Real-World Study of Osimertinib in Korean Patients with Epidermal Growth Factor Receptor T790M Mutation–Positive Non–Small Cell Lung Cancer
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Purpose Although osimertinib is the standard-of-care treatment of epidermal growth factor receptor (<i>EGFR</i>) T790M mutation–positive non–small cell lung cancer, real-world evidence on the efficacy of osimertinib is not enough to reflect the complexity of the entire course of treatment. Herein, we report on the use of osimertinib in patients with <i>EGFR</i> T790M mutation–positive non–small cell lung cancer who had previously received EGFR tyrosine kinase inhibitor (TKI) treatment in Korea.Materials and Methods Patients with confirmed <i>EGFR</i> T790M after disease progression of prior EGFR-TKI were enrolled and administered osimertinib 80 mg daily. The primary effectiveness outcome was progression-free survival, with time-to-treatment discontinuation, treatment and adverse effects leading to treatment discontinuation, and overall survival being the secondary endpoints.Results A total of 558 individuals were enrolled, and 55.2% had investigator-assessed responses. The median progression-free survival was 14.2 months (95% confidence interval [CI], 13.0 to 16.4), and the median time-to-treatment discontinuation was 15.0 months (95% CI, 14.1 to 15.9). The median overall survival was 36.7 months (95% CI, 30.9 to not reached). The benefit with osimertinib was consistent regardless of the age, sex, smoking history, and primary <i>EGFR</i> mutation subtype. However, hepatic metastases at the time of diagnosis, the presence of plasma <i>EGFR</i> T790M, and the shorter duration of prior EGFR-TKI treatment were poor predictors of osimertinib treatment. Ten patients (1.8%), including three with pneumonitis, had to discontinue osimertinib due to severe adverse effects.Conclusion Osimertinib demonstrated its clinical effectiveness and survival benefit for <i>EGFR</i> T790M mutation–positive in Korean patients with no new safety signals.
Abstract
Purpose Although osimertinib is the standard-of-care treatment of epidermal growth factor receptor (<i>EGFR</i>) T790M mutation–positive non–small cell lung cancer, real-world evidence on the efficacy of osimertinib is not enough to reflect the complexity of the entire course of treatment. Herein, we report on the use of osimertinib in patients with <i>EGFR</i> T790M mutation–positive non–small cell lung cancer who had previously received EGFR tyrosine kinase inhibitor (TKI) treatment in Korea.Materials and Methods Patients with confirmed <i>EGFR</i> T790M after disease progression of prior EGFR-TKI were enrolled and administered osimertinib 80 mg daily. The primary effectiveness outcome was progression-free survival, with time-to-treatment discontinuation, treatment and adverse effects leading to treatment discontinuation, and overall survival being the secondary endpoints.Results A total of 558 individuals were enrolled, and 55.2% had investigator-assessed responses. The median progression-free survival was 14.2 months (95% confidence interval [CI], 13.0 to 16.4), and the median time-to-treatment discontinuation was 15.0 months (95% CI, 14.1 to 15.9). The median overall survival was 36.7 months (95% CI, 30.9 to not reached). The benefit with osimertinib was consistent regardless of the age, sex, smoking history, and primary <i>EGFR</i> mutation subtype. However, hepatic metastases at the time of diagnosis, the presence of plasma <i>EGFR</i> T790M, and the shorter duration of prior EGFR-TKI treatment were poor predictors of osimertinib treatment. Ten patients (1.8%), including three with pneumonitis, had to discontinue osimertinib due to severe adverse effects.Conclusion Osimertinib demonstrated its clinical effectiveness and survival benefit for <i>EGFR</i> T790M mutation–positive in Korean patients with no new safety signals.
참고문헌 (27)
- Siegel RL, "Cancer statistics, 2020", CA Cancer J Clin, 70, pp.7~30 (2020)
- Santarpia M, "Osimertinib in the treatment of non-small-cell lung cancer : design, development and place in therapy", Lung Cancer(Auckl), 8, pp.109~125 (2017)
- Cho BC, "Real-world use of osimertinib in non-small cell lung cancer : ASTRIS study Korean subgroup analysis", Curr Med Res Opin, 36, pp.477~482 (2020)
- Majeed U, "Targeted therapy in advanced non-small cell lung cancer : current advances and future trends", J Hematol Oncol, 14, pp.108~ (2021)
- Lee Jae Guk, "Recent Trends of Lung Cancer in Korea", Tuberculosis and Respiratory Diseases, 84(2), pp.89~95 (2021), 대한결핵및호흡기학회[DOI]
- Sequist LV, "Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations", J Clin Oncol, 31, pp.3327~3334 (2013)
- Maemondo M, "Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR", N Engl J Med, 362, pp.2380~2388 (2010)
- Shepherd FA, "Erlotinib in previously treated non-small-cell lung cancer", N Engl J Med, 353, pp.123~132 (2005)
- Wu SG, "Management of acquired resistance to EGFR TKI-targeted therapy in advanced non-small cell lung cancer", Mol Cancer, 17, pp.38~ (2018)
- Oh DK, "Efficacy, safety, and resistance profile of osimertinib in T790M mutation-positive non-small cell lung cancer in real-world practice", PLoS One, 14, pp.e0210225~ (2019)
- Cross DA, "AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer", Cancer Discov, 4, pp.1046~1061 (2014)
- Mok TS, "Osimertinib or platinum-pemetrexed in EGFR T790M-positive lung cancer", N Engl J Med, 376, pp.629~640 (2017)
- Marinis F, "ASTRIS : a global real-world study of osimertinib in >3000 patients with EGFR T790M positive non-small-cell lung cancer", Future Oncol, 15, pp.3003~3014 (2019)
- Lee JC, "Real-world treatment patterns in patients with EGFR mutation-positive NSCLC receiving a first-line, first-or second-generation EGFR tyrosine kinase inhibitor in South Korea and Taiwan", Asian Pac J Cancer Biol, 6, pp.123~132 (2021)
- Hochmair MJ, "Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer : final analysis of the GioTag study", Future Oncol, 16, pp.2799~2808 (2020)
- Papadimitrakopoulou VA, "Osimertinib versus platinum-pemetrexed for patients with EGFR T790M advanced NSCLC and progression on a prior EGFR-tyrosine kinase inhibitor : AURA3 overall survival analysis", Ann Oncol, 31, pp.1536~1544 (2020)
- Blumenthal GM, "Analysis of time-to-treatment discontinuation of targeted therapy, immunotherapy, and chemotherapy in clinical trials of patients with non-small-cell lung cancer", Ann Oncol, 30, pp.830~838 (2019)
- Lim JU, "Management of oligometastasis and oligoprogression in patients with epidermal growth factor receptor mutation-positive NSCLC in the era of third-generation tyrosine kinase inhibitors", Clin Lung Cancer, 22, pp.e786~92 (2021)
- Wu YL, "Pan-Asian adapted Clinical Practice Guidelines for the management of patients with metastatic non-small-cell lung cancer : a CSCO-ESMO initiative endorsed by JSMO, KSMO, MOS, SSO and TOS", Ann Oncol, 30, pp.171~210 (2019)
- Choi MG, "Different prognostic implications of hepatic metastasis according to front-line treatment in non-small cell lung cancer : a real-world retrospective study", Transl Lung Cancer Res, 10, pp.2551~2561 (2021)
- Zheng D, "Plasma EGFR T790M ctDNA status is associated with clinical outcome in advanced NSCLC patients with acquired EGFR-TKI resistance", Sci Rep, 6, pp.20913~ (2016)
- Yu HA, "Concurrent alterations in EGFR-mutant lung cancers associated with resistance to EGFR kinase inhibitors and characterization of MTOR as a mediator of resistance", Clin Cancer Res, 24, pp.3108~3118 (2018)
- Chen M, "Concurrent driver gene mutations as negative predictive factors in epidermal growth factor receptor-positive non-small cell lung cancer", EBioMedicine, 42, pp.304~310 (2019)
- Ramalingam SS, "Mechanisms of acquired resistance to first-line osimertinib : preliminary data from the phase III FLAURA study", Ann Oncol, 29(Suppl 8), pp.VIII740~ (2018)
- Kim ES, "EGFR tyrosine kinase inhibitors for EGFR mutation-positive non-small-cell lung cancer : outcomes in Asian populations", Future Oncol, 17, pp.2395~2408 (2021)
- Lorenzi M, "First-line osimertinib in patients with EGFR-mutant advanced non-small cell lung cancer : outcome and safety in the real world : FLOWER study", Oncologist, 27, pp.87~88 (2021)
- Ohe Y, "Real-world use of osimertinib for epidermal growth factor receptor T790M-positive non-small cell lung cancer in Japan", Jpn J Clin Oncol, 50, pp.909~919 (2020)