title: Chemoimmunotherapy with oral low-dose fludarabine, cyclophosphamide and rituximab (old-FCR) as treatment for elderly patients with chronic lymphocytic leukaemia.
abstract: Median age at diagnosis for chronic lymphocytic leukaemia (CLL) patients is now 72 years, thus a consistent number of patients may not tolerate standard doses i.v. of fludarabine, cyclophosphamide and rituximab (FCR), the best available therapy, due to unacceptable myelotoxicity and risk of severe infections. We studied safety and efficacy of the addition of rituximab to the oral low-dose FC regimen (old-FCR) in a selected population of 30 elderly (median age 75, 15 untreated, 15 treated with 1 prior therapy) CLL patients. Complete remission (CR) rate was 80% in the untreated patients (overall response rate, ORR 93%), and 30% in pretreated patients (ORR 74%). Progression free survivals (PFS) were 45 months and 30 months in the untreated and treated patients, respectively. In patients achieving CR, old-FCR led to PFS of 67 months. Moreover, haematological toxicity was mild (grade 3-4: 15%) and patients were treated mostly in outpatient clinic. Old-FCR could be a good therapy option for elderly CLL patients outside clinical trials, larger studies are needed to confirm our findings.
authors.affiliation: Hematology, Azienda Ospedaliera Universitaria, Siena, Italy. Electronic address: gozzetti@unisi.it.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Gozzetti
authors.affiliation: Hematology, Azienda Ospedaliera Universitaria, Siena, Italy.
authors.forename: Veronica
authors.initials: V
authors.lastname: Candi
authors.affiliation: Hematology, Azienda Ospedaliera Universitaria, Siena, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Fabbri
authors.affiliation: Hematology, Azienda Ospedaliera Universitaria, Siena, Italy.
authors.forename: Luana
authors.initials: L
authors.lastname: Schiattone
authors.affiliation: Hematology, Azienda Ospedaliera Universitaria, Siena, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Cencini
authors.affiliation: Hematology, Azienda Ospedaliera Universitaria, Siena, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Lauria
authors.affiliation: Hematology, Azienda Ospedaliera Universitaria, Siena, Italy.
authors.forename: Adele
authors.initials: A
authors.lastname: Frasconi
authors.affiliation: Hematology, Azienda Ospedaliera Universitaria, Siena, Italy.
authors.forename: Rosaria
authors.initials: R
authors.lastname: Crupi
authors.affiliation: Hematology, Azienda Ospedaliera Universitaria, Siena, Italy.
authors.forename: Donatella
authors.initials: D
authors.lastname: Raspadori
authors.affiliation: Hematology, Azienda Ospedaliera Universitaria, Siena, Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Papini
authors.affiliation: Hematology, Azienda Ospedaliera Universitaria, Siena, Italy.
authors.forename: Marzia
authors.initials: M
authors.lastname: Defina
authors.affiliation: Hematology, Azienda Ospedaliera Universitaria, Siena, Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Bartalucci
authors.affiliation: Hematology, Azienda Ospedaliera Universitaria, Siena, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Bocchia
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D012189:Retrospective Studies; D000069283:Rituximab; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab; D003520:Cyclophosphamide; D014740:Vidarabine; C024352:fludarabine
keywords: Chronic lymphocytic leukaemia; Cyclofosphamide; Fludarabine