Chlorambucil plus rituximab as front-line therapy for elderly and/or unfit chronic lymphocytic leukemia patients: correlation with biologically-based risk stratification.

First-line treatment for young/fit patients with chronic lymphocytic leukemia (CLL) is the combination of flu- d arabine, cyclophosphamide and rituximab (FCR), which has improved these patients’ progression-free survival a nd overall survival, 1 b ut is poorly tolerated by elderly patients or patients with comorbidities. 2 Such patients have been historically treated with chlorambucil, which is well tolerated but does not improve survival. 3 To improve outcomes, chlorambucil has been combined with anti-CD20 monoclonal antibodies. Three prospec- tive studies 4-6 and one retrospective 7 one investigated the combination of chlorambucil with rituximab (Chl-R) as front-line treatment for elderly CLL patients or for younger patients unsuitable for fludarabine-based thera- pies. Overall response rates ranging from 66% to 84% have been reported, with complete response rates of 8- 26% and progression-free survival from 16.3 to 34.7 months