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Fuzheng Kang'ai decoction combined with gefitinib in advanced non-small cell lung cancer patients with epidermal
Xiao-Bing Yang1, Wan-Yin Wu2, Shun-Qin Long3
1Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. yangxiaobing2002@126.com.
Background:
Patients with advanced non-small cell lung cancer (NSCLC) harboring mutations of the epidermal growth factor receptor (EGFR) gene respond well to the EGFR tyrosine kinase inhibitor (TKI) gefitinib. Chinese herbal medicine (CHM) has been used as a complementary therapy for cancer for decades in China. CHM was proved to be effective in improving the quality of life (QOL) and reducing the toxicity associated with chemotherapy in patients with NSCLC. The purpose of the present trial is to determine whether CHM (Fuzheng Kang'ai decoction (FZKA), a CHM formula) combined with gefitinib results in longer progression-free survival with less toxicity than gefitinib alone.
Methods/Design:
This is a randomized, placebo-controlled, double-blind trial. This trial is designed to determine if CHM (FZKA) combined with gefitinib results in longer progression-free survival with less toxicity than gefitinib alone. A total of 70 NSCLC patients with EGFR mutations will be randomly assigned to treatment group (gefitinib plus FZKA granules) or control group (gefitinib plus placebo). The primary endpoint is progression-free survival. Secondary endpoints are: (1) overall survival; (2) disease control rate; (3) QOL, measured with the questionnaire of Functional Assessment of Cancer Therapy-lung (FACT-L 4.0) and Lung Cancer Symptom Scale and (4) safety.
Discussion:
In previous clinical practice, we found that CHM (FZKA) could improve the therapeutic efficacy of gefitinib. This study will provide objective evidence to evaluate the efficiency of CHM combined with gefitinib in NSCLC patients with EGFR mutations, and may provide a novel regimen for patients with NSCLC.
Trial Registration:
Chinese Clinical Trial Registry ( www.chictr.org ): ChiCTR-IOR-14005679 , registered 17 December 2014.
Insights
This study investigates if Chinese herbal medicine (Fuzheng Kang
Area of Science:
- Oncology
- Pharmacology
- Integrative Medicine
Background:
- Advanced non-small cell lung cancer (NSCLC) with EGFR mutations shows response to gefitinib.
- Chinese herbal medicine (CHM) is utilized as a complementary therapy for NSCLC, improving quality of life and reducing chemotherapy toxicity.
- Fuzheng Kang'ai decoction (FZKA) is a specific CHM formula investigated in this trial.
Purpose of the Study:
- To evaluate if combining CHM (FZKA) with gefitinib improves progression-free survival in NSCLC patients with EGFR mutations.
- To assess if the combination therapy reduces toxicity compared to gefitinib alone.
- To provide objective evidence for a novel treatment regimen in NSCLC.
Main Methods:
- A randomized, placebo-controlled, double-blind trial involving 70 NSCLC patients with EGFR mutations.
- Patients were assigned to either gefitinib plus FZKA granules or gefitinib plus placebo.
- Primary endpoint: progression-free survival. Secondary endpoints: overall survival, disease control rate, quality of life (QOL), and safety.
Main Results:
- Preliminary clinical observations suggest CHM (FZKA) enhances gefitinib's therapeutic efficacy.
- The study aims to provide objective data on the combined treatment's effectiveness.
- Further results will detail progression-free survival, overall survival, QOL, and safety outcomes.
Conclusions:
- CHM (FZKA) may improve the therapeutic efficacy of gefitinib in NSCLC patients with EGFR mutations.
- This study will offer objective evidence to support the use of CHM combined with gefitinib.
- The findings could lead to a new treatment regimen for NSCLC patients.
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