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Lung Cancer
The Clinical Impact of Capmatinib in the Treatment of Advanced Non–Small Cell Lung Cancer with MET Exon 14 Skipping Mutation or Gene Amplification
Wonyoung Choi, Seog-Yun Park, Youngjoo Lee, Kun Young Lim, Minjoung Park, Geon Kook Lee, Ji-Youn Han
Cancer Res Treat. 2021;53(4):1024-1032.   Published online January 29, 2021
DOI: https://doi.org/10.4143/crt.2020.1331
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
Capmatinib, an oral MET kinase inhibitor, has demonstrated its efficacy against non–small cell lung cancer (NSCLC) with MET dysregulation. We investigated its clinical impact in advanced NSCLC with MET exon 14 skipping mutation (METex14) or gene amplification.
Materials and Methods
Patients who participated in the screening of a phase II study of capmatinib for advanced NSCLC were enrolled in this study. MET gene copy number (GCN), protein expression, and METex14 were analyzed and the patients’ clinical outcome were retrospectively reviewed.
Results
A total of 72 patients were included in this analysis (group A: GCN ≥ 10 or METex14, n=14; group B: others, n=58). Among them, 13 patients were treated with capmatinib (group A, n=8; group B, n=5), and the overall response rate was 50% for group A, and 0% for group B. In all patients, the median overall survival (OS) was 20.2 months (95% confidence interval [CI], 6.9 to not applicable [NA]) for group A, and 11.3 months (95% CI, 8.2 to 20.3) for group B (p=0.457). However, within group A, median OS was 21.5 months (95% CI, 20.8 to NA) for capmatinib-treated, and 7.5 months (95% CI, 3.2 to NA) for capmatinib-untreated patients (p=0.025). Among all capmatinib-untreated patients (n=59), group A showed a trend towards worse OS to group B (median OS, 7.5 months vs. 11.3 months; p=0.123).
Conclusion
Our data suggest that capmatinib is a new compelling treatment for NSCLC with MET GCN ≥ 10 or METex14 based on the improved survival within these patients.

Citations

Citations to this article as recorded by  
  • Exploring Cellular Plasticity and Resistance Mechanisms in Lung Cancer: Innovations and Emerging Therapies
    Caiyu Jiang, Shenglong Xie, Kegang Jia, Gang Feng, Xudong Ren, Youyu Wang
    Journal of Pharmaceutical Analysis.2025; : 101179.     CrossRef
  • EGFR and PI3K Signalling Pathways as Promising Targets on Circulating Tumour Cells from Patients with Metastatic Gastric Adenocarcinoma
    Ann-Katrin Piper, Chelsea Penney, Jacqueline Holliday, Gary Tincknell, Yafeng Ma, Sarbar Napaki, Klaus Pantel, Daniel Brungs, Marie Ranson
    International Journal of Molecular Sciences.2024; 25(10): 5565.     CrossRef
  • Understanding the treatment response and resistance to targeted therapies in non-small cell lung cancer: clinical insights and perspectives
    Hang Zhang, Yingying Zhang, Yingying Zhu, Tian Dong, Zheng Liu
    Frontiers in Oncology.2024;[Epub]     CrossRef
  • Synthesis and bioassay of 3-Aryl -1-(pyridin-4-yl)benzo[4,5]imidazo[1,2-d][1,2,4]- triazin-4(3H)-ones as anti-cancer agents
    Bassam Abu Thaher, Ihab Al-Masri, Kanan Wahedy, Rami Morjan, Saeb Aliwaini, Iman Mahmoud Al atter, Aayat Ahmed Elmabhouh, Areej khaled AL ibwaini, Saba Luay Alkhaldi, Basem Qeshta, Claus Jacob, Hans-Peter Deigner
    Naunyn-Schmiedeberg's Archives of Pharmacology.2023; 396(8): 1797.     CrossRef
  • RNA splicing alterations in lung cancer pathogenesis and therapy
    Yueren Yan, Yunpeng Ren, Yufang Bao, Yongbo Wang
    Cancer Pathogenesis and Therapy.2023; 1(4): 272.     CrossRef
  • Clinicopathological characteristics of Non-Small Cell Lung Cancer (NSCLC) patients with c-MET exon 14 skipping mutation, MET overexpression and amplification
    Caixia Ding, Yanyi Qiu, Juan Zhang, Wei Wei, Hongbian Gao, Yong Yuan, Xiaomin Wang
    BMC Pulmonary Medicine.2023;[Epub]     CrossRef
  • Long-Term Efficacy, Safety, and Subgroup Analysis of Savolitinib in Chinese Patients With NSCLCs Harboring MET Exon 14 Skipping Alterations
    Shun Lu, Jian Fang, Xingya Li, Lejie Cao, Jianying Zhou, Qisen Guo, Zongan Liang, Ying Cheng, Liyan Jiang, Nong Yang, Zhigang Han, Jianhua Shi, Yuan Chen, Hua Xu, Helong Zhang, Gongyan Chen, Rui Ma, Sanyuan Sun, Yun Fan, Songhua Fan, Jie Yu, Puhan Lu, Xia
    JTO Clinical and Research Reports.2022; 3(10): 100407.     CrossRef
  • HPLC with Fluorescence and Photodiode Array Detection for Quantifying Capmatinib in Biological Samples: Application to In Vivo and In Vitro Studies
    Aref Zayed, Sana’a A. Jaber, Jomana Al Hroot, Sahar Hawamdeh, Nehad M. Ayoub, Nidal A. Qinna
    Molecules.2022; 27(23): 8582.     CrossRef
  • Evaluation of MET alteration in EGFR-mutant non-small cell lung cancer patients treated with EGFR tyrosine kinase inhibitor from paired biopsy: A retrospective cohort study
    Bo Mi Ku, Sungwon Park, Sehhoon Park, Hyun Ae Jung, Jong-Mu Sun, Se-Hoon Lee, Jin Seok Ahn, Yoon-La Choi, Myung-Ju Ahn
    Precision and Future Medicine.2022; 6(4): 233.     CrossRef
  • Targeted Treatment of Non-Small Cell Lung Cancer: Focus on Capmatinib with Companion Diagnostics
    Matthew Z Guo, Kristen A Marrone, Alexander Spira, David M Waterhouse, Susan C Scott
    OncoTargets and Therapy.2021; Volume 14: 5321.     CrossRef
  • 7,068 View
  • 286 Download
  • 10 Web of Science
  • 10 Crossref
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Lung cancer
Phase II Study of Pemetrexed as a Salvage Chemotherapy for Thymidylate Synthase–Low Squamous Cell Lung Cancer
Mihong Choi, Heung Tae Kim, Ji-Youn Han, Geon Kook Lee, Soo-Hyun Lee, Kun Young Lim, Jungnam Joo, Hye Jin Won, Jin Soo Lee, Youngjoo Lee
Cancer Res Treat. 2021;53(1):87-92.   Published online August 13, 2020
DOI: https://doi.org/10.4143/crt.2020.741
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
Squamous cell carcinomas (SqCC) of the lung often express high levels of thymidylate synthase (TS), which is associated with primary resistance to pemetrexed. We explored the efficacy of pemetrexed in a selected population of patients with lung SqCC with low TS expression.
Materials and Methods
In this single-arm phase II trial, we enrolled 32 previously-treated patients with advanced lung SqCC exhibiting low immunohistochemical staining for TS (i.e., in 10% or less of tumor cells). The primary endpoint was 12-week progression-free survival (PFS) rate.
Results
Of 32 patients, eight patients (25%) had an Eastern Cooperative Oncology Group performance status of 2, and seven patients (22%) had previously received three or more lines of chemotherapy. The disease control rate from pemetrexed treatment was 30%, and no objective response was observed. The 12-week PFS rate was 24.5% (95% confidence interval [CI], 13.0 to 46.1). Median PFS was 1.3 months (95% CI, 1.3 to 2.7), and median overall survival was 11.8 months (95% CI, 8.1 to not applicable). Most of adverse events were grade 1 or 2.
Conclusion
Pemetrexed demonstrated modest activity as a salvage chemotherapy in patients with advanced lung SqCC with low TS expression, although its toxicity was generally manageable.

Citations

Citations to this article as recorded by  
  • Bioengineered miR-7-5p modulates non–small cell lung cancer cell metabolism to improve therapy
    Gavin M. Traber, Mei-Juan Tu, Su Guan, Neelu Batra, Ai-Ming Yu
    Molecular Pharmacology.2025; 107(1): 100006.     CrossRef
  • 7,039 View
  • 129 Download
  • 1 Crossref
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Lung Cancer Screening with Low-Dose CT in Female Never Smokers: Retrospective Cohort Study with Long-term National Data Follow-up
Hyae Young Kim, Kyu-Won Jung, Kun Young Lim, Soo-Hyun Lee, Jae Kwan Jun, Jeongseon Kim, Bin Hwangbo, Jin Soo Lee
Cancer Res Treat. 2018;50(3):748-756.   Published online July 17, 2017
DOI: https://doi.org/10.4143/crt.2017.312
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
Because of growing concerns about lung cancer in female never smokers, chest low-dose computed tomography (LDCT) screening is often performed although it has never shown clinical benefits. We examinewhether or not female never smokers really need annual LDCT screening when the initial LDCT showed negative findings.
Materials and Methods
This retrospective cohort study included 4,365 female never smokers aged 40 to 79 years who performed initial LDCT from Aug 2002 to Dec 2007. Lung cancer diagnosis was identified from the Korea Central Cancer Registry Database registered until December 31, 2013. We calculated the incidence, cumulative probability, and standardized incidence ratio (SIR) of lung cancer by Lung Imaging Reporting and Data System (Lung-RADS) categories showed on initial LDCT.
Results
After median follow-up of 9.69 years, 22 (0.5%) had lung cancer. Lung cancer incidence for Lung-RADS category 4 was 1,848.4 (95% confidence interval [CI], 1,132.4 to 3,017.2) per 100,000 person-years and 16.4 (95% CI, 7.4 to 36.4) for categories 1, 2, and 3 combined. The cumulative probability of lung cancer for category 4 was 10.6% at 5 years and 14.8% at 10 years while they were 0.07% and 0.17% when categories 1, 2, and 3 were combined. The SIR for subjects with category 4 was 43.80 (95% CI, 25.03 to 71.14), which was much higher than 0.47 (95% CI, 0.17 to 1.02) for categories 1, 2, and 3 combined.
Conclusion
Considering the low risk of lung cancer development in female never smokers, it seems unnecessary to repeat annual LDCT screening for at least 5 years or even longer unless the initial LDCT showed Lung-RADS category 4 findings.

Citations

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  • Radiological Changes in Chest CT findings of School Cafeteria Workers: A Comparative Study with Age-Matched Controls
    Jung Hee Hong, Jin Young Kim, Kiook Baek
    Safety and Health at Work.2025;[Epub]     CrossRef
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    Kay Choong See
    Singapore Medical Journal.2024;[Epub]     CrossRef
  • Cooking oil fume exposure and Lung-RADS distribution among school cafeteria workers of South Korea
    Minjun Kim, Yangho Kim, A Ram Kim, Woon Jung Kwon, Soyeoun Lim, Woojin Kim, Cheolin Yoo
    Annals of Occupational and Environmental Medicine.2024;[Epub]     CrossRef
  • Distribution of Solid Lung Nodules Presence and Size by Age and Sex in a Northern European Nonsmoking Population
    Jiali Cai, Marleen Vonder, Gert Jan Pelgrim, Mieneke Rook, Gerdien Kramer, Harry J.M. Groen, Geertruida H. de Bock, Rozemarijn Vliegenthart
    Radiology.2024;[Epub]     CrossRef
  • Low Dose Computed Tomography for Lung Cancer Screening in Tuberculosis Endemic Countries: A Systematic Review and Meta-Analysis
    Vikram Damaraju, Juhu Kiran Krushna Karri, Gayathri Gandrakota, Yamini Marimuthu, Adimulam Ganga Ravindra, Rajeev Aravindakshan, Navneet Singh
    Journal of Thoracic Oncology.2024;[Epub]     CrossRef
  • Toward More Effective Lung Cancer Risk Stratification to Empower Screening Programs for the Asian Nonsmoking Population
    Fu-Zong Wu, Yeun-Chung Chang
    Journal of the American College of Radiology.2023; 20(2): 156.     CrossRef
  • ACR Appropriateness Criteria® Lung Cancer Screening: 2022 Update
    Kim L. Sandler, Travis S. Henry, Arya Amini, Saeed Elojeimy, Aine Marie Kelly, Christopher T. Kuzniewski, Elizabeth Lee, Maria D. Martin, Michael F. Morris, Neeraja B. Peterson, Constantine A. Raptis, Gerard A. Silvestri, Arlene Sirajuddin, Betty C. Tong,
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    Yifei Mao, Jiali Cai, Marjolein A. Heuvelmans, Rozemarijn Vliegenthart, Harry J. M. Groen, Matthijs Oudkerk, Marleen Vonder, Monique D. Dorrius, Geertruida H. de Bock
    European Radiology.2023; 34(3): 1877.     CrossRef
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    Po-Chih Chang, Shah-Hwa Chou, Che-Yu Chuang, I-Hsiao Yang, Yu-Wei Liu, Ming-Cheng Shi, Reu-Sheng Sheu, Ting-Wei Chang
    Formosan Journal of Surgery.2022; 55(3): 102.     CrossRef
  • Lung cancer screening in never-smokers: facts and remaining issues
    Maurizio V. Infante, Giuseppe Cardillo
    European Respiratory Journal.2020; 56(5): 2002949.     CrossRef
  • Low-dose chest computed tomographic screening and invasive diagnosis of pulmonary nodules for lung cancer in never-smokers
    Yeon Wook Kim, Hye-Rin Kang, Byoung Soo Kwon, Sung Yoon Lim, Yeon Joo Lee, Jong Sun Park, Young-Jae Cho, Ho Il Yoon, Kyung Won Lee, Jae Ho Lee, Choon-Taek Lee
    European Respiratory Journal.2020; 56(5): 2000177.     CrossRef
  • Predicting Lung Cancer Occurrence in Never-Smoking Females in Asia: TNSF-SQ, a Prediction Model
    Li-Hsin Chien, Chung-Hsing Chen, Tzu-Yu Chen, Gee-Chen Chang, Ying-Huang Tsai, Chin-Fu Hsiao, Kuan-Yu Chen, Wu-Chou Su, Wen-Chang Wang, Ming-Shyan Huang, Yuh-Min Chen, Chih-Yi Chen, Sheng-Kai Liang, Chung-Yu Chen, Chih-Liang Wang, Mei-Hsuan Lee, Ren-Hua C
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    Hye-Rin Kang, Jun Yeun Cho, Sang Hoon Lee, Yeon Joo Lee, Jong Sun Park, Young-Jae Cho, Ho Il Yoon, Kyung Won Lee, Jae Ho Lee, Choon-Taek Lee
    Journal of Thoracic Oncology.2019; 14(3): 436.     CrossRef
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    Journal of Thoracic Oncology.2019; 14(9): 1513.     CrossRef
  • 14,645 View
  • 357 Download
  • 16 Web of Science
  • 14 Crossref
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Randomized Phase II Study of Afatinib Plus Simvastatin Versus Afatinib Alone in Previously Treated Patients with Advanced Nonadenocarcinomatous Non-small Cell Lung Cancer
Youngjoo Lee, Ki Hyeong Lee, Geon Kook Lee, Soo-Hyun Lee, Kun Young Lim, Jungnam Joo, Yun Jung Go, Jin Soo Lee, Ji-Youn Han
Cancer Res Treat. 2017;49(4):1001-1011.   Published online January 13, 2017
DOI: https://doi.org/10.4143/crt.2016.546
AbstractAbstract PDFPubReaderePub
Purpose
This phase II study examined whether the addition of simvastatin to afatinib provides a clinical benefit compared with afatinib monotherapy in previously treated patients with nonadenocarcinomatous non-small cell lung cancer (NA-NSCLC).
Materials and Methods
Patientswith advancedNA-NSCLCwho progressed after one ortwo chemotherapy regimens were randomly assigned to a simvastatin (40 mg/day) plus afatinib (40 mg/day) (AS) arm or to an afatinib (A) arm. The primary endpoint was response rate (RR).
Results
Sixty-eight patients were enrolled (36 in the AS arm and 32 in the A arm). The RR was 5.7% (95% confidence interval [CI], 0.7 to 19.2) for AS and 9.4% (95% CI, 2.0 to 25.0) for A (p=0.440). In arms AS and A, the median progression-free survival (PFS) was 1.0 versus 3.6 months (p=0.240) and the overall survival was 10.0 months versus 7.0 months (p=0.930), respectively. Skin rash, stomatitis, and diarrhea were the most common adverse events in both arms. More grade 3 or 4 diarrhea was observed in arm A (18.8% vs. 5.6% in arm AS). In all patients, the median PFS for treatment including afatinib was not correlated with the status of epidermal growth factor receptor (EGFR) mutation (p=0.122), EGFR fluorescence in situ hybridization (p=0.944), or EGFR immunohistochemistry (p=0.976). However, skin rash severity was significantly related to the risk of progression for afatinib (hazard ratio for skin rash grade ≥ 2 vs. grade < 2, 0.44; 95% CI, 0.25 to 0.78; p=0.005).
Conclusion
There were no significant differences in the efficacy between AS and A arms in patients with NA-NSCLC.

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  • 347 Download
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Incorporating Erlotinib or Irinotecan Plus Cisplatin into Chemoradiotherapy for Stage III Non-small Cell Lung Cancer According to EGFR Mutation Status
Youngjoo Lee, Ji-Youn Han, Sung Ho Moon, Byung-Ho Nam, Kun Young Lim, Geon Kook Lee, Heung Tae Kim, Tak Yun, Hye Jin An, Jin Soo Lee
Cancer Res Treat. 2017;49(4):981-989.   Published online January 6, 2017
DOI: https://doi.org/10.4143/crt.2016.522
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
Concurrent chemoradiotherapy (CCRT) is the standard care for stage III non-small cell lung cancer (NSCLC) patients; however, a more effective regimen is needed to improve the outcome by better controlling occult metastases. We conducted two parallel randomized phase II studies to incorporate erlotinib or irinotecan-cisplatin (IP) into CCRT for stage III NSCLC depending on epidermal growth factor receptor (EGFR) mutation status.
Materials and Methods
Patients with EGFR-mutant tumors were randomized to receive three cycles of erlotinib first and then either CCRT with erlotinib followed by erlotinib (arm A) or CCRT with IP only (arm B). Patients with EGFR unknown or wild-type tumors were randomized to receive either three cycles of IP before (arm C) or after CCRT with IP (arm D).
Results
Seventy-three patients were screened and the study was closed early because of slow accrual after 59 patients were randomized. Overall, there were seven patients in arm A, five in arm B, 22 in arm C, and 25 in arm D. The response rate was 71.4% and 80.0% for arm A and B, and 70.0% and 73.9% for arm C and D. The median overall survival (OS) was 39.3 months versus 31.2 months for arm A and B (p=0.442), and 16.3 months versus 25.3 months for arm C and D (p=0.050). Patients with sensitive EGFR mutations had significantly longer OS than EGFR-wild patients (74.8 months vs. 25.3 months, p=0.034). There were no unexpected toxicities.
Conclusion
Combined-modality treatment by molecular diagnostics is feasible in stage III NSCLC. EGFR-mutant patients appear to be a distinct subset with longer survival.

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ERCC1 Expression-Based Randomized Phase II Study of Gemcitabine/Cisplatin Versus Irinotecan/Cisplatin in Patients with Advanced Non-small Cell Lung Cancer
Ji-Youn Han, Geon Kook Lee, Kun Young Lim, Young Ju Lee, Byung Ho Nam, Jin Soo Lee
Cancer Res Treat. 2017;49(3):678-687.   Published online October 11, 2016
DOI: https://doi.org/10.4143/crt.2016.365
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
We evaluated the clinical utility of excision repair cross-complementation group 1 (ERCC1) expression as a predictive biomarker for platinum-based chemotherapy in advanced non-small cell lung cancer (NSCLC).
Materials and Methods
Eligible patients were randomly assigned to the GP (gemcitabine 1,250 mg/m2 on days 1 and 8, and cisplatin 75 mg/m2 on day 1 every 3 weeks) or IP (irinotecan 65 mg/m2 and cisplatin 30 mg/m2 on days 1 and 8 every 3 weeks) arm. The primary goal of this study was to compare the response rate (RR) of the GP and IP arms according to the ERCC1 expression level.
Results
A total of 279 patients were randomly assigned to the GP (n=139) and IP (n=140) arms, among which 63% were ERCC1-positive and 268 patients were assessable for the RR. The GP and IP arms did not differ significantly with respect to the RR (29.8% vs. 27.0%, respectively; p=0.082), median progression-free survival (PFS; 4.5 months vs. 3.9 months, respectively; p=0.117), and overall survival (OS; 16.5 months vs. 16.7 months, respectively; p=0.313). When comparing the efficacy between the ERCC1-positive and ERCC1-negative groups, there was no significant difference in the RR (GP, 28.2% vs. 32.6%, respectively, p=0.509; IP, 30.2% vs. 21.6%, respectively, p=0.536), median PFS (GP, 4.6 months vs. 5.0 months, respectively, p=0.506; IP, 3.9 months vs. 3.7 months, respectively, p=0.748), or median OS (GP, 18.6 months vs. 11.9 months, respectively, p=0.070; IP, 17.5 months vs. 14.0 months, respectively, p=0.821).
Conclusion
Immunohistochemical analysis of the ERCC1 expression level did not differentiate the efficacy of platinum-based chemotherapy in advanced NSCLC.

Citations

Citations to this article as recorded by  
  • Meta‐Analysis of ERCC1 Protein Expression and Platinum Chemosensitivity in Non‐Small‐Cell Lung Cancer
    Guoping Li, Dan Cheng, Jamal A. Mahajna
    Evidence-Based Complementary and Alternative Medicine.2020;[Epub]     CrossRef
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    Yu-Liang Huang, Jun-Rong Wu, Min Fang, Hui-Liu Zhao, Zhi-Min Liu, Jian Ye, Ling-Sha Huang, Bo Zhu
    Medicine.2019; 98(14): e15090.     CrossRef
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