Abstract
Background: To determine the clinical activity and safety of Chinese herbal medicine (CHM) combined with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) in patients with advanced pulmonary adenocarcinoma (ADC) and the ability of CHM combined with EGFR-TKI to activate EGFR mutations. Methods: Three hundred and fifty-four patients were randomly assigned to EGFR-TKI (erlotinib 150 mg/d, gefitinib 250 mg/d, or icotinib 125 mg tid/d) plus CHM (TKI+CHM, N = 185) or EGFR-TKI plus placebo (TKI+placebo, N = 169). Progression-free survival (PFS) was the primary end point; the secondary end points were overall survival (OS), objective response rate (ORR), disease control rate (DCR), quality of life [Functional Assessment of Cancer Therapy-Lung (FACT-L) and Lung Cancer Symptom Scale (LCSS)], and safety. Results: The median PFS was significantly longer for the TKI+CHM group (13.50 months; 95% CI, 11.20–16.46 months) than with the EGFR-TKI group (10.94 months; 95% CI, 8.97–12.45 months; hazard ratio, 0.68; 95% CI, 0.51–0.90; P = 0.0064). The subgroup analyses favored TKI+CHM as a first-line treatment (15.97 vs. 10.97 months, P = 0.0447) rather than as a second-line treatment (11.43 vs. 9.23 months, P = 0.0530). Patients with exon 19 deletion had a significantly longer PFS than with 21 L858R. The addition of CHM to TKI significantly improved the ORR (64.32% vs. 52.66%, P = 0.026) and QoL. Drug-related grade 1–2 adverse events were less common with TKI+CHM. Conclusions: TKI+CHM improved PFS when compared with TKI alone in patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC).Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT01745302.
Highlights
epidermal growth factor receptor (EGFR)-TKIs have proved effective in first- or second-line therapy for advanced non-small-cell lung cancer (NSCLC) (Mok et al, 2009; Zhou et al, 2011; Shi et al, 2017)
A meta-analysis of randomized trials of treatment-native patients reported that EGFR-TKIs statistically significantly prolonged PFS overall, but because of the high rate of crossover at progression, EGFR-TKI had a shorter overall survival (OS) than those who were randomly assigned to chemotherapy (12.8 months, 95% CI : 11.4–14.3 vs. 19.8 months, 95% CI: 17.6–21.7) (Lee et al, 2017)
EGFR T790M is a mutation associated with acquired resistance to EGFR-TKI therapy and has been reported in approximately 60% of patients with disease progression after the initial treatment with erlotinib and gefitinib (Yu et al, 2013; Yu et al, 2015)
Summary
To determine the clinical activity and safety of Chinese herbal medicine (CHM) combined with epidermal growth factor receptor tyrosine kinase inhibitors (EGFRTKI) in patients with advanced pulmonary adenocarcinoma (ADC) and the ability of CHM combined with EGFR-TKI to activate EGFR mutations
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