中国癌症杂志 ›› 2018, Vol. 28 ›› Issue (11): 833-839.doi: 10.19401/j.cnki.1007-3639.2018.11.006

• 论著 • 上一篇    下一篇

中医药联合甲磺酸阿帕替尼治疗Ⅳ期恶性肿瘤的单臂单中心临床研究

周 迪,刘苓霜,姜 怡,阮广欣,沈丽萍,郭慧茹,单孟俊   

  1. 上海市中医肿瘤临床医学中心,上海中医药大学附属龙华医院肿瘤科,上海200032
  • 出版日期:2018-11-30 发布日期:2018-12-14
  • 通信作者: 刘苓霜 E-mail: liuls107@163.com
  • 基金资助:
    上海市卫生和计划生育委员会科研课题(201840158);龙华医院科技创新项目(CX201705);上海市卫生和计划委员会中医药科研课题(2018JQ004)。

Single arm and single center clinical research on traditional Chinese medicine in combination with apatinib for the treatment of stage Ⅳ malignant tumor

ZHOU Di, LIU Lingshuang, JIANG Yi, RUAN Guangxin, SHEN Liping, GUO Huiru, SHAN Mengjun   

  1. Shanghai Center for Clinical Medicine of Traditional Chinese Medicine, Department of Oncology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
  • Published:2018-11-30 Online:2018-12-14
  • Contact: LIU Lingshuang E-mail: liuls107@163.com

摘要: 背景与目的:目前,甲磺酸阿帕替尼在中国仅被批准用于晚期胃癌三线治疗,而近年来研究表明,抗血管生成药物在多种晚期实体瘤中疗效显著。以中西医结合为主的综合治疗模式在抗肿瘤治疗中存在优势。该研究旨在观察中医药联合甲磺酸阿帕替尼干预二线治疗失败后Ⅳ期恶性肿瘤患者的短期临床疗效及安全性。方法:选择2016年1月—2017年7月上海中医药大学附属龙华医院肿瘤科收治的21例二线治疗失败后的晚期恶性肿瘤患者为研究对象,治疗方案为甲磺酸阿帕替尼500 mg,口服,每天1次,28 d为1个疗程(可根据患者不良反应分级进行剂量调整),同时联合中药静脉制剂+口服辨证中药汤剂治疗,评价短期临床疗效和安全性。结果:21例患者经中医辨证联合甲磺酸阿帕替尼靶向治疗1个疗程后,部分缓解(partial response,PR)6例,疾病稳定(stable disease,SD)15例,总有效率(overall response rate,ORR)为27.27%,疾病控制率(disease control rate,DCR)为95.45%;治疗后肿瘤标志物CEA、CA125、CYFRA211及神经元特异性烯醇化酶(neuron-specific enolase,NSE)明显下降,与治疗前相比差异有统计学意义(P<0.05),所有患者均未见4级不良反应。结论:对于二线治疗失败后的晚期恶性肿瘤患者,中医联合血管生成靶向药物甲磺酸阿帕替尼疗效明确,不良反应可耐受。本研究为进一步开展中医药联合甲磺酸阿帕替尼治疗的大样本、随机、对照研究提供了前期临床数据支持。

关键词: 中医药, 甲磺酸阿帕替尼, 恶性肿瘤, 临床疗效

Abstract: Background and purpose: Apatinib is only approved for third-line treatment of advanced gastric cancer in China. However in recent years, antiangiogenic drugs have shown remarkable efficacy in a variety of advanced solid tumors. A large number of clinical studies have confirmed that the comprehensive treatment mode based on the combination of Chinese and Western medicine can achieve good results in anti-tumor treatment. The purpose of this study was to observe the short-term clinical efficacy and safety of apatinib combined with traditional Chinese medicine in the patients with stage Ⅳ malignant tumor after failure of second-line intervention. Methods: Twenty-one patients with advanced malignant tumor were recruited after second-line treatment from January 2016 to July 2017 in Department of Oncology, Longhua Hospital. Patients were administered with traditional Chinese medicine intravenous preparation and herbal decoction combined with apatinib of 500 mg once per day after failure of the secondline treatment. Each cycle was 28 d. Dose adjustment was made according to the National Cancer Institute classification of patients’ adverse reactions. The efficacy and toxicity of traditional Chinese medicine combined with apatinib and the survival of patients were analyzed. Results: In 21 cases, there were 6 cases of partial response (PR) and 15 cases of stable disease (SD). The overall response rate was 27.27%, and the disease control rate was 95.45%. There was no serious adverse reaction in all patients. The tumor markers including CEA, CA125, CYFRA211 and NSE were significantly decreased after treatment. The difference was statistically significant compared with those measured before the treatment (P<0.05). And no grade 4 side effect was found. Conclusion: To the patients with advanced malignant tumor who failed the second-line treatment, traditional Chinese medicine combined with apatinib is effective and well-tolerated. Our preliminary clinical data provides support for the further randomized controlled study with a large sample size.

Key words: Traditional Chinese medicine, Apatinib, Malignant tumor, Clinical effect