title: Intensive BFM chemotherapy for childhood ALL: interim analysis of the AIEOP-ALL 91 study. Associazione Italiana Ematologia Oncologia Pediatrica.
abstract: OBJECTIVE
  Since 1988 the AIEOP has used BFM-based chemotherapy for childhood ALL. Current organization and results and role of cranial irradiation in the AIEOP-ALL 91 study are reported.
  
  
  METHODS
  From 1991 to 1995, 1194 children (< 15 years) with non-B ALL, were enrolled and assigned to the standard risk [SR: age > 1 year, non-T-ALL, BFM risk factor (RF) < 0.8], intermediate risk (IR: RF > or = 0.8 but < 1.7, or with RF < 0.8 and age < 1 year, or T-ALL), or high risk [HR: RF > or = 1.7, or t(9;22), or t(4;11) or prednisone poor response or late response or CNS involvement] groups. All patients received initially protocol Ia. Thereafter SR patients received HD-MTX 2 g/m2, a modified protocol II, and continuation therapy with triple intrathecal chemotherapy (TIT); IR patients received protocol Ib, HD-MTX 5 g/m2, protocol II and continuation therapy with TIT; HR patients received 9 polychemotherapy blocks, cranial irradiation and continuation therapy. Duration of treatment was 24 months. A randomized study was conducted to evaluate the impact of high-dose asparaginase in non high risk patients: the results of this study cannot be disclosed yet.
  
  
  RESULTS
  One thousand one hundred and fifty-two (96.5%) patients achieved CR. Overall EFS (SE) at 5-years was 71.0% (1.4), with a survival of 80.3% (1.3). Relapse occurred in 262 children (21.9%), either in the marrow (n = 192 isolated and 32 with other sites, 18.7%), in the CNS (n = 18, 1.5%), or elsewhere (n = 20, 1.7%). 5-year EFS (SE) was 83.3% (2.4) in SR, 74.7% (1.8) in IR, and 39.7% (3.5) in HR groups, respectively.
  
  
  CONCLUSIONS
  Overall cure rate was higher than in the previous AIEOP-ALL 88 study. Treatment intensification with polychemotherapy blocks did not improve results in HR. Cranial irradiation can be safely omitted in over 80% of children treated with BFM based chemotherapy.
authors.affiliation: Clinica Pediatrica dell'Università di: Milano, Ospedale S. Gerardo, Monza, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Conter
authors.forename: M
authors.initials: M
authors.lastname: Aricò
authors.forename: M G
authors.initials: MG
authors.lastname: Valsecchi
authors.forename: C
authors.initials: C
authors.lastname: Rizzari
authors.forename: A
authors.initials: A
authors.lastname: Testi
authors.forename: R
authors.initials: R
authors.lastname: Miniero
authors.forename: M T
authors.initials: MT
authors.lastname: Di Tullio
authors.forename: L
authors.initials: L
authors.lastname: Lo Nigro
authors.forename: A
authors.initials: A
authors.lastname: Pession
authors.forename: R
authors.initials: R
authors.lastname: Rondelli
authors.forename: C
authors.initials: C
authors.lastname: Messina
authors.forename: N
authors.initials: N
authors.lastname: Santoro
authors.forename: P G
authors.initials: PG
authors.lastname: Mori
authors.forename: G
authors.initials: G
authors.lastname: De Rossi
authors.forename: P
authors.initials: P
authors.lastname: Tamaro
authors.forename: D
authors.initials: D
authors.lastname: Silvestri
authors.forename: A
authors.initials: A
authors.lastname: Biondi
authors.forename: G
authors.initials: G
authors.lastname: Basso
authors.forename: G
authors.initials: G
authors.lastname: Masera
mesh_terms: D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001215:Asparaginase / Q000008:administration & dosage; D016026:Bone Marrow Transplantation; D002648:Child; D002675:Child, Preschool; D002869:Chromosome Aberrations; D003131:Combined Modality Therapy; D016371:Cranial Irradiation; D003520:Cyclophosphamide / Q000008:administration & dosage; D003561:Cytarabine / Q000008:administration & dosage; D003630:Daunorubicin / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007223:Infant; D007558:Italy / Q000453:epidemiology; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D015122:Mercaptopurine / Q000008:administration & dosage; D008727:Methotrexate / Q000008:administration & dosage; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000145:classification / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D011241:Prednisone / Q000008:administration & dosage; D011379:Prognosis; D012074:Remission Induction; D012306:Risk; D013866:Thioguanine / Q000008:administration & dosage; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D003561:Cytarabine; D014750:Vincristine; D003907:Dexamethasone; D004317:Doxorubicin; D003520:Cyclophosphamide; D015122:Mercaptopurine; D001215:Asparaginase; D013866:Thioguanine; D002955:Leucovorin; D011241:Prednisone; D008727:Methotrexate; D003630:Daunorubicin