Early cytoreduction represents a cornerstone in adult ALL treatment strategy, several approaches either with single agent or polychemotherapy have been applied to obtain this goal. In the ALL0288 GIMEMA study, PDN pre-treatment response was firstly proved as an independent powerful factor on CR achievement and DFS in adult ALL. 7d-PDN pre-treatment was reintroduced in LAL2000 study and even the same LAL0496 whole therapeutic plan (induction and post-CR treatment) was maintained. The aim of present study was to analyze the impact of PDN pre-treatment addition to a similar induction and post-CR treatment. From April 1996 to December 2005, 1017- 584 males, median age 32.5 y, (range 14.0-60.1 y)- adult ALL were consecutively enrolled in the LAL0496 study- 482 pts, median age 30.5 y-, and LAL 2000- 535 pts, median age 34.8 y-, respectively. The median follow-up of the whole population was 58.3 mos (range 0.3-152.6). As initial WBC count,immunophenotype incidence, there were no significant differences between the two studies; BCR/ABL rearrangement occurred in 25% and 29.57% of patients in LAL0496 and LAL2000, respectively. In LAL 2000, at PDN pre-treatment response (as blast cell < 1000 at d.0) evaluation, 384 (75.89%) resulted PDN-responders, 122 (24.11%) no-responders. In LAL2000, PDN-responder patients median OS and DFS were 34.2 and 24.1 vs. 20.4 and 10.2 of no responders, and 23.4 and 19.2 mos in LAL0496 patients (p=0.0221 and p=0.0178), respectively. Furthermore median DFS in B and T PDN-responders was 24.3, 22.1 vs. 9.1 and 11.6 mos in no responders respectively (p=0.0554). In multivariate analysis, CR achievement, was influenced by protocol–in favour of LAL2000-, age and immunophenotype (p=0.0269, p < 0.0001 and p=0.0002, respec- tively); OS by protocol age and WBC count (p=0.004, p < 0.0001 and p < 0.0001, respectively). DFS was influenced by age and WBC count (p < 0.0001, p < 0.0001, respectively). In LAL2000 PDN response confirmed to be a powerful factor on CR rate, OS and DFS. Furthermore it demonstrated to overcome the impact of immunophenotype on DFS.
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