| Autor: |
Xiao-Bing, Yang, Xiao-Shu, Chai, Wan-Yin, Wu, Shun-Qin, Long, Hong, Deng, Zong-Qi, Pan, Wen-Feng, He, Yu-Shu, Zhou, Gui-Ya, Liao, Shu-Jing, Xiao |
| Rok vydání: |
2014 |
| Předmět: |
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| Zdroj: |
Chinese journal of integrative medicine. 24(10) |
| ISSN: |
1672-0415 |
| Popis: |
To evaluate the effect of Fuzheng Kang'ai Formula (, FZKA) plus gefitinib in patients with advanced non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations.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.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 P0.01), MST of 21.5 months (95% CI 17.28-25.73) vs. 18.3 months (95% CI 17.97-18.63; log-rank P0.01). ORR and DCR in GF group and G group were 65.7% vs. 57.1%, 94.3% vs. 80.0%, respectively (P0.05). The most common toxic effects in the GF group and G group were rash or acne (42.8% vs. 57.1%, P0.05), diarrhea (11.5% vs. 31.4%, P0.05), and stomatitis (2.9% vs. 8.7%, P0.05).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. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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