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Original Articles

Dasatinib discontinuation in patients with chronic-phase chronic myeloid leukemia and stable deep molecular response: the DASFREE study

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Pages 650-659 | Received 09 Jul 2019, Accepted 21 Sep 2019, Published online: 24 Oct 2019

References

  • Cortes JE, Saglio G, Kantarjian HM. Final 5-year study results of DASISION: the Dasatinib versus Imatinib Study in treatment-Naive chronic myeloid leukemia patients trial. J Clin Oncol. 2016;34(20):2333–2340.
  • 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.
  • National Cancer Institute. 2006. Common terminology criteria for adverse events, v3.0; [cited 2018 Feb 1]. Available from: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf
  • Clapp GD, Lepoutre T, El Cheikh R, et al. Implication of the autologous immune system in BCR-ABL transcript variations in chronic myelogenous leukemia patients treated with imatinib. Cancer Res. 2015;75(19):4053–4062.
  • Pophali PA, Patnaik MM. The role of new tyrosine kinase inhibitors in chronic myeloid leukemia. Cancer J. 2016;22(1):40–50.
  • Thielen N, Richter J, Baldauf M, et al. Leukemic stem cell quantification in newly diagnosed patients with chronic myeloid leukemia predicts response to nilotinib therapy. Clin Cancer Res. 2016;22(16):4030–4038.
  • Branford S, Yeung DT, Ross DM, et al. Early molecular response and female sex strongly predict stable undetectable BCR-ABL1, the criteria for imatinib discontinuation in patients with CML. Blood. 2013;121(19):3818–3824.
  • Etienne G, Guilhot J, Rea D, et al. Long-term follow-up of the French Stop Imatinib (STIM1) study in patients with chronic myeloid leukemia. J Clin Oncol. 2017;35(3):298–305.
  • Hochhaus A, Masszi T, Giles FJ, et al. Treatment-free remission following frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the ENESTfreedom study. Leukemia. 2017;31(7):1525–1531.
  • Kumagai T, Nakaseko C, Nishiwaki K, et al. Discontinuation of dasatinib after deep molecular response for over 2 years in patients with chronic myelogenous leukemia and the unique profiles of lymphocyte subsets for successful discontinuation: a prospective, multicenter Japanese trial (D-STOP Trial). Blood. 2016;128:791.
  • Mahon FX, Rea D, Guilhot J, et al. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010;11(11):1029–1035.
  • Mahon F-X, Boquimpani C, Takahashi N, et al. Long-term treatment-free remission (TFR) in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) after stopping second-line (2L) nilotinib: ENESTop 144-wk results. J Clin Oncol. 2018;36(15):7003.
  • Nicolini FE, Noël M-P, Escoffre M, et al. Preliminary report of the STIM2 study: a multicenter Stop Imatinib trial for chronic phase chronic myeloid leukemia de novo patients on imatinib. Blood. 2013;122:654.
  • Okada M, Imagawa J, Tanaka H, et al. Final 3-year results of the dasatinib discontinuation trial in patients with chronic myeloid leukemia who received dasatinib as a second-line treatment. Clin Lymphoma Myeloma Leuk. 2018;18(5):353–360. e351.
  • Radich JP, Masszi T, Casares MTG, et al. Long-term treatment-free remission (TFR) following frontline (1L) nilotinib in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP): ENESTfreedom 144-wk results. J Clin Oncol. 2018;36(15 suppl):7063.
  • Rea D, Nicolini FE, Tulliez M, et al. Discontinuation of dasatinib or nilotinib in chronic myeloid leukemia: interim analysis of the STOP 2G-TKI study. Blood. 2017;129(7):846–854.
  • Ross DM, Branford S, Seymour JF, et al. Patients with chronic myeloid leukemia who maintain a complete molecular response after stopping imatinib treatment have evidence of persistent leukemia by DNA PCR. Leukemia. 2010;24(10):1719–1724.
  • Ross DM, Branford S, Seymour JF, et al. Safety and efficacy of imatinib cessation for CML patients with stable undetectable minimal residual disease: results from the TWISTER study. Blood. 2013;122(4):515–522.
  • Ross DM, Masszi T, Gómez Casares MT, et al. Durable treatment-free remission in patients with chronic myeloid leukemia in chronic phase following frontline nilotinib: 96-week update of the ENESTfreedom study. J Cancer Res Clin Oncol. 2018;144(5):945–954.
  • Rousselot P, Huguet F, Rea D, et al. Imatinib mesylate discontinuation in patients with chronic myelogenous leukemia in complete molecular remission for more than 2 years. Blood. 2007;109(1):58–60.
  • Saussele S, Richter J, Guilhot J, et al. Discontinuation of tyrosine kinase inhibitor therapy in chronic myeloid leukaemia (EURO-SKI): a prespecified interim analysis of a prospective, multicentre, non-randomised, trial. Lancet Oncol. 2018;19(6):747–757.
  • Saußele S, Richter J, Hochhaus A, et al. The concept of treatment-free remission in chronic myeloid leukemia. Leukemia. 2016;30(8):1638–1647.
  • Dusetzina SB, Winn AN, Abel GA, et al. Cost sharing and adherence to tyrosine kinase inhibitors for patients with chronic myeloid leukemia. J Clin Oncol. 2014;32(4):306–311.
  • Giona F, Putti MC, Micalizzi C, et al. Long-term results of high-dose imatinib in children and adolescents with chronic myeloid leukaemia in chronic phase: the Italian experience. Br J Haematol. 2015;170(3):398–407.
  • Williams LA, Gonzalez AGG, Ault P, et al. Measuring the symptom burden associated with the treatment of chronic myeloid leukemia. Blood. 2013;122(5):641–647.
  • Caldemeyer L, Akard LP. Rationale and motivating factors for treatment-free remission in chronic myeloid leukemia. Leuk Lymphoma. 2016;57(12):2739–2751.
  • National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN Guidelines®): chronic myeloid leukemia. Version 1.2019; [cited 2008 Oct 8]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/cml.pdf
  • Hochhaus A, Saussele S, Rosti G, et al. Chronic myeloid leukaemia: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28(4):iv41–iv51.
  • Rousselot P, Charbonnier A, Cony-Makhoul P, et al. Loss of major molecular response as a trigger for restarting tyrosine kinase inhibitor therapy in patients with chronic-phase chronic myelogenous leukemia who have stopped imatinib after durable undetectable disease. J Clin Oncol. 2014;32(5):424–430.
  • Mori S, Vagge E, le Coutre P, et al. Age and dPCR can predict relapse in CML patients who discontinued imatinib: the ISAV study. Am J Hematol. 2015;90(10):910–914.
  • Horn M, Glauche I, Muller MC, et al. Model-based decision rules reduce the risk of molecular relapse after cessation of tyrosine kinase inhibitor therapy in chronic myeloid leukemia. Blood. 2013;121(2):378–384.
  • Stein AM, Bottino D, Modur V, et al. BCR-ABL transcript dynamics support the hypothesis that leukemic stem cells are reduced during imatinib treatment. Clin Cancer Res. 2011;17(21):6812–6821.
  • Takahashi N, Kyo T, Maeda Y, et al. Discontinuation of imatinib in Japanese patients with chronic myeloid leukemia. Haematologica. 2012;97(6):903–906.
  • Roeder I, Horn M, Glauche I, et al. Dynamic modeling of imatinib-treated chronic myeloid leukemia: functional insights and clinical implications. Nat Med. 2006;12(10):1181–1184.