EGFR molecular profiling in advanced NSCLC: A prospective phase II study in molecularly/clinically selected patients pretreated with chemotherapy

Journal of Thoracic Oncology

Volumn 7, Issue 4, 2012, Pages 672-680

  Milella, Michele ^a   Nuzzo, Carmen ^a   Bria, Emilio ^a   Sperduti, Isabella ^a   Visca, Paolo ^a   Buttitta, Fiamma ^b   Antoniani, Barbara ^a   Merola, Roberta ^a   Gelibter, Alain ^a   Cuppone, Federica ^a   D'Alicandro, Valerio ^a   Ceribelli, Anna ^a   Rinaldi, Massimo ^a   Cianciulli, Anna ^a   Felicioni, Lara ^b   Malatesta, Sara ^b   Marchetti, Antonio ^b   Mottolese, Marcella ^a   Cognetti, Francesco ^a  

^a REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

^b Clinical Research Center   (Italy)

Author keywords

EGFR; KRAS; Non small cell lung cancer; Tyrosine kinase inhibitors

Indexed keywords

ERLOTINIB; GEFITINIB; K RAS PROTEIN; PROTEIN KINASE B;

ARTICLE; CANCER GROWTH; CANCER SURVIVAL; CIGARETTE SMOKING; ENZYME PHOSPHORYLATION; FEMALE; GENE AMPLIFICATION; GENE DOSAGE; GENE MUTATION; GENETIC ANALYSIS; HISTOPATHOLOGY; HUMAN; LUNG ADENOCARCINOMA; LUNG ALVEOLUS CELL CARCINOMA; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; ONCOGENE K RAS; PATIENT SELECTION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; PROTEIN EXPRESSION; SEX DIFFERENCE; TREATMENT OUTCOME;

CARCINOMA, NON-SMALL-CELL LUNG; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MULTIVARIATE ANALYSIS; MUTATION; PROSPECTIVE STUDIES; PROTEIN KINASE INHIBITORS; PROTO-ONCOGENE PROTEINS; RAS PROTEINS; RECEPTOR, EPIDERMAL GROWTH FACTOR;

EID: 84858766310     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/JTO.0b013e31824a8bde     Document Type: Article

References (45)

1. Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin 2010;60:277-300.
2. Kris MG, Benowitz SI, Adams S, et al. Clinical cancer advances 2010: annual report on progress against cancer from the American Society of Clinical Oncology. J Clin Oncol 2010;28:5327-5347.
3. Spira A, Ettinger DS. Multidisciplinary management of lung cancer. N Engl J Med 2004;350:379-392. (Pubitemid 38101633)
4. Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. Non-small Cell Lung Cancer Collaborative Group. BMJ 1995;311:899-909.
5. Comis RL. The current situation: erlotinib (Tarceva) and gefitinib (Iressa) in non-small cell lung cancer. Oncologist 2005;10:467-470. (Pubitemid 41266327)
6. Siegel-Lakhai WS, Beijnen JH, Schellens JH. Current knowledge and future directions of the selective epidermal growth factor receptor inhibitors erlotinib (Tarceva) and gefitinib (Iressa). Oncologist 2005;10:579-589. (Pubitemid 41429121)
7. 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. N Engl J Med 2004;350:2129-2139. (Pubitemid 38637993)
8. Paez JG, Jänne PA, Lee JC, et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004;304:1497-1500. (Pubitemid 38720929)
9. Pao W, Miller VA. Epidermal growth factor receptor mutations, small-molecule kinase inhibitors, and non-small-cell lung cancer: current knowledge and future directions. J Clin Oncol 2005;23:2556-2568.
10. Sharma SV, Bell DW, Settleman J, Haber DA. Epidermal growth factor receptor mutations in lung cancer. Nat Rev Cancer 2007;7:169-181.
11. Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009;361:947-957.
12. Lee JS, Park K, Kim S, et al. A randomized phase III study of gefitinib (IRESSATM) versus standard chemotherapy (gemcitabine plus cisplatin) as first-line treatment for never-smokers with advanced or metastatic adenocarcinoma of the lung. 13th World Conference of Lung Cancer 2009, San Francisco, 2009, p. S283.
13. Zhou C, Wu Y-L, Chen G, et al.; on behalf of the OPTIMAL investigators. Efficacy results from the randomised phase III OPTIMAL (CTONG 0802) study comparing first-line erlotinib versus carboplatin (CBDCA) plus gemcitabine (GEM), in chinese advanced non small-cell lung cancer (NSCLC) patients (pts) with EGFR activating mutations. ESMO2010 late-breaking abstracts [LBA13]. Ann Oncol 2010;21:viii6.
14. Maemondo M, Inoue A, Kobayashi K, et al.; North-East Japan Study Group. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 2010;362:2380-2388.
15. Mitsudomi T, Morita S, Yatabe Y, et al.; West Japan Oncology Group. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial. Lancet Oncol 2010;11:121-128.
16. Bria E, Milella M, Cuppone F, et al. Outcome of advanced NSCLC patients harboring sensitizing EGFR mutations randomized to EGFR tyrosine kinase inhibitors or chemotherapy as first-line treatment: a meta-analysis. Ann Oncol 2011;22:2277-2285.
17. Clark GM. Prognostic factors versus predictive factors: examples from a clinical trial of erlotinib. Mol Oncol 2008;1:406-412.
18. Govindan R. INTERESTing biomarker to select IDEAL patients for epidermal growth factor receptor tyrosine kinase inhibitors: yes, for EGFR mutation analysis, others, I PASS. J Clin Oncol 2010;28:713-715.
19. Zhu CQ, da Cunha Santos G, Ding K, et al.; National Cancer Institute of Canada Clinical Trials Group Study BR.21. Role of KRAS and EGFR as biomarkers of response to erlotinib in National Cancer Institute of Canada Clinical Trials Group Study BR.21. J Clin Oncol 2008;26:4268-4275.
20. Tsao MS, Sakurada A, Cutz JC, et al. Erlotinib in lung cancer-molecular and clinical predictors of outcome. N Engl J Med 2005;353:133-144. (Pubitemid 41058345)
21. Therasse P, Arbuck SG, Eisenhauer EA, 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 2000;92:205-216.
22. A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med 2001;20:859-866. (Pubitemid 32249085)
23. Anne-Laure B, Carolin S. Maximally selected Chi-squared statistics and non-monotonic associations: an exact approach based on two cutpoints. Comput Stat Data Anal 2007;51:6295-6306.
24. Filsoufi F, Rahmanian PB, Castillo JG, Chikwe J, Adams DH. Logistic risk model predicting postoperative respiratory failure in patients undergoing valve surgery. Eur J Cardiothorac Surg 2008;34:953-959.
25. Lemeshow S, Le Gall JR. Modeling the severity of illness of ICU patients. A systems update. JAMA 1994;272:1049-1055. (Pubitemid 24294657)
26. Marchetti A, Martella C, Felicioni L, et al. EGFR mutations in non-small-cell lung cancer: analysis of a large series of cases and development of a rapid and sensitive method for diagnostic screening with potential implications on pharmacologic treatment. J Clin Oncol 2005;23:857-865. (Pubitemid 46224186)
27. Marchetti A, Milella M, Felicioni L, et al. Clinical implications of KRAS mutations in lung cancer patients treated with tyrosine kinase inhibitors: an important role for mutations in minor clones. Neoplasia 2009;11:1084-1092.
28. Merola R, Mottolese M, Orlandi G, et al. Analysis of aneusomy level and HER-2 gene copy number and their effect on amplification rate in breast cancer specimens read as 21 in immunohistochemical analysis. Eur J Cancer 2006;42:1501-1506. (Pubitemid 43903166)
29. Eberhard DA, Giaccone G, Johnson BE; Non-Small-Cell Lung Cancer Working Group. Biomarkers of response to epidermal growth factor receptor inhibitors in Non-Small-Cell Lung Cancer Working Group: standardization for use in the clinical trial setting. J Clin Oncol 2008;26:983-994. (Pubitemid 351398092)
30. Novelli F, Milella M, Melucci E, et al. A divergent role for estrogen receptor-beta in node-positive and node-negative breast cancer classified according to molecular subtypes: an observational prospective study. Breast Cancer Res 2008;10:R74.
31. Gridelli C, Ciardiello F, Feld R, et al. International multicenter randomized phase III study of first-line erlotinib (E) followed by second-line cisplatin plus gemcitabine (CG) versus first-line CG followed by second-line E in advanced non-small cell lung cancer (aNSCLC): the TORCH trial. J Clin Oncol (Meeting Abstracts) 2010;28:7508.
32. Shepherd FA, Douillard JY, Fukuoka M, et al. Gefitinib versus docetaxel in patients with pretreated advanced non-small-cell lung cancer (NSCLC): meta-analysis from four randomized clinical trials. 13th World Conference of Lung Cancer 2009, San Francisco, 2009, p. S291.
33. Cappuzzo F, Ligorio C, Jänne PA, et al. Prospective study of gefitinib in epidermal growth factor receptor fluorescence in situ hybridization-positive/phospho-Akt-positive or never smoker patients with advanced non-small-cell lung cancer: the ONCOBELL trial. J Clin Oncol 2007;25:2248-2255. (Pubitemid 46954651)
34. Inoue A, Suzuki T, Fukuhara T, 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 2006;24:3340-3346. (Pubitemid 46638887)
35. Rosell R, Moran T, Queralt C, et al.; Spanish Lung Cancer Group. Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med 2009;361:958-967.
36. Hann CL Brahmer JR. "Who should receive epidermal growth factor receptor inhibitors for non-small cell lung cancer and when?" Curr Treat Options Oncol 2007;8:28-37.
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. J Clin Oncol 2005;23:5900-5909.
38. Cappuzzo F, Marchetti A, Skokan M, et al. Increased MET gene copy number negatively affects survival of surgically resected non-small-cell lung cancer patients. J Clin Oncol 2009;27:1667-1674.
39. D'Angelo SP, Janjigian YY, Kris MG, et al. Impact of EGFR and KRAS mutations on survival in 1,000 patients with resected lung adeno carcinoma. J Clin Oncol (Meeting Abstracts) 2010;28:7011.
40. Goss GD, Lorimer I, Tsao MS, et al. A phase III randomized, double-blind, placebo-controlled trial of the epidermal growth factor receptor inhibitor gefitinb in completely resected stage IB-IIIA non-small cell lung cancer (NSCLC): NCIC CTG BR.19. J Clin Oncol (Meeting Abstracts) 2010;28:LBA7005.
41. Kris MG, Lau CY, Ang D, et al. Initial results of LC-MAP: an institutional program to routinely profile tumor specimens for the presence of mutations in targetable pathways in all patients with lung adenocarcinoma. J Clin Oncol (Meeting Abstracts) 2010;28:7009.
42. Brugger W, Triller N, Blasinska-Morawiec M, et al. Biomarker analyses from the phase III placebo-controlled SATURN study of maintenance erlotinib following first-line chemotherapy for advanced NSCLC. J Clin Oncol (Meeting Abstracts) 2009;27:8020.
43. Pao W, Wang TY, Riely GJ, et al. KRAS mutations and primary resistance of lung adenocarcinomas to gefitinib or erlotinib. PLoS Med 2005;2:e17.
44. Florescu M, Hasan B, Seymour L, Ding K, Shepherd FA; National Cancer Institute of Canada Clinical Trials Group. A clinical prognostic index for patients treated with erlotinib in National Cancer Institute of Canada Clinical Trials Group study BR.21. J Thorac Oncol 2008;3:590-598. (Pubitemid 351787301)
45. Kim ST, Lee J, Sun JM, et al. Prognostic model to predict outcomes in non-small cell lung cancer patients with erlotinib as salvage treatment. Oncology 2010;79:78-84.