Gefitinib plus Fuzheng Kang'ai Formula(扶正抗癌方) in Patients with Advanced Non-Small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation:A Randomized Controlled Trial  

作　　者：YANG Xiao-bing CHAI Xiao-shu WU Wan-yin LONG Shun-qin DENG Hong PAN Zong-qi HE Wen-feng ZHOU Yu-shu LIAO Gui-ya XIAO Shu-jing 

机构地区：[1]Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine

出　　处：《Chinese Journal of Integrative Medicine》2018年第10期734-740,共7页中国结合医学杂志（英文版）

基　　金：Supported by the National Natural Science Foundation of China(No.81273965,81503507);the Natural Science Foundation of Guangdong Province(No.2015A030310245)

摘　　要：Objective： To evaluate the effect of Fuzheng Kang＇ai Formula （扶正抗癌方, FZKA） plus gefitinib in patients with advanced non-small cell lung cancer with epidermal growth factor receptor （EGFR） mutations. Methods： A randomized controlled trial was conducted from 2009 to 2012 in South China. Seventy chemotherapynaive patients diagnosed with stage ⅢB/Ⅳ non-small cell lung cancer with EGFR mutations were randomly assigned to GF group [gefitinib （250 mg/day orally） plus FZKA （250 mL, twice per day, orally）; 35 cases] or G group （gefitinib 250 mg/day orally; 35 cases） according to the random number table and received treatment until progression of the disease, or development of unacceptable toxicities. The primary endpoint [progression-free survival （PFS）] and secondary endpoints [median survival time （MST）, objective response rate （ORR）, disease control rate （DCR） and safety] were observed. Results： No patient was excluded after randomization. GF group had significantly longer PFS and MST compared with the G group, with median PFS of 12.5 months （95% CI 3.30-21.69） vs. 8.4 months （95% CI 6.30-10.50; log-rank P〈0.01）, MST of 21.5 months （95% CI 17.28-25.73） vs. 18.3 months （95% CI 17.97-18.63; log-rank P〈0.01）. ORR and DCR in GF group and G group were 65.7% vs. 57.1%, 94.3% vs. 80.0%, respectively （P〉0.05）. The most common toxic effects in the GF group and G group were rash or acne （42.8% vs. 57.1%, P〉0.05）, diarrhea （11.5% vs. 31.4%, P〈0.05）, and stomatitis （2.9% vs. 8.7%, P〉0.05）. Conclusion： Patients with advanced non-small cell lung cancer selected by EGFR mutations have longer PFS, MST with less toxicity treated with gefitinib plus FZKA than gefitinib alone.Objective： To evaluate the effect of Fuzheng Kang＇ai Formula （扶正抗癌方, FZKA） plus gefitinib in patients with advanced non-small cell lung cancer with epidermal growth factor receptor （EGFR） mutations. Methods： A randomized controlled trial was conducted from 2009 to 2012 in South China. Seventy chemotherapynaive patients diagnosed with stage ⅢB/Ⅳ non-small cell lung cancer with EGFR mutations were randomly assigned to GF group [gefitinib （250 mg/day orally） plus FZKA （250 mL, twice per day, orally）; 35 cases] or G group （gefitinib 250 mg/day orally; 35 cases） according to the random number table and received treatment until progression of the disease, or development of unacceptable toxicities. The primary endpoint [progression-free survival （PFS）] and secondary endpoints [median survival time （MST）, objective response rate （ORR）, disease control rate （DCR） and safety] were observed. Results： No patient was excluded after randomization. GF group had significantly longer PFS and MST compared with the G group, with median PFS of 12.5 months （95% CI 3.30-21.69） vs. 8.4 months （95% CI 6.30-10.50; log-rank P〈0.01）, MST of 21.5 months （95% CI 17.28-25.73） vs. 18.3 months （95% CI 17.97-18.63; log-rank P〈0.01）. ORR and DCR in GF group and G group were 65.7% vs. 57.1%, 94.3% vs. 80.0%, respectively （P〉0.05）. The most common toxic effects in the GF group and G group were rash or acne （42.8% vs. 57.1%, P〉0.05）, diarrhea （11.5% vs. 31.4%, P〈0.05）, and stomatitis （2.9% vs. 8.7%, P〉0.05）. Conclusion： Patients with advanced non-small cell lung cancer selected by EGFR mutations have longer PFS, MST with less toxicity treated with gefitinib plus FZKA than gefitinib alone.

关 键 词：non-small cell lung cancer GEFITINIB Chinese medicine combination therapy sensitizing effect Fuzheng Kang＇ai Formula randomized controlled trial 

分 类 号：R734.2[医药卫生—肿瘤]