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Clinical Effectiveness of Erlova in EGFR-Mutated Non-Small Cell Lung Cancer: An Affordable Price with Clinical Benefit |
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| Authors: | Sharareh SeifiBabak SalimiZahra Esfahani-MonfaredRamin RadmaneshSaeed YaghoubifardSara TalebianpourAdnan Khosravi |
| Affiliation: | 1Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.2Department of Pharmacoeconomy and Pharmaceutcal Management, Faculty of Pharmacy, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.3Department of R&D, Osveh Pharmaceutcal CO, Tehran, Iran. |
| Abstract: | Background: Thyrosin kinase inhibitors (TKIs) is approved for the first line treatment of non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation. This study performed to assess clinical effectiveness and safety of Erlova (generic form of Erlotinib). Methods: Somatic mutations of EGFR gene were studied in tumor tissue by polymerase chain reaction (PCR) and bi-directional sequencing in 513 chemonaive and histologically verified lung adenocarcinoma Iranian patients. Patients with EGFR mutation received Erlova at 150 mg/day as first line treatment. Primary endpoint was progression free survival (PFS). Results: About 21% (n=109) cases had EGFR mutation. Most EGFR mutations were occurred at exon 19. Among them, sixty nine patients treated with Erlova. Median PFS was 11.4 months and objective response rate (ORR) was about 88%. Most frequent treatment related adverse events was skin rash. Conclusion: Our findings showed Erlova had remarkable effectiveness. In mutation-positive patients with EGFR, Erlova can be used safely instead of other tyrosine-kinase inhibitors. |
| Keywords: | Carcinoma Non-Small-Cell Lung safety Erlotinib Hydrochloride |
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