title: Efficacy and safety of rituximab plus low-dose oral fludarabine and cyclophosphamide as first-line treatment of elderly patients with indolent non-Hodgkin lymphomas.
abstract: Indolent non-Hodgkin lymphomas (iNHLs) are B-cell neoplasms for which no consensus is available about optimal first-line therapy. Chemoimmunotherapy with fludarabine, cyclophospamide and rituximab is very effective, but may give severe hematological and non-hematological toxicity at standard doses, especially in elderly patients. In this phase II study, 25 untreated elderly patients with iNHL received rituximab (375 mg/m(2)) plus low-dose oral fludarabine (25 mg/m(2) for 4 consecutive days) and cyclophosphamide (150 mg/m(2) for 4 consecutive days) for four monthly cycles. Twenty-three patients were responsive (92%) and 12 patients achieved a complete remission (48%). Twenty-one patients (84%) were alive, median follow-up was 30 months and median event-free survival (EFS) was not reached. Patients who we previously treated with chemotherapy alone had a shorter EFS (median 20 months). Compliance was good, with mild toxicity. This regimen is effective for elderly patients with iNHL. The addition of rituximab results in long EFS without affecting toxicity.
authors.affiliation: Unit of Hematology, University Hospital of Siena , Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Fabbri
authors.forename: Emanuele
authors.initials: E
authors.lastname: Cencini
authors.forename: Luigi
authors.initials: L
authors.lastname: Rigacci
authors.forename: Giulia
authors.initials: G
authors.lastname: Bartalucci
authors.forename: Benedetta
authors.initials: B
authors.lastname: Puccini
authors.forename: Roberto
authors.initials: R
authors.lastname: Dottori
authors.forename: Alessandro
authors.initials: A
authors.lastname: Gozzetti
authors.forename: Alberto
authors.initials: A
authors.lastname: Bosi
authors.forename: Monica
authors.initials: M
authors.lastname: Bocchia
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001853:Bone Marrow / Q000473:pathology; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D000069283:Rituximab; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab; D003520:Cyclophosphamide; D014740:Vidarabine; C024352:fludarabine