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Bridging the Gap between Trial Adverse Events and Real-World Data
Sang Hyuk Kim, Hyun Lee, Dong Won Park
Cancer Res Treat. 2024;56(3):972-973.   Published online January 10, 2024
DOI: https://doi.org/10.4143/crt.2024.019
PDFPubReaderePub
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Original Articles
Lung and Thoracic cancer
Real-World Study of Osimertinib in Korean Patients with Epidermal Growth Factor Receptor T790M Mutation–Positive Non–Small Cell Lung Cancer
Jang Ho Lee, Eun Young Kim, Cheol-Kyu Park, Shin Yup Lee, Min ki Lee, Seong-Hoon Yoon, Jeong Eun Lee, Sang Hoon Lee, Seung Joon Kim, Sung Yong Lee, Jun Hyeok Lim, Tae-Won Jang, Seung Hun Jang, Kye Young Lee, Seung Hyeun Lee, Sei Hoon Yang, Dong Won Park, Chan Kwon Park, Hye Seon Kang, Chang Dong Yeo, Chang-Min Choi, Jae Cheol Lee
Cancer Res Treat. 2023;55(1):112-122.   Published online July 19, 2022
DOI: https://doi.org/10.4143/crt.2022.381
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
Although osimertinib is the standard-of-care treatment of epidermal growth factor receptor (EGFR) 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 EGFR 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 EGFR 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 EGFR mutation subtype. However, hepatic metastases at the time of diagnosis, the presence of plasma EGFR 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 EGFR T790M mutation–positive in Korean patients with no new safety signals.

Citations

Citations to this article as recorded by  
  • The importance of re-biopsy in the era of molecular therapy for lung cancer
    Nensi Lalic, Daliborka Bursac, Marko Bojovic, Marko Nemet, Ivan Ergelasev
    Srpski arhiv za celokupno lekarstvo.2024; 152(3-4): 209.     CrossRef
  • Detection of EGFR exon 20 insertion mutations in non-small cell lung cancer: implications for consistent nomenclature in precision medicine
    Jieun Park, Boram Lee, Ji-Young Song, Minjung Sung, Mi Jeong Kwon, Chae Rin Kim, Sangjin Lee, Young Kee Shin, Yoon-La Choi
    Pathology.2024; 56(5): 653.     CrossRef
  • Real‐world study of lazertinib as second‐line or greater treatment in advanced non‐small cell lung cancer
    Jeong Uk Lim, Kyuhwan Kim, Kyu Yean Kim, Hye Seon Kang, Ah. Young Shin, Chang Dong Yeo, Sung Kyoung Kim, Chan Kwon Park, Sang Haak Lee, Seung Joon Kim
    Thoracic Cancer.2024; 15(19): 1513.     CrossRef
  • Comparative effectiveness of lazertinib in patients with EGFR T790M-positive non-small-cell lung cancer using a real-world external control
    Ha-Lim Jeon, Meesong Kwak, Sohee Kim, Hye-Yeon Yu, Ju-Young Shin, Hyun Ae Jung
    Scientific Reports.2024;[Epub]     CrossRef
  • A Randomized, Multi-Center, Open Label Study to Compare the Safety and Efficacy between Afatinib Monotherapy and Combination Therapy with HAD-B1 for the Locally Advanced or Metastatic NSCLC Patients with EGFR Mutations
    Eunbin Kwag, Soo-Dam Kim, Seong-Hoon Shin, Chulho Oak, So-Jung Park, Jun-Yong Choi, Seong Hoon Yoon, In-Cheol Kang, Mi-Kyung Jeong, Hyun Woo Lee, Sun-Hwi Bang, Ji Woong Son, Sanghun Lee, Seung Joon Kim, Hwa-Seung Yoo
    Integrative Cancer Therapies.2024;[Epub]     CrossRef
  • Clinical utility of repeated rebiopsy for EGFR T790M mutation detection in non-small cell lung cancer
    Eun Hye Lee, Se Hyun Kwak, Kyeong Yeon Kim, Chi Young Kim, Sang Hoon Lee, Seok-Jae Heo, Yoon Soo Chang, Eun Young Kim
    Frontiers in Oncology.2024;[Epub]     CrossRef
  • Real-world evidence of osimertinib in Chinese patients with EGFR T790M-positive non-small cell lung cancer: a subgroup analysis from ASTRIS study
    Qing Zhou, He-Long Zhang, Li-Yan Jiang, Yuan-Kai Shi, Yuan Chen, Jin-Ming Yu, Cai-Cun Zhou, Yong He, Yan-Ping Hu, Zong-An Liang, Yue-Yin Pan, Wen-Lei Zhuo, Yong Song, Gang Wu, Gong-Yan Chen, You Lu, Cui-Ying Zhang, Yi-Ping Zhang, Ying Cheng, Shun Lu, Chan
    Journal of Cancer Research and Clinical Oncology.2023; 149(12): 10771.     CrossRef
  • 7,056 View
  • 328 Download
  • 9 Web of Science
  • 7 Crossref
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Lung Cancer
Risk of Coronavirus Disease 2019 Occurrence, Severe Presentation, and Mortality in Patients with Lung Cancer
Bumhee Yang, Hayoung Choi, Sun-Kyung Lee, Sung Jun Chung, Yoomi Yeo, Yoon Mi Shin, Dong Won Park, Tai Sun Park, Ji-Yong Moon, Tae-Hyung Kim, Yun Su Sim, Ho Joo Yoon, Jang Won Sohn, Hyun Lee, Sang-Heon Kim
Cancer Res Treat. 2021;53(3):678-684.   Published online December 28, 2020
DOI: https://doi.org/10.4143/crt.2020.1242
AbstractAbstract PDFPubReaderePub
Purpose
This study aimed to analyze whether patients with lung cancer have a higher susceptibility of coronavirus disease 2019 (COVID-19), severe presentation, and higher mortality than those without lung cancer.
Materials and Methods
A nationwide cohort of confirmed COVID-19 (n=8,070) between January 1, 2020, and May 30, 2020, and a 1:15 age-, sex-, and residence-matched cohort (n=121,050) were constructed. A nested case-control study was performed to compare the proportion of patients with lung cancer between the COVID-19 cohort and the matched cohort.
Results
The proportion of patients with lung cancer was significantly higher in the COVID-19 cohort (0.5% [37/8,070]) than in the matched cohort (0.3% [325/121,050]) (p=0.002). The adjusted odds ratio [OR] of having lung cancer was significantly higher in the COVID-19 cohort than in the matched cohort (adjusted OR, 1.51; 95% confidence interval [CI], 1.05 to 2.10). Among patients in the COVID-19 cohort, compared to patients without lung cancer, those with lung cancer were more likely to have severe COVID-19 (54.1% vs. 13.2%, p < 0.001), including mortality (18.9% vs. 2.8%, p < 0.001). The adjusted OR for the occurrence of severe COVID-19 in patients with lung cancer relative to those without lung cancer was 2.24 (95% CI, 1.08 to 4.74).
Conclusion
The risk of COVID-19 occurrence and severe presentation, including mortality, may be higher in patients with lung cancer than in those without lung cancer.

Citations

Citations to this article as recorded by  
  • Impact of physical activity on all-cause mortality in individuals with non-cystic fibrosis bronchiectasis
    Sang Hyuk Kim, Hayoung Choi, Kyungdo Han, Jin-Hyung Jung, Bumhee Yang, Hyun Lee
    Frontiers in Medicine.2025;[Epub]     CrossRef
  • Association between rheumatoid arthritis and interstitial lung disease and impact of serologic status: a large-scale longitudinal study
    Bo-Guen Kim, Hyun Lee, Yeonghee Eun, Kyungdo Han, Jin-Hyung Jung, Hayoung Choi, Hyungjin Kim, Dong Wook Shin
    Scientific Reports.2025;[Epub]     CrossRef
  • COVID-19 and risk of long-term mortality in COPD: a nationwide population-based cohort study
    Hyun Lee, Sang Hyuk Kim, Cho Yun Jeong, Jee-Eun Chung, Youlim Kim, Kyung Hoon Min, Kwang Ha Yoo, Jong Seung Kim, Ji-Yong Moon
    BMJ Open Respiratory Research.2025; 12(1): e002694.     CrossRef
  • Comprehensive risk assessment for pulmonary manifestations in systemic lupus erythematosus: a large-scale Korean population-based longitudinal study
    Bo-Guen Kim, Jiyeong Kim, Yeonghee Eun, Dong Won Park, Sang-Heon Kim, Hyun Lee
    RMD Open.2025; 11(1): e005267.     CrossRef
  • Increased Risk of New-Onset Asthma After COVID-19: A Nationwide Population-Based Cohort Study
    Bo-Guen Kim, Hyun Lee, Sang Woo Yeom, Cho Yun Jeong, Dong Won Park, Tai Sun Park, Ji-Yong Moon, Tae-Hyung Kim, Jang Won Sohn, Ho Joo Yoon, Jong Seung Kim, Sang-Heon Kim
    The Journal of Allergy and Clinical Immunology: In Practice.2024; 12(1): 120.     CrossRef
  • Risk of newly diagnosed interstitial lung disease after COVID-19 and impact of vaccination: a nationwide population-based cohort study
    Bo-Guen Kim, Hyun Lee, Cho Yun Jeong, Sang Woo Yeom, Dong Won Park, Tai Sun Park, Ji-Yong Moon, Tae-Hyung Kim, Jang Won Sohn, Ho Joo Yoon, Jong Seung Kim, Sang-Heon Kim
    Frontiers in Public Health.2024;[Epub]     CrossRef
  • Microwave ablation for high-risk pulmonary nodules in patients infected with the Omicron variant of Sars-Cov-2 within 3 months: a retrospective analysis of safety and efficacy
    Yuxian Chen, Yang Li, Hong Meng, Chunhai Li, Fanlei Kong
    Frontiers in Oncology.2024;[Epub]     CrossRef
  • A year of experience with COVID‐19 in patients with cancer: A nationwide study
    Mina Khosravifar, Sogol Koolaji, Negar Rezaei, Ali Ghanbari, Seyedeh Melika Hashemi, Erfan Ghasemi, Ali Bitaraf, Ozra Tabatabaei‐Malazy, Nazila Rezaei, Sahar Mohammadi Fateh, Arezou Dilmaghani‐Marand, Rosa Haghshenas, Ameneh Kazemi, Erfan Pakatchian, Farz
    Cancer Reports.2023;[Epub]     CrossRef
  • Risk factors for mortality among lung cancer patients with covid-19 infection: A systematic review and meta-analysis
    Mingyue Wu, Siru Liu, Changyu Wang, Yuxuan Wu, Jialin Liu, Yoon-Seok Chung
    PLOS ONE.2023; 18(9): e0291178.     CrossRef
  • International Association for the Study of Lung Cancer Study of the Impact of Coronavirus Disease 2019 on International Lung Cancer Clinical Trials
    Matthew P. Smeltzer, Giorgio V. Scagliotti, Heather A. Wakelee, Tetsuya Mitsudomi, Upal Basu Roy, Russell C. Clark, Renee Arndt, Clayton D. Pruett, Karen L. Kelly, Peter Ujhazy, Melissa L. Johnson, Yesim Eralp, Carlos H. Barrios, Fabrice Barlesi, Fred R.
    Journal of Thoracic Oncology.2022; 17(5): 651.     CrossRef
  • Conceptual Framework for Cancer Care During a Pandemic Incorporating Evidence From the COVID-19 Pandemic
    Vivienne Milch, Anne E. Nelson, Melissa Austen, Debra Hector, Scott Turnbull, Rahul Sathiaraj, Carolyn Der Vartanian, Rhona Wang, Cleola Anderiesz, Dorothy Keefe
    JCO Global Oncology.2022;[Epub]     CrossRef
  • COVID-19 and Lung Cancer Survival: An Updated Systematic Review and Meta-Analysis
    Simone Oldani, Fausto Petrelli, Giuseppina Dognini, Karen Borgonovo, Maria Chiara Parati, Mara Ghilardi, Lorenzo Dottorini, Mary Cabiddu, Andrea Luciani
    Cancers.2022; 14(22): 5706.     CrossRef
  • Interstitial lung disease increases susceptibility to and severity of COVID-19
    Hyun Lee, Hayoung Choi, Bumhee Yang, Sun-Kyung Lee, Tai Sun Park, Dong Won Park, Ji-Yong Moon, Tae-Hyung Kim, Jang Won Sohn, Ho Joo Yoon, Sang-Heon Kim
    European Respiratory Journal.2021; 58(6): 2004125.     CrossRef
  • Mortality in adult patients with solid or hematological malignancies and SARS-CoV-2 infection with a specific focus on lung and breast cancers: A systematic review and meta-analysis
    Marco Tagliamento, Elisa Agostinetto, Marco Bruzzone, Marcello Ceppi, Kamal S. Saini, Evandro de Azambuja, Kevin Punie, C. Benedikt Westphalen, Gilberto Morgan, Paolo Pronzato, Lucia Del Mastro, Francesca Poggio, Matteo Lambertini
    Critical Reviews in Oncology/Hematology.2021; 163: 103365.     CrossRef
  • Characteristics and outcomes of the Korean patients with coronavirus disease 2019; analyses of the national database
    Sang-Heon Kim
    Allergy, Asthma & Respiratory Disease.2021; 9(3): 113.     CrossRef
  • 8,561 View
  • 198 Download
  • 14 Web of Science
  • 15 Crossref
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