title: Chlorambucil plus Rituximab as Front-Line Therapy in Elderly/Unfit Patients Affected by B-Cell Chronic Lymphocytic Leukemia: Results of a Single-Centre Experience.
abstract: The current standard first line therapy for fit patients with B-CLL/SLL is based on combination of fludarabine-cyclophosphamide and rituximab. However, elderly patients or patients with comorbidities poorly tolerate purine analogue-based chemotherapy and they are often treated with Chlorambucil (Chl) only. However, complete response (CR) and overall response (OR) rates with Chl are relatively low. We now investigated whether the addition of Rituximab to Chl will improve the efficacy without impairing the tolerability in elderly and unfit patients. We included in our study 27 elderly or unfit patients that had not received prior therapy. All patients were treated with Chl (1mg/Kg per 28-day cycle for 8 cycles) plus Rituximab (375 mg/m(2) for the first course and 500 mg/m(2) for subsequent cycles until the 6(th) cycle). We obtained an OR rate of 74%. The most frequent adverse effect was grade 3-4 neutropenia, which occurred in 18.5% of the patients. Infections or grade 3-4 extra-hematological side effects were not recorded. None of the patients required reduction of dose, delay of therapy or hospitalization. Overall, these data suggest that Chl-R is an effective and well tolerated regimen in elderly/unfit patients with CLL.
authors.affiliation: Department of Hematology, Catholic University of Rome, "A. Gemelli" Hospital, Largo A. Gemelli 8, Rome, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Laurenti
authors.forename: Barbara
authors.initials: B
authors.lastname: Vannata
authors.forename: Idanna
authors.initials: I
authors.lastname: Innocenti
authors.forename: Francesco
authors.initials: F
authors.lastname: Autore
authors.forename: Francesco
authors.initials: F
authors.lastname: Santini
authors.forename: Nicola
authors.initials: N
authors.lastname: Piccirillo
authors.forename: Tommaso
authors.initials: T
authors.lastname: Za
authors.forename: Silvia
authors.initials: S
authors.lastname: Bellesi
authors.forename: Sara
authors.initials: S
authors.lastname: Marietti
authors.forename: Simona
authors.initials: S
authors.lastname: Sica
authors.forename: Dimitar G
authors.initials: DG
authors.lastname: Efremov
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Leone