Benefits and risks of ponatinib versus bosutinib following treatment failure of two prior tyrosine kinase inhibitors in patients with chronic phase chronic myeloid leukemia: a matching-adjusted indirect comparison

References

• Hochhaus A, La Rosee P, Muller MC, et al. Impact of BCR-ABL mutations on patients with chronic myeloid leukemia. Cell Cycle 2011;10:250–60
   PubMed Web of Science ®Google Scholar
• Kantarjian HM, Deisseroth A, Kurzrock R, et al. Chronic myelogenous leukemia: a concise update. Blood 1993;82:691-703
   PubMed Web of Science ®Google Scholar
• Sasaki K, Strom SS, O’Brien S, et al. Relative survival in patients with chronic-phase chronic myeloid leukaemia in the tyrosine-kinase inhibitor era: analysis of patient data from six prospective clinical trials. Lancet Haematol 2015;2:e186-93
   PubMed Web of Science ®Google Scholar
• Haznedaroglu IC. Drug therapy in the progressed CML patient with multi-TKI failure. Mediterr J Hematol Infect Dis 2015;7:e2015014
   PubMed Web of Science ®Google Scholar
• Henk HJ, Woloj M, Shapiro M, et al. Real-world analysis of tyrosine kinase inhibitor treatment patterns among patients with chronic myeloid leukemia in the United States. Clin Ther 2015;37:124-33
   PubMed Web of Science ®Google Scholar
• National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: chronic myelogenous leukemia. Version 1.2017 2016. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cml.pdf [Last accessed 11 December 2016]
   Google Scholar
• Jabbour E, Kantarjian H. Chronic myeloid leukemia: 2016 update on diagnosis, therapy, and monitoring. Am J Hematol 2016;91:252-65
   PubMed Web of Science ®Google Scholar
• Ribeiro BF, Miranda EC, Albuquerque DM, et al. Treatment with dasatinib or nilotinib in chronic myeloid leukemia patients who failed to respond to two previously administered tyrosine kinase inhibitors – a single center experience. Clinics (Sao Paulo) 2015;70:550-5
   PubMed Web of Science ®Google Scholar
• Ibrahim AR, Paliompeis C, Bua M, et al. Efficacy of tyrosine kinase inhibitors (TKIs) as third-line therapy in patients with chronic myeloid leukemia in chronic phase who have failed 2 prior lines of TKI therapy. Blood 2010;116:5497-500
   PubMed Web of Science ®Google Scholar
• Garg RJ, Kantarjian H, O’Brien S, et al. The use of nilotinib or dasatinib after failure to 2 prior tyrosine kinase inhibitors: long-term follow-up. Blood 2009;114:4361-8
   PubMed Web of Science ®Google Scholar
• Iclusig (ponatinib) tablets for oral use: Prescribing Information. Cambridge, MA, USA: ARIAD Pharmaceuticals Inc., 2017. Available at: http://www.iclusig.com/pi [Last accessed 23 January 2018]
   Google Scholar
• Bosulif (bosutinib) tablets for oral use: Prescribing Information. New York, NY, USA: Pfizer Inc., 2017. Available at: http://labeling.pfizer.com/ShowLabeling.aspx?id=884 [Last accessed 23 January 2018]
   Google Scholar
• Puttini M, Coluccia AM, Boschelli F, et al. In vitro and in vivo activity of SKI-606, a novel Src-Abl inhibitor, against imatinib-resistant Bcr-Abl + neoplastic cells. Cancer Res 2006;66:11314-22
   PubMed Web of Science ®Google Scholar
• Redaelli S, Piazza R, Rostagno R, et al. Activity of bosutinib, dasatinib, and nilotinib against 18 imatinib-resistant BCR/ABL mutants. J Clin Oncol 2009;27:469-71
   PubMed Web of Science ®Google Scholar
• Branford S, Melo JV, Hughes TP. Selecting optimal second-line tyrosine kinase inhibitor therapy for chronic myeloid leukemia patients after imatinib failure: does the BCR-ABL mutation status really matter? Blood 2009;114:5426-35
   PubMed Web of Science ®Google Scholar
• Miller GD, Bruno BJ, Lim CS. Resistant mutations in CML and Ph(+)ALL – role of ponatinib. Biologics 2014;8:243-54
   PubMedGoogle Scholar
• Cortes JE, Kantarjian HM, Brummendorf TH, et al. Safety and efficacy of bosutinib (SKI-606) in chronic phase Philadelphia chromosome-positive chronic myeloid leukemia patients with resistance or intolerance to imatinib. Blood 2011;118:4567-76
   PubMed Web of Science ®Google Scholar
• Khoury HJ, Cortes JE, Kantarjian HM, et al. Bosutinib is active in chronic phase chronic myeloid leukemia after imatinib and dasatinib and/or nilotinib therapy failure. Blood 2012;119:3403-12
   PubMed Web of Science ®Google Scholar
• Cortes JE, Khoury HJ, Kantarjian HM, et al. Long-term bosutinib for chronic phase chronic myeloid leukemia after failure of imatinib plus dasatinib and/or nilotinib. Am J Hematol 2016;91:1206-14
   PubMed Web of Science ®Google Scholar
• Bosulif (bosutinib) 100-mg film-coated tablets: Summary of Product Characteristics. Sandwich, UK: Pfizer Ltd., 2016. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002373/WC500141721.pdf [Last accessed 22 October 2016]
   Google Scholar
• O’Hare T, Shakespeare WC, Zhu X, et al. AP24534, a pan-BCR-ABL inhibitor for chronic myeloid leukemia, potently inhibits the T315I mutant and overcomes mutation-based resistance. Cancer Cell 2009;16:401-12
   PubMed Web of Science ®Google Scholar
• Cortes JE, Kim DW, Pinilla-Ibarz J, et al. A phase 2 trial of ponatinib in Philadelphia chromosome-positive leukemias. N Engl J Med 2013;369:1783-96
   PubMed Web of Science ®Google Scholar
• Parker WT, Yeung DT, Yeoman AL, et al. The impact of multiple low-level BCR-ABL1 mutations on response to ponatinib. Blood 2016;127:1870-80
   PubMed Web of Science ®Google Scholar
• Cortes JE, Kim DW, Pinilla-Ibarz J, et al. Ponatinib efficacy and safety in Philadelphia chromosome-positive leukemia: final 5-year results of the phase 2 PACE trial. Blood 2018;132:393–404
   Google Scholar
• Iclusig (ponatinib) 15-mg film-coated tablets: Summary of Product Characteristics. Leatherhead, UK: Ariad Pharma Ltd., 2016. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002695/WC500145646.pdf [Last accessed 22 October 2016]
   Google Scholar
• Jansen JP, Fleurence R, Devine B, et al. Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 1. Value Health 2011;14:417-28
   PubMed 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
• Signorovitch JE, Sikirica V, Erder MH, et al. Matching-adjusted indirect comparisons: a new tool for timely comparative effectiveness research. Value Health 2012;15:940-7
   PubMed Web of Science ®Google Scholar
• Hochhaus A, Cortes JE, Kim D-W, et al. Efficacy and safety of ponatinib in CP-CML patients by number of prior tyrosine kinase inhibitors: 4-year follow-up of the phase 2 PACE trial (presented at the American Society of Hematology [ASH] 57th Annual Meeting & Exposition, Orlando, FL, USA, 5–8 December 2015). Blood (ASH Annual Meeting Abstracts) 2015;126:4025
   Google Scholar
• Gambacorti-Passerini C, Cortes JE, Lipton JH, et al. Safety and efficacy of second-line bosutinib for chronic phase chronic myeloid leukemia over a five-year period: final results of a phase 1/2 study. Haematologica 2018;103:1298–307
   Google Scholar
• Signorovitch JE, Betts KA, Reichmann WM, et al. One-year and long-term molecular response to nilotinib and dasatinib for newly diagnosed chronic myeloid leukemia: a matching-adjusted indirect comparison. Curr Med Res Opin 2015;31:315-22
   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
• Muresan B, Mamolo C, Cappelleri JC, et al. Matching-adjusted indirect treatment comparison of bosutinib, dasatinib, nilotinib and ponatinib on survival for second line chronic phase chronic myeloid leukemia patients (presented at the American Society of Hematology [ASH] 58th Annual Meeting, San Diego, CA, USA, 3–6 December 2016). Blood (ASH Annual Meeting Abstracts) 2016;128:3095
   Google Scholar
• Lipton JH, Bryden P, Sidhu MK, et al. Comparative efficacy of tyrosine kinase inhibitor treatments in the third-line setting, for chronic-phase chronic myelogenous leukemia after failure of second-generation tyrosine kinase inhibitors. Leuk Res 2015;39:58-64
   PubMed Web of Science ®Google Scholar
• Baccarani M, Deininger MW, Rosti G, et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood 2013;122:872-84
   PubMed Web of Science ®Google Scholar
• Pearson E, McGarry L, Gala S, et al. Disease-related mortality exceeds treatment-related mortality in patients with chronic myeloid leukemia on second-line or later therapy. Leuk Res 2016;43:1-8
   PubMed Web of Science ®Google Scholar
• Lipton JH, Shah D, Tongbram V, et al. Comparative efficacy among 3rd line post-imatinib chronic phase-chronic myeloid leukemia (CP-CML) patients after failure of dasatinib or nilotinib tyrosine kinase inhibitors (presented at the American Society of Hematology [ASH] 56th Annual Meeting, San Francisco, CA, USA, 6–9 December 2014). Blood (ASH Annual Meeting Abstracts) 2014;124:4551
   Google Scholar