Impact of EGFR inhibitor in non-small cell lung cancer on progression-free and overall survival: A meta-analysis

Journal of the National Cancer Institute

Volumn 105, Issue 9, 2013, Pages 595-605

  Lee, Chee Khoon ^a   Brown, Chris ^a   Gralla, Richard J ^b   Hirsh, Vera ^c   Thongprasert, Sumitra ^d   Tsai, Chun Ming ^e   Tan, Eng Huat ^f   Ho, James Chung Man ^g   Chu, Da Tong ^h   Zaatar, Adel ⁱ   Osorio Sanchez, Jemela Anne ^j   Vu, Vu Van ^k   Au, Joseph Siu Kie ^l   Inoue, Akira ^m   Lee, Siow Ming ⁿ   Gebski, Val ^a   Yang, James Chih Hsin ^o  

^a UNIVERSITY OF SYDNEY   (Australia)

^b ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^c ROYAL VICTORIA HOSPITAL   (Canada)

^d CHIANG MAI UNIVERSITY   (Thailand)

^e TAIPEI VETERANS GENERAL HOSPITAL   (Taiwan)

^f DIVISION OF MEDICAL ONCOLOGY   (Singapore)

^g UNIVERSITY OF HONG KONG   (Hong Kong)

^h CANCER HOSPITAL   (China)

ⁱ Gleneagles Medical Centre   (Malaysia)

^j St Paul of Chartes   (Philippines)

^k Ho Chi Minh City Oncology Hospital   (Viet Nam)

^l QUEEN ELIZABETH HOSPITAL   (Hong Kong)

^m TOHOKU UNIVERSITY HOSPITAL   (Japan)

ⁿ UNIVERSITY COLLEGE LONDON   (United Kingdom)

^o NATIONAL TAIWAN UNIVERSITY   (Taiwan)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; CISPLATIN; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE INHIBITOR; ERLOTINIB; GEFITINIB; GEMCITABINE; NAVELBINE; PACLITAXEL; PEMETREXED; PLACEBO;

ADVANCED CANCER; CALCULATION; CANCER COMBINATION CHEMOTHERAPY; DRUG EFFICACY; GENE MUTATION; HAZARD RATIO; HUMAN; LUNG NON SMALL CELL CANCER; META ANALYSIS; MONOTHERAPY; OVERALL SURVIVAL; PREDICTIVE VALUE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; REVIEW; TREATMENT DURATION; TREATMENT OUTCOME;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; CISPLATIN; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; FEMALE; GLUTAMATES; GUANINE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; MUTATION; PROTEIN KINASE INHIBITORS; PROTEIN-TYROSINE KINASES; QUINAZOLINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECEPTOR, EPIDERMAL GROWTH FACTOR; SURVIVAL ANALYSIS; TAXOIDS;

EID: 84877291745     PISSN: 00278874     EISSN: 14602105     Source Type: Journal    
DOI: 10.1093/jnci/djt072     Document Type: Review

References (57)

1. Sato M, Shames DS, Gazdar AF, Minna JD. A translational view of the molecular pathogenesis of lung cancer. J Thorac Oncol. 2007;2(4):327-343.
2. Sun S, Schiller JH, Gazdar A F. Lung cancer in never smokers-a different disease. Nat Rev Cancer. 2007;7(10):778-790.
3. Tang X, Shigematsu H, Bekele BN, et al. EGFR tyrosine kinase domain mutations are detected in histologically normal respiratory epithelium in lung cancer patients. Cancer Res. 2005;65(17):7568-7572.
4. 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(21):2129-2139.
5. Paez JG, Jänne PA, Lee JC, et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science. 2004;304(5676):1497-1500.
6. 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):13306-13311.
7. 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(10):2277-2285.
8. Petrelli F, Borgonovo K, Cabiddu M, Barni S. Efficacy of EGFR tyros-ine kinase inhibitors in patients with EGFR-mutated non-small-cell lung cancer: a meta-analysis of 13 randomized trials. Clin Lung Cancer. 2012;13(2):107-114.
9. Gao G, Ren S, Li A, et al. Epidermal growth factor receptor-tyrosine kinase inhibitor therapy is effective as first-line treatment of advanced non-small-cell lung cancer with mutated EGFR: a meta-analysis from six phase III randomized controlled trials. Int J Cancer. 2012:131(5):E822-829.
10. Kwak EL, Bang Y-J, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med. 2010;363(18): 1693-1703.
11. Shaw AT, Camidge DR, Engelman JA, et al. Clinical activity of crizotinib in advanced non-small cell lung cancer (NSCLC) harboring ROS1 gene rearrangement. J Clin Oncol. 2012;30(15 suppl):7508.
12. Ciuleanu T, Stelmakh L, Cicenas S, et al. Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN): a randomised multicentre, open-label, phase 3 study. Lancet Oncol. 2012;13(3):300-308.
13. Cappuzzo F, Ciuleanu T, Stelmakh L, et al. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2010;11(6):521-529.
14. Garassino MC, Martelli O, Bettini A, et al. TAILOR: phase III trial comparing erlotinib with docetaxel in the second-line treatment of NSCLC patients with wild-type (wt) EGFR. J Clin Oncol. 2012;30(15 suppl): LBA7501.
15. Parmar MK, Torri V, Stewart L. Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints. Stat Med. 1998;17(24):2815-2834.
16. Zhou C, Wu Y-L, Chen G, et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2011;12(8):735-742.
17. Maemondo M, Inoue A, Kobayashi K, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010;362(25):2380- 2388.
18. Rosell R, Carcereny E, Gervais R, et al. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012;13(3):239-246.
19. Mok TS, Wu Y-L, Thongprasert S, et al. Gefitinib or carboplatin-pacli- taxel in pulmonary adenocarcinoma. N Engl J Med. 2009;361(10):947-957.
20. Fukuoka M, Wu Y-L, Thongprasert S, et al. Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer in Asia (IPASS). J Clin Oncol. 2011;29(21):2866-2874.
21. Mitsudomi T, Morita S, Yatabe Y, et al. Gefitinib versus cisplatin plus doc-etaxel 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(2):121-128.
22. Herbst RS, Prager D, Hermann R, et al. TRIBUTE: a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and pacli-taxel chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol. 2005;23(25):5892-5899.
23. Han J-Y, Park K, Kim S-W, et al. First-SIGNAL: First-line single-agent iressa versus gemcitabine and cisplatin trial in never-smokers with adeno-carcinoma of the lung. J Clin Oncol. 2012;30(10):1122-1128.
24. Giaccone G, Herbst RS, Manegold C, et al. Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial-INTACT 1. J Clin Oncol. 2004;22(5):777-784.
25. Herbst RS, Giaccone G, Schiller JH, et al. Gefitinib in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer: a phase III trial-INTACT 2. J Clin Oncol. 2004;22(5):785-794.
26. Gatzemeier U, Pluzanska A, Szczesna A, et al. Phase III study of erlotinib in combination with cisplatin and gemcitabine in advanced non-small-cell lung cancer: the Tarceva Lung Cancer Investigation Trial. J Clin Oncol. 2007;25(12):1545-1552.
27. Reck M, Von Pawel J, Fischer JR, et al. Erlotinib versus carboplatin/vinorelbine in elderly patients (age 70 or older) with advanced non-small cell lung carcinoma (NSCLC): a randomized phase II study of the German Thoracic Oncology Working Group. J Clin Oncol. 2010;28(15 suppl):7565.
28. Douillard J-Y, Shepherd FA, Hirsh V, et al. Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: data from the randomized phase III INTEREST trial. J Clin Oncol. 2010;28(5):744-752.
29. Kim ES, Hirsh V, Mok T, et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet. 2008;372(9652):1809-1818.
30. Zhang L, Ma S, Song X, et al. Gefitinib versus placebo as maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer (INFORM; C-TONG 0804): a multicentre, double-blind randomised phase 3 trial. Lancet Oncol. 2011;13(5):466-475.
31. Maruyama R, Nishiwaki Y, Tamura T, et al. Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer. J Clin Oncol. 2008;26(26):4244-4252.
32. Perol M, Chouaid C, Milleron BJ, et al. Maintenance with either gemcit-abine or erlotinib versus observation with predefined second-line treatment after cisplatin-gemcitabine induction chemotherapy in advanced NSCLC: IFCT-GFPC 0502 phase III study. J Clin Oncol. 2010;28(15 suppl):7507.
33. Mitsudomi T, Morita S, Yatabe Y, et al. Updated overall survival results of WJTOG 3405, a randomized phase III trial comparing gefitinib (G) with cisplatin plus docetaxel (CD) as the first-line treatment for patients with non-small cell lung cancer harboring mutations of the epidermal growth factor receptor (EGFR). J Clin Oncol. 2012;30(15 suppl):7521.
34. Yang JC-H, Schuler MH, Yamamoto N, et al. LUX-Lung 3: a randomized, open-label, phase III study of afatinib versus pemetrexed and cisplatin as first-line treatment for patients with advanced adenocarcinoma of the lung harboring EGFR-activating mutations.J Clin Oncol. 2012;30(15 suppl):LBA7500.
35. Zhou C, Wu YL, Liu X, et al. Overall survival (OS) results from OPTIMAL (CTONG0802), a phase III trial of erlotinib (E) versus carboplatin plus gemcitabine (GC) as first-line treatment for Chinese patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC). J Clin Oncol. 2012;30(15 suppl):7520.
36. Lee S, Rudd R, Khan I, et al. TOPICAL: Randomized phase III trial of erlotinib compared with placebo in chemotherapy-naive patients with advanced non-small cell lung cancer (NSCLC) and unsuitable for first-line chemotherapy. J Clin Oncol. 2010;28(15 suppl):7504.
37. 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. 2005;23(16 suppl):7028.
38. Inoue A, Kobayashi K, Maemondo M, et al. Final overall survival results of NEJ002, a phase III trial comparing gefitinib to carboplatin (CBDCA) plus paclitaxel (TXL) as the first-line treatment for advanced non-small cell lung cancer (NSCLC) with EGFR mutations. J Clin Oncol. 2011;29(15 suppl):7519.
39. Zhu C-Q, da Cunha Santos G, Ding K, et al. 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(26):4268-4675.
40. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005;353(2):123-132.
41. 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(9496):1527-1537.
42. Sun JM, Lee KH, Kim SW, et al. Gefitinib versus pemetrexed as second-line treatment in patients with nonsmall cell lung cancer previously treated with platinum-based chemotherapy (KCSG-LU08-01) [published online ahead of print June 6, 2012]. Cancer. 2012. doi:10.1002/cncr.27630.
43. Lee SM, Khan I, Upadhyay S, et al. First-line erlotinib in patients with advanced non-small-cell lung cancer unsuitable for chemotherapy (TOPICAL): a double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2012;13(11):1161-1170.
44. Pérol M, Chouaid C, Pérol D, et al. Randomized, phase III study of gemcitabine or erlotinib maintenance therapy versus observation, with predefined second-line treatment, after cisplatin-gemcitabine induction chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol. 2012;30(28):3516-3524.
45. Bell DW, Lynch TJ, Haserlat SM, et al. Epidermal growth factor receptor mutations and gene amplification in non-small-cell lung cancer: molecular analysis of the IDEAL/INTACT gefitinib trials. J Clin Oncol. 2005;23(31):8081-8092.
46. Hotta K, Kiura K, Fujiwara Y, et al. Role of survival post-progression in phase III trials of systemic chemotherapy in advanced non-small-cell lung cancer: a systematic review. PLoS One. 2011;6(11):e26646.
47. Fleming TR. Standard versus adaptive monitoring procedures: a commentary. Stat Med. 2006;25(19):3305-3312.
48. Fleming TR, Rothmann MD, Lu HL. Issues in using progression-free survival when evaluating oncology products. J Clin Oncol. 2009;27(17):2874-2880.
49. Dodd LE, Korn EL, Freidlin B, et al. Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense? J Clin Oncol. 2008;26(22):3791-3796.
50. Ciardiello F, Caputo R, Bianco R, et al. Antitumor effect and potentiation of cytotoxic drugs activity in human cancer cells by ZD-1839 (Iressa), an epidermal growth factor receptor-selective tyrosine kinase inhibitor. Clin Cancer Res. 2000;6(5):2053-2063.
51. Sirotnak FM, Zakowski MF, Miller VA, Scher HI, Kris MG. Efficacy of cytotoxic agents against human tumor xenografts is markedly enhanced by coadministration of ZD1839 (Iressa), an inhibitor of EGFR tyrosine kinase. Clin Cancer Res. 2000;6(12):4885-4892.
52. Jänne PA, Wang X, Socinski MA, et al. Randomized phase II trial of erlo-tinib alone or with carboplatin and paclitaxel in patients who were never or light former smokers with advanced lung adenocarcinoma: CALGB 30406 trial. J Clin Oncol. 2012;30(17):2063-2069.
53. Luis P-A. Beyond first-line NSCLC therapy: chemotherapy or erlotinib? Lancet Oncol. 2012;13(3):225-227.
54. Tsiatis AC, Norris-Kirby A, Rich RG, et al. Comparison of Sanger sequencing, pyrosequencing, and melting curve analysis for the detection of KRAS mutations: diagnostic and clinical implications. J Mol Diagn. 2010;12(4):425-432.
55. Maheswaran S, Sequist LV, Nagrath S, et al. Detection of mutations in EGFR in circulating lung-cancer cells. N Engl J Med. 2008;359(4):366-377.
56. Rosell R, Molina MA, Costa C, et al. Pretreatment EGFR T790M mutation and BRCA1 mRNA expression in erlotinib-treated advanced non-small-cell lung cancer patients with EGFR mutations. Clin Cancer Res. 2011;17(5):1160-1168.
57. Su K-Y, Chen H-Y, Li K-C, et al. Pretreatment epidermal growth factor receptor (EGFR) T790M mutation predicts shorter egfr tyrosine kinase inhibitor response duration in patients with non-small-cell lung cancer. J Clin Oncol. 2012;30(4):433-440.