Abstract
BackgroundPatients 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/DesignThis 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.DiscussionIn 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 registrationChinese Clinical Trial Registry (www.chictr.org): ChiCTR-IOR-14005679, registered 17 December 2014.
Highlights
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
In previous clinical practice, we found that Chinese herbal medicine (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
Summary
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. Non-small cell lung cancer (NSCLC) accounts for 85 to 90% of all cases of lung cancer, and platinum-based doublet chemotherapy is the standard treatment for advanced NSCLC. The discovery of targeted therapy has led to a new era of individualized treatment in lung cancer; epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) have been a new paradigm of lung cancer treatment. Two randomized phase III trials from Japan demonstrated that progression-free survival (PFS) with gefitinib was significantly longer than platinum-based chemotherapy as a first-line treatment in patients with advanced NSCLC who carried activating EGFR mutation [10,11]. Adverse effects of gefitinib (such as rash, acne or diarrhea) have sometimes resulted in discontinuation of treatment [13]
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