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Blood, 15 August 2007, Vol. 110, No. 4, pp. 1105-1111. Prepublished online as a Blood First Edition Paper on April 18, 2007; DOI 10.1182/blood-2006-12-061689.
CLINICAL TRIALS AND OBSERVATIONS Antimetabolite therapy for lesser-risk B-lineage acute lymphoblastic leukemia of childhood: a report from Children's Oncology Group Study P92011 Department of Pediatrics, Wake Forest University Medical Center, Winston-Salem, NC; 2 Children's Oncology Group, Arcadia, CA; 3 Pediatric Blood and Marrow Transplant Division, Duke University Medical Center, Durham, NC; 4 Department of Epidemiology and Health Policy Research, University of Florida, Gainesville; 5 Pediatric Hematology/Oncology, Medical College of Georgia, Augusta; 6 University of Mississippi Medical Center Children's Hospital, Jackson; 7 Pediatrics/Medical Genetics, Wake Forest University Medical Center, Winston-Salem, NC; 8 Department of Genetics, University of Alabama at Birmingham; and 9 Pediatric Hematology/Oncology, Medical College of Wisconsin, Milwaukee Pediatric Oncology Group (POG) protocol 9201 enrolled children with lesser-risk B-lineage acute lymphoblastic leukemia (ALL) defined by age (1-9), white blood cell count (WBC) less than 50 x 109/L (50 000/µL), DNA findings of trisomies 4 and 10 (or DNA index > 1.16), and lack of overt central nervous system (CNS) leukemia. After vincristine, prednisone, and asparaginase induction, 650 of 653 eligible patients attained remission (3 induction deaths) and received 6 courses of intravenous methotrexate (1 g/m2) with daily mercaptopurine. Weekly intramuscular methotrexate was added during maintenance; pulses of vincristine and prednisone were administered with periodic intrathecal chemotherapy. Treatment duration was 2.5 years. No alkylators, epipodophylotoxins, anthracyclines, or radiation were given. The 6-year event-free survival (EFS) was 86.6% with overall survival (OS) of 97.2%. Patients with less than 5% marrow blasts on induction day 15 had superior EFS. A difference not reaching conventional statistical significance (P = .068) was noted for superior outcomes in patients with trisomies of chromosomes 4 and 10 versus those lacking double trisomies. Sex, ethnicity, CNS status, and WBC were not predictive. This indicates the great majority of children with lesser-risk B-lineage ALL are curable without agents with substantial late effects.
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