Laurenti L et al. – Oral combination fludarabine and cyclophosphamide is an effective, safe, and well-tolerated regimen in chronic lymphocytic leukemia (CLL) pts with low-risk biological parameters Methods
Study of efficacy and safety of oral fludarabine and cyclophosphamide as front-line therapy in CLL and the influence of immunoglobulin variable region heavy chain (IgVH) gene mutation status, interphase cytogenetic abnormalities, and expression of ZAP-70 and CD38 on clinical outcome
Oral administration of fludarabine (30 mg m2) and cyclophosphamide (250 mg m2) for 3 consecutive days every 4 wks for 6 cycles for 37 pts with previously untreated CLL
Pts: 18 pts had unmutated and 15 had mutated IgVH genes; 9 pts had the ‘high risk’ cytogenetic abnormality del(11q22.3) or del(17p13.1); 15 pts were ZAP-70-positive and 8 were CD38-positive
Results
Of 35 pts, 14 (40%) had complete response; 13 (37%) had partial response
Median progression-free survival (PFS): 23 mo
Median time to re-treatment (TTR): 38 mo
Significantly lower overall response rate (43% vs 85%), shorter PFS (22 vs 27 mo), shorter TTR (22 vs 40 mo) in ‘high risk’ cytogenetic abnormalities group
TTR shorter in IgVH-unmutated vs IgVH-mutated patients (26 vs 41 mo)
See all
