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

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 m L, 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.