A review of the benefit–risk profile of gefitinib in Asian patients with advanced non‐small‐cell lung cancer

References

• Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74–108
   PubMed Web of Science ®Google Scholar
• Ferlay J, Bray, F, Pisani P, Parkin DM. GLOBOCAN 2002. Cancer incidence, mortality and prevalence worldwide. IARC cancer base No. 5, Version 2. Lyon, France: IARC Press; 2004
   Google Scholar
• Fossella FV, Devore R, Kerr RN, et al. Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. J Clin Oncol 2000;18:2354–62
   PubMed Web of Science ®Google Scholar
• Fukuoka M, Yano S, Giaccone G, et al. Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer. J Clin Oncol 2003;21:2237–46
   PubMed Web of Science ®Google Scholar
• Shepherd FA, Dancey J, Ramlau R, et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 2000;18:2095–103
   PubMed Web of Science ®Google Scholar
• Kishi K, Homma S, Miyamoto A, et al. Factors predicting the efficacy of gefitinib in patients with advanced non-small cell lung cancer (NSCLC). J Clin Oncol (meeting abstracts) 2005;23:644s [abs 7095]. Available from http://meeting.jco.org/cgi/content/abstract/23/16_suppl/7095
   Google Scholar
• Fujiwara Y, Kiura K, Toyooka S, et al. Effect of epidermal growth factor receptor gene mutations on adverse events of gefitinib in patients with non-small cell lung cancer. J Clin Oncol (meeting abstracts) 2005;23:644s [abs 7096]. Available from http://meeting.jco.org/cgi/content/abstract/23/16_suppl/7096
   Google Scholar
• Hotta K, Matsuo K, Ueoka H, et al. Continued gefitinib treatment after disease stabilisation prolongs survival of Japanese patients with non-small-cell lung cancer: Okayama Lung Cancer Study Group experience. Ann Oncol 2005;16:1817–23
   PubMed Web of Science ®Google Scholar
• Nakagawa M, Teramukai S, Tada H, et al. Hypoalbuminemia as a risk factor of interstitial lung disease (ILD) during gefitinib treatment in patients with non-small cell lung cancer (NSCLC): A JMTO study. J Clin Oncol (meeting abstracts) 2005;23:667s [abs 7190]. Available from http://meeting.jco.org/cgi/content/abstract/23/16_suppl/7190
   Google Scholar
• Takano T, Ohe Y, Sakamoto H, et al. Epidermal growth factor receptor gene mutations and increased copy numbers predict gefitinib sensitivity in patients with recurrent non-small-cell lung cancer. J Clin Oncol 2005;23:6829–37
   PubMed Web of Science ®Google Scholar
• Nakagawa K, Tamura T, Negoro S, et al. Phase I pharmaco-kinetic trial of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor gefitinib (‘Iressa’, ZD1839) in Japanese patients with solid malignant tumours. Ann Oncol 2003;14:922–30
   PubMed Web of Science ®Google Scholar
• Nishiwaki Y, Yano S, Tamura T, et al. Subset analysis of data in the Japanese patients with NSCLC from IDEAL 1 study on gefitinib. Gan To Kagaku Ryoho 2004;31:567–73
   PubMedGoogle Scholar
• Kakiuchi S, Daigo Y, Ishikawa N, et al. Prediction of sensitivity of advanced non-small cell lung cancers to gefitinib (Iressa, ZD1839). Hum Mol Genet 2004;13:3029–43
   PubMed Web of Science ®Google Scholar
• Kim YH, Ishii G, Goto K, et al. Dominant papillary subtype is a significant predictor of the response to gefitinib in adeno-carcinoma of the lung. Clin Cancer Res 2004;10:7311–7
   PubMed Web of Science ®Google Scholar
• Matsuura K, Kudoh S, Mitsuoka S, et al. Evaluating a prognostic factor in advanced adenocarcinoma of the lung who have treated with gefitinib. Proc Am Clin Oncol 2004;23:696s [abs 7334]. Available from http://meeting.jco.org/cgi/content/abstract/22/14_suppl/7334
   Google Scholar
• Goto K, Kim E, Kubota K, et al. Association of multiple pulmonary metastases with response to gefitinib in patients with non-small cell lung cancer. Proc Am Soc Clin Oncol 2004;23:637s [abs 7098]. Available from http://meeting.jco.org/cgi/content/abstract/22/14_suppl/7098
   Google Scholar
• Hotta K, Kiura K, Ueoka H, et al. Effect of gefitinib (‘Iressa’, ZD1839) on brain metastases in patients with advanced non-small-cell lung cancer. Lung Cancer 2004;46:255–61
   PubMed Web of Science ®Google Scholar
• Kaneda H, Tamura K, Kurata T, et al. Retrospective analysis of the predictive factors associated with the response and survival benefit of gefitinib in patients with advanced non-small-cell lung cancer. Lung Cancer 2004;46:247–54
   PubMed Web of Science ®Google Scholar
• Katakami N, Okazaki M, Kinose D, et al. A retrospective analysis of the outcome of patients (pts) in advanced recurrent adenocarcinoma of the lung who have received gefitinib after treatment of platinum-based regimen. Proc Am Soc Clin Oncol 2003;22:666 [abs 2679]. Available from http://www.asco.org/ac/1,1003,_12–002636-00_18-0023-00_19-00104409,00.asp
   Google Scholar
• Kinoshita A, Fukuda M, Nagashima S, et al. Pulmonary damage during gefitinib monotherapy in patients with non-small cell lung cancer. Proc Am Soc Clin Oncol 2003;22:698 [abs 2809]. Available from http://www.asco.org/ac/1,1003,_12-002636-00_18-0023-00_19-00103351,00.asp
   Google Scholar
• Takano T, Ohe Y, Kusumoto M, et al. Risk factors for inter-stitial lung disease and predictive factors for tumor response in patients with advanced non-small cell lung cancer treated with gefitinib. Lung Cancer 2004;45:93–104
   PubMed Web of Science ®Google Scholar
• Guan Z-Z, Zhang L, Li LY, et al. Efficacy of gefitinib on Chinese patients with locally advanced or metastatic non-small-cell lung cancer: a clinical trial. Chin J Cancer 2005;24:980–4
   Google Scholar
• Jiang G, Hong X, Fan M, et al. Iressa for refractory non-small-cell lung cancer: a preliminary report. Chin J Lung Cancer 2004;7:305–8
   Google Scholar
• Li W, Li L, Li J, Zhou Q. Iressa for the non-small lung cancer patients who failed prior chemotherapy and radiotherapy. Chin J Lung Cancer 2004;7:321–4
   Google Scholar
• Wu YL, Yang X, Yang J-J, et al. ZD1839 for the treatment of heavily pretreated non-small cell lung cancer. Proc Am Soc Clin Oncol 2004;23:698s [abs 7341]. Available from http://meeting.jco.org/cgi/content/abstract/22/14_suppl/7341
   Google Scholar
• Zhang XT, Li LY, Mu XL, et al. The EGFR mutation and its correlation with response of gefitinib in previously treated Chinese patients with advanced non-small-cell lung cancer. Ann Oncol 2005;16:1334–42
   PubMed Web of Science ®Google Scholar
• Mu X-L, Li L-Y, Zhang X-T, et al. Evaluation of safety and efficacy of gefitinib (Iressa, ZD1839) as monotherapy in a series of Chinese patients with advanced non-small-cell lung cancer: experience from a compassionate-use programme. BMC Cancer 2004;4: 51–9
   Google Scholar
• Zheng D, Yamadori T, Hirashima T, et al. The salvage regimen for patients with advanced non-small-cell lung cancer who failed prior chemotherapy: once-daily single oral agent Iressa. Chin J Lung Cancer 2004;7:313–7
   Google Scholar
• Park B-B, Park JO, Kim SW, et al. Gefitinib (IRESSA) as a second-line treatment for advanced non-small-cell lung cancer patients who failed first-line chemotherapy in Korea [abstract B101]. The 17th Annual ACCR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics: Discovery, Biology and Clinical Applications, Pennsylvania Convention Center, Philadelphia, PA, USA, November 14–18, 2005. Available from www.aacr.org/Uploads/DocumentRepository/pdf_files/2005MTCT/MT05_abstracts_B.pdf
   Google Scholar
• Kim YT, Kim C, Sohn JH, et al. The effect of ZD1839 (Iressa) in the treatment of refractory non small cell lung cancer. Cancer Res Treat 2003;35:502–6
   Google Scholar
• Park J, Park BB, Kim JY, et al. Gefitinib (ZD1839) mono-therapy as a salvage regimen for previously treated advanced non-small cell lung cancer. Clin Cancer Res 2004;10:4383–8
   PubMed Web of Science ®Google Scholar
• Lee SW, Kim DR, Lee SD, et al. The efficacy of ZD1839 (Iressa) in patients with advanced non-small-cell lung cancer which has progressed after previous chemotherapy. Tuberc Respir Dis 2004;57:160–7
   Google Scholar
• Han SW, Hwang PG, Chung DH, et al. Epidermal growth factor receptor (EGFR) downstream molecules as response predictive markers for gefitinib (Iressa, ZD1839) in chemotherapy-resistant non-small cell lung cancer. Int J Cancer 2005;113:109–15
   PubMed Web of Science ®Google Scholar
• Kim KS, Jeong JY, Kim YC, et al. Predictors of the response to gefitinib in refractory non-small cell lung cancer. Clin Cancer Res 2005;11:2244–51
   PubMed Web of Science ®Google Scholar
• Chiu C-H, Tsai C-M, Chen Y-M, et al. Gefitinib is active in patients with brain metastases from non-small cell lung cancer and response is related to skin toxicity. Lung Cancer 2005;47:129–38
   Google Scholar
• Chang G-C, Chen K-C, Yang T-Y, et al. Activity of gefitinib in advanced non-small-cell lung cancer with very poor performance status. Invest New Drugs 2005;23:73–7
   Google Scholar
• Thatcher N, Chang A, Parikh P, et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 2005;366:1527–37
   PubMed Web of Science ®Google Scholar
• Nishio M, Taguchi F, Ohyanagi F, et al. Correlation between gefitinib efficacy and HER family expression in recurrent non-small-cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 2004;23:217s [abs 3091]. Available from http://meeting.jco.org/cgi/content/abstract/22/14_suppl/3091
   Google Scholar
• Miyazaki H, Honda S, Morita S, et al. Possibility of the specific efficacy of gefitinib for miliary lung metastasis in non-small-cell lung cancer. Eur Respir J 2004;24:48 [abs 1948]
   Google Scholar
• Huang S-F, Liu H-P, Li L-H, et al. High frequency of epidermal growth factor receptor mutations with complex patterns in non-small cell lung cancers related to gefitinib responsiveness in Taiwan. Clin Cancer Res 2004;10:8195–203
   Google Scholar
• Wong N-S, Lim ST, Lim W-T, et al. ZD1839 is more effective in patients (pts) with non-small cell lung cancer (NSCLC) who were lifetime non-tobacco users. Proc Am Soc Clin Oncol 2003;22:694s [abs 2790]. Available from http://www.asco.org/ac/1,1003,_12–002636–00_18-0023-00_19-00102613,00.asp
   Google Scholar
• Sirisinha T, Jirajarus M, Sirachainan E, et al. Gefitinib treatment for locally advanced and metastatic NSCLC under expanded access program at Ramathibodi hospital. First Asia Pacific Lung Cancer Conference, Chiang Mai, Thailand, August 25–27, 2004 [abstract 21]
   Google Scholar
• Yoshimura M, Nakamura S, Morita S, et al. Very rapid tumor re-growth after discontinuation of gefitinib. Lung Cancer 2003;41\(Suppl 2):S289–S290 [abs 68]
   Google Scholar
• Hotta K, Kiura K, Tabata M, et al. 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 2005; 11:417–24
   PubMed Web of Science ®Google Scholar
• Niho S, Kubota K, Goto K, et al. First-line single agent of gefitinib in patients (pts) with advanced non-small cell lung cancer (NSCLC): a phase II study. Proc Am Soc Clin Oncol 2004;23:628s [abs 7059]. Available from http://meeting.jco.org/cgi/content/abstract/22/14_suppl/7059
   Google Scholar
• Kasahara K, Kimura H, Yoshimoto A, et al. A phase II study of gefitinib monotherapy for chemotherapy-naive patients with non-small cell lung cancer. J Clin Oncol (meeting abstracts) 2005;23:638s [abs 7074]. Available from http://meeting.jco.org/cgi/content/abstract/23/16_suppl/7074
   Google Scholar
• Suzuki R, Hasegawa Y, Baba K, et al. A phase II study of first-line single agent of gefitinib in patients (pts) with stage IV non-small cell lung cancer (NSCLC). J Clin Oncol (meeting abstracts) 2005;23:640s [abs 7082]. Available from http://meeting.jco.org/cgi/content/abstract/23/16_suppl/7082
   Google Scholar
• Lee DH, Han JY, Lee HG, et al. A phase II study of gefitinib as a first-line therapy of advanced or metastatic adenocarcinoma of the lung in lifetime non-smokers. Proc Am Soc Clin Oncol 2005;23:638s [abs 7072]. Available from http://meeting.jco.org/cgi/content/abstract/23/16_suppl/7072
   Google Scholar
• Cella D, Herbst RS, Lynch TJ, et al. Clinically meaningful improvement in symptoms and quality of life for patients with non-small-cell lung cancer receiving gefitinib in a randomized controlled trial. J Clin Oncol 2005;23:2946–54
   PubMed Web of Science ®Google Scholar
• Han SW, Jeong S, Choi IS, et al. EGFR and K-ras mutations as determinants of gefitinib sensitivity in non-small-cell lung cancer (NSCLC). J Clin Oncol (meeting abstracts) 2005;23:639s [abs 7078]. Available from http://meeting.jco.org/cgi/content/abstract/23/16_suppl/7078
   Google Scholar
• Lynch TJ, Bell DW, Sordella R, et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. New Engl J Med 2004;350:2129–39
   PubMed Web of Science ®Google Scholar
• Paez JG, Jänne PA, Lee JC, et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004;304:1497–500
   PubMed Web of Science ®Google Scholar
• Mitsudomi T, Kosaka T, Endoh H, et al. Mutations of the epidermal growth factor receptor gene predict prolonged survival after gefitinib treatment in patients with non-small-cell lung cancer with postoperative recurrence. J Clin Oncol 2005;23:2513–20
   PubMed Web of Science ®Google Scholar
• Chou TY, Chiu CH, Li LH, et al. Mutation in the tyrosine kinase domain of epidermal growth factor receptor is a predictive and prognostic factor for gefitinib treatment in patients with non-small cell lung cancer. Clin Cancer Res 2005;11:3750–7
   PubMed Web of Science ®Google Scholar
• Wu Y, Lin J, Wang K, et al. EGFR mutations in lung cancers and sensitivity to gefitinib in Chinese. J Clin Oncol (meeting abstracts) 2005;23:639s [abs 7089]. Available from http://meeting.jco.org/cgi/content/abstract/23/16_suppl/7089
   Google Scholar
• Pao W, Miller V, Zakowski M, et al. EGFR receptor gene mutations are common in lung cancers from ‘never smokers’ and are associated with sensitivity of tumors to gefitinib and erlotinib. Proc Natl Acad Sci USA 2004;101:13306–11
   PubMed Web of Science ®Google Scholar
• Han S-W, Kim T-Y, Hwang PG, et al. Predictive and prognostic impact of epidermal growth factor receptor mutation in non-small-cell lung cancer patients treated with gefitinib. J Clin Oncol 2005;23:2493–501
   Google Scholar
• Kosaka T, Yatabe Y, Endoh H, et al. Mutations of the epidermal growth factor receptor gene in lung cancer: biological and clinical implications. Cancer Res 2004;64:8919–23
   PubMed Web of Science ®Google Scholar
• Kobayashi S, Boggon TJ, Dayaram T, et al. EGFR mutation and resistance of non-small-cell lung cancer to gefitinib. New Engl J Med 2005;352:786–92
   PubMed Web of Science ®Google Scholar
• Toyooka S, Kiura K, Mitsudomi T. EGFR mutation and response of lung cancer to gefitinib. New Engl J Med 2005;352:2136
   PubMed Web of Science ®Google Scholar
• Pao W, Miller VA, Politi KA, et al. Acquired resistance of lung adenocarcinomas to gefitinib or erlotinib is associated with a second mutation in the EGFR kinase domain. PLoS Med 2005;2(3):e73
   PubMed Web of Science ®Google Scholar
• Tamaoki M, Gushima H, Tsutani K. Pharmacogenomics in Asia. Pharmacogenomics 2004;5:1023–7
   PubMed Web of Science ®Google Scholar
• Chowbay B, Zhou S, Lee EJ. An interethnic comparison of polymorphisms of the genes encoding drug-metabolizing enzymes and drug transporters: experience in Singapore. Drug Metab Rev 2005;37:327–78
   Google Scholar
• Efferth T, Volm M. Pharmacogenetics for individualized cancer chemotherapy. Pharmacol Ther 2005;107:155–76
   PubMed Web of Science ®Google Scholar
• Gandara DR, Ohe Y, Kubota K, et al. Japan-SWOG common arm analysis of paclitaxel/carboplatin in advanced stage non-small cell lung cancer (NSCLC): a model for prospective comparison of cooperative group trials. Proc Am Soc Clin Oncol 2004;23:616s [abs 7007]. Available from http://meeting.jco.org/cgi/content/abstract/22/14_suppl/7007
   Google Scholar
• Ieki R, Saitoh E, Shibuya M. Acute lung injury as a possible adverse drug reaction related to gefitinib. Eur Respir J 2003;22:179–81
   Google Scholar
• Inoue A, Saijo Y, Maemondo M, et al. Severe acute interstitial pneumonia and gefitinib. Lancet 2003;361:137–9
   PubMed Web of Science ®Google Scholar
• Okamoto I, Suga M. Pulmonary toxicity due to chemotherapy how is the risk and benefit from ZD1839 treatment against non-small cell lung cancer? Intern Med 2003;42:926–7
   PubMed Web of Science ®Google Scholar
• Rabinowits G, Herchenhorn D, Rabinowits M, et al. Fatal pulmonary toxicity in a patient treated with gefitinib for non-small cell lung cancer after previous hemolytic-uremic syndrome due to gemcitabine. Anticancer Drugs 2003;14: 665–8
   PubMed Web of Science ®Google Scholar
• Sumpter K, Congleton J, Harper-Wynne C, O’Brien M. Severe acute interstitial pneumonia and gefitinib [letter]. Lung Cancer 2004;43:367–8
   Google Scholar
• Raghu G, Nyberg F, Morgan G. The epidemiology of interstitial lung disease and its association with lung cancer. Br J Cancer 2004;91(Suppl 2):S3–S10
   Google Scholar
• Forsythe B, Faulkner K. Overview of the tolerability of gefitinib (IRESSA) monotherapy. Clinical experience in non-small-cell lung cancer. Drug Saf 2004;27:1081–92
   Google Scholar
• Yoshida S. The results of gefitinib prospective investigation. Med Drug J 2005;41:772–89
   Google Scholar
• Seto T, Yamamoto N. Interstitial lung diseases (ILD) induced by gefitinib in patients with advanced non-small cell lung cancer (NSCLC): results of a West Japan Thoracic Oncology Group (WJTOG) epidemiological survey. Proc Am Soc Clin Oncol 2004;23:629s [abs 7064]. Available from http://meeting.jco.org/cgi/content/abstract/22/14_suppl/7064
   Google Scholar
• Camus P, Kudoh S, Ebina M. Interstitial lung disease associated with drug therapy. Br J Cancer 2004;91(Suppl 2):S18–S23
   Google Scholar
• Higenbottam T, Kuwano K, Nemery B, Fujita Y. Understanding the mechanisms of drug-associated interstitial lung disease. Br J Cancer 2004;91(Suppl 2):S31–S37
   PubMedGoogle Scholar
• Müller NL, White DA, Jiang H, Gemma A. Diagnosis and management of drug-associated interstitial lung disease. Br J Cancer 2004;91\(Suppl 2):S24–S30
   Google Scholar
• Onn A, Tsuboi M, Thatcher N. Treatment of non-small-cell lung cancer: a perspective on the recent advances and the experience with gefitinib. Br J Cancer 2004;91(Suppl 2):S11–S17
   Google Scholar
• Ho C, Murray N, Laskin J, et al. Asian ethnicity and adeno-carcinoma histology continues to predict response to gefitinib in patients treated for advanced non-small-cell carcinoma of the lung in North America. Lung Cancer 2005;49:225–31
   PubMed Web of Science ®Google Scholar