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Tolerability and Outcomes of First-Line Pemetrexed-Cisplatin Followed by Gefitinib Maintenance Therapy Versus Gefitinib Monotherapy in Korean Patients with Advanced Nonsquamous Non-small Cell Lung Cancer: A Post Hoc Descriptive Subgroup Analysis of a Randomized, Phase 3 Trial
Jin Hyoung Kang, Myung-Ju Ahn, Dong-Wan Kim, Eun Kyung Cho, Joo-Hang Kim, Sang Won Shin, Xin Wang, Jong Seok Kim, Mauro Orlando, Keunchil Park
Cancer Res Treat. 2016;48(2):458-464.   Published online October 14, 2015
DOI: https://doi.org/10.4143/crt.2015.135
AbstractAbstract PDFPubReaderePub
Purpose
We recently reported on a randomized, open-label, phase 3 trial comparing pemetrexed-cisplatin chemotherapy followed by gefitinib maintenance therapy (PC/G) with gefitinib monotherapy in patients with non-small cell lung cancer (NSCLC). Here, we report on a post hoc subgroup analysis of that study assessing the demographics and disposition of the Korean patient subgroup, and comparing the tolerability of PC/G and gefitinib monotherapy and the tumor response with respect to epidermal growth factor receptor (EGFR) status.
Materials and Methods
Patients, who were ≥ 18 years, chemonaïve, Korean, light ex-smokers/never-smokers with advanced NSCLC, were randomly assigned (1:1) to PC/G or gefitinib monotherapy. Treatment-emergent adverse events (TEAEs) were graded, and tumor response was measured as change in lesion sum from baseline at best response. The study was registered with ClinicalTrials. gov, NCT01017874.
Results
Overall, 111 Korean patients were treated (PC/G, 51; gefitinib, 60). Between-arm characteristics were balanced and similar to those of the overall population. Treatment discontinuations due to adverse events were low (PC/G: 1, 2.0%; gefitinib: 7, 11.7%). Overall, 92 patients (82.9%) reported ≥ 1 TEAE (PC/G, 44; gefitinib, 48); few patients (PC/G, 16; gefitinib, 7) reported severe TEAEs; the most frequent was neutropenia (PC/G arm) and elevated alanine aminotransferase (gefitinib arm). The lesion sum was decreased by PC/G treatment in most patients, regardless of EGFRmutation status, while gefitinib monotherapy reduced the lesion sum in EGFR-positive patients but had no effect in EGFR-negative patients.
Conclusion
Our results confirm that both PC/G and gefitinib were well tolerated in Korean patients, regardless of EGFR status; however, patients with EGFR wild-type NSCLC may not benefit from gefitinib monotherapy.

Citations

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  • Gefitinib for advanced non-small cell lung cancer
    Esther HA Sim, Ian A Yang, Richard Wood-Baker, Rayleen V Bowman, Kwun M Fong
    Cochrane Database of Systematic Reviews.2018;[Epub]     CrossRef
  • 12,292 View
  • 141 Download
  • 1 Web of Science
  • 1 Crossref
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Epidermal Growth Factor Receptor Mutation Status in the Treatment of Non-small Cell Lung Cancer: Lessons Learned
Dae Ho Lee, Vichien Srimuninnimit, Rebecca Cheng, Xin Wang, Mauro Orlando
Cancer Res Treat. 2015;47(4):549-554.   Published online April 29, 2015
DOI: https://doi.org/10.4143/crt.2014.362
AbstractAbstract PDFPubReaderePub
Advances in oncology research have led to identification of tumor-specific biomarkers, some of which are important predictive indicators and ideal targets for novel therapeutics. One such biomarker in non-small cell lung cancer (NSCLC) is the epidermal growth factor receptor (EGFR). Patients with NSCLC who harbor an activating EGFR mutation show a more favorable response to treatment with an EGFR inhibitor, such as gefitinib, erlotinib, or afatinib, than to chemotherapy. The prevalence of EGFR mutations in East Asian patients is higher than that in other populations, and in some clinical settings, patients have been treated with EGFR inhibitors based on clinicopathologic characteristics with no information on EGFR status. However, based on results from a series of studies in which East Asian patients with advanced non-squamous NSCLC were treated with EGFR inhibitors alone or in combination with standard chemotherapy, this may not be the best practice because EGFRmutation status was found to be a key predictor of outcome. Data from these studies highlight the necessity of EGFR testing in determining the most suitable treatment for patients with advanced or metastatic NSCLC.

Citations

Citations to this article as recorded by  
  • Epidermal Growth Factor Receptor Mutation Status and the Impact on Clinical Outcomes in Patients with Non-Small Cell Lung Cancer
    HM Huang, Y Wei, JJ Wang, FY Ran, Y Wen, QH Chen, BF Zhang
    Balkan Journal of Medical Genetics.2023; 25(2): 29.     CrossRef
  • EGFR Mutation Status in Lung Adenocarcinoma-Associated Malignant Pleural Effusion and Efficacy of EGFR Tyrosine Kinase Inhibitors
    Jiyoul Yang, Ok-Jun Lee, Seung-Myoung Son, Chang Gok Woo, Yusook Jeong, Yaewon Yang, Jihyun Kwon, Ki Hyeong Lee, Hye Sook Han
    Cancer Research and Treatment.2018; 50(3): 908.     CrossRef
  • Traditional Korean Medicine for Skin Toxic Side Effects from Afatinib in a Non-Small Cell Lung Cancer Patient: A Case Report
    So-hyun Shim, Hee-jeong Seo, Jin-yong Choi, Go-eun Bae, Hyung-bum Seo, So-yeon Kim, Chang-woo Han, Seong-ha Park, Young-ju Yun, In Lee, Jung-nam Kwon, Jin-woo Hong, Jun-yong Choi
    The Journal of Internal Korean Medicine.2018; 39(5): 973.     CrossRef
  • MET Exon 14 Skipping Mutations in Lung Adenocarcinoma: Clinicopathologic Implications and Prognostic Values
    Geun Dong Lee, Seung Eun Lee, Doo-Yi Oh, Dan-bi Yu, Hae Min Jeong, Jooseok Kim, Sungyoul Hong, Hun Soon Jung, Ensel Oh, Ji-Young Song, Mi-Sook Lee, Mingi Kim, Kyungsoo Jung, Jhingook Kim, Young Kee Shin, Yoon-La Choi, Hyeong Ryul Kim
    Journal of Thoracic Oncology.2017; 12(8): 1233.     CrossRef
  • Predicting EGFR mutation status in lung cancer:Proposal for a scoring model using imaging and demographic characteristics
    Ali Sabri, Madiha Batool, Zhaolin Xu, Drew Bethune, Mohamed Abdolell, Daria Manos
    European Radiology.2016; 26(11): 4141.     CrossRef
  • Clinicopathologic characteristics of EGFR, KRAS, and ALK alterations in 6,595 lung cancers
    Boram Lee, Taebum Lee, Se-Hoon Lee, Yoon-La Choi, Joungho Han
    Oncotarget.2016; 7(17): 23874.     CrossRef
  • The Difference of Clinical Characteristics Between Patients With Exon 19 Deletion and Those With L858R Mutation in Nonsmall Cell Lung Cancer
    Yaxiong Zhang, Dacheng He, Wenfeng Fang, Shiyang Kang, Gang Chen, Shaodong Hong, Jin Sheng, Jianhua Zhan, Nan Chen, Zhihuang Hu, Cong Xue, Yunpeng Yang, Yuxiang Ma, Tao Qin, Ting Zhou, Yan Huang, Li Zhang
    Medicine.2015; 94(44): e1949.     CrossRef
  • 12,547 View
  • 86 Download
  • 6 Web of Science
  • 7 Crossref
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Original Article
Pemetrexed-Erlotinib, Pemetrexed Alone, or Erlotinib Alone as Second-Line Treatment for East Asian and Non-East Asian Never-Smokers with Locally Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer: Exploratory Subgroup Analysis of a Phase II Trial
Dae Ho Lee, Jung Shin Lee, Jie Wang, Te-Chun Hsia, Xin Wang, Jongseok Kim, Mauro Orlando
Cancer Res Treat. 2015;47(4):616-629.   Published online November 24, 2014
DOI: https://doi.org/10.4143/crt.2014.051
AbstractAbstract PDFPubReaderePub
Purpose
This subgroup analysis of a phase II trial was conducted to assess possible ethnicity-based trends in efficacy and safety in East Asian (EA) and non-EA populations with nonsquamous non-small cell lung cancer (NSCLC).
Materials and Methods
Never-smoker patients (n=240) with locally advanced or metastatic nonsquamous NSCLC included 133 EA patients randomized to pemetrexed supplemented with dexamethasone, folic acid, and vitamin B12 plus erlotinib (pemetrexed-erlotinib) (n=41), erlotinib (n=49), or pemetrexed (n=43), and 107 non-EA patients randomized to pemetrexed-erlotinib (n=37), erlotinib (n=33), or pemetrexed (n=37). The primary endpoint, progression-free survival (PFS), was analyzed using a multivariate Cox model.
Results
Consistent with the results of the overall study, a statistically significant difference in PFS among the three arms was noted in the EA population favoring pemetrexed-erlotinib (overall p=0.003) as compared with either single-agent arm (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.29 to 0.79; p=0.004 vs. erlotinib; HR, 0.40; 95% CI, 0.23 to 0.70; p=0.001 vs. pemetrexed). The EA patients treated with pemetrexed-erlotinib achieved a longer median PFS (7.4 months) compared with erlotinib (4.5 months) and pemetrexed (4.0 months). The PFS results also numerically favored pemetrexed-erlotinib in the non-EA population (overall p=0.210) (HR, 0.62; 95% CI, 0.37 to 1.05; p=0.078 vs. erlotinib; HR, 0.75; 95% CI, 0.42 to 1.32; p=0.320 vs. pemetrexed) (median PFS: pemetrexed-erlotinib, 6.7 months; erlotinib, 3.0 months; pemetrexed, 4.4 months).
Conclusion
The PFS results from this subset analysis in both EA and non-EA populations are consistent with the results in the overall population. The PFS advantage for pemetrexed-erlotinib is significant compared with the single agents in EA patients.

Citations

Citations to this article as recorded by  
  • Association of Hypokalemia Incidence and Better Treatment Response in NSCLC Patients: A Meta-Analysis and Systematic Review on Anti-EGFR Targeted Therapy Clinical Trials
    Jiawei Zhou, Jianling Bai, Yuanping Yue, Xin Chen, Theis Lange, Dongfang You, Yang Zhao
    Frontiers in Oncology.2022;[Epub]     CrossRef
  • Non-Smoking-Associated Lung Cancer: A distinct Entity in Terms of Tumor Biology, Patient Characteristics and Impact of Hereditary Cancer Predisposition
    Elisabeth Smolle, Martin Pichler
    Cancers.2019; 11(2): 204.     CrossRef
  • Pemetrexed versus Gefitinib as Second-line Treatment for Advanced Non-small Cell Lung Cancer: A Meta-analysis Based on Randomized Controlled Trials
    Huiyu Wang, Zunjing Zhang, Feng Liu, Miaoying Zhou, Handi Lv
    Pteridines.2019; 30(1): 171.     CrossRef
  • A Review of Regimens Combining Pemetrexed With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor in the Treatment of Advanced Nonsquamous Non–Small-Cell Lung Cancer
    James Chih-Hsin Yang, Tony Mok, Baohui Han, Mauro Orlando, Tarun Puri, Keunchil Park
    Clinical Lung Cancer.2018; 19(1): 27.     CrossRef
  • Randomized Phase 2 Trial of Pharmacodynamic Separation of Pemetrexed and Intercalated Erlotinib Versus Pemetrexed Alone for Advanced Nonsquamous, Non–small-cell Lung Cancer
    Tianhong Li, Bilal Piperdi, William V. Walsh, Mimi Kim, Laurel A. Beckett, Rasim Gucalp, Missak Haigentz, Venu G. Bathini, Huiyu Wen, Kaili Zhou, Patricia B. Pasquinelli, Srikanth Gajavelli, Meera Sreedhara, Xianhong Xie, Primo N. Lara, David R. Gandara,
    Clinical Lung Cancer.2017; 18(1): 60.     CrossRef
  • Erlotinib intercalating pemetrexed/cisplatin versus erlotinib alone in Chinese patients with brain metastases from lung adenocarcinoma: a prospective, non-randomised, concurrent controlled trial (NCT01578668)
    Haihong Yang, Qiuhua Deng, Yuan Qiu, Jun Huang, Yubao Guan, Fengnan Wang, Xin Xu, Xinyun Yang
    ESMO Open.2017; 2: e000112.     CrossRef
  • Gene mutation discovery research of non-smoking lung cancer patients due to indoor radon exposure
    Jung Ran Choi, Seong Yong Park, O Kyu Noh, Young Wha Koh, Dae Ryong Kang
    Annals of Occupational and Environmental Medicine.2016;[Epub]     CrossRef
  • Epidermal Growth Factor Receptor Mutation Status in the Treatment of Non-small Cell Lung Cancer: Lessons Learned
    Dae Ho Lee, Vichien Srimuninnimit, Rebecca Cheng, Xin Wang, Mauro Orlando
    Cancer Research and Treatment.2015; 47(4): 549.     CrossRef
  • 12,710 View
  • 137 Download
  • 8 Crossref
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