Dasatinib treatment long-term results among imatinib-resistant/intolerant patients with chronic phase chronic myeloid leukemia are favorable in daily clinical practice

References

• Hochhaus A, Larson RA, Guilhot F, et al. Long-term outcomes of imatinib treatment for chronic myeloid leukemia. N Engl J Med. 2017;376(10):917–927.
   PubMed Web of Science ®Google Scholar
• Hochhaus A, Baccarani M, Deininger M, et al. Dasatinib induces durable cytogenetic responses in patients with chronic myelogenous leukemia in chronic phase with resistance or intolerance to imatinib. Leukemia. 2008;22(6):1200–1206.
   PubMed Web of Science ®Google Scholar
• Kantarjian H, Pasquini R, Lévy V, et al. Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia resistant to imatinib at a dose of 400 to 600 milligrams daily: two-year follow-up of a randomized phase 2 study (START-R). Cancer. 2009;115(18):4136–4147.
   PubMed Web of Science ®Google Scholar
• Hochhaus A, Müller MC, Radich J, et al. Dasatinib-associated major molecular responses in patients with chronic myeloid leukemia in chronic phase following imatinib failure: response dynamics and predictive value. Leukemia. 2009;23(9):1628–1633.
   PubMed Web of Science ®Google Scholar
• Shah NP, Kantarjian HM, Kim DW, et al. Intermittent target inhibition with dasatinib 100 mg once daily preserves efficacy and improves tolerability in imatinib-resistant and -intolerant chronic-phase chronic myeloid leukemia. J Clin Oncol. 2008;26(19):3204–3212.
   PubMed Web of Science ®Google Scholar
• Shah NP, Kim DW, Kantarjian H, et al. Potent, transient inhibition of BCR-ABL with dasatinib 100 mg daily achieves rapid and durable cytogenetic responses and high transformation-free survival rates in chronic phase chronic myeloid leukemia patients with resistance, suboptimal response or intolerance to imatinib. Haematologica. 2010;95(2):232–240.
   PubMed Web of Science ®Google Scholar
• Shah NP, Rousselot P, Schiffer C, et al. Dasatinib in imatinib-resistant or -intolerant chronic-phase, chronic myeloid leukemia patients: 7-year follow-up of study CA180-034. Am J Hematol. 2016;91(9):869–874.
   PubMed Web of Science ®Google Scholar
• Yilmaz M, Kantarjian H, Jabbour E, et al. Similar outcome of patients with chronic myeloid leukemia treated with imatinib in or out of clinical trials. Clin Lymphoma Myeloma Leuk. 2013;13(6):693–699.
   PubMed Web of Science ®Google Scholar
• Castagnetti F, Di Raimondo F, De Vivo A, et al. A population-based study of chronic myeloid leukemia patients treated with imatinib in first line. Am J Hematol. 2017;92(1):82–87.
   PubMed Web of Science ®Google Scholar
• Hoffmann VS, Baccarani M, Hasford J, et al. Treatment and outcome of 2904 CML patients from the EUTOS population-based registry. Leukemia. 2017;31(3):593–601.
   PubMed Web of Science ®Google Scholar
• Cony-Makhoul P, Gardembas M, Coiteux V, et al. Nilotinib after imatinib first-line: a real-life longitudinal cohort of patients with chronic myeloid leukaemia in chronic phase. Br J Haematol. 2018;180(3):356–364.
   PubMed Web of Science ®Google Scholar
• Tiribelli M, Bonifacio M, Binotto G, et al. Excellent outcomes of 2G-TKI therapy after imatinib failure in chronic phase CML patients. Oncotarget. 2018;9(18):14219–14227.
   PubMedGoogle Scholar
• Geelen IGP, Thielen N, Janssen JJWM, et al. Treatment outcome in a population-based, 'real-world' cohort of patients with chronic myeloid leukemia. Haematologica. 2017;102(11):1842–1849.
   PubMed Web of Science ®Google Scholar
• Kizaki M, Okamoto S, Tauchi T, et al. Current and future perspectives on the TARGET system: the registration system for Glivec established by the JSH. Int J Hematol. 2008;88(4):409–417.
   PubMed Web of Science ®Google Scholar
• Shepherd P, Dhanapala C, Maguire C, et al. Successful use of National Cancer Registry data to monitor the effective use of imatinib for treating chronic myeloid leukaemia. Scott Med J. 2008;53(3):8–12.
   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(1):124–133.
   PubMed Web of Science ®Google Scholar
• Zackova D, Klamova H, Dusek L, et al. Imatinib as the first-line treatment of patients with chronic myeloid leukemia diagnosed in the chronic phase: can we compare real life data to the results from clinical trials? Am J Hematol. 2011;86(3):318–321.
   PubMed Web of Science ®Google Scholar
• Zackova D, Klamova H, Muzik J, et al. Efficacy and tolerance of dasatinib after imatinib failure or intolerance for patients with chronic myeloid leukemia treated in three different hospitals compare well with results achievable in formal clinical trials. Leuk Lymphoma. 2013;54(10):2310–2313.
   PubMed Web of Science ®Google Scholar
• Faber E, Mužík J, Koza V, et al. Treatment of consecutive patients with chronic myeloid leukaemia in the cooperating centres from the Czech Republic and the whole of Slovakia after 2000 – a report from the population-based CAMELIA Registry. Eur J Haematol. 2011;87(2):157–168.
   PubMed Web of Science ®Google Scholar
• Cross NC, Melo JV, Feng L, et al. An optimised multiplex polymerase chain reaction (PCR) for detection of BCR-ABL fusion mRNAs in hematological disorders. Leukemia. 1994;8:186–189.
   PubMed Web of Science ®Google Scholar
• Müller MC, Cross NC, Erben P, et al. Harmonization of molecular monitoring of CML therapy in Europe. Leukemia. 2009;23(11):1957–1963.
   PubMed Web of Science ®Google Scholar
• Beillard E, Pallisgaard N, van der Velden VH, et al. Evaluation of candidate control genes for diagnosis and residual disease detection in leukemic patients using “'real-time' quantitative reverse-transcriptase polymerase chain reaction (RQ-PCR) – a Europe against cancer program”. Leukemia. 2003;17(12):2474–2486.
   PubMed Web of Science ®Google Scholar
• Gabert J, Beillard E, van der Velden VHJ, et al. Standardization and quality control studies of ‘real-time’ quantitative reverse transcriptase polymerase chain reaction of fusion gene transcripts for residual disease detection in leukemia – a Europe Against Cancer Program. Leukemia. 2003;17(12):2318–2357.
   PubMed Web of Science ®Google Scholar
• Soverini S, Hochhaus A, Nicolini FE, et al. BCR-ABL kinase domain mutation analysis in chronic myeloid leukemia patients treated with tyrosine kinase inhibitors: recommendations from an expert panel on behalf of European LeukemiaNet. Blood. 2011;118(5):1208–1215.
   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(6):872–884.
   PubMed Web of Science ®Google Scholar
• Pfirrmann M, Hochhaus A, Lauseker M, et al. Recommendations to meet statistical challenges arising from endpoints beyond overall survival in clinical trials on chronic myeloid leukemia. Leukemia. 2011;25(9):1433–1438.
   PubMed Web of Science ®Google Scholar
• Guilhot J, Baccarani M, Clark RE, et al. Definitions, methodological and statistical issues for phase 3 clinical trials in chronic myeloid leukemia: a proposal by the European LeukemiaNet. Blood. 2012;119(25):5963–5971.
   PubMed Web of Science ®Google Scholar
• Cortes JE, Saglio G, Kantarjian HM, et al. Final 5-year study results of DASISION: the Dasatinib versus Imatinib Study in Treatment-Naïve Chronic Myeloid Leukemia Patients Trial. J Clin Oncol. 2016;34(20):2333–2340.
   PubMed Web of Science ®Google Scholar
• Visani G, Breccia M, Gozzini A, et al. Dasatinib, even at low doses, is an effective second-line therapy for chronic myeloid leukemia patients resistant or intolerant to imatinib. Results from a real life-based Italian multicenter retrospective study on 114 patients. Am J Hematol. 2010;85(12):960–963.
   PubMed Web of Science ®Google Scholar
• Naqvi K, Jabbour E, Skinner J, et al. Early results of lower dose dasatinib (50 mg daily) as frontline therapy for newly diagnosed chronic-phase chronic myeloid leukemia. Cancer. 2018;124(13):2740–2747.
   PubMed Web of Science ®Google Scholar
• Hehlmann R, Lauseker M, Saußele S, et al. Assessment of imatinib as first-line treatment of chronic myeloid leukemia: 10-year survival results of the randomized CML study IV and impact of non-CML determinants. Leukemia. 2017;31(11):2398–2406.
   PubMed Web of Science ®Google Scholar
• Hochhaus A, Saglio G, Hughes TP, et al. Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial. Leukemia. 2016;30(5):1044–1054.
   PubMed Web of Science ®Google Scholar
• Saglio G, Le Coutre P, Cortes J, et al. Evaluation of cardiovascular ischemic event rates in dasatinib-treated patients using standardized incidence ratios. Ann Hematol. 2017;96(8):1303–1313.
   PubMed Web of Science ®Google Scholar
• Suh KJ, Lee JY, Shin DY, et al. Analysis of adverse events associated with dasatinib and nilotinib treatments in chronic-phase chronic myeloid leukemia patients outside clinical trials. Int J Hematol. 2017;106(2):229–239.
   PubMed Web of Science ®Google Scholar
• Hehlmann R, Cortes JE, Zyczynski T, et al. Tyrosine kinase inhibitor interruptions, discontinuations and switching in patients with chronic-phase chronic myeloid leukemia in routine clinical practice: SIMPLICITY. Am J Hematol. 2019;94(1):46–54.
   PubMed Web of Science ®Google Scholar
• Iurlo A, Galimberti S, Abruzzese E, et al. Pleural effusion and molecular response in dasatinib-treated chronic myeloid leukemia patients in a real-life Italian multicenter series. Ann Hematol. 2018;97(1):95–100.
   PubMed Web of Science ®Google Scholar
• Gora-Tybor J, Medras E, Calbecka M, et al. Real-life comparison of severe vascular events and other non-hematological complications in patients with chronic myeloid leukemia undergoing second-line nilotinib or dasatinib treatment. Leuk Lymphoma. 2015;56(8):2309–2314.
   PubMed Web of Science ®Google Scholar
• Fox LC, Cummins KD, Costello B, et al. The incidence and natural history of dasatinib complications in the treatment of chronic myeloid leukemia. Blood Adv. 2017;1(13):802–811.
   PubMed Web of Science ®Google Scholar