title: Rituximab with cyclophosphamide, vincristine, non-pegylated liposomal doxorubicin and prednisone as first-line treatment for splenic marginal zone lymphoma: a Fondazione Italiana Linfomi phase II study.
abstract: Rituximab® provides high response rates and effective disease palliation in patients with splenic marginal zone lymphoma (SMZL). We conducted a phase II trial in patients with SMZL who were either untreated or were splenectomized but had shown disease progression within 1 year after splenectomy. Treatment consisted of six courses of Rituximab with cyclophosphamide, vincristine, non-pegylated liposomal doxorubicin and prednisone (R-COMP). Fifty-one patients were eligible for the analysis. The overall response rate was 84%. The 6-year progression-free survival and overall survival were 54% and 72%, respectively. Toxicity was substantial (grade≥3 neutropenia: 26%; grade≥3 infections: 8%). Of the 15 deaths, two occurred on treatment (one sepsis and one pneumonia). Six deaths were due to lymphoma progression, four to secondary neoplasia, one to sepsis, one to pneumonia and one to splenectomy complications. R-COMP should be restricted to patients with bulky disease associated with symptoms or to patients with possible histological transformation.
authors: a A.O.U. Policlinico Paolo Giaccone , Palermo , Italy.
authors: Emilio
authors: E
authors: Iannitto
authors: b University of Modena and Reggio Emilia , Modena , Italy.
authors: Stefano
authors: S
authors: Luminari
authors: c University of Palermo , Palermo , Italy.
authors: Claudio
authors: C
authors: Tripodo
authors: a A.O.U. Policlinico Paolo Giaccone , Palermo , Italy.
authors: Salvatrice
authors: S
authors: Mancuso
authors: b University of Modena and Reggio Emilia , Modena , Italy.
authors: Marina
authors: M
authors: Cesaretti
authors: b University of Modena and Reggio Emilia , Modena , Italy.
authors: Luigi
authors: L
authors: Marcheselli
authors: d Arcispedale S. Maria Nuova - IRCCS , Reggio Emilia , Italy.
authors: Francesco
authors: F
authors: Merli
authors: e Azienda Ospedaliera Bianchi Melacrino Morelli , Reggio Calabria , Italy.
authors: Caterina
authors: C
authors: Stelitano
authors: f Azienda Ospedaliera Universitaria "San Martino" , Genova , Italy.
authors: Angelo Michele
authors: AM
authors: Carella
authors: g Presidio Ospedaliero Madonna delle Grazie , Matera , Italy.
authors: Alberto
authors: A
authors: Fragasso
authors: e Azienda Ospedaliera Bianchi Melacrino Morelli , Reggio Calabria , Italy.
authors: Elisa
authors: E
authors: Montechiarello
authors: h Department of Hematology , Pescara , Italy.
authors: Giuseppina
authors: G
authors: Ricciuti
authors: i University La Sapienza , Roma , Italy.
authors: Alessandro
authors: A
authors: Pulsoni
authors: j University of Pavia and Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS), Fondazione Policlinico , San Matteo, Pavia , Italy.
authors: Marco
authors: M
authors: Paulli
authors: c University of Palermo , Palermo , Italy.
authors: Vito
authors: V
authors: Franco
authors: b University of Modena and Reggio Emilia , Modena , Italy.
authors: Massimo
authors: M
authors: Federico
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers; D001706:Biopsy; D001853:Bone Marrow / Q000473:pathology; D002423:Cause of Death; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D016130:Immunophenotyping; D007558:Italy; D053208:Kaplan-Meier Estimate; D016393:Lymphoma, B-Cell / Q000175:diagnosis* / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011241:Prednisone / Q000008:administration & dosage; D011379:Prognosis; D000069283:Rituximab / Q000008:administration & dosage; D013160:Splenic Neoplasms / Q000175:diagnosis* / Q000188:drug therapy* / Q000401:mortality; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D015415:Biomarkers; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone
keywords: Splenic marginal zone lymphoma; first line; rituximab