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Dose Intensification of Methotrexate and Cytarabine During ORIGINAL ARTICLE Dose Intensification of Methotrexate and Cytarabine During Intensified Continuation Chemotherapy for High-risk B-Precursor Acute Lymphoblastic Leukemia: POG 9406: A Report From the Children’s Oncology Group Richard L. Tower, MD,* Tamekia L. Jones, PhD,w Bruce M. Camitta, MD,* Barbara L. Asselin, MD,z Beverly A. Bell, MD,y Allen Chauvenet, MD, PhD,8 Meenakshi Devidas, PhD,z Edward C. Halperin, MD,# Jeanette Pullen, MD,** Jonathan J. Shuster, PhD,ww Naomi Winick, MD,zz and Joanne Kurtzberg, MDyy Conclusions: Increasing MTX dosing to 2.5 g/m2 did not improve Purpose: To determine the efficacy and toxicity of higher dose outcomes in higher risk pediatric B-precursor ALL. Giving high- versus standard dose intravenous methotrexate (MTX) and pulses dose cytarabine and asparaginase pulses instead of standard dose of high-dose cytosine arabinoside with asparaginase versus stand- cytarabine and teniposide produced nonsignificant differences in ard dose cytosine arabinoside and teniposide during intensified outcomes, allowing for teniposide to be removed from ALL continuation therapy for higher risk pediatric B-precursor acute therapy. lymphoblastic leukemia (ALL). Key Words: methotrexate, cytarabine, acute lymphoblastic leuke- Patients and Methods: From 1994 to 1999, the Pediatric Oncology mia, pediatric Group conducted a randomized phase III clinical trial in higher risk pediatric B-precursor ALL. A total of 784 patients were (J Pediatr Hematol Oncol 2014;36:353–361) randomized in a 2Â2 factorial design to receive MTX 1 g/m2 versus 2.5 g/m2 and to cytosine arabinoside/teniposide versus high-dose cytosine arabinoside/asparaginase during intensified continuation therapy. he survival of children with acute lymphoblastic leuke- Tmia (ALL) has increased dramatically over the past 50 Results: Patients receiving standard dose MTX had a 5-year dis- years.1–14 Multiagent systemic chemotherapy, prophylactic ease-free survival (DFS) of 71.8 ± 2.4%; patients receiving higher central nervous system (CNS) therapy, and intensive sup- dose MTX had a 5-year DFS of 71.7 ± 2.4% (P = 0.55). Outcomes portive care have contributed to this progress.15 In addi- on cytosine arabinoside/teniposide (DFS of 70.4 ± 2.4) were sim- ilar to higher dose cytosine arabinoside/asparaginase (DFS of tion, the ability to better identify children at higher risk of 73.1 ± 2.3%) (P = 0.41). Overall survival rates were not different relapse has led to risk-stratified treatment protocols. Using between MTX doses or cytosine arabinoside/teniposide versus factors such as patient age, white blood cell count (WBC) at cytosine arabinoside/asparaginase. diagnosis, cytogenetics, and DNA index, a group of patients with B-precursor ALL with a higher risk of relapse can be selected to receive intensified therapy.16 Early Pediatric Oncology Group (POG) protocols Received for publication July 22, 2013; accepted January 24, 2014. From the *MACC Fund Center for Cancer and Blood Disorders, demonstrated that antimetabolite therapy was inadequate 4,17 Medical College of Wisconsin and Children’s Hospital of Wiscon- for many higher risk patients. In POG protocol 8602 sin, Milwaukee, WI; wDepartment of Biostatistics, Colleges of (1986 to 1991) the 5-year event-free survival for higher risk Medicine and Public Health and Health Professions; wwDepartment patients was 60% versus 80% for standard risk patients.4,18 of Health Outcomes and Policy and Clinical and Translational Science Institute, College of Medicine, University of Florida; This study examined whether adding cytarabine (cytosine zChildren’s Oncology Group, Department of Biostatistics, arabinoside, ara-C) or L-asparaginase to methotrexate Gainesville, FL; zDepartment of Pediatrics, Golisano Children’s (MTX)-based intensification therapy improved overall Hospital at University of Rochester Medical Center, Rochester; outcomes.18,19 Overall outcomes improved, but it was #New York Medical College, Valhalla, NY; yDepartment of Pediatrics, Georgia Health Sciences University, Augusta, GA; unclear whether ara-C had any independent effect. 8Department of Pediatrics, Charleston Division, West Virginia POG 9006 (1991 to 1994) tested the Goldie-Coldman University, Charleston, WV; **Department of Pediatric Hematol- hypothesis of using rotating combinations of antileukemic ogy/Oncology, University of Mississippi Medical Center, Jackson, drugs (including ara-C) versus intensified intravenous mer- MS; zzDepartment of Pediatrics, University of Texas Southwestern 2 Medical Center, Dallas, TX; and yyPediatric Blood and Marrow captopurine (6-MP) plus MTX (1 g/m ) alone during early 20 Transplant Program, Duke University Medical Center, Durham, consolidation. Early interim analysis showed that rotating NC. intensified consolidation appeared to be more effective and Supported by the following NIH grants: COG Chairs grant the study was closed.20 After data maturation, however, there U10CA98543; POG Statistical Center grant U10CA30969; COG Statistics and Data Center grant U10CA98413. was no significant difference in leukemia-free survival 4 The authors declare no conflict of interest. between the 2 treatments. Although not seen in POG 9006, Reprints: Richard L. Tower, MD, MACC Fund Center for Cancer and intensification with intermediate dose MTX (1 g/m2)has Blood Disorders, Medical College of Wisconsin, MFRC 3018, 8701 improved event-free survival in children with ALL.21–24 Watertown Plank Road, Milwaukee, WI 53226 (e-mail: rtower@ mcw.edu). In 1994, POG opened a group-wide randomized phase Copyright r 2014 by Lippincott Williams & Wilkins III clinical trial (POG 9406) to study the role of intensified J Pediatr Hematol Oncol Volume 36, Number 5, July 2014 www.jpho-online.com | 353 Tower et al J Pediatr Hematol Oncol Volume 36, Number 5, July 2014 chemotherapy in children with higher risk B-precursor or Z5% blasts at day 43 were considered to be induction ALL. The primary objectives of the study were to (1) failures. Intensified continuation therapy was started after determine the efficacy of higher dose (2.5 g/m2 over 24 h) remission and count recovery. versus standard dose (1 g/m2 over 24 h) intravenous MTX Patients who achieved a complete remission were during intensified continuation therapy and (2) determine randomized in a 2Â2 factorial design to 30 weeks of whether pulses of high-dose ara-C (3 g/m2 Â4 doses) with intensification with regimens A, B, C, or D. Regimens A asparaginase were superior to pulses of teniposide and ara- and B had standard MTX dosing (1 g/m2), whereas regi- C (150 mg/m2/dÂ72 h) during intensified continuation mens C and D had a higher dose of MTX (2.5 g/m2). therapy. We report the results of this trial. Leucovorin dosing was the same for all regimens. Regimens A and C used teniposide/standard dose ara-C, whereas PATIENTS AND METHODS regimens B and D contained high-dose ara-C/asparaginase. Teniposide was temporarily unavailable (March 26, 1999 to Patients June 11, 1999). During this time etoposide 330 mg/m2 was POG 9406 enrolled patients between November 15, substituted for teniposide. Each intensification course 1994 and November 15, 1999. Local institutional review began when: (1) absolute neutrophil count Z500/mL; (2) board approval and written informed consent from the platelet count Z75,000/mL; (3) total bilirubin <1.7 mg/dL; patient and/or a parent were required before enrollment. (4) alanine aminotransferase <10 to 20Â upper limit of normal for age; and (5) creatinine was normal for age. Eligibility Initially, triple intrathecal therapy was used for CNS Eligibility included: (1) newly diagnosed B-precursor prophylaxis. There was an excess of neurotoxicity, espe- ALL, (2) enrollment on the POG 9400 classification study, cially seizures. Neurotoxicity included subcategories of and (3) meeting the criteria for high-risk B-precursor ALL. mood, headache, cortical (includes seizures), sensory, Those criteria were: (1) age 10.00 to 21.99 years without motor, cerebellar, hearing, and vision. After a July 29, 1999 trisomies of chromosomes 4 and 10 (if cytogenetic studies amendment, intrathecal (IT) therapy was changed to MTX were informative [karyotypically abnormal]) or with DNA alone. Further analysis indicated that the neurotoxicity index r1.16 if cytogenetic studies were uninformative; (2) resulted from the interaction of several factors, including any age with presence of t(1;19), t(4;11), t(9;22), CNS leu- the repetitive use of IV MTX and the timing of IT injections kemia or testicular disease; or (3) age 1.001 to 9.99 years in relation to IV MTX with leucovorin rescue. Therefore, with initial WBCZ50,000/mL without trisomies of chro- on November 15, 1999, the study was amended to add mosomes 4 and 10 or with DNA index r1.16 (if cytoge- leucovorin after all intensive continuation lumbar punctu- netic studies were uninformative). Patients below 12 res that did not coincide with IV MTX and after all months of age were not eligible. maintenance lumbar punctures. Interim analyses by the Data Monitoring Committee Definition of Disease and Response revealed that the outcomes on the higher dose MTX arms CNS leukemia was defined as (1) cerebral spinal fluid were inferior to the standard dose MTX arms, and it was WBCZ5 WBC/mL with leukemic blasts without peripheral unlikely that the higher dose arm could ever prove to be blood contamination; or (2) any involvement of the eye, superior to the standard dose arm. Therefore, on November brain or spinal cord parenchyma, or cranial nerves. Com- 15, 1999, all patients in intensification were switched to the plete remission was defined as <5% leukemic blasts in a lower dose of MTX. cellular bone marrow and no evidence of leukemia Patients with CNS leukemia at diagnosis received involvement elsewhere. Relapse was defined as recurrence craniospinal radiation (2400 cGy in 12 fractions to the brain of disease whether in marrow (>25% blasts) or an extra- and 1400 cGy in 10 fractions to the spine) at the beginning medullary site (biopsy confirmed). of year 2 of therapy. No IT therapy was given after com- pleting irradiation.
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