中药（健皮布散）与 II 期和 III 期结肠癌患者辅助化疗的完成率：随机临床试验

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer Pub Date : 2024-11-02 DOI:10.1016/j.ejca.2024.115109

Lingyun Sun , Yun Xu , Nan Chen , Chunze Zhang , Aiwen Wu , Huaqing Wang , Yutong Fei , Peng Shu , Dechang Diao , Jianping Cheng , Yuping Chu , Tianshu Liu , Wei Wang , Ye Yuan , Baozhu Zeng , Yang Cao , Shundong Cang , Huijuan Cao , Tong Zhang , Yang Zheng , Yufei Yang

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引用次数: 0

摘要

目的许多癌症患者表示有兴趣在化疗期间使用中药，但对中药的益处和风险却知之甚少。这项多中心、III 期、随机、安慰剂对照试验纳入了术后计划接受 CAPOX（卡培他滨和奥沙利铂）化疗的 II 期（高复发风险）和 III 期结肠癌患者。患者按 1:1 随机分配接受 JPBS 或安慰剂治疗。主要结果是计划化疗周期的完成率。次要结果包括相对剂量强度（RDI）、化疗引起的毒性反应、生活质量（通过埃德蒙顿症状评估系统ESAS测量）、不良事件（AEs）和严重不良事件（SAEs）。按照年龄（65/≤65岁）和TNM分期（II/III期）进行了预定义的亚组分析。JPBS 组的化疗完成率明显高于安慰剂组（63.0% 对 47.6%，P = 0.003）。JPBS 组的奥沙利铂 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% 对 42.4%，P = 0.001）和年轻患者（66.9% 对 48.8%，P = 0.004）的手术完成率。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（16.2% vs. 12.4%，P = 0.012）。结论JPBS提高了II期和年轻结肠癌患者的化疗完成率，同时不影响耐受性。需要进一步研究其机制和长期效果。

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Chinese herbal medicine (JianPi-BuShen) and completion rate of adjuvant chemotherapy for patients with stage II and III colon cancer: A randomized clinical trial

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.

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来源期刊

European Journal of Cancer 医学-肿瘤学

CiteScore

11.50

自引率

4.80%

发文量

953

审稿时长

23 days

期刊介绍： The European Journal of Cancer (EJC) serves as a comprehensive platform integrating preclinical, digital, translational, and clinical research across the spectrum of cancer. From epidemiology, carcinogenesis, and biology to groundbreaking innovations in cancer treatment and patient care, the journal covers a wide array of topics. We publish original research, reviews, previews, editorial comments, and correspondence, fostering dialogue and advancement in the fight against cancer. Join us in our mission to drive progress and improve outcomes in cancer research and patient care.