Page 92 - 2018_09-Mondo

N.K.A. van Eijkelenburg et al.
bination of clofarabine, liposomal daunorubicin and high- dose cytarabine, while having an acceptable toxicity pro- file, even in heavily pre-treated patients. Of interest, clo- farabine has been taken forward in front-line treatment in the AML-BFM 2012 study (EudraCT: 2013-000018-39) as an induction randomization, albeit low-dose cytarabine is used rather than high-dose.
Acknowledgments
We are grateful to all physicians and study staff who took care of the patients and contributed data for this study. We thank Dr. Simon Joel for the useful advice on the pharmacokinetic section of this study. Satianand Ramnarain was the trial-manager respon- sible for this study. The study was performed with financial sup- port from Sanofi and by the KiKa-foundation grant number 26.
References
1. GormanMF,JiL,KoRH,etal.Outcomefor children treated for relapsed or refractory acute myelogenous leukemia (rAML): a Therapeutic Advances in Childhood Leukemia (TACL) Consortium study. Pediatr Blood Cancer. 2010;55(3):421-429.
2. Kaspers GJ, Zimmermann M, Reinhardt D, et al. Improved outcome in pediatric relapsed acute myeloid leukemia: results of a randomized trial on liposomal daunoru- bicin by the International BFM Study Group. J Clin Oncol. 2013;31(5):599-607.
3. Zwaan CM, Kolb EA, Reinhardt D, et al. Collaborative Efforts Driving Progress in Pediatric Acute Myeloid Leukemia. J Clin Oncol. 2015;33(27):2949-2962.
4. Milligan DW, Wheatley K, Littlewood T, Craig JI, Burnett AK, Group NHOCS. Fludarabine and cytosine are less effective than standard ADE chemotherapy in high- risk acute myeloid leukemia, and addition of G-CSF and ATRA are not beneficial: results of the MRC AML-HR randomized trial. Blood. 2006;107(12):4614-4622.
5. Ehlers S, Herbst C, Zimmermann M, et al. Granulocyte colony-stimulating factor (G- CSF) treatment of childhood acute myeloid leukemias that overexpress the differentia- tion-defective G-CSF receptor isoform IV is associated with a higher incidence of relapse. J Clin Oncol. 2010;28(15):2591- 2597.
6. SanderA,ZimmermannM,DworzakM,et al. Consequent and intensified relapse ther- apy improved survival in pediatric AML: results of relapse treatment in 379 patients of three consecutive AML-BFM trials. Leukemia. 2010;24(8):1422-1428.
7. KremerLC,vanderPalHJ,OffringaM,van Dalen EC, Voute PA. Frequency and risk factors of subclinical cardiotoxicity after anthracycline therapy in children: a sys- tematic review. Ann Oncol. 2002;13(6):819- 829.
8. Lipshultz SE, Colan SD, Gelber RD, Perez- Atayde AR, Sallan SE, Sanders SP. Late car- diac effects of doxorubicin therapy for acute lymphoblastic leukemia in child- hood. N Engl J Med. 1991;324(12):808-815.
9. Pui CH, Jeha S, Kirkpatrick P. Clofarabine. Nat Rev Drug Discov. 2005;4(5):369-370.
10. Bonate PL, Arthaud L, Cantrell WR Jr, Stephenson K, Secrist JA 3rd, Weitman S. Discovery and development of clofarabine: a nucleoside analogue for treating cancer. Nat Rev Drug Discov. 2006;5(10):855-863.
11. FaderlS,GandhiV,O'BrienS,etal.Results of a phase 1-2 study of clofarabine in com- bination with cytarabine (ara-C) in relapsed and refractory acute leukemias. Blood. 2005;105(3):940-947.
12. Jeha S, Gandhi V, Chan KW, et al.
Clofarabine, a novel nucleoside analog, is active in pediatric patients with advanced leukemia. Blood. 2004;103(3):784-789.
13. Jeha S, Razzouk B, Rytting M, et al. Phase II study of clofarabine in pediatric patients with refractory or relapsed acute myeloid leukemia. J Clin Oncol. 2009;27(26):4392- 4397.
14. Tiley S, Claxton D. Clofarabine in the treat- ment of acute myeloid leukemia in older adults. Ther Adv Hematol. 2013;4(1):5-13.
15. 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(4):549-555.
16. Burnett AK, Russell NH, Kell J, et al. European development of clofarabine as treatment for older patients with acute myeloid leukemia considered unsuitable for intensive chemotherapy. J Clin Oncol. 2010;28(14):2389-2395.
17. Burnett AK, Russell NH, Hunter AE, et al. Clofarabine doubles the response rate in older patients with acute myeloid leukemia but does not improve survival. Blood. 2013;122(8):1384-1394.
18. Burnett AK, Russell NH, Hills RK, et al. A comparison of clofarabine with ara-C, each in combination with daunorubicin as induction treatment in older patients with acute myeloid leukaemia. Leukemia. 2017; 31(2):310-317.
19. Lowenberg B, Pabst T, Maertens J, et al. Therapeutic value of clofarabine in younger and middle-aged (18-65 years) adults with newly diagnosed AML. Blood. 2017;129(12):1636-1645.
20. Abd Elmoneim A, Gore L, Ricklis RM, et al. Phase I dose-escalation trial of clofarabine followed by escalating doses of fractionat- ed cyclophosphamide in children with relapsed or refractory acute leukemias. Pediatr Blood Cancer. 2012;59(7):1252- 1258.
21. Hijiya N, Gaynon P, Barry E, et al. A multi- center phase I study of clofarabine, etopo- side and cyclophosphamide in combination in pediatric patients with refractory or relapsed acute leukemia. Leukemia. 2009; 23(12):2259-2264.
22. Hijiya N, Thomson B, Isakoff MS, et al. Phase 2 trial of clofarabine in combination with etoposide and cyclophosphamide in pediatric patients with refractory or relapsed acute lymphoblastic leukemia. Blood. 2011;118(23):6043-6049.
23. Shukla N, Kobos R, Renaud T, Steinherz LJ, Steinherz PG. Phase II trial of clofarabine with topotecan, vinorelbine, and thiotepa in pediatric patients with relapsed or refrac- tory acute leukemia. Pediatr Blood Cancer. 2014;61(3):431-435.
24. Cooper TM, Alonzo TA, Gerbing RB, et al.
AAML0523: a report from the Children's Oncology Group on the efficacy of clofara- bine in combination with cytarabine in pediatric patients with recurrent acute myeloid leukemia. Cancer. 2014; 120(16):2482-2489.
25. Kearns P, Graham NJ, Cummins B, et al. Phase I study of clofarabine and liposomal daunorubicin in childhood acute myeloid leukemia [abstract]. J Clin Oncol. 2011; 29(Suppl 15):Abstract 9521.
26. 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(1):45-51.
27. 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(20):2492-2499.
28. Creutzig U, Zimmermann M, Bourquin JP, et al. Randomized trial comparing liposo- mal daunorubicin with idarubicin as induc- tion for pediatric acute myeloid leukemia: results from Study AML-BFM 2004. Blood. 2013;122(1):37-43.
29. Creutzig U, Diekamp S, Zimmerman M, Reinhardt D. Longitudinal evaluation of early and late anthracycline carciotoxicity in children with AML. Pediatr Blood Cancer. 2007;48(7):651-662.
30. Berg SL, Bonate PL, Nuchtern JG, et al. Plasma and cerebrospinal fluid pharmaco- kinetics of clofarabine in nonhuman pri- mates. Clin Cancer Res. 2005;11(16):5981- 5983.
31. Bonate PL, Craig A, Gaynon P, et al. Population pharmacokinetics of clofara- bine, a second-generation nucleoside ana- log, in pediatric patients with acute leukemia. J Clin Pharmacol. 2004;44(11):1309-1322.
32. Joel S, Ghazaly E, Smith H, Kearns P, Saha V. The plasma and intracellular pharmaco- kinetics of clofarabine in pediatric leukemia patients. Cancer Res. 2007;67(Suppl 9):Abstract 1566.
33. Zwaan CM, Reinhardt D, Zimmerman M, et al. Salvage treatment for children with refractory first or second relapse of acute myeloid leukaemia with gemtuzumab ozogamicin: results of a phase II study. Br J Haematol. 2010;148(5):768-776.
34. Kaspers GJ. How I treat paediatric relapsed acute myeloid leukaemia. Br J Haematol. 2014;166(5):636-645.
35. Creutzig U, Zimmermann M, Dworzak MN, et al. The prognostic significance of early treatment response in pediatric relapsed acute myeloid leukemia: results of the international study Relapsed AML 2001/01. Haematologica. 2014;99(9):1472- 1478.
1492
haematologica | 2018; 103(9)