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Treatment of Ph1 and/or BCR-ABL positive acute lymphoblastic leukemia Results of the French-Belgian LALA-94 trial

Treatment of Ph1 and/or BCR-ABL positive acute lymphoblastic leukemia Results of the French-Belgian LALA-94 trial

Blood 96(11 Part 1): 829a, November 16

701 consecutive patients with ALL (15-55y) were enrolled in the prospective LALA-94 trial between June 1994 and February 2000. They all received a standard 4-drug/4-week induction. 154 of them (22%) were diagnosed before Day 35 with Ph1+/BCR-ABL+ (72%), Ph1+ (8%), or BCR-ABL+ (20%) ALL and 147/154 were included in this analysis (median age, 42y; median WBC, 17.109/L; m/M/mM/ukn bcr, 93/37/5/12; median follow-up, 3.4y). After induction, all were eligible to receive an intensive MTZ-IDaraC course as consolidation or salvage, followed by 1-2 pre-transplant MTX-Aspa courses. Allogeneic (either matched related or unrelated donor) or autologous stem cell transplantation (SCT) was offered to all responding patients. CR rates after induction (Time 1), after consolidation/salvage (Time 2), and at transplant time (Time 3) were 54%, 66%, and 60%, respectively. Among 64 patients alive in failure at Time 1, the salvage rate at Time 2 was 41%. Among 102 patients in CR at Time 1 or 2, there was a 18% early relapse rate at Time 3. Response at Time 3 had a strong prognostic value for survival (estimated 2-year survival, 38% for CR patients versus 9% for failed patients; P<0.0001). SCT was planned in 87 CR patients (43 allo-ID; 12 allo-MUD; 32 auto) and 73 (84%) were actually transplanted in CR (40 allo-ID, 10 allo-MUD, 23 auto). In addition, 22 patients were transplanted in failure/relapse (15 allo-ID, 6 allo-MUD, 1 auto). In univariate analysis, WBC<25.109/L at diagnosis and non-blastic marrow at Day 8 were prognostic factors for CR at Time 3 (P=0.05 and 0.04, respectively). In multivariate analysis, persistent blasts at Day 8 and advanced age were predictive of poor survival (P=0.01 and 0.04, respectively). Myeloid markers, karyotype features, and bcr type had no prognostic significance. Higher transplant-related mortality and higher post-graft relapse rate (estimated 1-year relapse rate, 39% versus 24%) leading to worse survival (P=0.02) was observed in patients allografted in failure/relapse when compared to those allografted in CR. In the 73 patients transplanted in CR, post-graft EFS was significantly shorter after autologous SCT (17/23 relapses and 4/23 deaths in CR) than after allogeneic SCT (18/50 relapses and 12/50 deaths in CR) (estimated 18-month EFS, 22% versus 43%; P=0.01), without significant difference in overall survival. BCR-ABL RT-PCR results at Time 1, 2, and 3 and their potent prognostic significance according to transplant procedures are under central reviewing.

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Accession: 035980575

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