Venetoclax plus intensive chemotherapy with cladribine, idarubicin, and cytarabine in patients with newly diagnosed acute myeloid leukaemia or high-risk myelodysplastic syndrome: a cohort from a single-centre, single-arm, phase 2 trial

The Lancet Haematology - Tập 8 - Trang e552-e561 - 2021
Tapan M Kadia1, Patrick K Reville2, Gautam Borthakur1, Musa Yilmaz1, Steven Kornblau1, Yesid Alvarado1, Courtney D Dinardo1, Naval Daver1, Nitin Jain1, Naveen Pemmaraju1, Nicholas Short1, Sa A Wang3, Rebecca S S Tidwell4, Rabiul Islam1, Marina Konopleva1, Guillermo Garcia-Manero1, Farhad Ravandi1, Hagop M Kantarjian1
1Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
2Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
3Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
4Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Tài liệu tham khảo

Willemze, 2014, High-dose cytarabine in induction treatment improves the outcome of adult patients younger than age 46 years with acute myeloid leukemia: results of the EORTC-GIMEMA AML-12 trial, J Clin Oncol, 32, 219, 10.1200/JCO.2013.51.8571 Löwenberg, 2011, Cytarabine dose for acute myeloid leukemia, N Engl J Med, 364, 1027, 10.1056/NEJMoa1010222 Li, 2014, High-dose cytarabine in acute myeloid leukemia treatment: a systematic review and meta-analysis, PLoS One, 9 Kantarjian, 2021, Acute myeloid leukemia: current progress and future directions, Blood Cancer J, 11, 41, 10.1038/s41408-021-00425-3 Löwenberg, 2009, High-dose daunorubicin in older patients with acute myeloid leukemia, N Engl J Med, 361, 1235, 10.1056/NEJMoa0901409 Fernandez, 2009, Anthracycline dose intensification in acute myeloid leukemia, N Engl J Med, 361, 1249, 10.1056/NEJMoa0904544 Burnett, 2015, A randomized comparison of daunorubicin 90 mg/m2 vs 60 mg/m2 in AML induction: results from the UK NCRI AML17 trial in 1206 patients, Blood, 125, 3878, 10.1182/blood-2015-01-623447 Devillier, 2015, Comparison of 60 or 90 mg/m(2) of daunorubicin in induction therapy for acute myeloid leukemia with intermediate or unfavorable cytogenetics, Am J Hematol, 90, E29, 10.1002/ajh.23884 Mandelli, 2009, Daunorubicin versus mitoxantrone versus idarubicin as induction and consolidation chemotherapy for adults with acute myeloid leukemia: the EORTC and GIMEMA Groups Study AML-10, J Clin Oncol, 27, 5397, 10.1200/JCO.2008.20.6490 Pautas, 2010, Randomized study of intensified anthracycline doses for induction and recombinant interleukin-2 for maintenance in patients with acute myeloid leukemia age 50 to 70 years: results of the ALFA-9801 study, J Clin Oncol, 28, 808, 10.1200/JCO.2009.23.2652 Gandhi, 1993, Fludarabine potentiates metabolism of cytarabine in patients with acute myelogenous leukemia during therapy, J Clin Oncol, 11, 116, 10.1200/JCO.1993.11.1.116 Holowiecki, 2004, Addition of cladribine to daunorubicin and cytarabine increases complete remission rate after a single course of induction treatment in acute myeloid leukemia. Multicenter, phase III study, Leukemia, 18, 989, 10.1038/sj.leu.2403336 Holowiecki, 2012, Cladribine, but not fludarabine, added to daunorubicin and cytarabine during induction prolongs survival of patients with acute myeloid leukemia: a multicenter, randomized phase III study, J Clin Oncol, 30, 2441, 10.1200/JCO.2011.37.1286 Jain, 2016, Cladribine combined with idarubicin and ara-C (CLIA) as a frontline and salvage treatment for young patients (≤65 yrs) with acute myeloid leukemia, Blood, 128, 10.1182/blood.V128.22.1639.1639 DiNardo, 2020, Azacitidine and venetoclax in previously untreated acute myeloid leukemia, N Engl J Med, 383, 617, 10.1056/NEJMoa2012971 Wei, 2020, Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial, Blood, 135, 2137, 10.1182/blood.2020004856 DiNardo, 2020, 10-day decitabine with venetoclax for newly diagnosed intensive chemotherapy ineligible, and relapsed or refractory acute myeloid leukaemia: a single-centre, phase 2 trial, Lancet Haematol, 7, e724, 10.1016/S2352-3026(20)30210-6 Patel, 2019, Ultra-rapid reporting of GENomic targets (URGENTseq): clinical next-generation sequencing results within 48 Hours of sample collection, J Mol Diagn, 21, 89, 10.1016/j.jmoldx.2018.08.002 Xu, 2017, How do we use multicolor flow cytometry to detect minimal residual disease in acute myeloid leukemia?, Clin Lab Med, 37, 787, 10.1016/j.cll.2017.07.004 Cheson, 2003, Revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, J Clin Oncol, 21, 4642, 10.1200/JCO.2003.04.036 Thall, 1995, Bayesian sequential monitoring designs for single-arm clinical trials with multiple outcomes, Stat Med, 14, 357, 10.1002/sim.4780140404 Chua, 2020, Chemotherapy and Venetoclax in Elderly Acute Myeloid Leukemia Trial (CAVEAT): a phase Ib dose-escalation study of venetoclax combined with modified intensive chemotherapy, J Clin Oncol, 38, 3506, 10.1200/JCO.20.00572 Stone, 2017, Midostaurin plus chemotherapy for acute myeloid leukemia with a FLT3 mutation, N Engl J Med, 377, 454, 10.1056/NEJMoa1614359