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Comparison of first and third generation EGFR-TKIs for the treatment of advanced non-small cell lung cancer: A
Maitri Shah1, Kashvi Shah1, Hetvi Dave1
1Pharm.D section, L. M. College of Pharmacy, Ahmedabad, India.
Abstract:
BackgroundWorldwide, lung cancer stands as a leading cause of mortality, with EGFR-mutated metastatic non-small cell lung cancer (NSCLC) accounting for a large percentage of cases in the Indian population. Different generations of EGFR-tyrosine kinase inhibitors (TKIs) are available to treat EGFR-mutated NSCLC. The purpose of our research was to evaluate and compare the superiority of osimertinib over gefitinib/erlotinib in terms of clinical effectiveness and safety.MethodsA retrospective observational cohort study was conducted at the Clinical Oncology Center in the Western region of India. Patients suffering from EGFR-mutated metastatic NSCLC were recruited for the study. The response of EGFR-TKIs was assessed using objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and incidence of adverse events (AE).ResultsA total of 75 patients treated with EGFR TKIs were enrolled in the study. The ORR of osimertinib and gefitinib/erlotinib was 11.11% and 25.64% (p = 0.142) and DCR was found to be 69.44% and 82.05% (p = 0.28) respectively. Osimertinib and gefitinib/erlotinib had respective median PFS of 8.43 and 10.68 months. The incidence of AE of osimertinib and gefitinib/erlotinib was 1.94 and 2.49 respectively.ConclusionOsimertinib was not found to be superior over gefitinib/erlotinib based on clinical effectiveness. Though it showed a better safety profile, the cost of the treatment of osimertinib over gefitinib/erlotinib was not justifiable.
Insights
Osimertinib did not show superiority over gefitinib/erlotinib for EGFR-mutated metastatic non-small cell lung cancer (NSCLC) in India. While safer, its higher cost was not justified by clinical effectiveness.
Area of Science:
- Oncology
- Pharmacology
- Clinical Research
Background:
- Lung cancer is a major global cause of death.
- Epidermal Growth Factor Receptor (EGFR)-mutated metastatic non-small cell lung cancer (NSCLC) is prevalent in India.
- First- and second-generation EGFR-tyrosine kinase inhibitors (TKIs) like gefitinib/erlotinib and third-generation TKIs like osimertinib are used for treatment.
Purpose of the Study:
- To compare the clinical effectiveness and safety of osimertinib against gefitinib/erlotinib in Indian patients with EGFR-mutated metastatic NSCLC.
- To evaluate objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and adverse events (AE).
Main Methods:
- Retrospective observational cohort study in Western India.
- Inclusion of patients with EGFR-mutated metastatic NSCLC.
- Assessment of treatment response using ORR, DCR, PFS, and AE incidence.
Main Results:
- No statistically significant difference in ORR (11.11% vs 25.64%) or DCR (69.44% vs 82.05%) between osimertinib and gefitinib/erlotinib.
- Median PFS was 8.43 months for osimertinib and 10.68 months for gefitinib/erlotinib.
- Osimertinib showed a lower incidence of adverse events (1.94 vs 2.49).
Conclusions:
- Osimertinib was not clinically superior to gefitinib/erlotinib in this patient cohort.
- Osimertinib demonstrated a better safety profile.
- The higher cost of osimertinib was not justified by its clinical effectiveness compared to gefitinib/erlotinib.
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