中药（健脾补肾）联合辅助化疗治疗 II、III 期结肠癌患者的完全缓解率：一项随机临床试验。
Chinese herbal medicine (JianPi-BuShen) and completion rate of adjuvant chemotherapy for patients with stage II and III colon cancer: A randomized clinical trial.
机构信息
Xiyuan Hospital, China Academy of Chinese Medical Sciences, China.
Xiyuan Hospital, China Academy of Chinese Medical Sciences, China.
出版信息
Eur J Cancer. 2024 Dec;213:115109. doi: 10.1016/j.ejca.2024.115109. Epub 2024 Nov 2.
PURPOSE
Many cancer patients express interest in using herbal medicine during chemotherapy, but little is known about its benefits and risks. This study aimed to evaluate the effects of the Chinese herbal medicine JianPi-BuShen formula (JPBS) on adjuvant chemotherapy completion in colon cancer patients.
PATIENTS AND METHODS
This multi-center, phase III, randomized, placebo-controlled trial included patients with stage II (high risk for recurrence) and stage III colon cancer following surgery, planning to receive CAPOX (capecitabine and oxaliplatin) chemotherapy. Patients were randomized 1:1 to receive either JPBS or a placebo. The primary outcome was the completion rate of planned chemotherapy cycles. Secondary outcomes included relative dose intensity (RDI), chemotherapy-induced toxicities, quality of life (measured by the Edmonton Symptom Assessment System - ESAS), adverse events (AEs), and serious AEs (SAEs). Predefined subgroup analyses were performed by age (>65/≤65) and TNM stage (II/III).
RESULTS
A total of 376 participants were analyzed, with a median age of 60.3 years; 56.9 % were male, and 67.6 % had stage III disease. Chemotherapy completion was significantly higher in the JPBS group than in the placebo group (63.0 % vs. 47.6 %, P = 0.003). Oxaliplatin RDI was also higher in the JPBS group (P = 0.049). Subgroup analyses showed JPBS significantly improved completion rates for stage II patients (73.0 % vs. 42.4 %, P = 0.001) and younger patients (66.9 % vs. 48.8 %, P = 0.004). JPBS reduced grade ≥ 2 vomiting (3.8 % vs. 6.4 %, P = 0.007) but increased grade ≥ 2 thrombocytopenia (16.2 % vs. 12.4 %, P = 0.012). Quality of life improved in stage II and younger patients.
CONCLUSION
JPBS improved chemotherapy completion rates in stage II and younger colon cancer patients without compromising tolerability. Further research is needed to explore its mechanisms and long-term effects.
目的
许多癌症患者在化疗期间表示有兴趣使用草药，但对其益处和风险知之甚少。本研究旨在评估中药健脾补肾方（JPBS）对结肠癌患者辅助化疗完成的影响。
方法
这是一项多中心、III 期、随机、安慰剂对照试验，纳入了手术后计划接受 CAPOX（卡培他滨和奥沙利铂）化疗的 II 期（复发风险高）和 III 期结肠癌患者。患者按 1:1 随机接受 JPBS 或安慰剂治疗。主要结局是计划化疗周期的完成率。次要结局包括相对剂量强度（RDI）、化疗相关毒性、生活质量（采用埃德蒙顿症状评估系统-ESAS 评估）、不良事件（AE）和严重不良事件（SAE）。根据年龄（>65/≤65）和 TNM 分期（II/III）进行了预设亚组分析。
结果
共分析了 376 名参与者，中位年龄为 60.3 岁；56.9%为男性，67.6%为 III 期疾病。JPBS 组的化疗完成率明显高于安慰剂组（63.0% vs. 47.6%，P=0.003）。JPBS 组奥沙利铂 RDI 也更高（P=0.049）。亚组分析显示，JPBS 显著提高了 II 期患者（73.0% vs. 42.4%，P=0.001）和年轻患者（66.9% vs. 48.8%，P=0.004）的完成率。JPBS 减少了≥2 级呕吐（3.8% vs. 6.4%，P=0.007），但增加了≥2 级血小板减少症（16.2% vs. 12.4%，P=0.012）。II 期和年轻患者的生活质量得到改善。
结论
JPBS 提高了 II 期和年轻结肠癌患者的化疗完成率，且不影响耐受性。需要进一步研究以探讨其机制和长期效果。
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