Indirect comparison of the efficacy and safety of gefitinib and cetuximab‑based therapy in patients with advanced non‑small‑cell lung cancer

Tang,Jifeng; Zhang,Hena; Yan,Jianzhou; Shao,Rong

doi:10.3892/mco.2014.424

Indirect comparison of the efficacy and safety of gefitinib and cetuximab‑based therapy in patients with advanced non‑small‑cell lung cancer

Authors:
- Jifeng Tang
- Hena Zhang
- Jianzhou Yan
- Rong Shao
View Affiliations

Affiliations: The Research Center of National Drug Policy and Ecosystem, Nanjing, Jiangsu 211198, P.R. China
Published online on: September 22, 2014 https://doi.org/10.3892/mco.2014.424
Pages: 145-150

Metrics: Total Views: 0 (Spandidos Publications: | PMC Statistics: )

Metrics: Total PDF Downloads: 0 (Spandidos Publications: | PMC Statistics: )

Cited By (CrossRef): 0 citations Loading Articles...

Abstract

The aim of this study was to systematically evaluate the efficacy and safety of gefitinib and cetuximab‑based therapies in patients with advanced non‑small‑cell lung cancer (NSCLC). The studies to be used for the comparisons were selected from the available literature on gefitinib and cetuximab‑based therapies compared to conventional chemotherapy in patients with advanced NSCLC. The meta‑analysis was performed with RevMan 5.0 software and the Bucher approach was applied to conduct the indirect comparisons. A total of 4 studies, including 935 patients, on gefitinib therapy vs. conventional chemotherapy and 4 studies, including 1,015 patients, on cetuximab‑based therapy vs. conventional chemotherapy, were used for indirect comparisons. As regards efficacy, the risk ratio (RR) of objective response rate and 1‑year survival rate between gefitinib and cetuximab‑based therapies in patients with advanced NSCLC were 0.99 [95% confidence interval (CI): 0.75‑1.32; p=0.9584] and 0.85 (95% CI: 0.71‑1.01; p=0.0696), respectively, and the mean difference of progression‑free survival and overall survival (OS) were ‑0.15 (95% CI: ‑0.90 to 0.60; p=0.6946) and ‑1.84 (95% CI: ‑3.53 to ‑0.15; p=0.0331), respectively. As regards safety, the RR of grade 3/4 adverse events (AEs) was 0.29 (95% CI: 0.19‑0.44; p=0.0001). The results demonstrated that cetuximab‑based therapy was superior to gefitinib therapy in terms of OS and inferior to gefitinib therapy in terms of AEs, whereas there were no significant differences in terms of efficacy and safety between the two therapies on other endpoints adopted for advanced NSCLC. However, further well‑designed randomized controlled trials and continuous studies are required to confirm our findings.

View Figures

View References

1	Ozkaya S, Findik S, Dirican A and Atici AG: Long-term survival rates of patients with stage IIIB and IV non-small cell lung cancer treated with cisplatin plus vinorelbine or gemcitabine. Exp Ther Med. 4:1035–1038. 2012.PubMed/NCBI
2	Mendelsohn J and Baselga J: The EGF receptor family as targets for cancer therapy. Oncogene. 19:6550–6565. 2000. View Article : Google Scholar : PubMed/NCBI
3	Ku GY, Haaland BA and de Lima Lopes G Jr: Gefitinib vs. chemotherapy as first-line therapy in advanced non-small cell lung cancer: meta-analysis of phase III trials. Lung Cancer. 74:469–473. 2011. View Article : Google Scholar : PubMed/NCBI
4	Lin H, Jiang J, Liang X, Zhou X and Huang R: Chemotherapy with cetuximab or chemotherapy alone for untreated advanced non-small-cell lung cancer: a systematic review and meta-analysis. Lung Cancer. 70:57–62. 2010. View Article : Google Scholar : PubMed/NCBI
5	Higgins JPT and Green S: Cochran. Handbook for Systematic Reviews of Interventions, version 5.1.0. The Cochrane Collaboration, . 2011, https://www.cochrane-handbook.orgAccessed. June 3–2013
6	Liu M: Design and Implementation Methods of Systematic Reviews and Meta-analysis. People's Medical Publishing House; Beijing: pp. 86–89. 2011, (In Chinese).
7	Jadad AR, Moore RA, Carroll D, et al: Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 17:1–12. 1996. View Article : Google Scholar
8	Schulz KF, Altman DG, Moher D, et al: CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 8(18)2010. View Article : Google Scholar
9	DerSimonian R and Laird N: Meta-analysis in clinical trials. Controlled clinical trials. 7:177–188. 1986. View Article : Google Scholar : PubMed/NCBI
10	Zhang HN, Yan JZ, Tang JF and Shao R: Indirect comparisons for efficacy of gefitinib and erlotinib in patients with non-small cell lung cancer. Chin J Pharm Econ. 1:15–19. 2013.(In Chinese).
11	Silagy C, Lancaster T, Stead L, et al: Nicotin. replacement therapy for smoking cessation. The Cochrane Library, John Wiley & Sons; Oxford: 2004
12	Liao WQ: Simulation Study of Multivariate Meta-analysis and Indirect Comparisons. Southern Medical University; Guangzhou: pp. 23–26. 2011, (In Chinese).
13	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. 372:1809–1818. 2008. View Article : Google Scholar : PubMed/NCBI
14	Mitsudomi T, Morita S, Yatabe Y, et al West Japan Oncology Group: 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. 11:121–128. 2010. View Article : Google Scholar
15	Morère JF, Bréchot JM, Westeel V, et al: Randomized phase II trial of gefitinib or gemcitabine or docetaxel chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2 or 3 (IFCT-0301 study). Lung Cancer. 70:301–307. 2010.PubMed/NCBI
16	Ahn MJ, Yang JC, Liang J, et al: Randomized phase II trial of first-line treatment with pemetrexed-cisplatin, followed sequentially by gefitinib or pemetrexed, in East Asian, never-smoker patients with advanced non-small cell lung cancer. Lung Cancer. 77:346–352. 2012. View Article : Google Scholar : PubMed/NCBI
17	Rosell R, Robinet G, Szczesna A, et al: Randomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer. Ann Oncol. 19:362–369. 2008. View Article : Google Scholar : PubMed/NCBI
18	Butts CA, Bodkin D, Middleman EL, et al: Randomized phase II study of gemcitabine plus cisplatin or carboplatin, with or without cetuximab, as first-line therapy for patients with advanced or metastatic non-small-cell lung cancer. J Clin Oncol. 25:5777–5784. 2007. View Article : Google Scholar : PubMed/NCBI
19	Pirker R, Pereira JR, Szczesna A, et al FLEX Study Team: Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 373:1525–1531. 2009. View Article : Google Scholar : PubMed/NCBI
20	Lynch TJ, Patel T, Dreisbach L, et al: Cetuximab and first-line taxane/carboplatin chemotherapy in advanced non-small-cell lung cancer: results of the randomized multicenter phase III trial BMS099. J Clin Oncol. 28:911–917. 2010. View Article : Google Scholar : PubMed/NCBI
21	Ibrahim EM: Frontline gefitinib in advanced non-small cell lung cancer: meta-analysis of published randomized trials. Ann Thorac Med. 5:153–160. 2010. View Article : Google Scholar : PubMed/NCBI
22	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. View Article : Google Scholar : PubMed/NCBI
23	Tsao MS, Sakurada A, Cutz JC, et al: Erlotinib in lung cancer - molecular and clinical predictors of outcome. New Engl J Med. 353:133–144. 2005. View Article : Google Scholar : PubMed/NCBI
24	Pirker R, Pereira JR, von Pawel J, et al: EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol. 13:33–42. 2012. View Article : Google Scholar : PubMed/NCBI
25	Caldwell DM, Ades AE and Higgins JP: Simultaneous comparison of multiple treatments: combining direct and indirect evidence. BMJ. 331:897–900. 2005. View Article : Google Scholar : PubMed/NCBI
26	Bucher HC, Guyatt GH, Griffith LE and Walter SD: The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol. 50:683–691. 1997. View Article : Google Scholar
27	Song F, Harvey I and Lilford R: Adjusted indirect comparison may be less biased than direct comparison for evaluating new pharmaceutical interventions. J Clin Epidemiol. 61:455–463. 2008. View Article : Google Scholar : PubMed/NCBI
28	Song F, Altman DG, Glenny AM and Deeks JJ: Validity of indirect comparison for estimating efficacy of competing interventions: empirical evidence from published meta-analyses. BMJ. 326(472)2003. View Article : Google Scholar : PubMed/NCBI