title: Treatment of adult acute lymphoblastic leukemia (ALL): long-term follow-up of the GIMEMA ALL 0288 randomized study.
abstract: The GIMEMA ALL 0288 trial was designed to evaluate the impact of a 7-day prednisone (PDN) pretreatment on complete remission (CR) achievement and length, the influence of the addition of cyclophosphamide (random I) to a conventional 4-drug induction on CR rate and duration, and whether an early post-CR intensification (random II) by an 8-drug consolidation could improve CR duration. Median follow-up of this study was 7.3 years. From January 1988 to April 1994, among 794 adult (> 12 but < 60 years) patients registered, 778 were eligible. Their median age was 27.5 years; 73% had B-lineage acute lymphoblastic leukemia (ALL) and 22% had T-lineage disease; 18% showed associated myeloid markers; 47 of 216 analyzed patients (22%) had Philadelphia chromosome-positive ALL. Response to PDN pretreatment was observed in 65% of cases. CR was achieved in 627 patients (82%). Resistant patients and induction death rates were 11% and 7%, respectively. Random II was applied to 388 patients with CR; 201 had maintenance alone and 187 had consolidation followed by maintenance. The relapse rate was 60%; isolated central nervous system relapses were 8% of all CRs and 13% of all relapses. Median survival (overall survival [OS]), continuous complete remission (CCR), and disease-free survival (DFS) were 2.2, 2.4, and 2 years, respectively. PDN pretreatment response resulted the main independent factor influencing CR achievement, OS, CCR, and DFS; the addition of cyclophosphamide in induction significantly influenced CR achievement in a multivariate analysis. Neither induction intensification nor early consolidation appeared to influence CCR and DFS duration. For the first time PDN pretreatment response proved to be a powerful factor predicting disease outcome in adult ALL patients.
authors.affiliation: Department of Cellular Biotechnology and Hematology, Università degli Studi La Sapienza, Via Benevento, 6-00161, Rome, Italy.
authors.forename: Luciana
authors.initials: L
authors.lastname: Annino
authors.forename: Maria Luce
authors.initials: ML
authors.lastname: Vegna
authors.forename: Andrea
authors.initials: A
authors.lastname: Camera
authors.forename: Giorgina
authors.initials: G
authors.lastname: Specchia
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Visani
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Fioritoni
authors.forename: Felicetto
authors.initials: F
authors.lastname: Ferrara
authors.forename: Antonio
authors.initials: A
authors.lastname: Peta
authors.forename: Stefania
authors.initials: S
authors.lastname: Ciolli
authors.forename: Wilma
authors.initials: W
authors.lastname: Deplano
authors.forename: Francesco
authors.initials: F
authors.lastname: Fabbiano
authors.forename: Simona
authors.initials: S
authors.lastname: Sica
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Raimondo
authors.forename: Nicola
authors.initials: N
authors.lastname: Cascavilla
authors.forename: Antonio
authors.initials: A
authors.lastname: Tabilio
authors.forename: Pietro
authors.initials: P
authors.lastname: Leoni
authors.forename: Rosangela
authors.initials: R
authors.lastname: Invernizzi
authors.forename: Michele
authors.initials: M
authors.lastname: Baccarani
authors.forename: Bruno
authors.initials: B
authors.lastname: Rotoli
authors.forename: Sergio
authors.initials: S
authors.lastname: Amadori
authors.forename: Franco
authors.initials: F
authors.lastname: Mandelli
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000633:toxicity; D002648:Child; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D011241:Prednisone / Q000008:administration & dosage; D011379:Prognosis; D012074:Remission Induction / Q000379:methods; D016019:Survival Analysis
chemical_list: D003520:Cyclophosphamide; D011241:Prednisone