Journal of Clinical Oncology, Vol 16, 246-254, Copyright © 1998 by American Society of Clinical Oncology
Intermediate-dose intravenous methotrexate with intravenous mercaptopurine is superior to repetitive low-dose oral methotrexate with intravenous mercaptopurine for children with lower-risk B-lineage acute lymphoblastic leukemia: a Pediatric Oncology Group phase III trial
DH Mahoney Jr, J Shuster, R Nitschke, SJ Lauer, N Winick, CP Steuber and B Camitta
Texas Children's Cancer Center, Baylor College of Medicine, Houston, USA. dmahoney@msmail.his.Tch.Tmc.edu
PURPOSE: To determine whether early intensification with 12 courses of
intravenous methotrexate and intravenous mercaptopurine (IVMTX/IVMP) is
superior to 12 courses of repetitive, low-dose oral MTX with I.V. MP
(LDMTX/IVMP) for prevention of relapse in children with lower-risk B-
lineage acute lymphoblastic leukemia (ALL). PATIENTS AND METHODS: Seven
hundred nine patients were entered onto the study. Vincristine, prednisone,
and asparaginase were used for remission induction. Patients were
randomized to receive intensification with either IVMTX 1,000 mg/m2 plus
IVMP 1,000 mg/m2 (regimen A) or LDMTX 30 mg/m2 every 6 hours for six doses
with IVMP 1,000 mg/m2 (regimen B). Twelve courses were administered at
2-week intervals. Triple intrathecal therapy (TIT) was used for CNS
prophylaxis. Continuation therapy included standard oral MP, weekly MTX,
and TIT every 12 weeks for 2 years. RESULTS: Six hundred ninety-nine (99%)
patients achieved remission. Three hundred forty-nine were assigned to
regimen A and 350 to regimen B. The estimated 4-year continuous complete
remission (CCR) rate for patients treated with regimen A is 80.3% (SE =
2.9%) and with regimen B is 75.9% (SE = 3.1%). By log-rank analysis,
regimen A demonstrated superior CCR (P = .013). Transient
neutropenia/thrombocytopenia, bacterial sepsis, neurotoxicity, stomatitis,
and hospitalizations were more frequent among patients treated on regimen
A. CONCLUSION: Intensification with IVMTX/IVMP is more effective than
LDMTX/IVMP for prevention of relapse in children with B-precursor ALL at
lower risk for relapse.
This article has been cited by other articles:
|
|
|
|
 
K. R. Schultz, D. J. Pullen, H. N. Sather, J. J. Shuster, M. Devidas, M. J. Borowitz, A. J. Carroll, N. A. Heerema, J. E. Rubnitz, M. L. Loh, et al.
Risk- and response-based classification of childhood B-precursor acute lymphoblastic leukemia: a combined analysis of prognostic markers from the Pediatric Oncology Group (POG) and Children's Cancer Group (CCG)
Blood,
February 1, 2007;
109(3):
926 - 935.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
Y. Matloub, S. Lindemulder, P. S. Gaynon, H. Sather, M. La, E. Broxson, R. Yanofsky, R. Hutchinson, N. A. Heerema, J. Nachman, et al.
Intrathecal triple therapy decreases central nervous system relapse but fails to improve event-free survival when compared with intrathecal methotrexate: results of the Children's Cancer Group (CCG) 1952 study for standard-risk acute lymphoblastic leukemia, reported by the Children's Oncology Group
Blood,
August 15, 2006;
108(4):
1165 - 1173.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. C. Barredo, M. Devidas, S. J. Lauer, A. Billett, M. Marymont, J. Pullen, B. Camitta, N. Winick, W. Carroll, and A. K. Ritchey
Isolated CNS Relapse of Acute Lymphoblastic Leukemia Treated With Intensive Systemic Chemotherapy and Delayed CNS Radiation: A Pediatric Oncology Group Study
J. Clin. Oncol.,
July 1, 2006;
24(19):
3142 - 3149.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. D. Cole, R. A. Drachtman, A. K. Smith, S. Cate, R. A. Larson, D. S. Hawkins, J. Holcenberg, K. Kelly, and B. A. Kamen
Phase II Trial of Oral Aminopterin for Adults and Children with Refractory Acute Leukemia
Clin. Cancer Res.,
November 15, 2005;
11(22):
8089 - 8096.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
B. C. Bostrom, M. R. Sensel, H. N. Sather, P. S. Gaynon, M. K. La, K. Johnston, G. R. Erdmann, S. Gold, N. A. Heerema, R. J. Hutchinson, et al.
Dexamethasone versus prednisone and daily oral versus weekly intravenous mercaptopurine for patients with standard-risk acute lymphoblastic leukemia: a report from the Children's Cancer Group
Blood,
May 15, 2003;
101(10):
3809 - 3817.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Clarke, P. Gaynon, I. Hann, G. Harrison, G. Masera, R. Peto, and S. Richards
CNS-Directed Therapy for Childhood Acute Lymphoblastic Leukemia: Childhood ALL Collaborative Group Overview of 43 Randomized Trials
J. Clin. Oncol.,
May 1, 2003;
21(9):
1798 - 1809.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. S. Gaynon, B. C. Bostrom, R. J. Hutchinson, B. J. Lange, J. B. Nachman, P. G. Steinherz, M. G. Sensel, M. K. Lee, D. O. Stram, and H. N. Sather
Duration of Hospitalization as a Measure of Cost on Children's Cancer Group Acute Lymphoblastic Leukemia Studies
J. Clin. Oncol.,
April 1, 2001;
19(7):
1916 - 1925.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
L. B. Silverman, R. D. Gelber, V. K. Dalton, B. L. Asselin, R. D. Barr, L. A. Clavell, C. A. Hurwitz, A. Moghrabi, Y. Samson, M. A. Schorin, et al.
Improved outcome for children with acute lymphoblastic leukemia: results of Dana-Farber Consortium Protocol 91-01
Blood,
March 1, 2001;
97(5):
1211 - 1218.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
B. A. Kamen, E. Rubin, J. Aisner, and E. Glatstein
High-Time Chemotherapy or High Time for Low Dose
J. Clin. Oncol.,
August 16, 2000;
18(16):
2935 - 2937.
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. A. Felix, B. J. Lange, and J. M. Chessells
Pediatric Acute Lymphoblastic Leukemia: Challenges and Controversies in 2000
Hematology,
January 1, 2000;
2000(1):
285 - 302.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
C.-H. Pui and W. E. Evans
Acute Lymphoblastic Leukemia
N. Engl. J. Med.,
August 27, 1998;
339(9):
605 - 615.
[Full Text]
[PDF]
|
|
|
|
