Abstract
Epidermal growth factor receptor tyrosine-kinase inhibitors (EGFR-TKIs) are standard treatment for advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation. However, EGFR mutation testing is not attainable in approximately 20% of patients. The current study examined intercalating and maintaining gefitinib treatment in stage IIIB/IV non-squamous NSCLC, never or former light smoking patients with unknown EGFR mutation status. Briefly, 219 patients who achieved stable disease (SD) with gemcitabine (1250 mg/m2) plus carboplatin (5 AUC) were randomized at 1:1 ratio to continue chemotherapy (n = 110) or intercalating gefitinib (250 mg/day on days 15–25 of each cycle until disease progress (n = 109). Progression-free survival (PFS) was 9.7 vs. 4.2 month in the gefitinib vs. control arm (HR: 0.41, 95% CI: 0.31–0.56; P < 0.001). Overall survival (OS) was also longer in the gefitinib arm (20.1 vs. 15.4 months; HR: 0.68; 95% CI 0.48–0.97; P = 0.0323). Adverse events, including diarrhea, dermal reaction and thrombocytopenia, were more common in the gefitinib arm. In conclusion, intercalating and maintenance gefitinib treatment is a viable option for advanced NSCLC patients with unknown EGFR mutation status in subpopulations with high EFGR mutation rate.
Highlights
Epidermal growth factor receptor tyrosine-kinase inhibitors (EGFR-TKIs) are standard treatment for advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation
Between June 2011 and September 2014, 220 eligible subjects were randomized to a control (n = 110) or gefitinib arm (n = 109, 1 patient withdrew without any treatment) (Fig. 1)
The 7 subjects with EGFR sensitive mutations in the gefitinib arm (n = 7) had longer median progression-free survival (PFS) (12.1 months, 95% confidence intervals (CI), 4.0–18.7) vs. those in the control arm (n = 10; 3.9 months, 95% CI, 2.0–4.6) (Table 3)
Summary
Epidermal growth factor receptor tyrosine-kinase inhibitors (EGFR-TKIs) are standard treatment for advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation. Despite availability of massive, parallel-sequencing technologies enabling efficient, simultaneous detection of driver mutations in lung cancer[15, 16], up-front assessment of EGFR mutation status in all patients with advanced NSCLC is not attainable for a number of reasons, including non-evaluable/unavailable samples (in approximately 20% of the samples) and lack of access to affordable testing technologies, in the Asia-Pacific region and other less developed regions of the world[17] For this subset of patients, we speculate that intercalating EGFR-TKI into chemotherapy could provide some benefits
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