title: Modified BFM therapy for children with previously untreated acute lymphoblastic leukemia and unfavorable prognostic features. Report of Children's Cancer Study Group Study CCG-193P.
abstract: The Children's Cancer Study Group's (CCG) clinical trials in acute lymphoblastic leukemia (ALL) prior to 1981 consistently demonstrated that patients presenting with a white blood cell count (WBC) greater than or equal to 50,000/microliter or the "lymphoma syndrome" had a less than 40% 3-year event-free survival (EFS). The Berlin Frankfurt Munster (BFM) 76/79 study suggested that the prognosis of these patients could be improved. Before testing this therapy in a randomized setting, 29 CCG institutions used it for treatment of 209 newly diagnosed children with ALL and an initial WBC greater than or equal to 50,000/microliter or the lymphoma syndrome. In the intensive phases of therapy, 77% of cumulative parenteral doses and 55% of cumulative oral doses were within 10% of protocol requirements or were modified appropriately for reported toxicity. One hundred ninety-five patients achieved remission (93.3%). Eleven patients died in remission (5.6%)--10 during the intensive reinduction/reconsolidation phase. The 4-year EFS (+/- 1 SD) was 62% (+/- 3.7%) with a median follow-up of 40 months. Only one patient has had an isolated CNS relapse. These results appear superior to past CCG studies for high-risk patients and extend observations made from studies of similar therapy.
authors.affiliation: University of Chicago, Wyler Children's Hospital, Illinois.
authors.forename: P S
authors.initials: PS
authors.lastname: Gaynon
authors.forename: W A
authors.initials: WA
authors.lastname: Bleyer
authors.forename: P G
authors.initials: PG
authors.lastname: Steinherz
authors.forename: J Z
authors.initials: JZ
authors.lastname: Finklestein
authors.forename: P S
authors.initials: PS
authors.lastname: Littman
authors.forename: D R
authors.initials: DR
authors.lastname: Miller
authors.forename: G H
authors.initials: GH
authors.lastname: Reaman
authors.forename: H N
authors.initials: HN
authors.lastname: Sather
authors.forename: G D
authors.initials: GD
authors.lastname: Hammond
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001853:Bone Marrow / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004334:Drug Administration Schedule; D006801:Humans; D007223:Infant; D007958:Leukocyte Count; D010349:Patient Compliance; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000401:mortality; D011379:Prognosis