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.
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CLINICAL TRIALS AND OBSERVATIONS
Antimetabolite therapy for lesser-risk B-lineage acute lymphoblastic leukemia of childhood: a report from Children's Oncology Group Study P9201
Allen R. Chauvenet1,2,
Paul L. Martin3,
Meenakshi Devidas2,4,
Stephen B. Linda2,4,
Beverly A. Bell5,
Joanne Kurtzberg3,
Jeanette Pullen6,
Mark J. Pettenati7,
Andrew J. Carroll8,
Jonathan J. Shuster4, and
Bruce Camitta9
1 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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