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

Journal of Clinical Oncology

Volumn 25, Issue 16, 2007, Pages 2248-2255

  Cappuzzo, Federico ^a   Ligorio, Claudia ^a   Jänne, Pasi A ^a   Toschi, Luca ^a   Rossi, Elisa ^a   Trisolini, Rocco ^a   Paioli, Daniela ^a   Holmes, Alison J ^a   Magrini, Elisabetta ^a   Finocchiaro, Giovanna ^a   Bartolini, Stefania ^a   Cancellieri, Alessandra ^a   Ciardiello, Fortunato ^a   Patelli, Marco ^a   Crino, Lucio ^a   Varella Garcia, Marileila ^a  

^a HUMANITAS CLINICAL AND RESEARCH CENTER   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; EPIDERMAL GROWTH FACTOR RECEPTOR; EPIDERMAL GROWTH FACTOR RECEPTOR 2; GEFITINIB; K RAS PROTEIN; PROTEIN KINASE B; ANTINEOPLASTIC AGENT; QUINAZOLINE DERIVATIVE;

ADULT; AGED; ARTICLE; CANCER GROWTH; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG SENSITIVITY; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; FOLLOW UP; GENE AMPLIFICATION; GENE EXPRESSION; GENE MUTATION; HUMAN; HUMAN TISSUE; IMMUNOHISTOCHEMISTRY; INTERSTITIAL LUNG DISEASE; LUNG NON SMALL CELL CANCER; MALE; MUTATIONAL ANALYSIS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; SMOKING; TISSUE CULTURE; TREATMENT RESPONSE; CHEMISTRY; GENETICS; LUNG TUMOR; MIDDLE AGED; MORTALITY; MUTATION; PHOSPHORYLATION; PROSPECTIVE STUDY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; FEMALE; HUMANS; IN SITU HYBRIDIZATION, FLUORESCENCE; LUNG NEOPLASMS; MALE; MIDDLE AGED; MUTATION; PHOSPHORYLATION; PROSPECTIVE STUDIES; PROTO-ONCOGENE PROTEINS C-AKT; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR; SMOKING;

EID: 34250161814     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2006.09.4300     Document Type: Article

References (50)

1. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al: Erlotinib in previously treated non-small cell lung cancer. N Engl J Med 353:123-132, 2005
2. Fukuoka M, Yano S, Giaccone G, et al: Multiinstitutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer. J Clin Oncol 21:2237-2246, 2003
3. 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 290:2149-2158, 2003
4. Perez-Soler R, Chachoua A, Hammond LA, et al: Determinants of tumor response and survival with erlotinib in patients with non-small-cell lung cancer. J Clin Oncol 22:3238-3247, 2004
5. 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. J Clin Oncol 22:1103-1109, 2004
6. 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 23:5892-5899, 2005
7. 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). J Clin Oncol 23:627s, 2005 (suppl, abstr 7028)
8. Thacher 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 366:1527-1537, 2005
9. Sanchez-Cespedes M, Ahrendt SA, Piantadosi S, et al: Chromosomal alterations in lung adenocarcinoma from smokers and nonsmokers. Cancer Res 61:1309-1313, 2001
10. Ahrendt SA, Decker PA, Alawi EA, et al: Cigarette smoking is strongly associated with mutation of the KRAS gene in patients with primary adenocarcinoma of the lung. Cancer 92:1525-1530, 2001
11. Slebos RJ, Hruban RH, Dalesio O, et al: Relationship between KRAS oncogene activation and smoking in adenocarcinoma of the human lung. J Natl Cancer Inst 83:1024-1027, 1991
12. Pao W, Wang TY, Riely GJ, et al: KRAS mutations and primary resistance of lung adenocarcinomas to gefitinib or erlotinib. PLoS Med 2:e17, 2005
13. 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 350:2129-2139, 2004
14. Paez JG, Jänne PA, Lee JC, et al: EGFR mutations in lung cancer: Correlation with clinical response to gefitinib therapy. Science 304:1497-1500, 2004
15. 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 97:643-655, 2005
16. Pao W, Miller V, Zakowski M, et al: EGF receptor gene mutations are common in lung cancer from never-smokers and are associated with sensitivity of tumors to gefitinib and erlotinib. Proc Natl Acad Sci U S A 101:13306-13311, 2004
17. 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 23:6829-6837, 2005
18. Shigematsu H, Lin L, Takahashi T, et al: Clinical and biological features associated with epidermal growth factor receptor gene mutations in lung cancers. J Natl Cancer Inst 97:339-346, 2005
19. Pham D, Kris MG, Riely GJ, et al: Use of cigarette-smoking history to estimate the likelihood of mutations in epidermal growth factor receptor gene exons 19 and 21 in lung adenocarcinomas. J Clin Oncol 24:1700-1704, 2006
20. Tsao MS, Sakurada A, Cutz JC, et al: Erlotinib in lung cancer: Molecular and clinical predictors of outcome. N Engl J Med 353:133-144, 2005
21. Hirsch FR, Varella-Garcia M, McCoy J, et al: Increased EGFR gene copy number detected by FISH associates with increased sensitivity to gefitinib in patients with bronchioloalveolar carcinoma subtypes: A Southwest Oncology Group Study. J Clin Oncol 23:6838-6845, 2005
22. Hirsch FR, Varella-Garcia M, Bunn PA, 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 24:5034-5042, 2006
23. Cappuzzo F, Magrini E, Ceresoli GL, et al: AKT phosphorylation and gefitinib efficacy in patients with advanced non-small cell lung cancer. J Natl Cancer Inst 96:1133-1141, 2004
24. Sordella R, Bell DW, Haber DA, et al: Gefitinib-sensitizing EGFR mutations in lung cancer activate anti-apoptotic pathways. Science 305:1163-1167, 2004
25. 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 non-small-cell lung cancer patients. J Clin Oncol 23:5007-5018, 2005
26. 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 92:205-216, 2000
27. Varella-Garcia M: Stratification of non-small cell lung cancer patients for therapy with epidermal growth factor receptor inhibitors: The EGFR fluorescence in situ hybridization assay. Diagn Pathol 1:19, 2006
28. 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. J Clin Oncol 21:2658-2663, 2003
29. Janne PA, Borras AM, Kuang Y, et al: A rapid and sensitive enzymatic method for epidermal growth factor receptor mutation screening. Clin Cancer Res 12:751-758, 2006
30. Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457-481, 1958
31. Agresti A: Categorical Data Analysis. New York, NY, John Wiley & Sons, 1990
32. National Cancer Institute: National Cancer Institute Common Toxicity Criteria version 2.0. http://ctep.cancer.gov/forms/CTCv20_4-30-992.pdf
33. Ceresoli GL, Cappuzzo F, Gregorc V, et al: Gefitinib in patients with brain metastases from non-small-cell lung cancer: A prospective trial. Ann Oncol 15:1042-1047, 2004
34. Heimberger AB, Learn CA, Archer GE, et al: Brain tumors in mice are susceptible to blockade of epidermal growth factor receptor (EGFR) with the oral, specific, EGFR-tyrosine kinase inhibitor ZD1839 (Iressa). Clin Cancer Res 8:3496-3502, 2002
35. Inoue A, Saijo Y, Maemondo M, et al: Severe acute interstitial pneumonia and gefitinib. Lancet 361:137-139, 2003
36. Niho S, Kubota K, Goto K, 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 24:64-69, 2006
37. 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 24:3340-3346, 2006
38. Lee DH, Han JY, Lee HG, et al: Gefitinib as a first-line therapy of advanced or metastatic adenocarcinoma of the lung in never-smokers. Clin Cancer Res 11:3032-3037, 2005
39. Kosaka T, Yatabe Y, Endoh H, et al: Mutations of the epidermal growth factor receptor gene in lung cancer: Biological and clinical implications. Cancer Res 64:8919-8923, 2004
40. Clark GM, Zborowski DM, Santabarbara P, et al: Smoking history and epidermal growth factor receptor expression as predictors of survival benefit from erlotinib for patients with non-small-cell lung cancer in the National Cancer Institute of Canada Clinical Trials Group study BR. 21. Clin Lung Cancer 7:389-394, 2006
41. Moasser MM, Basso A, Averbuch SD, et al: The tyrosine kinase inhibitor ZD1839 ("Iressa") inhibits HER2-driven signaling and suppresses the growth of HER2-overexpressing tumor cells. Cancer Res 61:7184-7188, 2001
42. Jackman DM, Yeap BY, Sequist LV, 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 12:3908-3914, 2006
43. 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 23:2513-2520, 2005
44. Riely GJ, Pao W, Pham D, 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 12:839-844, 2006
45. Hirsch FR, Franklin WA, McCoy J, et al: Predicting clinical benefit from EGFR TKIs: Not all EGFR mutations are equal. J Clin Oncol 24:18s, 2006 (suppl, abstr 7072)
46. Shigematsu H, Takahashi T, Nomura M, et al: Somatic mutations of the HER2 kinase domain in lung adenocarcinomas. Cancer Res 65:1642-1646, 2005
47. Pao W, Miller VA, Politi KA, et al: Acquired resistance of lung adenocarcinomas to gefitinib or erlotinib is associated with a second mutation in the EGFR kinase domain. PLoS Med 2:e73, 2005
48. Kobayashi S, Boggon TJ, Dayaram T, et al: EGFR mutation and resistance of non-small-cell lung cancer to gefitinib. N Engl J Med 352:786-792, 2005
49. Wang SE, Narasanna A, Perez-Torres M, et al: HER2 kinase domain mutation results in constitutive phosphorylation and activation of HER2 and EGFR and resistance to EGFR tyrosine kinase inhibitors. Cancer Cell 10:25-38, 2006
50. Cappuzzo F, Bemis L, Varella-Garcia M: HER2 gene mutation and response to trastuzumab therapy in non-small cell lung cancer. N Engl J Med 354:2619-2621, 2006