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Greenhalgh J, Bagust A, Boland A, et al. Erlotinib and gefitinib for treating non-small cell lung cancer that has progressed following prior chemotherapy (review of NICE technology appraisals 162 and 175): a systematic review and economic evaluation. Southampton (UK): NIHR Journals Library; 2015 Jun. (Health Technology Assessment, No. 19.47.)

Cover of Erlotinib and gefitinib for treating non-small cell lung cancer that has progressed following prior chemotherapy (review of NICE technology appraisals 162 and 175): a systematic review and economic evaluation

Erlotinib and gefitinib for treating non-small cell lung cancer that has progressed following prior chemotherapy (review of NICE technology appraisals 162 and 175): a systematic review and economic evaluation.

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Appendix 3Table of included studies and associated publications

TABLE 53

Table of included studies and associated publications

TrialAssociated publications
Bhatnagar et al.33Bhatnagar AR, Singh DP, Sharma R, Kumbhaj P. Docetaxel versus gefitinib in patients with locally advanced or metastatic NSCLC pretreated with platinum-based chemotherapy. J Thorac Oncol 2012;3:S159
BR.2131Shepherd FA, Pereira JR, Ciuleanu T, Eng HT, Hirsh V, Thongprasert S, et al. Erlotinib in previously treated non-small-cell lung cancer. New Engl J Med 2005;353:123–32
Bezjak A, Shepherd F, Tu D, Clark G, Santabarbara P, Pater J, et al. Symptom response in non-small-cell lung cancer (NSCLC) patients (pts) treated with erlotinib: quality of life analysis of the NCIC CTG BR.21 trial. J Clin Oncol: ASCO Annual Meeting Proceedings 2005;23:625
Bezjak A, Tu D, Seymour L, Clark G, Trajkovic A, Zukin M, et al. Symptom improvement in lung cancer patients treated with erlotinib: quality of life analysis of the National Cancer Institute of Canada Clinical Trials Group Study BR.21. J Clin Oncol 2006;24:3831–7
Zhu CQ, Da Cunha Santos G, Ding K, Sakurada A, Cutz JC, Liu N, 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;26:4268–75
DELTA40Okano Y, Ando M, Asami K, Fukuda M, Nakagawa H, Ibata H, et al. Randomized phase III trial of erlotinib (E) versus docetaxel (D) as second- or third-line therapy in patients with advanced non-small-cell lung cancer (NSCLC) who have wild-type or mutant epidermal growth factor receptor (EGFR): Docetaxel and Erlotinib Lung Cancer Trial (DELTA). J Clin Oncol: ASCO Annual Meeting Proceedings 2013;31:8006
INTEREST34Kim ES, Hirsh V, Mok T, Socinski MA, Gervais R, Wu YL, et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet 2008;372:1809–18
Douillard JY, Shepherd FA, Hirsh V, Mok T, Socinski MA, Gervais R, 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;28:744–52
ISEL39Chang A, Parikh P, Thongprasert S, Tan EH, Perng RP, Ganzon D, et al. Gefitinib (IRESSA) in patients of Asian origin with refractory advanced non-small-cell lung cancer: subset analysis from the ISEL study. J Thorac Oncol 2006;1:847–55
Thatcher N, Chang A, Parikh P, Pereira JR, Ciuleanu T, Von Pawel J, 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;366:1527–37
Hirsch FR, Varella-Garcia M, Bunn Jr PA, Franklin WA, Dziadziuszko R, Thatcher N, 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;24:5034–42
ISTANA35Lee D, Kim S, Park K, Kim J, Lee J, Shin S, et al. A randomized open-label study of gefitinib versus docetaxel in patients with advanced/metastatic non-small-cell lung cancer (NSCLC) who have previously received platinum-based chemotherapy [abstract no. 8025]. J Clin Oncol: ASCO Annual Meeting Proceedings 2008;26:430
Lee DH, Park K, Kim JH, Lee JS, Shin SW, Kang JH, et al. Randomized Phase III trial of gefitinib versus docetaxel in non-small-cell lung cancer patients who have previously received platinum-based chemotherapy. Clin Cancer Res 2010;16:1307–14
Kim et al.32Kim ST, Uhm JE, Lee J, Sun JM, Sohn I, Kim SW, et al. Randomized phase II study of gefitinib versus erlotinib in patients with advanced non-small-cell lung cancer who failed previous chemotherapy. Lung Cancer 2012;75:82–8
Ahn J, Kim S, Ahn M, Lee J, Uhm J, Sun J, et al. Randomized phase II study of gefitinib versus erlotinib in patients with advanced non-small-cell lung cancer who failed previous chemotherapy. J Clin Oncol 2010;28:7551
Li et al.36Li H, Wang X, Hua F. [Second-line treatment with gefitinib or docetaxel for advanced non-small-cell lung cancer]. Chin J Clin Oncol 2010;37:16–18
SIGN37Cufer T, Vrdoljak E. Results from a Phase II, open-label, randomized study (SIGN) comparing gefitinib with docetaxel as second-line therapy in patients with advanced (stage IIIb or IV) non-small-cell lung cancer [abstract]. J Clin Oncol: ASCO Annual Meeting Proceedings 2005;23:629
Cufer T, Vrdoljak E, Gaafar R, Erensoy I, Pemberton K. Phase II, open-label, randomized study (SIGN) of single-agent gefitinib (IRESSA) or docetaxel as second-line therapy in patients with advanced (stage IIIb or IV) non-small-cell lung cancer. Anti-Cancer Drugs 2006;17:401–9
TAILOR41Farina G, Longo F, Martelli O, Pavese I, Mancuso A, Moscetti L, et al. Rationale for treatment and study design of tailor: a randomized phase III trial of second-line erlotinib versus docetaxel in the treatment of patients affected by advanced non-small-cell lung cancer with the absence of epidermal growth factor receptor mutations. Clin Lung Cancer 2011;12:138–41
Garassino MC, Martelli O, Bettini A, Floriani I, Copreni E, Lauricella C, et al. TAILOR: a phase III trial comparing erlotinib with docetaxel as the second-line treatment of NSCLC patients with wild-type (wt) EGFR. J Clin Oncol 2012;30
Garassino MC, Marabese M, Broggini M, Lauricella C, Floriani I, Martelli O, et al. Effect of tumor-specific KRAS mutational status on impact of anti-EGFR therapy in non-small-cell lung cancer (NSCLC). J Clin Oncol 2010;1:7564
aGarassino MC, Martelli O, Broggini M, Farina G, Veronese S, Rulli E, et al. Erlotinib versus docetaxel as second-line treatment of patients with advanced non-small-cell lung cancer and wild-type EGFR tumours (TAILOR): a randomised controlled trial. Lancet Oncol 2013;14:981–8
TITAN42Ciuleanu T, Stelmakh L, Cicens S, Gonzlez EE. Efficacy and safety of erlotinib versus chemotherapy in second-line advanced non-small-cell lung cancer (NSCLC) with poor prognosis: the phase III TITAN study. Lung Cancer 2011;71:S44
Ciuleanu T, Stelmakh L, Cicenas S, Miliauskas S, Grigorescu AC, Hillenbach C, 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;13:300–8
V-15-3238Maruyama R, Nishiwaki Y, Tamura T, Yamamoto N, Tsuboi M, Nakagawa K, 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;26:4244–52
Sekine I, Ichinose Y, Nishiwaki Y, Yamamoto N, Tsuboi M, Nakagawa K, et al. Quality of life and disease-related symptoms in previously treated Japanese patients with non-small-cell lung cancer: results of a randomized phase III study (V-15-32) of gefitinib versus docetaxel. Ann Oncol 2009;20:1483–8
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Copyright © Queen’s Printer and Controller of HMSO 2015. This work was produced by Greenhalgh et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

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Bookshelf ID: NBK304031
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