Lb. Silverman et al., Improved outcome for children with acute lymphoblastic leukemia: results of Dana-Farber Consortium Protocol 91-01, BLOOD, 97(5), 2001, pp. 1211-1218
The Dana-Farber Cancer Institute (DFCI) acute lymphoblastic leukemia (ALL)
Consortium Protocol 91-01 was designed to improve the outcome of children w
ith newly diagnosed ALL while minimizing toxicity, Compared with prior prot
ocols, past-remission therapy was intensified by substituting dexamethasone
for prednisone and prolonging the asparaginase intensification from 20 to
30 weeks, Between 1991 and 1995, 377 patients (age, 0-18 years) were enroll
ed; 137 patients were considered standard risk (SR), and 240 patients were
high risk (HR), Following a 5.0-year median follow-up, the estimated 5-year
event-free survival (EFS) +/- SE for all patients was 83% +/- 2%, which is
superior to prior DFCI ALL Consortium protocols conducted between 1981 and
1991 (P = .03), There was no significant difference in 5-year EFS based up
on risk group (87% +/- 3% for SR and 81% +/- 3% for HR, P = .24), Age at di
agnosis was a statistically significant prognostic factor (P = .03), with i
nferior outcomes observed in infants and children 9 years or older, Patient
s who tolerated 25 or fewer weeks of asparaginase had a significantly worse
outcome than those who received at least 26 weeks of asparaginase (P < .01
, both univariate and multivariate). Older children (at least 9 years of ag
e) were significantly more likely to have tolerated 25 or fewer weeks of as
paraginase (P < .01), Treatment on Protocol 91-01 significantly improved th
e outcome of children with ALL, perhaps due to the prolonged asparaginase i
ntensification and/or the use of dexamethasone. The inferior outcome of old
er children may be due, in part, to increased intolerance of intensive ther
apy. (Blood. 2001;97:1211-1218) (C) 2001 by The American Society of Hematol
ogy.