Comparative efficacy of first-line ceritinib and crizotinib in advanced or metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer: an adjusted indirect comparison with external controls

References

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin 2016;66:7–30
   PubMed Web of Science ®Google Scholar
• World Health Organization. Cancer fact sheet. WHO; 2017. Available at: http://www.who.int/mediacentre/factsheets/fs297/en/ [Last accessed March 24, 2017]
   Google Scholar
• Novello S, Barlesi F, Califano R, et al. Metastatic non-small-cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2016;27(suppl 5):v1–v27
   PubMed Web of Science ®Google Scholar
• Yang P, Allen MS, Aubry MC, et al. Clinical features of 5,628 primary lung cancer patients: experience at Mayo Clinic from 1997 to 2003. Chest 2005;128:452–62
   PubMed Web of Science ®Google Scholar
• Penrod J, Korytowsky B, Petrilla A, et al. Survival of U.S. Medicare patients with advanced non-small cell lung cancer by line of therapy. J Clin Oncol 2014;32(5s (suppl; abstr 6582))
   Google Scholar
• Soria JC, Tan DS, Chiari R, et al. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study. Lancet 2017;389:917–29
   PubMed Web of Science ®Google Scholar
• Solomon BJ, Mok T, Kim DW, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med 2014;371:2167–77
   PubMed Web of Science ®Google Scholar
• Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer. N Engl J Med 2017;377:829–38
   PubMed Web of Science ®Google Scholar
• Kwak EL, Bang YJ, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med 2010;363:1693–703
   PubMed Web of Science ®Google Scholar
• Kang HJ, Lim HJ, Park JS, et al. Comparison of clinical characteristics between patients with ALK-positive and EGFR-positive lung adenocarcinoma. Respir Med 2014;108:388–94
   PubMed Web of Science ®Google Scholar
• Shaw AT, Kim DW, Nakagawa K, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med 2013;368:2385–94
   PubMed Web of Science ®Google Scholar
• Giroux-Leprieur E, Fallet V, Cadranel J, et al. Spotlight on crizotinib in the first-line treatment of ALK-positive advanced non-small-cell lung cancer: patients selection and perspectives. Lung Cancer (Auckl) 2016;7:83–90
   PubMedGoogle Scholar
• Sahu A, Prabhash K, Noronha V, et al. Crizotinib: a comprehensive review. South Asian J Cancer 2013;2:91–7
   PubMedGoogle Scholar
• U.S. Food and Drug Administration. FDA broadens ceritinib indication to previously untreated ALK-positive metastatic NSCLC. Silver Spring, MD: US FDA; July 25, 2017. Available at: https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm560873.htm [Last accessed June 1, 2018]
   Google Scholar
• National Institute for Health and Care Excellence. NICE guidance. Ceritinib for untreated ALK-positive non-small-cell lung cancer. Technology appraisal guidance [TA500]. London, UK: NICE; January 24, 2018. Available at: https://www.nice.org.uk/guidance/ta500/chapter/2-Information-about-ceritinib [Last accessed June 1, 2018]
   Google Scholar
• Nix NM, Brown KS. Ceritinib for ALK-rearrangement-positive non-small cell lung cancer. J Adv Pract Oncol 2015;6:156–60
   PubMedGoogle Scholar
• Au TH, Cavalieri CC, Stenehjem DD. Ceritinib: a primer for pharmacists. J Oncol Pharm Pract 2017;23:602–14
   PubMed Web of Science ®Google Scholar
• Thomas RK. Overcoming drug resistance in ALK-rearranged lung cancer. N Engl J Med 2014;370:1250–1
   PubMed Web of Science ®Google Scholar
• Gainor JF, Tan DS, De Pas T, et al. Progression-free and overall survival in ALK-positive NSCLC patients treated with sequential crizotinib and ceritinib. Clin Cancer Res 2015;21:2745–52
   PubMed Web of Science ®Google Scholar
• Katayama R, Khan TM, Benes C, et al. Therapeutic strategies to overcome crizotinib resistance in non-small cell lung cancers harboring the fusion oncogene EML4-ALK. Proc Natl Acad Sci USA 2011;108:7535–40
   PubMed Web of Science ®Google Scholar
• Shaw AT, Yeap BY, Solomon BJ, et al. Effect of crizotinib on overall survival in patients with advanced non-small-cell lung cancer harbouring ALK gene rearrangement: a retrospective analysis. Lancet Oncol 2011;12:1004–12
   PubMed Web of Science ®Google Scholar
• Signorovitch JE, Wu EQ, Betts KA, et al. Comparative efficacy of nilotinib and dasatinib in newly diagnosed chronic myeloid leukemia: a matching-adjusted indirect comparison of randomized trials. Curr Med Res Opin 2011;27:1263–71
   PubMed Web of Science ®Google Scholar
• Mateos MV, Hernandez JM, Hernandez MT, et al. Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: results of a multicenter phase 1/2 study. Blood 2006;108:2165–72
   PubMed Web of Science ®Google Scholar
• Kuss O, Legler T, Borgermann J. Treatments effects from randomized trials and propensity score analyses were similar in similar populations in an example from cardiac surgery. J Clin Epidemiol 2011;64:1076–84.
   PubMed Web of Science ®Google Scholar
• Smeeth L, Douglas I, Hall AJ, et al. Effect of statins on a wide range of health outcomes: a cohort study validated by comparison with randomized trials. Br J Clin Pharmacol 2009;67:99–109
   PubMed Web of Science ®Google Scholar
• Paz-Ares LG, de Marinis F, Dediu M, et al. PARAMOUNT: final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol 2013;31:2895–902
   PubMed Web of Science ®Google Scholar
• Guyot P, Ades AE, Ouwens MJ, et al. Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves. BMC Med Res Methodol 2012;12:9
   PubMed Web of Science ®Google Scholar
• Latimer N. NICE DSU technical support document 14: undertaking survival analysis for economic evaluations alongside clinical trials-extrapolation with patient-level data. London, UK: NICE; 2011. Available at: http://www.nicedsu.org.uk/NICE%20DSU%20TSD%20Survival%20analysis.updated%20March%202013.v2.pdf [Last accessed December 1, 2016]
   Google Scholar
• Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer. N Engl J Med 2017;377(9):829–838
   Web of Science ®Google Scholar
• Hirano K, Imbens GW. Estimation of causal effects using propensity score weighting: an application to data on right heart catheterization. Health Serv Outcomes Res Methodol 2001;2:259–278
   Google Scholar
• Rosenbaum PR, Rubin DB. The central role of the propensity score in observational studies for causal effects. Biometrika 1983;70:41–55
   Web of Science ®Google Scholar
• Signorovitch JE, Wu EQ, Yu AP, et al. Comparative effectiveness without head-to-head trials: a method for matching-adjusted indirect comparisons applied to psoriasis treatment with adalimumab or etanercept. Pharmacoeconomics 2010;28:935–45
   PubMed Web of Science ®Google Scholar
• Solomon BJ, Kim DW, Wu YL, et al. Final overall survival analysis from a study comparing first-line crizotinib versus chemotherapy in ALK-mutation-positive non-small-cell lung cancer. J Clin Oncol 2018;36:2251–8
   PubMed Web of Science ®Google Scholar
• Reck M, von Pawel J, Zatloukal P, et al. Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil. J Clin Oncol 2009;27:1227–34
   PubMed Web of Science ®Google Scholar
• Reck M, von Pawel J, Zatloukal P, et al. Overall survival with cisplatin–gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL). Ann Oncol 2010;21:1804–9
   PubMed Web of Science ®Google Scholar
• Felip E, Kim D, Mehra R, et al. 1295P—Efficacy and safety of ceritinib in patients (pts) with advanced anaplastic lymphoma kinase (ALK)-rearranged (ALK+) non-small cell lung cancer (NSCLC): an update of ASCEND-1. Ann Oncol 2014;25(suppl 4):iv456–iv7
   Google Scholar
• Camidge DR, Bang YJ, Kwak EL, et al. Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a phase 1 study. Lancet Oncol 2012;13:1011–9
   PubMed Web of Science ®Google Scholar
• Nishio M, Hirsh V, Kim DW, et al. Efficacy, safety, and patient-reported outcomes with crizotinib versus chemotherapy in Asian patients in a phase III study of previously treated advanced ALK-positive non-small cell lung cancer [abstract]. J Thorac Oncol 2013;8(suppl 2):S198–S9
   Google Scholar
• Cipriani A, Higgins JP, Geddes JR, et al. Conceptual and technical challenges in network meta-analysis. Ann Intern Med 2013;159:130–7
   PubMed Web of Science ®Google Scholar
• National Cancer Institute. FDA approves alectinib for initial treatment of ALK-positive lung cancer [Internet]. Bethesda, MD: NCI; 2017. Available at: https://www.cancer.gov/news-events/cancer-currents-blog/2017/alectinib-fda-untreated-lung-cancer [Last accessed August 1, 2018]
   Google Scholar
• ClinicalTrials.gov. A study of lorlatinib versus crizotinib in first line treatment of patients with ALK-positive NSCLC. Bethesda, MD; 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT03052608 [Last accessed July 7, 2017]
   Google Scholar
• ClinicalTrials.gov. eXalt3: study comparing X-396 (ensartinib) to crizotinib in ALK positive non-small cell lung cancer (NSCLC) patients. Bethesda, MD; 2016. Available at: https://clinicaltrials.gov/ct2/show/NCT02767804 [Last accessed November 7, 2018]
   Google Scholar
• Camidge DR, Kim HR, Ahn MJ, et al. Brigatinib versus crizotinib in ALK-positive non-small-cell lung cancer. N Engl J Med 2018
   Google Scholar
• Tan DS, Araujo A, Zhang J, et al. Comparative efficacy of ceritinib and crizotinib as initial ALK-targeted therapies in previously treated advanced NSCLC: an adjusted comparison with external controls. J Thorac Oncol 2016;11:1550–7
   Google Scholar