Epidermal growth factor receptor immunohistochemistry: Comparison of antibodies and cutoff points to predict benefit from gefitinib in a phase 3 placebo-controlled study in advanced nonsmall-cell lung cancer

Cancer

Volumn 112, Issue 5, 2008, Pages 1114-1121

  Hirsch, Fred R ^a   Dziadziuszko, Rafal ^a   Thatcher, Nick ^b   Mann, Helen ^c   Watkins, Claire ^c   Parums, Dinah V ^c   Speake, Georgina ^c   Holloway, Brian ^c   Bunn Jr , Paul A ^a   Franklin, Wilbur A ^a  

^a UNIVERSITY OF COLORADO CANCER CENTER   (United States)

^b CHRISTIE HOSPITAL   (United Kingdom)

^c ASTRAZENECA   (United Kingdom)

Author keywords

Cutoff point; Epidermal growth factor receptor; Immunohistochemistry; Nonsmall cell lung cancer; Phase 3 trial

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR; GEFITINIB; MONOCLONAL ANTIBODY; PLACEBO;

ADVANCED CANCER; APPARATUS; ARTICLE; CANCER PATIENT; CANCER SURVIVAL; CONTROLLED STUDY; DRUG RESPONSE; FEMALE; HAZARD RATIO; HUMAN; IMMUNOHISTOCHEMISTRY; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; PREDICTION; PRIORITY JOURNAL; PROTEIN EXPRESSION; SCORING SYSTEM; STAINING; TUMOR CELL;

ANTIBODIES, MONOCLONAL; CARCINOMA, NON-SMALL-CELL LUNG; FEMALE; HUMANS; IMMUNOHISTOCHEMISTRY; LUNG NEOPLASMS; MALE; PLACEBOS; PREDICTIVE VALUE OF TESTS; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR; TUMOR MARKERS, BIOLOGICAL;

EID: 39749191925     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.23282     Document Type: Article

References (31)

1. 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 (the IDEAL 1 Trial). J Clin Oncol. 2003;21:2237-2246.
2. Kris MG, Natale RB, Herbst RS, et al. Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial. JAMA. 2003;290:2149-2158.
3. Perez-Soler R. Phase II clinical trial data with the epidermal growth factor receptor tyrosine kinase inhibitor erlotinib (OSI-774) in non-small-cell lung cancer. Clin Lung Cancer. 2004;6(suppl 1):S20-S23.
4. 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: 1527-1537.
5. Hirsch FR, Varella-Garcia M, Bunn PA Jr, et al. Molecular predictors of outcome with gefitinib in a phase III placebo-controlled study in advanced non-small-cell lung cancer. J Clin Oncol. 2006;24:5034-5042.
6. Shepherd FA, Rodrigues PJ, Ciuleanu T, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005;353:123-132.
7. 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.
8. Cappuzzo F, Hirsch FR, Rossi E, et al. Epidermal growth factor receptor gene and protein and gefitinib sensitivity in non-small-cell lung cancer. J Natl Cancer Inst. 2005;97:643-655.
9. Bailey LR, Janas MSK, Bindlsev N, 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 [abstract]. J Clin Oncol. 2004;22: 7013.
10. Herbst RS, Prager D, Hermann R, et al. TRIBUTE: a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol. 2005;23:5892-5899.
11. Bailey LR, Kris MG, Wolf M, et al. Tumor EGFR membrane staining is not clinically relevant for predicting response in patients receiving gefitinib ('Iressa', ZD1939) monotherapy for pretreated advanced non-small-cell lung cancer: IDEAL1 and 2 [abstract]. Proc Am Assoc Cancer Res. 2003; 44:LB-212.
12. Hanna N, Lilenbaum R, Ansari R, et al. Phase II trial of cetuximab in patients with previously treated non-small-cell lung cancer. J Clin Oncol. 2006;24:5253-5258.
13. Rosell R, Daniel C, Ramlau R, et al. Randomized phase II study of cetuximab in combination with cisplatin (C) and vinorelbine (V) vs. CV alone in the first-line treatment of patients (pts) with epidermal growth factor receptor (EGFR)-expressing advanced non-small-cell lung cancer (NSCLC) [abstract]. J Clin Oncol. 2004;22(suppl 14S):7012.
14. Thienelt CD, Bunn PA Jr, Hanna N, et al. Multicenter phase I/II study of cetuximab with paclitaxel and carboplatin in untreated patients with stage IV non-small-cell lung cancer. J Clin Oncol. 2005;23:8786-8793.
15. Cunningham D, Humblet Y, Siena S, et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med. 2004;351:337-345.
16. Saltz LB, Meropol NJ, Loehrer PJ Sr, et al. Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. J Clin Oncol. 2004;22:1201-1208.
17. Chung KY, Shia J, Kemeny NE, et al. Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry. J Clin Oncol. 2005;23:1803-1810.
18. 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;23:2513-2520.
19. 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;23:6829-6837.
20. Taron M, Ichinose Y, Rosell R, 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. 2005;11:5878-5885.
21. Hirsch FR, 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. J Clin Oncol. 2005;23:6838-6845.
22. Wolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007;25:118-145.
23. Dybdal N, Leiberman G, Anderson S, et al. Determination of HER2 gene amplification by fluorescence in situ hybridization and concordance with the clinical trials immunohistochemical assay in women with metastatic breast cancer evaluated for treatment with trastuzumab. Breast Cancer Res Treat. 2005;93:3-11.
24. Hirsch FR, Varella-Garcia M, Bunn PA Jr, et al. Epidermal growth factor receptor in non-small-cell lung carcinomas: correlation between gene copy number and protein expression and impact on prognosis. J Clin Oncol. 2003;21:3798-3807.
25. Penault-Llorca F, Cayre A, Arnould L, et al. Is there an immunohistochemical technique definitively valid in epidermal growth factor receptor assessment? Oncol Rep. 2006; 16:1173-1179.
26. Bhargava R, Chen B, Klimstra DS, et al. Comparison of 2 antibodies for immunohistochemical evaluation of epidermal growth factor receptor expression in colorectal carcinomas, adenomas, and normal mucosa. Cancer. 2006;106:1857-1862.
27. Clark GM, Zborowski DM, Culbertson JL, et al. Clinical utility of epidermal growth factor receptor expression for selecting patients with advanced non-small cell lung cancer for treatment with erlotinib. J Thorac Oncol. 2006;1:837-846.
28. Francoual M, Etienne-Grimaldi MC, Formento JL, et al. EGFR in colorectal cancer: more than a simple receptor. Ann Oncol. 2006;17:962-967.
29. Defize LH, Boonstra J, Meisenhelder J, et al. Signal transduction by epidermal growth factor occurs through the subclass of high affinity receptors. J Cell Biol. 1989;109:2495-2507.
30. Defize LH, Arndt-Jovin DJ, Jovin TM, et al. A431 cell variants lacking the blood group A antigen display increased high affinity epidermal growth factor-receptor number, protein-tyrosine kinase activity, and receptor turnover. J Cell Biol. 1988;107:939-949.
31. Taillade L, Penault-Llorca F, Boulet T, et al. Immunohistochemical expression of biomarkers: a comparative study between diagnostic bronchial biopsies and surgical specimens of non-small-cell lung cancer. Ann Oncol. 2007; 18:1043-1050.