【摘 要】
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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
【机 构】
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Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou 510
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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.
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