Gefitinib-Induced Interstitial Lung Disease in Korean Lung Cancer Patients
2
조회
0
다운로드
2
인용
0
참고문헌
키워드
초록
Purpose Interstitial lung disease (ILD) is a serious adverse effect of gefitinib. We examined the inci- dence and clinical characteristics of drug-induced ILD in Korean non-small cell lung carci- noma patients treated with gefitinib. Materials and Methods A retrospective cohort study was performed in non-small cell lung cancer (NSCLC) patients who started gefitinib treatment at Seoul National University Hospital from January 2002 through December 2011. Patients who developed new abnormal radiologic findings with respiratory symptoms after gefitinib treatment were defined as having possible adverse pulmonary reactions. The patients’ medical records were reviewed independently by inves- tigators to identify the causes of pulmonary toxicities. Results Among the 1,114 patients evaluated, 128 patients (11.5%) developed pulmonary adverse reactions after taking gefitinib. An infectious complication occurred in 98 patients (8.8%) and 15 patients (1.3%) developed ILD. Nine of the 15 patients (60.0%) with gefitinib-induced ILD experienced a fatal clinical course that met either the Common Terminology Criteria for Adverse Events grade 4 (n=3) or grade 5 (n=6). In the multivariate analysis, a lower serum albumin level (! 3.0 g/dL) at baseline was significantly associated with the development of gefitinib-induced ILD (odds ratio, 3.91; 95% confidence interval, 1.20 to 12.71). Conclusion The incidence of gefitinib-induced ILD in Korean NSCLC patients was similar to that reported worldwide, but lower than values reported for Japanese population. ILD was usually a life- threatening adverse effect of gefitinib, and the development of ILD was significantly asso- ciated with a lower baseline serum albumin level.
Abstract
Purpose Interstitial lung disease (ILD) is a serious adverse effect of gefitinib. We examined the inci- dence and clinical characteristics of drug-induced ILD in Korean non-small cell lung carci- noma patients treated with gefitinib. Materials and Methods A retrospective cohort study was performed in non-small cell lung cancer (NSCLC) patients who started gefitinib treatment at Seoul National University Hospital from January 2002 through December 2011. Patients who developed new abnormal radiologic findings with respiratory symptoms after gefitinib treatment were defined as having possible adverse pulmonary reactions. The patients’ medical records were reviewed independently by inves- tigators to identify the causes of pulmonary toxicities. Results Among the 1,114 patients evaluated, 128 patients (11.5%) developed pulmonary adverse reactions after taking gefitinib. An infectious complication occurred in 98 patients (8.8%) and 15 patients (1.3%) developed ILD. Nine of the 15 patients (60.0%) with gefitinib-induced ILD experienced a fatal clinical course that met either the Common Terminology Criteria for Adverse Events grade 4 (n=3) or grade 5 (n=6). In the multivariate analysis, a lower serum albumin level (! 3.0 g/dL) at baseline was significantly associated with the development of gefitinib-induced ILD (odds ratio, 3.91; 95% confidence interval, 1.20 to 12.71). Conclusion The incidence of gefitinib-induced ILD in Korean NSCLC patients was similar to that reported worldwide, but lower than values reported for Japanese population. ILD was usually a life- threatening adverse effect of gefitinib, and the development of ILD was significantly asso- ciated with a lower baseline serum albumin level.
참고문헌 (25)
- Cohen MH, "FDA drug approval summary : gefitinib(ZD1839)(Iressa)tablets", Oncologist, 8, pp.303~306 (2003)
- Mok TS, "Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma", N Engl J Med, 361, pp.947~957 (2009)
- Maemondo M, "Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR", N Engl J Med, 362, pp.2380~2388 (2010)
- Inoue A, "Severe acute interstitial pneumonia and gefitinib", Lancet, 361, pp.137~139 (2003)
- Min JH, "Drug-induced interstitial lung disease in tyrosine kinase inhibitor therapy for non-small cell lung cancer: a review on current insight", Cancer Chemother Pharmacol, 68, pp.1099~1109 (2011)
- Han JY, "First-SIGNAL: first-line single-agent iressa versus gemcitabine and cisplatin trial in never-smokers with adenocarcinoma of the lung", J Clin Oncol, 30, pp.1122~1128 (2012)
- Lee DH, "Randomized Phase III trial of gefitinib versus docetaxel in nonsmall cell lung cancer patients who have previously received platinum-based chemotherapy", Clin Cancer Res, 16, pp.1307~1314 (2010)
- Sun JM, "Gefitinib versus pemetrexed as second-line treatment in patients with nonsmall cell lung cancer previously treated with platinum-based chemotherapy (KCSG-LU08-01): an open-label, phase 3 trial", Cancer, 118, pp.6234~6242 (2012)
- Kudoh S, "Interstitial lung disease in Japanese patients with lung cancer : a cohort and nested case-control study", Am J Respir Crit Care Med, 177, pp.1348~1357 (2008)
- 김범석, "How Molecular Understanding Affects to Prescribing Patterns and Clinical Outcome of Gefitinib in Non-small Cell Lung Cancer? 10 Year Experience of Single Institution", Cancer Research and Treatment, 45(3), pp.178~185 (2013), 대한암학회
- Vahid B, "Pulmonary complications of novel antineoplastic agents for solid tumors", Chest, 133, pp.528~538 (2008)
- Kang HJ, "Adverse pulmonary reactions associated with the use of mon-oclonal antibodies in cancer patients", Respir Med, 106, pp.443~450 (2012)
- Ando M, "Predictive factors for interstitial lung disease, antitumor response, and survival in non-small-cell lung cancer patients treated with gefitinib", J Clin Oncol, 24, pp.2549~2556 (2006)
- Takano T, "Risk factors for interstitial lung disease and predictive factors for tumor response in patients with advanced non-small cell lung cancer treated with gefitinib", Lung Cancer, 45, pp.93~104 (2004)
- Hotta K, "Interstitial lung disease in Japanese patients with non-small cell lung cancer receiving gefitinib : an analysis of risk factors and treatment outcomes in Okayama Lung Cancer Study Group", Cancer J, 11, pp.417~424 (2005)
- Nakagawa M, "Interstitial lung disease in gefitinib-treated Japanese patients with non-small cell lung cancer : a retrospective analysis : JMTO LC03-02", BMC Res Notes, 2, pp.157~ (2009)
- Hotta K, "Comparison of the incidence and pattern of interstitial lung disease during erlotinib and gefitinib treatment in Japanese Patients with non-small cell lung cancer : the Okayama Lung Cancer Study Group experience", J Thorac Oncol, 5, pp.179~184 (2010)
- Akamatsu H, "Interstitial lung disease associated with gefitinib in Japanese patients with EGFR-mutated non-small-cell lung cancer : combined analysis of two Phase III trials(NEJ 002and WJTOG 3405)", Jpn J Clin Oncol, 43, pp.664~668 (2013)
- Chang SC, "Gefitinib-related interstitial lung disease in Taiwanese patients with non-small-cell lung cancer", Clin Lung Cancer, 14, pp.55~61 (2013)
- Suzuki H, "Epidermal growth factor receptor tyrosine kinase inhibition augments a murine model of pulmonary fibrosis", Cancer Res, 63, pp.5054~5059 (2003)
- Lateef O, "Methotrexate pulmonary toxicity", Expert Opin Drug Saf, 4, pp.723~730 (2005)
- Li J, "Binding of gefitinib, an inhibitor of epidermal growth factor receptortyrosine kinase, to plasma proteins and blood cells : in vitro and in cancer patients", Invest New Drugs, 24, pp.291~297 (2006)
- Ter Heine R, "Fatal interstitial lung disease associated with high erlotinib and metabolite levels : a case report and a review of the literature", Lung Cancer, 75, pp.391~397 (2012)
- Forsythe B, "Overview of the tolerability of gefitinib(IRESSA)monotherapy : clinical experience in non-smallcell lung cancer", Drug Saf, 27, pp.1081~1092 (2004)
- Koo LC, "National differences in reporting 'pneumonia'and 'pneumonia interstitial' : an analysis of the WHO International Drug Monitoring Database on 15 drugs in nine countries for seven pulmonary conditions", Pharmacoepidemiol Drug Saf, 14, pp.775~787 (2005)