Chay Wen Yee, Tham Chee Kian, Toh Han Chong, Lim Hwee Yong, Tan Chee Kiat, Lim Cindy, Wang Who-Whong, Choo Su-Pin
1 Department of Medical Oncology, National Cancer Centre Singapore , Singapore, Singapore .
2 Novena Cancer Centre , Singapore, Singapore .
J Altern Complement Med. 2017 Aug;23(8):648-652. doi: 10.1089/acm.2016.0136. Epub 2017 Apr 4.
The majority of patients with hepatocellular carcinoma (HCC) are inoperable and results with conventional chemotherapy are dismal. Many end up with no treatment options and resort to alternative medicine. The authors report the use of Coriolus versicolor (CV) in advanced HCC patients with poor liver function or who were unfit to receive standard therapy.
Fifteen eligible cases were randomized 2:1 to either CV or placebo. The primary endpoint was the median time to progression (TTP) between both arms. Secondary endpoints include evaluating response rates, toxicity, quality of life (QOL), progression-free survival (PFS), and overall survival (OS). Further correlative studies were performed looking at the effect of CV on the immune system.
The median treatment duration was 1.5 cycles and 3 cycles on the placebo and CV arm, respectively. Median TTP was 2.5 (1.4-5.3) months compared to 4.2 (0.4-4.2) months in the CV and placebo arm, respectively, hazard ratio (HR) 0.70 (0.16-3.05 p = 0.634). Median PFS was 2.5 (1.4-5.3) months in the CV and 1.1 (0.4-4.2) months in the placebo arm, HR 0.42 (0.13-1.34, p = 0.144). Median OS was 6.5 (3.3-24.1) and 2.2 (0.8-23.3) months, respectively, HR 0.35 (0.10-1.25, p = 0.105). Social and emotional functioning scores were higher in the CV group compared to placebo group on treatment. CV subjects had less appetite loss and pain symptoms compared to placebo subjects during treatment.
There was no difference in TTP with use of CV compared to placebo. CV subjects generally had better QOL on treatment compared to placebo subjects. The utility of this supplement in patients whose primary treatment goal is palliation should be further explored.
大多数肝细胞癌(HCC)患者无法进行手术,传统化疗效果不佳。许多患者最终没有治疗选择,只能求助于替代医学。作者报告了云芝(CV)在肝功能差或不适合接受标准治疗的晚期HCC患者中的应用。
15例符合条件的患者按2:1随机分为CV组或安慰剂组。主要终点是两组之间的中位疾病进展时间(TTP)。次要终点包括评估缓解率、毒性、生活质量(QOL)、无进展生存期(PFS)和总生存期(OS)。还进行了进一步的相关性研究,观察CV对免疫系统的影响。
安慰剂组和CV组的中位治疗周期分别为1.5个周期和3个周期。CV组和安慰剂组的中位TTP分别为2.5(1.4 - 5.3)个月和4.2(0.4 - 4.2)个月,风险比(HR)为0.70(0.16 - 3.05,p = 0.634)。CV组的中位PFS为2.5(1.4 - 5.3)个月,安慰剂组为1.1(0.4 - 4.2)个月,HR为0.42(0.13 - 1.34,p = 0.144)。中位OS分别为6.5(3.3 - 24.1)个月和2.2(0.8 - 23.3)个月,HR为0.35(0.10 - 1.25,p = 0.105)。治疗期间,CV组的社会和情感功能评分高于安慰剂组。与安慰剂组相比,CV组患者在治疗期间食欲减退和疼痛症状较少。
与安慰剂相比,使用CV的TTP没有差异。与安慰剂组相比,CV组患者在治疗期间的生活质量总体更好。对于以姑息治疗为主要治疗目标的患者,这种补充剂的效用应进一步探索。