分），为期6周。他们每天一次口服含有700毫克胱氨酸和280毫克茶氨酸的氨基酸补充剂，无论从CRT开始到完成的CRT时间如何。主要终点是任何级别食管炎的发生率。次要终点是生活质量（QoL）和不良事件（AE）。
结果：共评估了26例患者。所有参与者在30个部分中完成60Gy的RT。食管炎的总发病率为73%；然而，未报告≥3级。没有AE可能与胱氨酸和茶氨酸有关。放化疗前后EuroQoL5维5级健康指数得分均值分别为0.952±0.0591和0.952±0.0515(P=0.89),治疗前后视觉模拟评分均值分别为67.9±15.4和79.4±13.2(P=0.0047),分别。
结论：我们的研究显示没有严重的食管炎，任何AE，接受CRT的NSCLC患者QoL也没有下降。半胱氨酸和茶氨酸可能有效减少严重的CRT诱导的食管炎。
背景：UMIN000052622，2023年10月26日，回顾性注册。
方法：本研究为前瞻性观察性研究。参与者来自不可切除的局部晚期NSCLC，他们计划每周接受紫杉醇或nab-紫杉醇/卡铂加放射治疗（60Gy，30个部分），为期6周。他们每天一次口服含有700毫克胱氨酸和280毫克茶氨酸的氨基酸补充剂，无论从CRT开始到完成的CRT时间如何。主要终点是任何级别食管炎的发生率。次要终点是生活质量（QoL）和不良事件（AE）。
结果：共评估了26例患者。所有参与者在30个部分中完成60Gy的RT。食管炎的总发病率为73%；然而，未报告≥3级。没有AE可能与胱氨酸和茶氨酸有关。放化疗前后EuroQoL5维5级健康指数得分均值分别为0.952±0.0591和0.952±0.0515(P=0.89),治疗前后视觉模拟评分均值分别为67.9±15.4和79.4±13.2(P=0.0047),分别。
结论：我们的研究显示没有严重的食管炎，任何AE，接受CRT的NSCLC患者QoL也没有下降。半胱氨酸和茶氨酸可能有效减少严重的CRT诱导的食管炎。
背景：UMIN000052622，2023年10月26日，回顾性注册。
