Intercalating and maintenance gefitinib plus chemotherapy versus chemotherapy alone in selected advanced non-small cell lung cancer with unknown EGFR status
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Hong Jian1, Wei Li2, Zhiyong Ma3
1Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
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.
Insights
Adding gefitinib to chemotherapy improved outcomes for advanced non-small cell lung cancer (NSCLC) patients with unknown EGFR mutation status. This strategy offers a viable treatment option when EGFR testing is unavailable.
Area of Science:
- Medical Oncology
- Thoracic Oncology
- Clinical Pharmacology
Background:
- Epidermal growth factor receptor tyrosine-kinase inhibitors (EGFR-TKIs) are standard for advanced non-small cell lung cancer (NSCLC) with EGFR mutations.
- EGFR mutation testing is unavailable for approximately 20% of NSCLC patients, necessitating alternative treatment strategies.
Purpose of the Study:
- To evaluate the efficacy and safety of intercalating and maintenance gefitinib in advanced non-squamous NSCLC patients with unknown EGFR mutation status.
- To determine if gefitinib improves progression-free survival (PFS) and overall survival (OS) compared to continued chemotherapy after initial chemoradiation.
Main Methods:
- A randomized controlled trial involving 219 patients with stage IIIB/IV non-squamous NSCLC who achieved stable disease (SD) on gemcitabine plus carboplatin.
- Patients were randomized 1:1 to either continue chemotherapy or receive intercalating gefitinib (250 mg/day) until disease progression.
- Progression-free survival (PFS), overall survival (OS), and adverse events were assessed.
Main Results:
- Intercalating gefitinib significantly improved PFS (9.7 vs. 4.2 months; HR: 0.41; P < 0.001) and OS (20.1 vs. 15.4 months; HR: 0.68; P = 0.0323) compared to the control arm.
- Adverse events, including diarrhea, dermal reactions, and thrombocytopenia, were more frequent in the gefitinib arm.
- The study identified a subpopulation with a high EGFR mutation rate where this strategy showed particular benefit.
Conclusions:
- Intercalating and maintenance gefitinib is a viable treatment option for advanced NSCLC patients with unknown EGFR mutation status, especially in populations with a high likelihood of EGFR mutations.
- This approach addresses the unmet need for effective treatments when EGFR testing is not feasible.
- Further research may refine patient selection for this therapeutic strategy.
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