Volumen: 19 # Number : 2
Publication Date : Mayo - Agosto Year: 2015
Clofarabine in Pediatric Patients with Refractory
or Relapsed Leukemia: the GATLA experience
Authors: Veron DA, Riccheri C, Makiya M, Aversa LA, Gutierrez M,
Fynn A, Schuttenberg V, Cédola A, Drozdowski C, Caferri H,
Bietti J, Gómez S, Elena GO, Arbesu G, Hollmann C,
Tramunt B, Tomasetti M, Zirone S, Rossi N,
L Martin, P Reichel, Freigeiro D,
Abstract: Introduction: The outcome in pediatric patients
with relapse-refractory acute leukemias is poor.
Clofarabine is an active agent in this high risk group
of patients.
Purpose: Report the GATLA experience in patients
with relapse-refractory acute leukemias treated with
clofarabine based regimens.
Methods: Between June 2007 and May 2013: 76
patients were included. Median age: 10,25 years
(1-20 ys). Gender: 52 boys and 24 girls. 39 were
treated in first relapse and 32 in subsequent relapses.
5 with refractory disease. 68 patients received
chemotherapy combined clofarabine-etoposidecyclophosphamide
(CLO 218), 6 patients received
clofarabine plus ara-c therapy and 2 patients were
treated with clofarabine alone (52mg / m2).
ALL: 69 (55 B/14 T): 37,6% (26/69) received only
1 prior treatment and 62.3% (43/69) of the patients
were treated with 2 or more therapeutic lines prior to
clofarabine regimens. Complete remission (CR) was
achieved in: 36/69 patients (52,2 %), 20/36 (55,5%)
in first relapse. No response occurred in 32/69
(46,3%) patients. 1 patient (1,5%) was not evaluable.
The duration mean of the remission: 17 weeks (first
relapse) and 12 weeks (second relapse). 45 patients
(65,2%) received only one course of clofarabine, 16
(23,1%) 2 courses, 5 (7,2%) 3 courses and 3 (4,5%)
4 courses. 18/69 (26%) proceeded to Hematopoietic
Stem Cell Transplantation (HSCT): 5/18 (27,8%)
are alive and disease free. 13 died after HSCT. Cause
of death: 40/69 (58%) disease progression, 6 (8,7%)
sepsis, 2 (2,9%) toxicity. 8 alive (5 received HSCT).
AML: 7 patients. 4 with refractory AML died
because of progression, 1 patient died in induction
from toxicity and 2 achieved CR (1 could undergo
HSCT and relapse/ 1 died from toxicity).
Conclusion: In our series, Clofarabine was well
tolerated in heavily pretreated children. The responseinrate
and the durability of remission observed are
better when clofarabine regimens are used earlier
(first relapse). 7 of the 8 living patients needed
only one course of clofarabine to achieve complete
remission, and 6 of the 8 received clofarabine as
second therapeutic line. Remission was short, so
the time to transplantation influenced the results.
Between the patients that received 4 courses of
therapy we observed aplastic anemia (1) and MDS
(1) with acquired immunodeficiency.
Key words: Clofarabine,
pediatric acute lymphoblastic leukemia,
pediatric acute myeloblastic leukemia,
relapsed acute leukemia,
refractory acute leukemia.
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