title: Two courses of four weekly infusions of rituximab with or without interferon-α2a: final results from a randomized phase III study in symptomatic indolent B-cell lymphomas.
abstract: Patients with advanced CD20 + indolent lymphoma, requiring therapy, were randomized to rituximab (four weekly infusions of 375 mg/m(2)) or to rituximab combined with 5 weeks of interferon-α2a (IFN-α2a) (3-4.5 MIU daily) as priming. Responding patients were eligible for a second cycle with the same allocated treatment. In total, 156 patients were randomized to rituximab and 157 to rituximab + IFN-α2a. In the intention-to treat (ITT) population, 244 patients (78%) responded to cycle 1. After a second cycle the complete remission/complete remission unconfirmed (CR/CRu) rate was 41% with the combination versus 24% with monotherapy (p = 0.005). The median time to treatment failure (primary endpoint) in ITT patients was 28 vs. 21.5 months, respectively (p = 0.302). After a long median follow-up (61 months), 33% (42% of patients responding to cycle 1) were still failure-free with an overall survival rate of 88% and with no difference between the treatment groups. The trial was registered at ClinicalTrials.gov Identifier: NCT01609010.
authors: a Division of Hematology, Department of Medicine at Huddinge , Karolinska Institute and University Hospital , Stockholm , Sweden.
authors: Eva
authors: E
authors: Kimby
authors: b Department of Oncology , Oslo University Hospital , Oslo , Norway.
authors: Björn
authors: B
authors: Östenstad
authors: c Department of Hematology , Rigshospitalet, Copenhagen , Denmark.
authors: Peter
authors: P
authors: Brown
authors: d Department of Oncology , Academic Hospital , Uppsala , Sweden.
authors: Hans
authors: H
authors: Hagberg
authors: e Department of Oncology , Norrlands University Hospital , Umeå , Sweden.
authors: Martin
authors: M
authors: Erlanson
authors: b Department of Oncology , Oslo University Hospital , Oslo , Norway.
authors: Harald
authors: H
authors: Holte
authors: f Department of Oncology , Lund University Hospital , Lund , Sweden.
authors: Ola
authors: O
authors: Linden
authors: e Department of Oncology , Norrlands University Hospital , Umeå , Sweden.
authors: Ann-Sofie
authors: AS
authors: Johansson
authors: g Department of Oncology , Malmö-Lund University Hospital , Malmö , Sweden.
authors: Tomas
authors: T
authors: Ahlgren
authors: h Department of Oncology , St Olavs Hospital , Trondheim , Norway.
authors: Karin
authors: K
authors: Wader
authors: a Division of Hematology, Department of Medicine at Huddinge , Karolinska Institute and University Hospital , Stockholm , Sweden.
authors: Björn Engelbrekt
authors: BE
authors: Wahlin
authors: i Department of Pathology , Oslo University Hospital , Oslo , Norway.
authors: Jan
authors: J
authors: Delabie
authors: j Department of Immunology , Genetics and Pathology, Uppsala University Hospital , Uppsala , Sweden.
authors: Christer
authors: C
authors: Sundström
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D023341:Chills / Q000139:chemically induced; D004334:Drug Administration Schedule; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005334:Fever / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects; D016393:Lymphoma, B-Cell / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012074:Remission Induction; D000069283:Rituximab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D000069283:Rituximab
keywords: Rituximab; biologic therapy; follicular lymphoma; indolent lymphoma; interferon-α2a; long-term survival