Risk of interstitial lung disease with gefitinib and erlotinib in advanced non-small cell lung cancer: A systematic review and meta-analysis of clinical trials

Lung Cancer

Volumn 83, Issue 2, 2014, Pages 231-239

  Shi, Liang ^a   Tang, Junfang ^a   Tong, Li ^a   Liu, Zhe ^a  

^a CAPITAL MEDICAL UNIVERSITY   (China)

Author keywords

Erlotinib; Gefitinib; Interstitial lung disease; Meta analysis; Non small cell lung cancer; Risk

Indexed keywords

ERLOTINIB; GEFITINIB;

ADVANCED CANCER; ARTICLE; HUMAN; INCIDENCE; INFORMATION RETRIEVAL; INTERSTITIAL LUNG DISEASE; LUNG NON SMALL CELL CANCER; META ANALYSIS; MORTALITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK ASSESSMENT; SYSTEMATIC REVIEW;

ERLOTINIB; GEFITINIB; INTERSTITIAL LUNG DISEASE; META-ANALYSIS; NON-SMALL CELL LUNG CANCER; RISK;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIALS AS TOPIC; HUMANS; INCIDENCE; LUNG DISEASES, INTERSTITIAL; LUNG NEOPLASMS; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR; RISK; SURVIVAL ANALYSIS;

EID: 84892889261     PISSN: 01695002     EISSN: 18728332     Source Type: Journal    
DOI: 10.1016/j.lungcan.2013.11.016     Document Type: Article

References (50)

1. Fukuoka M., Yano S., Giaccone G., Tamura T., Nakagawa K., Douillard J.Y., 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) [corrected]. J Clin Oncol 2003, 21:2237-2246.
2. Kris M.G., Natale R.B., Herbst R.S., Lynch T.J., Prager D., Belani C.P., 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. Cohen M.H., Johnson J.R., Chen Y.F., Sridhara R., Pazdur R. Fda drug approval summary: erlotinib (tarceva) tablets. Oncologist 2005, 10:461-466.
4. Petrelli F., Borgonovo K., Cabiddu M., Barni S. Efficacy of egfr tyrosine kinase inhibitors in patients with egfr-mutated non-small-cell lung cancer: a meta-analysis of 13 randomized trials. Clin Lung Cancer 2012, 13:107-114.
5. Inoue A., Saijo Y., Maemondo M., Gomi K., Tokue Y., Kimura Y., et al. Severe acute interstitial pneumonia and gefitinib. Lancet 2003, 361:137-139.
6. Niho S., Kubota K., Goto K., Yoh K., Ohmatsu H., Kakinuma R., 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 2006, 24:64-69.
7. Reck M., van Zandwijk N., Gridelli C., Baliko Z., Rischin D., Allan S., et al. Erlotinib in advanced non-small cell lung cancer: efficacy and safety findings of the global phase iv tarceva lung cancer survival treatment study. J Thorac Oncol 2010, 5:1616-1622.
8. Ando M., Okamoto I., Yamamoto N., Takeda K., Tamura K., Seto T., et al. Predictive factors for interstitial lung disease, antitumor response, and survival in non-small-cell lung cancer patients treated with gefitinib. J Clin Oncol 2006, 24:2549-2556.
9. AstraZeneca. Iressa product information. http://www.iressa.com/_mshost5259502/content/6906430/gefitinib-product-informationasdad.
10. Genentech Tarceva prescribing information. http://www.gene.com/gene/products/information/pdf/tarceva-prescribing.pdf.
11. Jadad A.R., Moore R.A., Carroll D., Jenkinson C., Reynolds D.J., Gavaghan D.J., et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Control Clin Trials 1996, 17:1-12.
12. Moher D., Liberati A., Tetzlaff J., Altman D.G. Preferred reporting items for systematic reviews and meta-analyses: the prisma statement. J Clin Epidemiol 2009, 62:1006-1012.
13. DerSimonian R., Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986, 7:177-188.
14. Higgins J.P., Thompson S.G., Deeks J.J., Altman D.G. Measuring inconsistency in meta-analyses. BMJ 2003, 327:557-560.
15. Herbst R.S., Giaccone G., Schiller J.H., Natale R.B., Miller V., Manegold C., 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, 22:785-794.
16. Giaccone G., Herbst R.S., Manegold C., Scagliotti G., Rosell R., Miller V., 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, 22:777-784.
17. Stinchcombe T.E., Peterman A.H., Lee C.B., Moore D.T., Beaumont J.L., Bradford D.S., et al. A randomized phase ii trial of first-line treatment with gemcitabine, erlotinib, or gemcitabine and erlotinib in elderly patients (age>=70 years) with stage iiib/iv non-small cell lung cancer. J Thorac Oncol 2011, 6:1569-1577.
18. Begg C.B., Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics 1994, 50:1088-1101.
19. Egger M., Davey S.G., Schneider M., Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997, 315:629-634.
20. Han J.Y., Park K., Kim S.W., Lee D.H., Kim H.Y., Kim H.T., et al. First-signal: first-line single-agent iressa versus gemcitabine and cisplatin trial in never-smokers with adenocarcinoma of the lung. J Clin Oncol 2012, 30:1122-1128.
21. Zhang L., Ma S., Song X., Han B., Cheng Y., Huang C., 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 2012, 13:466-475.
22. Sun J.M., Lee K.H., Kim S.W., Lee D.H., Min Y.J., Yun H.J., 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): an open-label, phase 3 trial. Cancer 2012, 118:6234-6242.
23. Maemondo M., Inoue A., Kobayashi K., Sugawara S., Oizumi S., Isobe H., et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated egfr. N Engl J Med 2010, 362:2380-2388.
24. Mitsudomi T., Morita S., Yatabe Y., Negoro S., Okamoto I., Tsurutani J., et al. Gefitinib versus cisplatin plus docetaxel 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, 11:121-128.
25. Takeda K., Hida T., Sato T., Ando M., Seto T., Satouchi M., et al. Randomized phase iii trial of platinum-doublet chemotherapy followed by gefitinib compared with continued platinum-doublet chemotherapy in japanese patients with advanced non-small-cell lung cancer: results of a west japan thoracic oncology group trial (wjtog0203). J Clin Oncol 2010, 28:753-760.
26. Lee D.H., Park K., Kim J.H., Lee J.S., Shin S.W., Kang J.H., 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, 16:1307-1314.
27. Mok T.S., Wu Y.L., Thongprasert S., Yang C.H., Chu D.T., Saijo N., et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009, 361:947-957.
28. Goss G., Ferry D., Wierzbicki R., Laurie S.A., Thompson J., Biesma B., et al. 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 2009, 27:2253-2260.
29. Kim E.S., Hirsh V., Mok T., Socinski M.A., Gervais R., Wu Y.L., et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (interest): a randomised phase iii trial. Lancet 2008, 372:1809-1818.
30. Maruyama 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, 26:4244-4252.
31. Crino L., Cappuzzo F., Zatloukal P., Reck M., Pesek M., Thompson J.C., et al. Gefitinib versus vinorelbine in chemotherapy-naive elderly patients with advanced non-small-cell lung cancer (invite): a randomized, phase ii study. J Clin Oncol 2008, 26:4253-4260.
32. Kelly K., Chansky K., Gaspar L.E., Albain K.S., Jett J., Ung Y.C., et al. Phase iii trial of maintenance gefitinib or placebo after concurrent chemoradiotherapy and docetaxel consolidation in inoperable stage iii non-small-cell lung cancer: swog s0023. J Clin Oncol 2008, 26:2450-2456.
33. 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. Anticancer Drugs 2006, 17:401-409.
34. Thatcher N., Chang A., Parikh P., Rodrigues P.J., 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, 366:1527-1537.
35. Mok T., Wu Y.L., Thongprasert S., Yu C., Zhang L., Ladrera G.E., et al. A randomized placebo-controlled phase iii study of intercalated erlotinib with gemcitabine/platinum in first-line advanced non-small cell lung cancer (nsclc): fastact-ii. J Clin Oncol 2012, 30:15s. (suppl; abstr 7519).
36. Zhou C., Wu Y.L., Chen G., Feng J., Liu X.Q., Wang C., 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, 12:735-742.
37. Rosell R., Carcereny E., Gervais R., Vergnenegre A., Massuti B., Felip E., 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, 13:239-246.
38. Ciuleanu T., Stelmakh L., Cicenas S., Miliauskas S., Grigorescu A.C., 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, 13:300-308.
39. Lee S.M., Khan I., Upadhyay S., Lewanski C., Falk S., Skailes G., 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, 13:1161-1170.
40. Cappuzzo F., Ciuleanu T., Stelmakh L., Cicenas S., Szczesna A., Juhasz E., et al. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol 2010, 11:521-529.
41. Mok T.S., Wu Y.L., Yu C.J., Zhou C., Chen Y.M., Zhang L., et al. Randomized, placebo-controlled, phase ii study of sequential erlotinib and chemotherapy as first-line treatment for advanced non-small-cell lung cancer. J Clin Oncol 2009, 27:5080-5087.
42. Lilenbaum R., Axelrod R., Thomas S., Dowlati A., Seigel L., Albert D., et al. Randomized phase ii trial of erlotinib or standard chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2. J Clin Oncol 2008, 26:863-869.
43. Gatzemeier U., Pluzanska A., Szczesna A., Kaukel E., Roubec J., De Rosa F., 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, 25:1545-1552.
44. Shepherd F.A., Rodrigues P.J., Ciuleanu T., Tan E.H., Hirsh V., Thongprasert S., et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005, 353:123-132.
45. Herbst R.S., Prager D., Hermann R., Fehrenbacher L., Johnson B.E., Sandler A., 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.
46. Takano T., Ohe Y., Kusumoto M., Tateishi U., Yamamoto S., Nokihara H., et al. Risk factors for interstitial lung disease and predictive factors for tumor response in patients with advanced non-small cell lung cancer treated with gefitinib. Lung Cancer 2004, 45:93-104.
47. Kudoh S., Kato H., Nishiwaki Y., Fukuoka M., Nakata K., Ichinose Y., et al. Interstitial lung disease in japanese patients with lung cancer: a cohort and nested case-control study. Am J Respir Crit Care Med 2008, 177:1348-1357.
48. Hotta K., Kiura K., Takigawa N., Yoshioka H., Harita S., Kuyama S., et al. Comparison of the incidence and pattern of interstitial lung disease during erlotinib and gefitinib treatment in japanese patients with non-small cell lung cancer: the okayama lung cancer study group experience. J Thorac Oncol 2010, 5:179-184.
49. Cataldo V.D., Gibbons D.L., Perez-Soler R., Quintas-Cardama A. Treatment of non-small-cell lung cancer with erlotinib or gefitinib. N Engl J Med 2011, 364:947-955.
50. Suzuki H., Aoshiba K., Yokohori N., Nagai A. Epidermal growth factor receptor tyrosine kinase inhibition augments a murine model of pulmonary fibrosis. Cancer Res 2003, 63:5054-5059.