title: ALL R-87 protocol in the treatment of children with acute lymphoblastic leukaemia in early bone marrow relapse.
abstract: Seventy-three children with acute lymphoblastic leukaemia (ALL) in first bone marrow (BM) relapse, occurring within 30 months from complete remission (CR), were enrolled in an Italian cooperative study (ALL R-87 protocol). This treatment programme consisted of an induction phase with intermediate-dose cytarabine (IDARA-C) plus idarubicin (IDA) and prednisone (PDN), followed by a multidrug consolidation therapy and bone marrow transplant (BMT). 55/73 children achieved CR (75.3%); 15 (20.5%) failed to respond and three (4.2%) died during induction. The response rate was significantly higher for children with a first CR duration > or = 12 months (P=0.0005) and for those with a white blood cell (WBC) count at relapse < 20 x 10(9)/l (P=0.004). The estimated disease-free survival (DFS +/- SE) at 82 months was 0.18 +/- 0.05 for all responders, and 0.70 +/- 0.14 for allotransplanted patients versus 0.05 +/- 0.05 for those autografted (P=0.001). The estimated probabilities of survival +/- SE and event-free survival (EFS +/- SE) at 83 months were 0.16 +/- 0.07 and 0.13 +/- 0.04, respectively. for all enrolled children. Univariate analysis showed that age < 10 years at initial diagnosis and B-lineage immunophenotype favourably influenced both DFS (P=0.001) and EFS probabilities (P=0.0014 and P=0.012, respectively), whereas a first CR duration > or = 12 months and a WBC count at relapse < 20 x 10(9)/l were associated only with a better EFS rate (P=0.026 and P=0.004, respectively). Our results show the efficacy of the IDA plus IDARA-C schedule used in the ALL R-87 protocol in high-risk relapsed ALL children. Allogeneic BMT proved effective for patients with an HLA sibling donor. In a multivariate analysis, age > or = 10 years at initial diagnosis (P=0.016) and WBC count at relapse > or = 20 x 10(9)/l (P=0.048) were independently associated with a worse disease outcome.
authors.affiliation: Ematologia, Dipartimento di Biotecnologie Cellulari ed Ematologia, Università La Sapienza, Roma, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Giona
authors.forename: A M
authors.initials: AM
authors.lastname: Testi
authors.forename: R
authors.initials: R
authors.lastname: Rondelli
authors.forename: S
authors.initials: S
authors.lastname: Amadori
authors.forename: W
authors.initials: W
authors.lastname: Arcese
authors.forename: G
authors.initials: G
authors.lastname: Meloni
authors.forename: M L
authors.initials: ML
authors.lastname: Moleti
authors.forename: A
authors.initials: A
authors.lastname: Ceci
authors.forename: M
authors.initials: M
authors.lastname: Pillon
authors.forename: E
authors.initials: E
authors.lastname: Madon
authors.forename: M
authors.initials: M
authors.lastname: Comis
authors.forename: A
authors.initials: A
authors.lastname: Pession
authors.forename: F
authors.initials: F
authors.lastname: Mandelli
mesh_terms: D000293:Adolescent; D000367:Age Factors; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016026:Bone Marrow Transplantation; D002648:Child; D002675:Child, Preschool; D003561:Cytarabine / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage; D007223:Infant; D007958:Leukocyte Count; D008297:Male; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy / Q000628:therapy*; D011241:Prednisone / Q000008:administration & dosage; D011446:Prospective Studies; D012008:Recurrence; D012307:Risk Factors; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D003561:Cytarabine; D011241:Prednisone; D015255:Idarubicin