Comparison of Two Regimens for the Treatment of Elderly Patients with Acute Lymphoblastic Leukaemia (ALL).

Acute lymphoblastic leukemia (ALL) represents a rare malignancy in the elderly and few authors have specifically focused on the treatment of ALL in this setting. We recently published the results of a prospective phase II study comprising an induction therapy with vincristine, Daunoxome, cyclophosphamide and prednisone (VDXD) given to 15 patients aged ≥ 60 years. Here, we updated the results after enrolling 17 patients treated from 1999 to 2002 (median age 69 years, range 61–79) and we compared these with the results obtained in 17 elderly patients treated according to the GIMEMA ALL 0288 protocol from 1994 to 1998 (median age 70, range 61–76). Most of patients in both groups had B-lineage ALL and an initial WBC count less than 30 x 10⁹/L. The most frequent karyotypic abnormality resulted the Ph which was detected in 4 (23%) and in 3 patients (17%) treated with 0288 and VDXD, respectively. BCR-ABL translocation was present in 45 % of patients treated with VDXD. Comorbidities were documented in 11 (65 %) patients treated with VDXD compared with 9 (58%) receiving 0288 regimen.

With VDXD combination elderly ALL had a higher CR rate than with 0288 protocol (76.5% vs 41%; p=0.037) likely due to both lower induction mortality (17.5% vs 35%; p=0.028) and less resistant disease (6% vs 24%; p=0.025). Infectious complications rate was similar (64% vs 53%) but they were the primary cause of death in 2 and 5 patients receiving VDXD and 0288, respectively. Non-hematological side effects were comparable. Median DFS was similar and resulted 18 months and 20 months with 0288 and VDXD treatment, respectively. Median EFS was 3.9 and 12.8 months, respectively (p = 0.0486). Particularly, 1-year EFS resulted 35% in patients receiving 0288 treatment compared with 53% in those given VDXD. Median OS was 4.5 an 21 months in the first and in the latter group of patients (p = 0.0239) with a two-year OS of 29% in 0288 and 38% in VDXD group.

Our results are encouraging and show that the administration of high-dose daunorubicin as liposomal compound in elderly ALL patients is not only feasible but also able to improve CR rate, EFS and OS without increase in toxicity.