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

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

doi:10.1007/s11655-017-2819-8

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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

OriginalPaper | Updated：2021-08-27

- 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
- 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
- 中国结合医学杂志（英文版） 2018年24卷第10期页码：734-740
- Affiliations：
  
  Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou,China
- Author bio：
- Funds：
  
  Supported by the National Natural Science Foundation of China (No. 81273965, 81503507) and the Natural Science Foundation of Guangdong Province (No. 2015A030310245)
- DOI：10.1007/s11655-017-2819-8
  中图分类号：
- 纸质出版日期：2018，
  
  网络出版日期：2017-8-9，
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Yang, Xb., Chai, Xs., Wu, Wy. et al. 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., Chin. J. Integr. Med. 24, 734–740 (2018). https://doi.org/10.1007/s11655-017-2819-8

Xiao-bing Yang, Xiao-shu Chai, Wan-yin Wu, et al. 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[J]. Chinese Journal of Integrative Medicine, 2018,24(10):734-740.
Yang, Xb., Chai, Xs., Wu, Wy. et al. 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., Chin. J. Integr. Med. 24, 734–740 (2018). https://doi.org/10.1007/s11655-017-2819-8 DOI：

Xiao-bing Yang, Xiao-shu Chai, Wan-yin Wu, et al. 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[J]. Chinese Journal of Integrative Medicine, 2018,24(10):734-740. DOI： 10.1007/s11655-017-2819-8.

摘要

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. 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 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). 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.

Abstract

To evaluate the effect of Fuzheng Kang’ai Formula (扶正抗癌方

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 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). 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 cancergefitinibChinese Medicinecombination therapysensitizing effectFuzheng Kang’ai Formularandomized controlled trial

Keywords

non-small cell lung cancergefitinibChinese Medicinecombination therapysensitizing effectFuzheng Kang’ai Formularandomized controlled trial

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