Review: Predictive and prognostic markers for epidermal growth factor receptor inhibitor therapy in non-small cell lung cancer

Therapeutic Advances in Medical Oncology

Volumn 1, Issue 3, 2009, Pages 137-144

  Peled, Nir ^a   Yoshida, Koichi ^a   Wynes, Murry W ^a   Hirsch, Fred R ^a  

^a UNIVERSITY OF COLORADO   (United States)

Author keywords

biomarkers; epidermal growth factor receptor; non small cell lung cancer

Indexed keywords

CARBOPLATIN; CETUXIMAB; CISPLATIN; DOCETAXEL; ERLOTINIB; GEFITINIB; NAVELBINE; PACLITAXEL; TAXANE DERIVATIVE;

ASIAN; BRONCHIOLOALVEOLAR LUNG CANCER; CLINICAL TRIAL; COLON CANCER; DECISION MAKING; DRUG EFFICACY; FLUORESCENCE IN SITU HYBRIDIZATION; GENE NUMBER; HUMAN; LUNG CANCER; LUNG NON SMALL CELL CANCER; MULTIPLE CYCLE TREATMENT; MUTATION; PREDICTION; PRIORITY JOURNAL; PROGNOSIS; PROTEIN EXPRESSION; PROTEOMICS; REVIEW; TREATMENT RESPONSE;

EID: 77953413866     PISSN: 17588340     EISSN: None     Source Type: Journal    
DOI: 10.1177/1758834009347923     Document Type: Review

References (47)

1. Camidge, D.R., Kabbinavar, F., Martins, R., Schnell, F., Witta, S., Eisen, T. et al. (2008) EGFR biomarker-selected randomized phase II study of erlotinib (E) or intercalated E with carboplatin/paclitaxel (C/P) in chemo-naive advanced NSCLC. Journal of Thoracic Oncology 3: S268.
2. Cappuzzo, F., Hirsch, F.R., Rossi, E., Bartolini, S., Ceresoli, G.L., Bemis, L. et al. (2005) Epidermal growth factor receptor gene and protein and gefitinib sensitivity in non-small-cell lung cancer. J Natl Cancer Inst 97: 643-655.
3. Cappuzzo, F., Ligorio, C., Janne, P.A., Toschi, L., Rossi, E., Trisolini, R. et al. (2007) 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 25: 2248-2255.
4. Cunningham, D., Humblet, Y., Siena, S., Khayat, D., Bleiberg, H., Santoro, A. et al. (2004) Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 351: 337-345.
5. Fukuoka, M., Yano, S., Giaccone, G., Tamura, T., Nakagawa, K., Douillard, J.Y. et al. (2003) Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer (The IDEAL 1 Trial) [corrected]. J Clin Oncol 21: 2237-2246.
6. Fukuoka, M., Sumitra Thongprasert, Y.-L.W., Yang, C.H., Chu, D.T., Saijo, N., Watkins, C. et al. (2009) Biomarker analyses from a phase III, randomized, open-label, first-line study of gefitinib vs carboplatin/paclitaxel in clinically selected patients with advanced non-small cell lung cancer in Asia (IPASS). J Clin Oncol.
7. Goss, G., Ferry, D., Wierzbicki, R., Laurie, S.A., Thompson, J., Biesma, B. et al. (2009) Randomized phase II study of gefitinib compared with placebo in chemotherapy-naive patients with advanced non-small-cell lung cancer and poor performance status. J Clin Oncol 27: 2253-2260.
8. Hirsch, F.R., Camidge, R.D., Kabbinavar, F., Richardson, K., Richardson, F., Wacker, B. et al. (2008 a) Biomarker status correlates with clinical benefit: phase 2 study of single-agent erlotinib (E) or E intercalated with carboplatin and paclitaxel (ECP) in an EGFR biomarker selected NSCLC population. Journal of Thoracic Oncology 3: S267.
9. Hirsch, F.R., Herbst, R.S., Olsen, C., Chansky, K., Crowley, J., Kelly, K. et al. (2008) Increased EGFR gene copy number detected by fluorescent in situ hybridization predicts outcome in non-small-cell lung cancer patients treated with cetuximab and chemotherapy. J Clin Oncol 26: 3351-3357.
10. Hirsch, F.R., Varella-Garcia, M., Bunn Jr, P.A., Di Maria, V.M., Veve, R., Bremmes, R.M. et al. (2003) 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 21: 3798-3807.
11. Hirsch, F.R., Varella-Garcia, M., Bunn Jr, P.A., Franklin, W.A., Dziadziuszko, R., Thatcher, N. et al. (2006) Molecular predictors of outcome with gefitinib in a phase III placebo-controlled study in advanced non-small-cell lung cancer. J Clin Oncol 24: 5034-5042.
12. Hirsch, F.R., Varella-Garcia, M., Cappuzzo, F., McCoy, J., Bemis, L., Xavier, A.C. et al. (2007) Combination of EGFR gene copy number and protein expression predicts outcome for advanced non-small-cell lung cancer patients treated with gefitinib. Ann Oncol 18: 752-760.
13. Hirsch, F.R., Varella-Garcia, M., Dziadziuszko, R., Xiao, Y., Gajapathy, S., Skokan, M. et al. (2008 b) Fluorescence in situ hybridization subgroup analysis of TRIBUTE, a phase III trial of erlotinib plus carboplatin and paclitaxel in non-small cell lung cancer. Clin Cancer Res 14: 6317-6323.
14. Hirsch, F.R., Varella-Garcia, M., McCoy, J., West, H., Xavier, A.C., Gumerlock, P. et al. (2005) 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 23: 6838-6845.
15. Jackman, D.M., Yeap, B.Y., Sequist, V.L., Lindeman, N., Holmes, A.J., Joshi, V.A. et al. (2006) 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: 3908-3914.
16. Khambata-Ford, S., Harbison, C.T., Hart, L.L., Awad, M., Xu, L., Dakhil, S. et al. (2009) KRAS mutations (MT) and EGFR-related markers as potential predictors of cetuximab benefit in first line advanced NSCLC: Results from the BMS 099 study. Journal of Thoracic Oncology (In press).
17. Kim, E.S., Hirsh V., Mok, T., Socinski, M.A., Gervais, R., Wu, Y.L. et al. (2008) Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet 372: 1809-1818.
18. Kris, M.G., Natale, R.B., Herbst, R.S., Lynch Jr, T.J., Prager, D., Belani, C.P. et al. (2003) 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 290: 2149-2158.
19. Lynch, T.J., Bell, D.W., Sordella, R., Gurubhagavatula, S., Okimoto, R.A., Brannigan, B.W. et al. (2004) Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 350: 2129-2139.
20. Lynch, T.J.P.T., Dreisbach, L., McCleod, M., Heim, W.J., Hermann, R., Paschold, E. et al. (2008) Overall survival (OS) results from the phase III trial BMS 099: cetuximab+taxane/carboplatin as first-line treatment for advanced NSCLC. Journal of Thoracic Oncology 3: 1490.
21. Massarelli, E., Varella-Garcia, M., Tang, X., Xavier, A.C., Ozburn, N.C., Liu, D.D. et al. (2007) KRAS mutation is an important predictor of resistance to therapy with epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancer. Clin Cancer Res 13: 2890-2896.
22. Meert, A.P., Martin, B., Delmotte, P., Berghmans, T., Lafitte, J.J., Mascaux, C. et al. (2002) The role of EGF-R expression on patient survival in lung cancer: a systematic review with meta-analysis. Eur Respir J 20: 975-981.
23. Miller, V.A., Riely, G.J., Zakowski, M.F., Li, A.R., Patel, J.D., Heelan, R.T. et al. (2008) Molecular characteristics of bronchioloalveolar carcinoma and adenocarcinoma, bronchioloalveolar carcinoma subtype, predict response to erlotinib. J Clin Oncol 26: 1472-1478.
24. Mitsudomi, T., Kosaka, T., Endoh, H., Horio, Y., Hida, T., Mori, S. et al. (2005) 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: 2513-2520.
25. Mok, T., Wu, Y., Thongprasert, S., Yang, C., Chu, D., Saijo, N. et al. (2008) Phase III, randomised, open-label, first-line study of gefitinib vs carboplatin/paclitaxel in clinically selected patients with advanced non-small cell lung cancer (IPASS). Ann Oncol 19: viii1-viii4.
26. O’Byrne, K.J., Carlos Barrios, I.B., Eschbach, C., Martens, U., Hotko, Y., Kortsik, C. et al. (2009) Molecular and clinical predictors of outcome for cetuximab in non-small cell lung cancer (NSCLC): data from the FLEX study. [Abstract]. J Clin Oncol 18S: 8007.
27. Okamoto, I., Kashii, T., Urata, Y., Hirashima, T., Kudoh, S., Ichinose, Y. et al. (2006) EGFR mutation-based phase II multicenter trial of gefitinib in advanced non-small cell lung cancer (NSCLC) patients (pts): Results of West Japan Thoracic Oncology Group trial (WJTOG0403). J Clin Oncol 24: Abstract #7073.
28. Paez, J.G., Janne, P.A., Lee, J.C., Tracy, S., Greulich, H., Gabriel, S. et al. (2004) EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 304: 1497-1500.
29. Pao, W., Miller, V.A., Politi, K.A., Riely, G.J., Somwar, R., Zakowski, M.F. et al. (2005 a) Acquired resistance of lung adenocarcinomas to gefitinib or erlotinib is associated with a second mutation in the EGFR kinase domain. PLoS Med 2: e73.
30. Pao, W., Wang, T.Y., Riely, G.J., Miller, V.A., Pan, Q., Ladanyi, M. et al. (2005) KRAS mutations and primary resistance of lung adenocarcinomas to gefitinib or erlotinib. PLoS Med 2: e17.
31. Paz-Ares, L., Sanchez, J.M., Garcia-Velasco, A., Massuti, B., Lopez-Vivanco, G., Provencio, M. et al. (2006) A prospective phase II trial of erlotinib in advanced non-small cell lung cancer (NSCLC) patients (p) with mutations in the tyrosine kinase (TK) domain of the epidermal growth factor receptor (EGFR). J Clin Oncol 24: Abstract #7020.
32. Pirker, R., Pereira, J.R., Szczesna, A., von Pawel, J., Krzakowski, M., Ramlau, R. et al. (2009) Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet 373: 1525-1531.
33. Riely, G.J., Pao, W., Pham, D., Li, A.R., Rizvi, N., Venkatraman, E.S. et al. (2006) 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: 839-844.
34. Sasaki, H., Shimizu, S., Okuda, K., Kawano, O., Yukiue, H., Yano, M. et al. (2008) Epidermal growth factor receptor gene amplification in surgical resected Japanese lung cancer. Lung Cancer 64: 295-300.
35. Sequist, V.L., Bell, D.W., Lynch, T.J. and Haber, D.A. ( 2007) Molecular predictors of response to epidermal growth factor receptor antagonists in non-small-cell lung cancer. J Clin Oncol 25: 587-595.
36. Sequist, V.L., Martins, R.G., Spigel, D., Grunberg, S.M., Spira, A., Janne, P.A. et al. (2008) First-line gefitinib in patients with advanced non-small-cell lung cancer harboring somatic EGFR mutations. J Clin Oncol 26: 2442-2449.
37. Sharma, V.S., Bell, D.W., Settleman, J. and Haber, D.A. ( 2007) Epidermal growth factor receptor mutations in lung cancer. Nat Rev Cancer 7: 169-181.
38. Shepherd, F.A., Rodrigues Pereira, J., Ciuleanu, T., Tan, E.H., Hirsh, V., Thongprasert, S. et al. (2005) Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353: 123-132.
39. Sordella, R., Bell, D.W., Haber, D.A. and Settleman, J. ( 2004) Gefitinib-sensitizing EGFR mutations in lung cancer activate anti-apoptotic pathways. Science 305: 1163-1167.
40. Sugio, K., Uramoto, H., Onitsuka, T., Mizukami, M., Ichiki, Y., Sugaya, M. et al. (2009) Prospective phase II study of gefitinib in non-small cell lung cancer with epidermal growth factor receptor gene mutations. Lung Cancer 64: 314-318.
41. Taguchi, F., Solomon, B., Gregorc, V., Roder, H., Gray, R., Kasahara, K. et al. (2007) Mass spectrometry to classify non-small-cell lung cancer patients for clinical outcome after treatment with epidermal growth factor receptor tyrosine kinase inhibitors: a multicohort cross-institutional study. J Natl Cancer Inst 99: 838-846.
42. Thatcher, N., Chang, A., Parikh, P., Rodrigues Pereira, J., Ciuleanu, T., von Pawel, J. et al. (2005) 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: 1527-1537.
43. Tsao, M.S., Sakurada, A., Cutz, J.C., Zhu, C.Q., Kamel-Reid, S., Squire, J. et al. (2005) Erlotinib in lung cancer - molecular and clinical predictors of outcome. N Engl J Med 353: 133-144.
44. Tsuchihashi, Z., Khambata-Ford, S., Hanna, N. and Janne, P.A. ( 2005) Responsiveness to cetuximab without mutations in EGFR. N Engl J Med 353: 208-209.
45. West, H., Chansky, K., Franklin, W.A., Hirsch, F.R., Crowley, J.J., Lau, D.H. et al. (2008) Long-term survival with gefitinib (ZD 1839) therapy for advanced bronchioloalveolar lung cancer (BAC): Southwest Oncology Group (SWOG) study S0126. J Clin Oncol 26: Abstract #8047.
46. Yun, C.H., Mengwasser, K.E., Toms, V.A., Woo, M.S., Greulich, H., Wong, K.K. et al. (2008) The T790M mutation in EGFR kinase causes drug resistance by increasing the affinity for ATP. Proc Natl Acad Sci USA 105: 2070-2075.
47. Zhu, C.Q., da Cunha Santos, G., Ding, K., Sakurada, A., Cutz, J.C., Liu, N. et al. (2008) 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 26: 4268-4275.