需要强有力的辅助策略来改善具有完全切除的ΙΙΙΙΑ期非小细胞肺癌(NSCLC)的患者的存活。我们旨在比较这些患者的中医(TCM)治疗与辅助化疗后观察的疗效。
■符合条件的患者按1:1随机分组,分别接受气阴辨证口服汤剂(中医组)或观察组(观察组)。干预持续了12个月。主要终点是1年无病生存期(DFS)。次要终点是DFS,生活质量,调节性T细胞(Tregs),和外周血Tregs表面的细胞毒性T淋巴细胞相关抗原-4(CTLA-4)。我们使用EORTCQLQ-LC43评估生活质量。
■在2019年4月29日至2021年11月11日之间,根据气阴辨证(n=38)或观察(n=37),将75例患者随机分配到口服汤剂。全分析集包括中医组35例,观察组35例。在中位随访24.2个月后,与观察相比,基于气阴辨证的口服汤剂改善了DFS(HR0.378,95%CI:0.157-0.912;P=0.03)。中医组1年DFS为82.1%,观察组为61.9%(P=.06)。随机化后三个月,总体健康评分,角色功能,情感功能,中医组的社会功能高于观察组(P<0.01),分数的疲劳,疼痛,失眠,食欲减退,便秘,咳嗽,而胸痛低于观察组(均P<.05);中医组Tregs比例与观察组比较差异无统计学意义(P=.58);中医组CTLA-4+Tregs比例低于观察组(P=.046)。两组均未发生不良事件。
■辅助化疗后基于气阴辨证的口服汤剂延长DFS,降低疾病复发和转移的风险,提高生活质量,并下调完全切除的III期NSCLC患者中CTLA-4+Treg的比例。
■中国临床试验注册,不。ChiCTR1800019396。注册日期:2018年11月9日。
UNASSIGNED: Powerful adjuvant strategies are required to improve the survival of patients with completely resected stage ΙΙΙA non-small cell lung cancer (NSCLC). We aimed to compare the efficacy of traditional Chinese medicine (TCM) treatment versus observation after adjuvant chemotherapy in these patients.
UNASSIGNED: Eligible patients were randomized 1:1 to receive either oral decoctions based on Qi-Yin syndrome differentiation (TCM group) or observation (observation group). The intervention lasted for 12 months. The primary endpoint was 1-year disease-free survival (DFS). Secondary endpoints were DFS, quality of life, regulatory T cells (Tregs), and cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) on the surface of Tregs in peripheral blood. We used EORTC QLQ-LC43 to evaluate quality of life.
UNASSIGNED: Between Apr 29, 2019, and Nov 11, 2021, 75 patients were randomly assigned to oral decoctions based on Qi-Yin syndrome differentiation (n = 38) or observation (n = 37). The full analysis set included 35 patients in the TCM group and 35 in the observation group. After a median follow-up of 24.2 months, oral decoctions based on Qi-Yin syndrome differentiation improved DFS compared with observation (HR 0.378, 95% CI: 0.157-0.912; P = .03). One-year DFS was 82.1% in the TCM group and 61.9% in the observation group (P = .06). Three months after randomization, scores of total health, role function, emotional function, and social function in the TCM group were higher than those in the observation group (P < .01 for all), scores of fatigue, pain, insomnia, appetite loss, constipation, cough, and chest pain were lower than those in the observation group (P < .05 for all); there was no significant difference in the proportion of Tregs between the TCM group and the observation group (P = .58); the proportion of CTLA-4+Tregs in the TCM group was lower than that in the observation group (P = .046). There were no adverse events that occurred in both groups.
UNASSIGNED: Oral decoctions based on Qi-Yin syndrome differentiation after adjuvant chemotherapy prolonged DFS, reduced the risk of disease recurrence and metastasis, improved quality of life, and down-regulated the proportion of CTLA-4+Tregs in completely resected stage ΙΙΙA NSCLC patients.
UNASSIGNED: Chinese Clinical
Trial Register, No. ChiCTR1800019396. Date of registration: 9 November 2018.