Efficacy and Safety of Original Versus Generic Erlotinib in Non-small Cell Lung Cancer with Epidermal Growth Factor Receptor Gene Mutations in Thailand: A Retrospective Cohort Study
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Keywords
Non-Small Cell Lung Cancer (NSCLC), Epidermal Growth Factor Receptor Genes (EGFR), erlotinib, generic drugs
Abstract
Background: Non-small cell lung cancer (NSCLC) is a major cause of cancer-related mortality, for which mutations in the epidermal growth factor receptor (EGFR) gene are common in Asian populations. Erlotinib, an EGFR tyrosine kinase inhibitor, has been used as the first-line therapy for EGFR-mutated NSCLC. Generic erlotinib has been introduced in Thailand to increase accessibility, but efficacy and safety are major concerns. Objective: This study aimed to compare the efficacy and safety of generic versus originator erlotinib among Thai patients using real-world data from two quaternary hospitals. Methods: A retrospective cohort study collected data from medical record of advanced or metastatic EGFR-mutated NSCLC receiving either generic or originator erlotinib between September 2019 and September 2021 from Maharaj Nakorn Chiang Mai Hospital and Sunpasitthiprasong Hospital, Thailand. Primary outcomes were clinical benefit rate (CBR) at 12 months, progression-free survival (PFS) and treatment-related adverse events. Kaplan-Meier survival curve with log-rank test and the propensity score (PS)-adjusted models were employed to estimate the difference of response rate and safety between the generic vs. the originator erlotinib. Results: One hundred and seven patients were included. CBR at 12 months of the generic vs. originator erlotinib were 75.4 and 74.0% (adjusted HR 1.47 [95%CI 0.45-4.83, p= 0.519]). Median PFS of the generic vs. originator erlotinib were 15.2 months and 18.9 months (adjusted HR 1.98 [95%CI 0.99-3.94, p = 0.053]). The incidence of any adverse events for the generic vs. originator was 21.0 and 36.0% (adjusted OR 0.84 [95%CI 0.26-2.71, p = 0.770]). Most adverse events comprised mild skin toxicity, with no significant difference between the two groups (adjusted OR 1.03 [95%CI 0.31-3.43, p = 0.958]). Conclusions: No significant differences were noted regarding efficacy or safety between generic and originator erlotinib. These findings support the use of generic erlotinib as a cost-effective alternative in Thailand.
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This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Dr. Phitjira Sanguanboonyaphong, Division of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Ubon Ratchathani University, Ubon Ratchathani, Thailand
Lecturer at Division of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Ubon Ratchathani University, Ubon Ratchathani 34190 Thailand
Asst. Prof. Dr. Narawadee Niamhun, Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand
Assistant Professor at Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200 Thailand
Asst. Prof. Dr. Jukapun Yoodee, Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand and Center for Medical and Health Technology Assessment (CM-HTA), Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand.
Assistant Professor at Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200 Thailand and Center for Medical and Health Technology Assessment (CM-HTA), Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200 Thailand.
Assoc. Prof. Dr. Busyamas Chewaskulyong, Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200 Thailand
Associate professor at Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200 Thailand.
Asst. Prof. Dr. Manit Saeteaw , Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen 40002 Thailand
Assistant Professor at Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen 40002 Thailand
Miss Nonthikun Pasukmoon, Department of Pharmacy, Sunpasitthiprasong Hospital, Ubon Ratchathani, Thailand.
Pharmacist at Department of Pharmacy, Sunpasitthiprasong Hospital, Ubon Ratchathani 34000 Thailand.
Asst. Prof. Dr. Buntitabhon Sirichanchuen, Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand and Center for Medical and Health Technology Assessment (CM-HTA), Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand.
Assistant Professor, Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand and Center for Medical and Health Technology Assessment (CM-HTA), Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand.