Single-Center Retrospective Clinical Evaluation of Venetoclax Combined with HMAs and Half-Dose CAG for Unfit or Refractory/Relapsed AML

References

• Siegel R, Jemal A, Ward E, et al. Cancer statistics. CA Cancer J Clin. 2020. doi:10.3322/caac.21590
   Web of Science ®Google Scholar
• Howlader N, Noone A, Krapcho M, et al. SEER Cancer Statistics Review, 1975–2016. National Cancer Institute; 2019.
   Google Scholar
• Döhner H, Estey E, Grimwade D, et al. Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood. 2017;129(4):424–447. doi:10.1182/blood-2016-08-733196
   PubMed Web of Science ®Google Scholar
• DiNardo CD, Pratz K, Pullarkat V. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood. 2019;133(1):7–17. doi:10.1182/blood-2018-08-868752
   PubMed Web of Science ®Google Scholar
• Thein MS, Ershler WB, Jemal A, Yates JW, Baer,MR. Outcome of older patients with acute myeloid leukemia: an analysis of SEER data over 3 decades. Cancer. 2013;119(15):2720–2727. doi:10.1002/cncr.28129
   PubMed Web of Science ®Google Scholar
• Walter RBO, Othus M, Burnett AK, et al. Resistance prediction in AML: analysis of 4601 patients from MRC/NCRI, HOVON/SAKK, SWOG and MD Anderson cancer center. Leukemia. 2015;29(2):312–320. doi:10.1038/leu.2014.242
   PubMed Web of Science ®Google Scholar
• Shah AAT, Andersson TM-L, Rachet B, Björkholm M, Lambert,PC. Survival and cure of acute myeloid leukaemia in England, 1971–2006: a population-based study. Br J Haematol. 2013;162(4):509–516. doi:10.1111/bjh.12425
   PubMed Web of Science ®Google Scholar
• Adams CM, Clark-Garvey S, Porcu P, Eischen,CM. Targeting the Bcl-2 family in B cell lymphoma. Front Oncol. 2019;8:636. doi:10.3389/fonc.2018.00636
   PubMed Web of Science ®Google Scholar
• Campos LRJ, Rouault JP, Sabido O, et al. High expression of bcl-2 protein in acute myeloid leukemia cells is associated with poor response to chemotherapy. Blood. 1993;81(11):3091–3096. doi:10.1182/blood.V81.11.3091.3091
   PubMed Web of Science ®Google Scholar
• Del Gaizo Moore VLA. Rational design of therapeutics targeting the BCL-2 family: are some cancer cells primed for death but waiting for a final push? Adv Exp Med Biol. 2008;615:159–175. doi:10.1007/978-1-4020-6554-5_8
   PubMed Web of Science ®Google Scholar
• Mehta SV, Shukla SN, Vora HH. Overexpression of Bcl2 protein predicts chemoresistance in acute myeloid leukemia: its correlation with FLT3. Neoplasma. 2013;60(06):666–675. doi:10.4149/neo_2013_085
   PubMedGoogle Scholar
• Konopleva M, Pollyea DA, Potluri J, et al. Efficacy and biological correlates of response in a Phase II study of venetoclax monotherapy in patients with acute myelogenous leukemia. Cancer Disc. 2016;6(10):1106–1117. doi:10.1158/2159-8290.CD-16-0313
   Web of Science ®Google Scholar
• DiNardo CD, Maiti A, Rausch,CR, et al. 10-day decitabine with venetoclax for newly diagnosed intensive chemotherapy ineligible, and relapsed or refractory acute myeloid leukaemia: a single-center, Phase 2 trial. Lancet Haematol. 2020;7(10):e724–e736. doi:10.1016/S2352-3026(20)30210-6
   PubMed Web of Science ®Google Scholar
• Wei AH, Montesinos P, Ivanov V. Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a Phase III randomised placebo-controlled trial. Blood. 2020;135(24):2137–2145. doi:10.1182/blood.2020004856
   PubMed Web of Science ®Google Scholar
• Hong M, Zhu H, Sun Q. Decitabine in combination with low-dose cytarabine, aclarubicin and G-CSF tends to improve prognosis in elderly patients with high-risk AML. Aging. 2020;12(7):5792–5811. doi:10.18632/aging.102973
   PubMedGoogle Scholar
• Qu Q, Liu L, Zhang Y, et al. Increasing aclarubicin dosage of the conventional CAG (low-dose cytarabine and aclarubicin in combination with granulocyte colony-stimulating factor) regimen is more efficacious as a salvage therapy than CAG for relapsed/refractory acute myeloid leukemia. Leuk Res. 2015;39(12):1353–1359. doi:10.1016/j.leukres.2015.09.014
   PubMed Web of Science ®Google Scholar
• Matthew Mei M, Aldoss I, Marcucci G, Pullarkat V. Hypomethylating agents in combination with venetoclax for acute myeloid leukemia: update on clinical trial data and practical considerations for use. Am J Hematol. 2019;94(3):358–362. doi:10.1002/ajh.25369
   PubMed Web of Science ®Google Scholar
• Institute. NIoHaNC. Common terminology criteria for adverseEvents (CTCAE), v5.0. Bethesda, MD, USA: National Institutes of Health and National Cancer Institute; 2017. Available from: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_5x7.pdf. Accessed March 1, 2021.
   Google Scholar
• Ofran Y, Rowe JM. Treatment for relapsed acute myeloid leukemia: what is new? Opinion Hematol. 2012;19(2):89–94.
   PubMed Web of Science ®Google Scholar
• Shipley JL, Butera JN. Acute myelogenous leukemia. Exp Hematol. 2009;36(7):649–658.
   Google Scholar
• Garciaz S, Hospital M-A, Alary A-S. Azacitidine plus venetoclax for the treatment of relapsed and newly diagnosed acute myeloid leukemia patients. Cancers. 2022;14(8):2025. doi:10.3390/cancers14082025
   PubMed Web of Science ®Google Scholar
• DiNardo CD, Lachowiez CA, Takahashi K. Venetoclax combined with FLAG-IDA induction and consolidation in newly diagnosed and relapsed or refractory acute myeloid leukemia. J Clin Oncol. 2021;39(25):2768–2778. doi:10.1200/JCO.20.03736
   PubMed Web of Science ®Google Scholar
• Karanes KJK C, Kopecky KJ, Head DR, et al. A phase III comparison of high dose ARA-C (HIDAC) versus HIDAC plus mitoxantrone in the treatment of first relapsed or refractory acute myeloid leukemia southwest oncology group study. Leukemia Res. 1999;23(9):787–794. doi:10.1016/S0145-2126(99)00087-9
   PubMed Web of Science ®Google Scholar
• Li YS JM, Wu DP, Liang H, et al. Aclarubicin and low-dose cytosine arabinoside in combination with granulocyte colony-stimulating factor in treating acute myeloid leukemia patients with relapsed or refractory disease and myelodysplastic syndrome: a multicenter study of 112 Chinese patients. Int J Hematol. 2005;82:48–54.
   PubMed Web of Science ®Google Scholar
• Liu YZ L, Si Y, Si Y, et al. Increasing the dose of aclarubicin in low-dose cytarabine and aclarubicin in combination with granulocyte colony-stimulating factor (CAG regimen) can safely and effectively treat relapsed or refractory acute myeloid leukemia. Int J Hematol. 2014;99(5):603–608. doi:10.1007/s12185-014-1528-8
   PubMed Web of Science ®Google Scholar
• Lee Dhy SR, Ahn JS, Kim YK, et al. The clinicaloutcome of FLAG chemotherapy without idarubicin in patients with relapsed or refractory acute myeloid leukemia. Korean Med. 2009;24(3):498–503.
   PubMed Web of Science ®Google Scholar
• Ganzel C, Ram R, Gural A. Venetoclax is safe and efficacious in relapsed/refractory AML. Leuk Lymphoma. 2020;61(9):2221–2225. doi:10.1080/10428194.2020.1761964
   PubMed Web of Science ®Google Scholar
• Mian M, Rinaldi A, Mensah AA. A meta-analysis of CAG (cytarabine, aclarubicin, G-CSF) regimen for the treatment of 1029 patients with acute myeloid leukemia and myelodysplastic syndrome. Hematol Oncol. 2011;30(1):46. doi:10.1002/hon.997
   PubMedGoogle Scholar
• Pei S, Pollyea A, Gustafson A, et al. Monocytic subclones confer resistance to venetoclax-based therapy in patients with acute myeloid leukemia. Cancer Discov. 2020;10(4):536–551. doi:10.1158/2159-8290.CD-19-0710
   PubMed Web of Science ®Google Scholar
• Niu X, Zhao J, Ma J. Binding of released Bim to Mcl-1 is a mechanism of intrinsic resistance to ABT-199 which can be overcome by combination with daunorubicin or cytarabine in AML cells. Clin Cancer Res. 2016;22(17):4440–4451. doi:10.1158/1078-0432.CCR-15-3057
   PubMed Web of Science ®Google Scholar
• Bose P, Gandhi V, Konopleva M. Pathways and mechanisms of venetoclax resistance. Leuk Lymphoma. 2017;58(9):2026–2039. doi:10.1080/10428194.2017.1283032
   PubMed Web of Science ®Google Scholar
• Stirewalt DL, Kopecky KJ, Meshinchi S. FLT3, RAS, and TP53 mutations in elderly patients with acute myeloid leukemia. Blood. 2001;97(11):3589–3595. doi:10.1182/blood.V97.11.3589
   PubMed Web of Science ®Google Scholar
• Fathi AT, Chen Y-B. Treatment of FLT3-ITD acute myeloid leukemia. Am J Blood Res. 2011;1(2):175–189.
   PubMedGoogle Scholar
• Lazenby M, Gilkes AF, Marrin C, Evans A, Hills RK, Burnett AK. The prognostic relevance of flt3 and npm1 mutations on older patients treated intensively or non-intensively: a study of 1312 patients in the UK NCRI AML16 trial. Leukemia. 2014;28(10):1953–1959. doi:10.1038/leu.2014.90
   PubMed Web of Science ®Google Scholar
• Kim KK, Maiti A, Loghavi S, et al. Outcomes of TP53 -mutant acute myeloid leukemia with decitabine and venetoclax. Cancer. 2021;127(20):3772–3781. doi:10.1002/cncr.33689
   PubMed Web of Science ®Google Scholar
• Venugopal SM, Shoukier M, Konopleva M, et al. Outcomes in patients with newly diagnosed TP53 -mutated acute myeloid leukemia with or without venetoclax-based therapy. Cancer. 2021;127(19):3541–3551. doi:10.1002/cncr.33675
   PubMed Web of Science ®Google Scholar
• Patel JP, Gönen M, Figueroa ME. Prognostic relevance of integrated genetic profiling in acute myeloid leukemia. N Engl J Med. 2012;366(12):1079–1089. doi:10.1056/NEJMoa1112304
   PubMed Web of Science ®Google Scholar
• Green CL, Evans CM, Zhao L. The prognostic significance of IDH2 mutations in AML depends on the location of the mutation. Blood. 2011;118(2):409–412. doi:10.1182/blood-2010-12-322479
   PubMed Web of Science ®Google Scholar
• Venugopal S, Takahashi K, Daver N, et al. Efficacy and safety of enasidenib and azacitidine combination in patients with IDH2 mutated acute myeloid leukemia and not eligible for intensive chemotherapy. Blood Cancer J. 2022;12(1):10. doi:10.1038/s41408-021-00604-2
   PubMed Web of Science ®Google Scholar
• Dombret H, Butrym JF, Butrym A, et al. International Phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015;126(3):291–299. doi:10.1182/blood-2015-01-621664
   PubMed Web of Science ®Google Scholar
• Kantarjian HM, Thomas XG, Dmoszynska A, et al. Multicenter, randomized, open-label, phase III trial of decitabine versus patient choice, with physician advice, of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukemia. J Clin Oncol. 2012;30(21):2670–2677. doi:10.1200/JCO.2011.38.9429
   PubMed Web of Science ®Google Scholar