title: Clinical activity and safety of combination immunotherapy with IFN-alpha 2a and Rituximab in patients with relapsed low grade non-Hodgkin's lymphoma.
abstract: OBJECTIVE
  To determine the clinical activity and safety of the combination immunotherapy of the chimeric anti-CD20 antibody, Rituximab, and Interferon (IFN)- alpha 2a
  
  
  METHODS
  Sixty-four patients with relapsed low-grade or follicular B-cell non Hodgkin's lymphoma received 4 infusion of Rituximab (375 mg/m(2) x dose) after priming and simultaneous treatment with IFN- alpha 2a.
  
  
  RESULTS
  The overall response rate was 70% with 33% complete responses. Median for duration of response is 19 months, after a median follow-up of 22 months. By univariate analysis none of the most common prognostic factors predicted for response to therapy. After treatment 10 patients become bcl-2 negative in the bone marrow, but no correlation between molecular and clinical response was found. Fifty-three patients (83%) had drug related or unknown origin adverse events. The number of adverse events per patient varied from 1 to 21. Considering all 272 events, 231 (85%) were grade 1 or 2, 36 (13%) grade 3 and 5 (2%) grade 4. Twenty-three patients required reduction in the dose and/or short discontinuation of IFN treatment, either during priming or subsequent treatment. The most frequent adverse events were leukopenia, fever, neutropenia, hypotension and thrombocytopenia.
  
  
  CONCLUSIONS
  this report shows that combination immunotherapy Rituximab + IFN- alpha 2a is active and relatively well tolerated. The overall response rate of 70% and the median duration remission of 19 months compare favorable with the results obtained with Rituximab alone in similar subset of patients. Randomized trials, investigating Rituximab versus combination immunotherapy are needed.
authors.affiliation: Dipartimento di Scienze Mediche, Oncologiche e Radiologiche, Università de Modena, Italy. ssacchi@unimo.it
authors.forename: S
authors.initials: S
authors.lastname: Sacchi
authors.forename: M
authors.initials: M
authors.lastname: Federico
authors.forename: U
authors.initials: U
authors.lastname: Vitolo
authors.forename: C
authors.initials: C
authors.lastname: Boccomini
authors.forename: D
authors.initials: D
authors.lastname: Vallisa
authors.forename: L
authors.initials: L
authors.lastname: Baldini
authors.forename: M
authors.initials: M
authors.lastname: Petrini
authors.forename: S
authors.initials: S
authors.lastname: Rupoli
authors.forename: F
authors.initials: F
authors.lastname: Di Raimondo
authors.forename: F
authors.initials: F
authors.lastname: Merli
authors.forename: V
authors.initials: V
authors.lastname: Liso
authors.forename: A
authors.initials: A
authors.lastname: Tabilio
authors.forename: G
authors.initials: G
authors.lastname: Saglio
authors.forename: G
authors.initials: G
authors.lastname: Vinci
authors.forename: M
authors.initials: M
authors.lastname: Brugiatelli
authors.forename: G
authors.initials: G
authors.lastname: Dastoli
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects*; D058846:Antibodies, Monoclonal, Murine-Derived; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects*; D007558:Italy; D008228:Lymphoma, Non-Hodgkin / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D012008:Recurrence; D000069283:Rituximab; D012449:Safety; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D000069283:Rituximab