Pooled analysis of the prospective trials of gefitinib monotherapy for EGFR-mutant non-small cell lung cancers

Lung Cancer

Volumn 58, Issue 1, 2007, Pages 95-103

  Costa, Daniel B ^a   Kobayashi, Susumu ^a   Tenen, Daniel G ^a   Huberman, Mark S ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

Author keywords

EGFR; Epidermal growth factor receptor; Exon 19 deletions; Gefitinib; L858R; Lung cancer; Mutation; Non small cell lung cancer; Phase II trials; Prospective; Tyrosine kinase inhibitors

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE INHIBITOR; GEFITINIB; STEROID;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CANCER CHEMOTHERAPY; CANCER PATIENT; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRY SKIN; EXON; FATIGUE; FEMALE; GENE MUTATION; GENOTYPE; HUMAN; INTERSTITIAL LUNG DISEASE; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; OVERALL SURVIVAL; PATIENT SELECTION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RASH; SIDE EFFECT; SKIN TOXICITY; TREATMENT RESPONSE;

ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; CHEMOTHERAPY, ADJUVANT; CLINICAL TRIALS, PHASE II AS TOPIC; DISEASE-FREE SURVIVAL; HUMANS; KAPLAN-MEIERS ESTIMATE; LUNG NEOPLASMS; MUTATION; NEOPLASM STAGING; PROSPECTIVE STUDIES; PROTEIN KINASE INHIBITORS; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR;

EID: 34548484397     PISSN: 01695002     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.lungcan.2007.05.017     Document Type: Article

References (62)

1. Jemal A., Siegel R., Ward E., Murray T., Xu J., and Thun M.J. Cancer statistics, 2007. CA. Cancer J Clin 57 (2007) 43-66
2. Schiller J.H., Harrington D., Belani C.P., Langer C., Sandler A., Krook J., et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346 (2002) 92-98
3. Johnson D.H., Fehrenbacher L., Novotny W.F., Herbst R.S., Nemunaitis J.J., Jablons D.M., et al. Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 22 (2004) 2184-2191
4. Sandler A., Gray R., Perry M.C., Brahmer J., Schiller J.H., Dowlati A., et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 355 (2006) 2542-2550
5. 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
6. 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
7. 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
8. Shigematsu H., Lin L., Takahashi T., Nomura M., Suzuki M., Wistuba I.I., et al. Clinical and biological features associated with epidermal growth factor receptor gene mutations in lung cancers. J Natl Cancer Inst 97 (2005) 339-346
9. 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 24 (2004) 8919-8923
10. Politi K., Zakowski M.F., Fan P.D., Schonfeld E.A., Pao W., and Varmus H.E. Lung adenocarcinomas induced in mice by mutant EGF receptors found in human lung cancers respond to a tyrosine kinase inhibitor or to down-regulation of the receptors. Genes Dev 20 (2006) 1496-1510
11. Ji H., Li D., Chen L., Shimamura T., Kobayashi S., McNamara K., et al. The impact of human EGFR kinase domain mutations on lung tumorigenesis and in vivo sensitivity to EGFR-targeted therapies. Cancer Cell 9 (2006) 485-495
12. Weinstein I.B. Cancer. Addiction to oncogenes-the Achilles heal of cancer. Science 297 (2002) 63-64
13. O'Brien S.G., Guilhot F., Larson R.A., Gathmann I., Baccarani M., Cervantes F., et al. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 348 (2003) 994-1004
14. Demetri G.D., von Mehren M., Blanke C.D., Van den Abbeele A.D., Eisenberg B., Roberts P.J., et al. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med 347 (2002) 472-480
15. Sharma S.V., Bell D.W., Settleman J., and Haber D.A. Epidermal growth factor receptor mutations in lung cancer. Nat Rev Cancer 7 (2007) 169-181
16. Sequist L.V., Bell D.W., Lynch T.J., and Haber D.A. Molecular predictors of response to epidermal growth factor receptor antagonists in non-small-cell lung cancer. J Clin Oncol 25 (2007) 587-595
17. 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
18. Uramoto H., and Mitsudomi T. Which biomarker predicts benefit from EGFR-TKI treatment for patients with lung cancer?. Br J Cancer 96 (2007) 857-863
19. 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
20. Kim K.S., Jeong J.Y., Kim Y.C., Na K.J., Kim Y.H., Ahn S.J., et al. Predictors of the response to gefitinib in refractory non-small cell lung cancer. Clin Cancer Res 11 (2005) 2244-2251
21. Huang S.F., Liu H.P., Li L.H., Ku Y.C., Fu Y.N., Tsai H.Y., 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 10 (2004) 8195-8203
22. 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
23. Han S.W., Kim T.Y., Hwang P.G., Jeong S., Kim J., Choi I.S., 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 23 (2005) 2493-2501
24. Cappuzzo F., Hirsch F.R., Rossi E., Bartolini S., Ceresoli G.L., Bemis L., et al. Epidermal growth factor receptor gene and protein and gefitinib sensitivity in non-small-cell lung cancer. J Natl Cancer Inst 97 (2005) 643-655
25. 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
26. Cortes-Funes H., Gomez C., Rosell R., Valero P., Garcia-Giron C., Velasco A., et al. Epidermal growth factor receptor activating mutations in Spanish gefitinib-treated non-small-cell lung cancer patients. Ann Oncol 16 (2005) 1081-1086
27. Taron M., Ichinose Y., Rosell R., Mok T., Massuti B., Zamora L., et al. Activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor are associated with improved survival in gefitinib-treated chemorefractory lung adenocarcinomas. Clin Cancer Res 11 (2005) 5878-5885
28. Zhang X.T., Li L.Y., Mu X.L., Cui Q.C., Chang X.Y., Song W., 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 16 (2005) 1334-1342
29. 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
30. Mu X.L., Li L.Y., Zhang X.T., Wang M.Z., Feng R.E., Cui Q.C., et al. Gefitinib-sensitive mutations of the epidermal growth factor receptor tyrosine kinase domain in Chinese patients with non-small cell lung cancer. Clin Cancer Res 11 (2005) 4289-4294
31. Tsao M.S., Sakurada A., Cutz J.C., Zhu C.Q., Kamel-Reid S., Squire J., et al. Erlotinib in lung cancer-molecular and clinical predictors of outcome. N Engl J Med 353 (2005) 133-144
32. Tomizawa Y., Iijima H., Sunaga N., Sato K., Takise A., Otani Y., et al. Clinicopathologic significance of the mutations of the epidermal growth factor receptor gene in patients with non-small cell lung cancer. Clin Cancer Res 11 (2005) 6816-6822
33. Rosell R., Ichinose Y., Taron M., Sarries C., Queralt C., Mendez P., et al. Mutations in the tyrosine kinase domain of the EGFR gene associated with gefitinib response in non-small-cell lung cancer. Lung Cancer 50 (2005) 25-33
34. Kondo M., Yokoyama T., Fukui T., Yoshioka H., Yokoi K., Nagasaka T., et al. Mutations of epidermal growth factor receptor of non-small cell lung cancer were associated with sensitivity to gefitinib in recurrence after surgery. Lung Cancer 50 (2005) 385-391
35. Yang S.H., Mechanic L.E., Yang P., Landi M.T., Bowman E.D., Wampfler J., et al. Mutations in the tyrosine kinase domain of the epidermal growth factor receptor in non-small cell lung cancer. Clin Cancer Res 11 (2005) 2106-2110
36. Bell D.W., Lynch T.J., Haserlat S.M., Harris P.L., Okimoto R.A., Brannigan B.W., et al. Epidermal growth factor receptor mutations and gene amplification in non-small-cell lung cancer: molecular analysis of the IDEAL/INTACT gefitinib trials. J Clin Oncol 23 (2005) 8081-8092
37. Niho S., Kubota K., Goto K., Yoh K., Ohmatsu H., Kakinuma R., et al. First-line single agent treatment with gefitinib in patients with advanced non-small-cell lung cancer: a phase II study. J Clin Oncol 24 (2006) 64-69
38. Shepherd F.A., Rodrigues Pereira J., Ciuleanu T., Tan E.H., Hirsh V., Thongprasert S., et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353 (2005) 123-132
39. Thatcher N., Chang A., Parikh P., Rodrigues Pereira J., Ciuleanu T., von Pawel J., 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 366 (2005) 1527-1537
40. Therasse P., Arbuck S.G., Eisenhauer E.A., Wanders J., Kaplan R.S., Rubinstein L., et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92 3 (2000) 205-216
41. Kaplan E.L., and Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 53 (1958) 457-481
42. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 50 (1966) 163-170
43. 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
44. 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
45. 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
46. Yoshida K., Yatabe Y., Park J.Y., Shimizu J., Horio Y., Matsuo K., et al. Prospective validation of 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
47. 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
48. van Zandwijk N., Mathy A., Boerrigter L., Ruijter H., Tielen I., de Jong D., et al. EGFR and KRAS mutations as criteria for treatment with tyrosine kinase inhibitors: retro- and prospective observations in non-small-cell lung cancer. Ann Oncol 18 (2007) 99-103
49. 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
50. Asahina H., Yamazaki K., and Kinoshita I. Reply: Appropriate prospective trials are warranted to determine differences between exon 19 deletions and L858R EGFR mutations in non-small cell lung cancer. Br J Cancer 96 (2007) 400
51. Janne P.A. Gefitinib for epidermal growth factor receptor mutant lung cancers: searching for a weapon of mass destruction. J Clin Oncol 24 (2006) 3319-3321
52. 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
53. 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
54. Satouchi M., Negoro S., Funada Y., Urata Y., Shimada T., Yoshimura S., et al. Predictive factors associated with prolonged survival in patients with advanced non-small-cell lung cancer (NSCLC) treated with gefitinib. Br J Cancer 96 (2007) 1191-1196
55. Ando M., Okamoto I., Yamamoto N., Takeda K., Tamura K., Seto T., et al. Predictive factors for interstitial lung disease, antitumor response, and survival in non-small-cell lung cancer patients treated with gefitinib. J Clin Oncol 24 (2006) 2549-2556
56. Druker B.J., Guilhot F., O'Brien S.G., Gathmann I., Kantarjian H., Gattermann N., et al. Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia. N Engl J Med 355 (2006) 2408-2417
57. 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
58. 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
59. 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
60. Kobayashi S., Ji H., Yuza Y., Meyerson M., Wong K.K., Tenen D.G., et al. An alternative inhibitor overcomes resistance caused by a mutation of the epidermal growth factor receptor. Cancer Res 65 (2005) 7096-7101
61. Kwak E.L., Sordella R., Bell D.W., Godin-Heymann N., Okimoto R.A., Brannigan B.W., et al. Irreversible inhibitors of the EGF receptor may circumvent acquired resistance to gefitinib. Proc Natl Acad Sci USA 102 (2005) 7665-7670
62. Yokouchi H., Yamazaki K., Kinoshita I., Konishi J., Asahina H., Sukoh N., et al. Clinical benefit of readministration of gefitinib for initial gefitinib-responders with non-small cell lung cancer. BMC Cancer 7 (2007) 51