Treatment of children with early pre-B and pre-B acute lymphocytic leukemia with antimetabolite-based intensification regimens: a Pediatric Oncology Group Study (original) (raw)

Long-Term Results of a Randomized Trial on Extended Use of High Dose l-Asparaginase for Standard Risk Childhood Acute Lymphoblastic Leukemia

Journal of Clinical Oncology, 2005

Purpose Between September 1991 and May 1997, within the International Berlin-Frankfurt-Muenster Study Group (I-BFM-SG), a randomized study was performed aimed at assessing the efficacy of prolonged use of high-dose l-asparaginase (HD-l-ASP) during continuation therapy in children with standard risk (SR) acute lymphoblastic leukemia (ALL), treated with a reduced BFM-type chemotherapy. Patients and Methods The Italian, Dutch, and Hungarian groups participated in this study denominated IDH-ALL-91, and 494 children were enrolled. Treatment consisted of a BFM-type modified backbone with omission of the IB part in induction and elimination of two doses of anthracyclines during reinduction in both arms at the beginning of continuation therapy. Patients were randomly assigned to receive (YES-ASP) or not (NO-ASP) 20 weekly HD-l-ASP (25,000 IU/m2). Results The event-free-survival and overall survival probabilities at 10 years for the entire group were 82.5% (1.8) and 90.3% (1.3), respectively...

Long-term results of three randomized trials (58831, 58832, 58881) in childhood acute lymphoblastic leukemia: a CLCG-EORTC report

Leukemia, 2000

We present here the long-term results of three randomized clinical trials conducted on children with newly diagnosed acute lymphoblastic leukemia (ALL) between 1983 and 1998 by the Children Leukemia Cooperative Group (CLCG) from EORTC. In study 58831/32, the overall event-free survival (EFS) rates (± s.e.) at 6 and 10 years were 66% ± 1.8% and 65% ± 1.8%, respectively, and the risk of isolated central nervous system (CNS) relapse was 6% ± 1% and 7% ± 1%, respectively. In patients with a standard risk of relapse the omission of cyclophosphamide had no adverse effect on disease-free survival rates at 10 years (trial 58831). In medium-and high-risk patients the omission of radiotherapy did not increase the risk of CNS or systemic relapse (trial 58832). In study 58881 (1989-1998) the overall EFS rate at 8 years was 68.4% ± 1.2% and the risk of isolated CNS relapse was 4.2% ± 0.5%. In this trial which adressed three randomized questions, the following results were obtained: the combination of cytarabine at high doses with methotrexate at high doses during interval therapy did not improve prognosis. The addition of 6-mercaptopurine iv during maintenance increased the risk of late relapse. E. coli asparaginase was more toxic and has a higher efficacy than Erwinia asparaginase. Leukocyte counts Ͼ100 × 10 9 /l, specific genetic abnormalities, a poor initial response to steroids or a high level of minimal residual disease at early time points were consistently associated with an adverse prognosis in the 58881 trial.

Antimetabolite therapy for lesser-risk B-lineage acute lymphoblastic leukemia of childhood: a report from Children's Oncology Group Study P9201

Blood, 2007

P9201 leukemia of childhood: a report from Children's Oncology Group Study Antimetabolite therapy for lesser-risk B-lineage acute lymphoblastic http://bloodjournal.hematologylibrary.org/content/110/4/1105.full.html Updated information and services can be found at: (372 articles) Plenary Papers (1722 articles) Free Research Articles (3712 articles) Clinical Trials and Observations Articles on similar topics can be found in the following Blood collections http://bloodjournal.hematologylibrary.org/site/misc/rights.xhtml#repub\_requests Information about reproducing this article in parts or in its entirety may be found online at: http://bloodjournal.hematologylibrary.org/site/misc/rights.xhtml#reprints Information about ordering reprints may be found online at: http://bloodjournal.hematologylibrary.org/site/subscriptions/index.xhtml Information about subscriptions and ASH membership may be found online at: Pediatric Oncology Group (POG) protocol 9201 enrolled children with lesser-risk Blineage acute lymphoblastic leukemia (ALL) defined by age , white blood cell count (WBC) less than 50 ؋ 10 9 /L (50 000/L), DNA findings of trisomies 4 and 10 (or DNA index > 1.

Long-term results of the pediatric oncology group studies for childhood acute lymphoblastic leukemia 1984–2001: a report from the children's oncology group

Leukemia, 2010

, the Pediatric Oncology Group (POG) conducted 12 acute lymphoblastic leukemia (ALL) studies. 10-year event free survival (EFS) for patients >12 months of age with Bprecursor ALL on Acute Leukemia in Children 14, 15, and 16 series were 66.7 ± 1.2%, 68.1 ± 1.4% and 73.2 ± 2.1%, respectively. Intermediate dose methotrexate (ID MTX; 1 g/m 2 ) improved outcomes for standard risk patients (10-year EFS 77.5 ± 2.7% vs. 66.3 ± 3.1% for oral MTX). Neither MTX intensification (2.5 g/m2) nor addition of cytosine arabinoside/daunomycin/ teniposide improved outcomes for higher risk patients. Intermediate dose mercaptopurine (1 g/m 2 ) failed to improve outcomes for either group. 10-year EFS for patients with T-cell ALL, POG 8704 and 9404, were 49.1 ± 3.1% and 72.2 ± 4.7%, respectively. Intensive asparaginase (10-year EFS 61.8% vs 42.7%) and high dose MTX (5 g/m 2 ) (10-year EFS 78.0% vs. 65.8%) improved

Childhood Acute Lymphoblastic Leukemia: Results of the Randomized Acute Lymphoblastic Leukemia Intercontinental-Berlin-Frankfurt-Münster 2009 Trial

Journal of Clinical Oncology, 2023

We prospectively treated 127 children with ALL with a risk-adapted regimen. All patients received the identical inductionconsolidation therapy. The early maintenance included intermediate dose methotrexate in patients with standard risk (n = 79) and medium risk (n = 39). In addition patients with high risk (n = 6) received high dose ARA-C followed by L-asparaginase. Intensification treatment and prophylactic cranial irradiation was also tailored according to the risk group. Treatment duration was 2 years. Complete remission was achieved in 97.6% of all patients. Treatment-related toxicity accounted for one death in complete remission. The probability of event-free survival (pEFS) for the combined group was 72% at a median follow-up of 42 months. The pEFS was higher in patients with standard risk (SR) than in patients with medium risk (MR) (80% versus 65%; p < 0.05) at 30 months, but attenuated in the follow-up evaluation at 42 months (76% versus 63%; p < 0.1). The number of high-risk patients was too small for statistical evaluation. Relapse within the first 18 months after diagnosis indicated a poor prognosis and was more common in patients with MR than in patients with SR. The immunophenotype of the leukemic cells was not found to constitute an independent risk factor after treatment has been risk-adapted. Patients with an initial white blood cell count of more than 50 x 109/1 had a worse prognosis than patients with a lower white blood cell count (p < 0.01).