Treatment of adult acute lymphoblastic leukemia (ALL): Long-term follow-up of the GIMEMA ALL 0288 randomized study

Luciana Annino, Maria Luce Vegna, Andrea Camera, Giorgina Specchia, Giuseppe Visani, Giuseppe Fioritoni, Felicetto Ferrara, Antonio Peta, Stefania Ciolli, Wilma Deplano, Francesco Fabbiano, Simona Sica, Francesco Di Raimondo, Nicola Cascavilla, Antonio Tabilio, Pietro Leoni, Rosangela Invernizzi, Michele Baccarani, Bruno Rotoli, Sergio AmadoriFranco Mandelli

Research output: Contribution to journalArticlepeer-review


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% B-lineage had 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.

Original languageEnglish
Pages (from-to)863-871
Number of pages9
Issue number3
Publication statusPublished - Feb 1 2002

ASJC Scopus subject areas

  • Hematology


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