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Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy

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Part 1. Gefitinib and Erlotinib for Non-Small Cell Lung Cancer (continued)


References

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33. Shepherd FA, Dancey J, Ramlau R, et al. Prospective randomized trial of docetaxel versus best supportive care in patients with nonsmall-cell lung cancer previously treated with platinum-based chemotherapy. Journal of Clinical Oncology 2000;18(10):2095-103.

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35. Massarelli E, Andre F, Liu DD, et al. A retrospective analysis of the outcome of patients who have received two prior chemotherapy regimens including platinum and docetaxel for recurrent non-small-cell lung cancer. Lung Cancer 2003;39:55-61.

36. Pao W, Wang TY, Riely GJ, et al. KRAS mutations and primary resistance of lung adenocarcinomas to gefitinibor erlotinib. PLoS Med 2005;2(1):e17.

37. Eberhard DA, Johnson BE, Amler LC, et al. Mutations in the epidermal growth factor receptor and in KRAS are predictive and prognostic indicators in patients with non-small-cell lung cancer treated with chemotherapy alone and in combination with erlotinib. Journal of Clinical Oncology 2005;23(25):5900-9.

38. Takano T, Ohe Y, Kusumoto M, et al. 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 2004;45(1):93-104.

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40. Cappuzzo F, Varella-Garcia M, Shigematsu H, et al. Increased HER2 gene copy number is associated with response to gefitinib therapy in epidermal growth factor receptor positive nonsmall-cell lung cancer patients. Journal of Clinical Oncology 2005;23(22):5007-18.

41. Hirsch F, Varella-Garcia M, McCoy J, et al. Increased epidermal growth factor receptor gene copy number detected by fluorescence in situ hybridization associates with increased sensitivity to gefitinib in patients with bronchioloalveolar carcinoma subtypes: a Southwest Oncology Group study. Journal of Clinical Oncology 2005;23(28):6838-45.

42. Tsao MS, Sakurada A, Cutz JC, et al. Erlotinib in lung cancer—molecular and clinical predictors of outcome. New England Journal of Medicine 2005;353(2):133-44.

43. Pao W, Miller VA, Politi KA, et al. Acquired resistance of lung adenocarcinomas to gefitinib or erlotinibis associated with a second mutation in the EGFR kinase domain. PLoS Med 2005;2(3):e73.

44. Kobayashi S, Boggon TJ, Dayaram T, et al. EGFR mutation and resistance of non-small-cell lung cancer to gefitinib. New England Journal of Medicine 2005;352(8):786-92.

45. Cappuzzo F, Bartolini S, Ceresoli GL, et al. Efficacy and tolerability of gefitinibin pretreated elderly patients with advanced non-small-cell lung cancer (NSCLC). British Journal of Cancer 2004;90(1):82-6.

46. Barlesi F, Tchouhadjian C, Doddoli C, et al. CYFRA 21-1 level predicts survival in non-small-cell lung cancer patients receiving gefitinib as third-line therapy. British Journal of Cancer 2005;92(1):13-4.

47. Dancey J, Shepherd FA, Gralla RJ, et al. Quality of life assessment of second-line docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy: results of a prospective, randomized phase III trial. Lung Cancer 2004;43:183-94.

48. Kim KS, Jeong JY, Kim YC, et al. Predictors of the response to gefitinib in refractory non-small cell lung cancer. Clinical Cancer Research 2005;11(6):2244-51.

49. 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. Journal of Clinical Oncology 2005;23(11):2513-20.

50. Takano T, Ohe Y, Yoshida T, et al. Evaluation of epidermal growth factor receptor (EGFR) mutations and gene copy numbers as predictors of clinical outcomes in Japanese patients with recurrent non-small-cell lung cancer (NSCLC) receiving gefitinib. 2005 ASCO Annual Meetings 2005; Abstract #7032.

51. Han SW, Kim TY, Hwang PG, et al. Predictive and prognostic impact of epidermal growth factor receptor mutation in non-small-cell lung cancer patients treated with gefitinib. Journal of Clinical Oncology 2005;23(11):2493-501.

52. 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. International Journal of  Cancer 2005;113(1):109-15.

53. Miller VA, Kris MG, Shah N, et al. Bronchioloalveolar pathologic subtype and smoking history predict sensitivity to gefitinib in advanced non-small-cell lung cancer. Journal of Clinical Oncology 2004;22(6):1103-9.

54. Matsuura K, Kudoh S, Mitsuoka S, et al. Evaluating a prognostic factor in advanced adenocarcinoma of the lung who have treated with gefitinib. Journal of Clinical Oncology 2004;22(14):334.

55. Ochs J, Grous JJ, Warner KL. Final survival and safety results for 21,064 non-small-cell lung cancer (NSCLC) patients who received compassionate use gefitinib in a U.S. expanded access program (EAP). Journal of Clinical Oncology 2004;22(14):060.

56. Simon GR, Ruckdeschel JC, Williams C, et al. Gefitinib (ZD1839) in previously treated advanced non-small-cell lung cancer: experience from a single institution. Cancer Control 2003;10(5):388-95.

57. Janne PA, Gurubhagavatula S, Yeap BY, et al. Outcomes of patients with advanced non-small cell lung cancer treated with gefitinib(ZD1839, "Iressa") on an expanded access study. Lung Cancer 2004;44(2):221-30.

58. Wu YL, Yang X, Yang J-J, et al. ZD1839 for the treatment of heavily pretreated non-small cell lung cancer. Journal of Clinical Oncology 2004;22(14):341.

59. Pallis AG, Mavroudis D, Androulakis N, et al. ZD1839, a novel, oral epidermal growth factor receptor-tyrosine kinase inhibitor, as salvage treatment in patients with advanced non-small cell lung cancer. Experience from a single center participating in a compassionate use program. Lung Cancer 2003;40(3):301-7.

60. 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(2):255-61.

61. Villaflor VM, Polowy CR, Coon JS, et al. Potential clinical prognostic factors in non-small cell lung cancer (NSCLC) patients treated with gefitinib. Journal of Clinical Oncology 2004;22(14):088.

62. Mohamed MK, Ramalingam S, Lin Y, et al. Skin rash and good performance status (PS) predict improved survival with gefitinib for patients with advanced non-small cell lung cancer (NSCLC). Journal of Clinical Oncology 2004;22(14):097.

63. Cappuzzo F, Magrini E, Ceresoli GL, et al. Aktphosphorylation and gefitinib efficacy in patients with advanced non-small-cell lung cancer. Journal of the National Cancer Institute 2004;96(15):1133-41.

64. 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. Journal of Clinical Oncology 2004;22(14):098.

65. Kishi K, Homma S, Miyamoto A, et al. Factors predicting the efficacy of gefitinib in patients with advanced non-small cell lung cancer (NSCLC). 2005 ASCO Annual Meetings 2005; Abstract #7095.

66. Taron M, Ichinose Y, Rosell R, et al. Epidermal growth factor receptor (EGFR) activating mutations (muts) in the tyrosine kinase(TK) domain correlate with gefitinib response in chemorefractory non-small-cell lung cancer (NSCLC). 2005 ASCO Annual Meetings 2005; Abstract #7087.

67. Gatzemeier U, Heller A, Foernzler D, et al. Exploratory analyses EGFR, kRAS mutations and other molecular markers in tumors of NSCLC patients (pts) treated with chemotherapy +/- erlotinib(TALENT). 2005 ASCO Annual Meetings 2005; Abstract #7028.

68. Gridelli C, Maione P, Castaldo V, et al. Gefitinib in elderly and unfit patients affected by advanced non-small-cell lung cancer. British Journal of Cancer 2003;89(10):1827-9.

69. Ervin TJ, Toothaker SR. Community practice experience with gefitinib(ZD1839) as treatment for patients with advanced non-small-cell lung cancer (NSCLC) within an expanded access clinical program. Journal of Clinical Oncology 2004;22(14):367.

70. Villaflor VM, Buckingham L, Gale M, et al. EGFR mutations and pAKT expression as potential predictors of gefitinib efficacy in non-small cell lung cancer (NSCLC) patients (pts). 2005 ASCO Annual Meetings 2005; Abstract #7077.

71. Hussain S, Zakowski MF, Kris MG, et al. Correlation of EGFR and KRAS mutation status, response to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors and survival with histologic subtypes of adenocarcinoma of the lung. 2005 ASCO Annual Meetings 2005; Abstract #7080.

72. Kim YH, Goto K, Ishii G, et al. Association of papillary subtype of lung adenocarcinoma with response to gefitinib. Journal of Clinical Oncology 2004;22(14):092.

73. Franklin WA, Chansky K, Gumerlock PH, et al. Association between activation of ErbB pathway genes and survival following gefitinib treatment in advanced BAC (SWOG 0126). Journal of Clinical Oncology 2004;22(14):015.

74. Parra HS, Cavina R, Latteri F, et al. Analysis of epidermal growth factor receptor expression as a predictive factor for response to gefitinib('Iressa', ZD1839) in non-small-cell lung cancer. British Journal of Cancer 2004;91(2):208-12.

75. Bailey LR, Janas M, Schmidt K, et al. Evaluation of epidermal growth factor receptor (EGFR) as a predictive marker in patients with non-small-cell lung cancer (NSCLC) receiving first-line gefitinib combined with platinum-based chemotherapy. Journal of Clinical Oncology 2004;22(14):013.

76. Han SW, Hwang PG, Chung DH, et al. Gefitinib monotherapy in previously treated advanced non-small cell lung cancer (NSCLC): An immunohistochemical (IHC) analysis of EGFR and its downstream molecules. Journal of Clinical Oncology 2004;22(14):096.

77. Polowy C, Coon J, Villaflor V, et al. Potential molecular prognostic factors in non-small cell lung cancer (NSCLC) patients treated with gefitinib. Journal of Clinical Oncology 2004;22(14):089.

78. Pao W, Zakowski M, Cordon-Cardo C, et al. Molecular characteristics of non-small cell lung cancer (NSCLC) patients sensitive to gefitinib. Journal of Clinical Oncology 2004;22(14):025 .

79. Miller VA, Zakowski M, Riely GJ, et al. EGFR mutation, immunohistochemistry (IHC) and chromogenicin situ hybridization (CISH) as predictors of sensitivity to erlotinib and gefitinib in patients (pts) with NSCLC. 2005 ASCO Annual Meetings 2005; Abstract #7031.

80. Cappuzzo F, Gregorc V, Rossi E, et al. Gefitinib in pretreated non-small-cell lung cancer (NSCLC): analysis of efficacy and correlation with HER2 and epidermal growth factor receptor expression in locally advanced or metastatic NSCLC. Journal of Clinical Oncology 2003;21(14):2658-63.

81. Cortas T, Eisenberg R, Fu P, et al. Activation state (phosphorylated) EGFR and STAT3 as prognostic markers in resected non-small cell lung cancer (NSCLC). 2005 ASCO Annual Meetings 2005; Abstract #7090.

82. 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 England Journal of Medicine 2004;350(21):2129-39.

83. Pao W, Miller V, Zakowski M, 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 2004;101(36):13306-11.

84. Paez JG, Janne PA, Lee JC, et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004;304:1497-50.

85. Huang SF, Liu HP, Li LH, 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. Clinical Cancer Research 2004;10(24):8195-203.

86. Tokumo M, Toyooka S, Kiura K, et al. The relationship between epidermal growth factor receptor mutations and clinicopathologic features in non-small cell lung cancers. Clinical Cancer Research 2005;11(3):1167-73.

87. Cortes-Funes H, Almanza C, Valero P, et al. Epidermal growth factor receptor (EGFR)-activating mutations (mut) and response to gefitinibin lung adenocarcinoma. Journal of Clinical Oncology 2005;23(16s):Abstract #7076.

88. Fujiwara Y, Kiura K, Toyooka S, et al. Effect of epidermal growth factor receptor gene mutations on adverse events of gefitinibin patients with non-small cell lung cancer. 2005 ASCO Annual Meetings 2005; Abstract #7096.

89. 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).2005 ASCO Annual Meetings 2005; Abstract #7078.

90. Kawada I, Soejima K, Watanabe H, et al. Quick screening of EGFR mutation using restriction fraction length polymorphism. 2005 ASCO Annual Meetings 2005; Abstract #7071.

91. Kris MG, Sandler A, Miller VA, et al. EGFR and KRAS mutations in patients with bronchioloalveolar carcinoma treated with erlotinib in a phase II multicenter trial. 2005 ASCO Annual Meetings 2005; Abstract #7029.

92. Lynch TJ, Bell D, Haber D, et al. Correlation of molecular markers including mutations with clinical outcomes in advanced non-small cell lung cancer (NSCLC) patients (pts) treated with gefitinib, chemotherapy or chemotherapy and gefitinib in IDEAL and INTACT clinical trials. 2005 ASCO Annual Meetings 2005; Abstract #7006.

93. Tsai C, Chiu C, Chou 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. 2005 ASCO Annual Meetings 2005; Abstract #7086.

94. Hirsch FR, Gandara DR, McCoy J, et al. Increased EGFR gene copy number detected by FISH is associated with increased sensitivity to gefitinib in patients with bronchioloalveolar carcinoma (BAC) (S0126). 2005 ASCO Annual Meetings 2005; Abstract #7030.

95. Fujiwara K, Kiura K, Gemba K, et al. Gefitinib ('Iressa', ZD1839) may restore chemosensitivity in NSCLC patients? Anticancer Research 2005;25(1B):547-9.

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