Prospective phase II study of gefitinib in non-small cell lung cancer with epidermal growth factor receptor gene mutations

Lung Cancer

Volumn 64, Issue 3, 2009, Pages 314-318

  Sugio, Kenji ^a   Uramoto, Hidetaka ^a   Onitsuka, Takamitsu ^a   Mizukami, Makiko ^a   Ichiki, Yoshinobu ^a   Sugaya, Masakazu ^a   Yasuda, Manabu ^a   Takenoyama, Mitsuhiro ^a   Oyama, Tsunehiro ^a   Hanagiri, Takeshi ^a   Yasumoto, Kosei ^a  

^a UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH   (Japan)

Author keywords

Acquired resistance; Adenocarcinoma; EGFR; NSCLC; Prospective study; T790M

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR; GEFITINIB;

ADULT; ADVANCED CANCER; AGED; AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; CANCER CONTROL; CANCER STAGING; CANCER SURGERY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; DRUG EFFICACY; DRY SKIN; EXON; FEMALE; GENE DELETION; GENE MUTATION; HUMAN; INFORMED CONSENT; LUNG NON SMALL CELL CANCER; MALE; NAIL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSPECTIVE STUDY; RASH; RECURRENT CANCER; SIDE EFFECT; SURVIVAL TIME; TREATMENT RESPONSE;

AGED; AGED, 80 AND OVER; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE-FREE SURVIVAL; EXONS; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; MUTATION; NEOPLASM STAGING; PROSPECTIVE STUDIES; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR; TREATMENT OUTCOME;

EID: 67349144683     PISSN: 01695002     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.lungcan.2008.09.010     Document Type: Article

References (34)

1. Ohe Y., Ohashi Y., Kubota K., Tamura T., Nakagawa K., Negoro S., et al. Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lung cancer: Four-Arm Cooperative Study in Japan. Ann Oncol 18 (2007) 317-323
2. Paez J.G., Janne P.A., Lee J.C., Tracy S., Greulich H., Gabriel S., et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 304 (2004) 1497-1500
3. Pao W., Miller V., Zakowski M., Doherty J., Politi K., Sarkaria I., et al. EGF 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 101 (2004) 13306-13311
4. Lynch T.J., Bell D.W., Sordella R., Gurubhagavatula S., Okimoto R.A., Brannigan B.W., et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 350 (2004) 2129-2139
5. Tokumo M., Toyooka S., Kiura K., Shigematsu H., Tomii K., Aoe M., et al. The relationship between epidermal growth factor receptor mutations and clinicopathologic features in non-small cell lung cancers. Clin Cancer Res 11 (2005) 1167-1173
6. Mitsudomi T., Kosaka T., Endoh H., Horio Y., Hida T., Mori S., 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 23 (2005) 2513-2520
7. Chou T.Y., Chiu C.H., Li L.H., Hsiao C.Y., Tzen C.Y., Chang K.T., 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 11 (2005) 3750-3757
8. Uramoto H., Sugio K., Oyama T., Ono K., Sugaya M., Yoshimatsu T., et al. Epidermal growth factor receptor mutations are associated with gefitinib sensitivity in non-small cell lung cancer in Japanese. Lung Cancer 51 (2006) 71-77
9. Sugio K., Uramoto H., Ono K., Oyama T., Hanagiri T., Sugaya M., et al. Mutations within the tyrosine kinase domain of EGFR gene specifically occur in lung adenocarcinoma patients with a low exposure of tobacco smoking. Br J Cancer 94 (2006) 896-903
10. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10 (1989) 1-10
11. Riely G.J., Politi K.A., Miller V.A., and Pao W. Update on epidermal growth factor receptor mutations in non-small cell lung cancer. Clin Cancer Res 12 (2006) 7232-7241
12. Mitsudomi T., and Yatabe Y. Mutations of the epidermal growth factor receptor gene and related genes as determinants of epidermal growth factor receptor tyrosine kinase inhibitors sensitivity in lung cancer. Cancer Sci 98 (2007) 1817-1824
13. Asahina H., Yamazaki K., Kinoshita I., Sukoh N., Harada M., Yokouchi H., et al. A phase II trial of gefitinib as first-line therapy for advanced non-small cell lung cancer with epidermal growth factor receptor mutations. Br J Cancer 95 (2006) 998-1004
14. Inoue A., Suzuki T., Fukuhara T., Maemondo M., Kimura Y., Morikawa N., et al. Prospective phase II study of gefitinib for chemotherapy-naive patients with advanced non-small-cell lung cancer with epidermal growth factor receptor gene mutations. J Clin Oncol 24 (2006) 3340-3346
15. Sunaga N., Tomizawa Y., Yanagitani N., Iijima H., Kaira K., Shimizu K., et al. Phase II prospective study of the efficacy of gefitinib for the treatment of stage III/IV non-small cell lung cancer with EGFR mutations, irrespective of previous chemotherapy. Lung Cancer 56 (2007) 383-389
16. Sutani A., Nagai Y., Udagawa K., Uchida Y., Koyama N., Murayama Y., et al. Gefitinib for non-small-cell lung cancer patients with epidermal growth factor receptor gene mutations screened by peptide nucleic acid-locked nucleic acid PCR clamp. Br J Cancer 95 (2006) 1483-1489
17. Yoshida K., Yatabe Y., Park J.Y., Shimizu J., Horio Y., Matsuo K., et al. Prospective validation for prediction of gefitinib sensitivity by epidermal growth factor receptor gene mutation in patients with non-small cell lung cancer. J Thorac Oncol 2 (2007) 22-28
18. Takano T., Ohe Y., Sakamoto H., Tsuta K., Matsuno Y., Tateishi U., 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 23 (2005) 6829-6837
19. Greulich H., Chen T.H., Feng W., Janne P.A., Alvarez J.V., Zappaterra M., et al. Oncogenic transformation by inhibitor-sensitive and -resistant EGFR mutants. PLoS Med 2 (2005) e313
20. Mulloy R., Ferrand A., Kim Y., Sordella R., Bell D.W., Haber D.A., et al. Epidermal growth factor receptor mutants from human lung cancers exhibit enhanced catalytic activity and increased sensitivity to gefitinib. Cancer Res 67 (2007) 2325-2330
21. Carey K.D., Garton A.J., Romero M.S., Kahler J., Thomson S., Ross S., et al. Kinetic analysis of epidermal growth factor receptor somatic mutant proteins shows increased sensitivity to the epidermal growth factor receptor tyrosine kinase inhibitor, erlotinib. Cancer Res 66 (2006) 8163-8171
22. Riely G.J., Pao W., Pham D., Li A.R., Rizvi N., Venkatraman E.S., et al. Clinical course of patients with non-small cell lung cancer and epidermal growth factor receptor exon 19 and exon 21 mutations treated with gefitinib or erlotinib. Clin Cancer Res 12 (2006) 839-844
23. Jackman D.M., Yeap B.Y., Sequist L.V., Lindeman N., Holmes A.J., Joshi V.A., et al. Exon 19 deletion mutations of epidermal growth factor receptor are associated with prolonged survival in non-small cell lung cancer patients treated with gefitinib or erlotinib. Clin Cancer Res 12 (2006) 3908-3914
24. Tamura K., Okamoto I., Kashii T., Negoro S., Hirashima T., Kudoh S., et al. Multicentre prospective phase II trial of gefitinib for advanced non-small cell lung cancer with epidermal growth factor receptor mutations: results of the West Japan Thoracic Oncology Group trial (WJTOG0403). Br J Cancer 98 (2008) 907-914
25. Kobayashi S., Boggon T.J., Dayaram T., Janne P.A., Kocher O., Meyerson M., et al. EGFR mutation and resistance of non-small-cell lung cancer to gefitinib. N Engl J Med 352 (2005) 786-792
26. Pao W., Miller V.A., Politi K.A., Riely G.J., Somwar R., Zakowski M.F., et al. Acquired resistance of lung adenocarcinomas to gefitinib or erlotinib is associated with a second mutation in the EGFR kinase domain. PLoS Med 2 (2005) e73
27. Engelman J.A., Zejnullahu K., Mitsudomi T., Song Y., Hyland C., Park J.O., et al. MET amplification leads to gefitinib resistance in lung cancer by activating ERBB3 signaling. Science 316 (2007) 1039-1043
28. Balak M.N., Gong Y., Riely G.J., Somwar R., Li A.R., Zakowski M.F., et al. Novel D761Y and common secondary T790M mutations in epidermal growth factor receptor-mutant lung adenocarcinomas with acquired resistance to kinase inhibitors. Clin Cancer Res 12 (2006) 6494-6501
29. Kosaka T., Yatabe Y., Endoh H., Yoshida K., Hida T., Tsuboi M., et al. Analysis of epidermal growth factor receptor gene mutation in patients with non-small cell lung cancer and acquired resistance to gefitinib. Clin Cancer Res 12 (2006) 5764-5769
30. Uramoto H., Uchiumi T., Izumi H., Kohno K., Oyama T., Sugio K., et al. A new mechanism for primary resistance to gefitinib in lung adenocarcinoma: the role of a novel G796A mutation in exon 20 of EGFR. Anticancer Res 27 (2007) 2297-2303
31. Costa D.B., Schumer S.T., Tenen D.G., and Kobayashi S. Differential responses to erlotinib in epidermal growth factor receptor (EGFR)-mutated lung cancers with acquired resistance to gefitinib carrying the L747S or T790M secondary mutations. J Clin Oncol 26 (2008) 1182-1184
32. Choong N.W., Dietrich S., Seiwert T.Y., Tretiakova M.S., Nallasura V., Davies G.C., et al. Gefitinib response of erlotinib-refractory lung cancer involving meninges-role of EGFR mutation. Nat Clin Pract Oncol 3 (2006) 50-57
33. Kosaka T., Yatabe Y., Endoh H., Kuwano H., Takahashi T., and Mitsudomi T. Mutations of the epidermal growth factor receptor gene in lung cancer: biological and clinical implications. Cancer Res 64 (2004) 8919-8923
34. Pao W., Wang T.Y., Riely G.J., Miller V.A., Pan Q., Ladanyi M., et al. KRAS mutations and primary resistance of lung adenocarcinomas to gefitinib or erlotinib. PLoS Med 2 (2005) e17