Efficacy of oral administration of cystine and theanine in colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery: a multi-institutional, randomized, double-blinded, placebo-controlled, phase II trial (JORTC-CAM03)
Efficacy of oral administration of cystine and theanine in colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery: a multi-institutional, randomized, double-blinded, placebo-controlled, phase II trial (JORTC-CAM03)
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DOI：
10.1007/s00520-019-05205-1
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发表时间：
2020-08-01
影响因子：
3.1
通讯作者：
Iwase, Satoru
中科院分区：
文献类型：
--
作者：
Hamaguchi, Reo;Tsuchiya, Takashi;Iwase, Satoru
目的结直肠癌患者基于卡培他滨的辅助化疗经常引起不良事件（AE），如腹泻、口腔炎、厌食和手足综合征（HFS）。据报道，胱氨酸和茶氨酸可以减轻一些化疗相关的 AE，因此也有望减轻卡培他滨诱导的 AE。因此，我们的目的是研究胱氨酸/茶氨酸治疗结直肠癌术后接受卡培他滨辅助化疗的患者的安全性和有效性。方法 100例术后接受卡培他滨辅助化疗的结直肠癌患者随机分为胱氨酸/茶氨酸组（n=52）和安慰剂组（n=48）。主要终点是根据日本临床肿瘤学组 (JCOG) 版本的 AE 通用术语标准 (CTCAE) v.4.0，1 级或以上腹泻的发生率。次要终点包括其他 AE 的发生率 (CTCAE v.4.0-JCOG)，以及根据 HFS 分级标准的 HFS 发生率。结果 两组卡培他滨诱发的 AE 无显着差异。然而，胱氨酸/茶氨酸组的1级或以上腹泻发生率往往低于安慰剂组（18.4% vs. 28.9%，p= 0.169），以及1级或以上HFS发生率（CTCAE v.4.0-JCOG或HFS分级量表）（67.4% vs. 77.8%，p= 0.185）。分别为 67.3% 和 80.0%，p= 0.124）。结论 本试验证明，术后接受卡培他滨辅助化疗的结直肠癌患者接受胱氨酸/茶氨酸治疗是安全的，并且有降低腹泻或 HFS 发生率的趋势。
Purpose Capecitabine-based adjuvant chemotherapy for colorectal cancer patients often causes adverse events (AEs), such as diarrhea, stomatitis, anorexia, and hand-foot syndrome (HFS). Cystine and theanine were reported to attenuate some chemotherapy-associated AEs, and hence are also expected to attenuate capecitabine-induced AEs. Therefore, we aimed to investigate the safety and efficacy of cystine/theanine treatment in colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery. Methods A total of 100 colorectal cancer patients treated with capecitabine as an adjuvant chemotherapy after surgery were randomly allocated into the cystine/theanine group (n= 52) or the placebo group (n= 48). The primary endpoint was incidence rate of diarrhea of grade 1 or higher in accordance with the Common Terminology Criteria for AEs (CTCAE) v.4.0, Japanese Clinical Oncology Group (JCOG) version. The secondary endpoints included incidence rates of other AEs (CTCAE v.4.0-JCOG), as well as the incidence rate of HFS according to the HFS grading scale. Results There were no significant differences in capecitabine-induced AEs between the two groups. However, the incidence rate of diarrhea of grade 1 or higher tended to be lower in the cystine/theanine group than the placebo group (18.4% vs. 28.9%,p= 0.169) as well as the incidence rate of HFS of grade 1 or higher (CTCAE v.4.0-JCOG or HFS grading scale) (67.4% vs. 77.8%,p= 0.185, 67.3% vs. 80.0%,p= 0.124, respectively). Conclusion This trial demonstrated that cystine/theanine treatment of colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery is safe and has the tendency to reduce the incidence rate of diarrhea or HFS.