Final results of a phase 2 trial of clofarabine and low-dose cytarabine alternating with decitabine in older patients with newly diagnosed acute myeloid leukemia

Cancer

Volumn 121, Issue 14, 2015, Pages 2375-2382

  Kadia, Tapan M ^a   Faderl, Stefan ^b   Ravandi, Farhad ^a   Jabbour, Elias ^a   Garcia Manero, Guillermo ^a   Borthakur, Gautam ^a   Ferrajoli, Alessandra ^a   Konopleva, Marina ^a   Burger, Jan ^a   Huang, Xuelin ^a   Wang, Xuemei ^a   Pierce, Sherry ^a   Brandt, Mark ^a   Feliu, Jennie ^a   Cortes, Jorge ^a   Kantarjian, Hagop ^a  

^a UNIVERSITY OF TEXAS   (United States)

^b John Theurer Cancer Center   (United States)

Author keywords

elderly acute myeloid leukemia (AML); low intensity; maintenance

Indexed keywords

ADENINE NUCLEOTIDE; ANTINEOPLASTIC AGENT; ARABINONUCLEOSIDE; AZACITIDINE; CLOFARABINE; CYTARABINE; DECITABINE;

AGED; ANALOGS AND DERIVATIVES; CHEMICALLY INDUCED; CLINICAL TRIAL; DRUG ADMINISTRATION; FEMALE; HUMAN; LEUKEMIA, MYELOID, ACUTE; MALE; MIDDLE AGED; NAUSEA; PHASE 2 CLINICAL TRIAL; REMISSION; TREATMENT OUTCOME; VERY ELDERLY;

ADENINE NUCLEOTIDES; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ARABINONUCLEOSIDES; AZACITIDINE; CYTARABINE; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; LEUKEMIA, MYELOID, ACUTE; MALE; MIDDLE AGED; NAUSEA; REMISSION INDUCTION; TREATMENT OUTCOME;

EID: 84934441484     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.29367     Document Type: Article

References (21)

1. Kantarjian H, O'Brien S, Cortes J, et al., Results of intensive chemotherapy in 998 patients age 65 years or older with acute myeloid leukemia or high-risk myelodysplastic syndrome: predictive prognostic models for outcome. Cancer. 2006; 106: 1090-1098.
2. Kantarjian H, Ravandi F, O'Brien S, et al., Intensive chemotherapy does not benefit most older patients (age 70 years or older) with acute myeloid leukemia. Blood. 2010; 116: 4422-4429.
3. Kantarjian HM, Gandhi V, Kozuch P, et al., Phase I clinical and pharmacology study of clofarabine in patients with solid and hematologic cancers. J Clin Oncol. 2003; 21: 1167-1173.
4. Faderl S, Garcia-Manero G, Jabbour E, et al., A randomized study of 2 dose levels of intravenous clofarabine in the treatment of patients with higher-risk myelodysplastic syndrome. Cancer. 2012; 118: 722-728.
5. Kantarjian HM, Erba HP, Claxton D, et al., Phase II study of clofarabine monotherapy in previously untreated older adults with acute myeloid leukemia and unfavorable prognostic factors. J Clin Oncol. 2010; 28: 549-555.
6. Faderl S, Gandhi V, O'Brien S, et al., Results of a phase 1-2 study of clofarabine in combination with cytarabine (ara-C) in relapsed and refractory acute leukemias. Blood. 2005; 105: 940-947.
7. Faderl S, Ravandi F, Huang X, et al., A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome. Blood. 2008; 112: 1638-1645.
8. Faderl S, Verstovsek S, Cortes J, et al., Clofarabine and cytarabine combination as induction therapy for acute myeloid leukemia (AML) in patients 50 years of age or older. Blood. 2006; 108: 45-51.
9. Faderl S, Wetzler M, Rizzieri D, et al., Clofarabine plus cytarabine compared with cytarabine alone in older patients with relapsed or refractory acute myelogenous leukemia: results from the CLASSIC I trial. J Clin Oncol. 2012; 30: 2492-2499.
10. Faderl S, Ravandi F, Huang X, et al., Clofarabine plus low-dose cytarabine followed by clofarabine plus low-dose cytarabine alternating with decitabine in acute myeloid leukemia frontline therapy for older patients. Cancer. 2012; 118: 4471-4477.
11. Fenaux P, Mufti GJ, Hellstrom-Lindberg E, et al., Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia. J Clin Oncol. 2010; 28: 562-569.
12. Al-Ali HK, Jaekel N, Junghanss C, et al., Azacitidine in patients with acute myeloid leukemia medically unfit for or resistant to chemotherapy: a multicenter phase I/II study. Leuk Lymphoma. 2012; 53: 110-117.
13. Maurillo L, Venditti A, Spagnoli A, et al., Azacitidine for the treatment of patients with acute myeloid leukemia: report of 82 patients enrolled in an Italian compassionate program. Cancer. 2012; 118: 1014-1022.
14. Thepot S, Itzykson R, Seegers V, et al., Azacitidine in untreated acute myeloid leukemia: a report on 149 patients. Am J Hematol. 2014; 89: 410-416.
15. Dombret H,. Results of a phase 3, multicenter, randomized, open-label study of azacytidine versus conventional care regimens in older patients with newly diagnosed acute myeloid leukemia. In: Proceedings from the 19th Congress of the European Hematology Association; June 12-15, 2014; Milan, Italy. Abstract LB-6212.
16. Cashen AF, Schiller GJ, O'Donnell MR, DiPersio JF,. Multicenter, phase II study of decitabine for the first-line treatment of older patients with acute myeloid leukemia. J Clin Oncol. 2010; 28: 556-561.
17. Lubbert M, Ruter BH, Claus R, et al., A multicenter phase II trial of decitabine as first-line treatment for older patients with acute myeloid leukemia judged unfit for induction chemotherapy. Haematologica. 2012; 97: 393-401.
18. 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: 2670-2677.
19. Blum W, Garzon R, Klisovic RB, et al., Clinical response and miR-29b predictive significance in older AML patients treated with a 10-day schedule of decitabine. Proc Natl Acad Sci U S A. 2010; 107: 7473-7478.
20. Ritchie EK, Feldman EJ, Christos PJ, et al., Decitabine in patients with newly diagnosed and relapsed acute myeloid leukemia. Leuk Lymphoma. 2013; 54: 2003-2007.
21. Lowenberg B, Ossenkoppele GJ, van Putten W, et al., High-dose daunorubicin in older patients with acute myeloid leukemia. N Engl J Med. 2009; 361: 1235-1248.