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
2015 (English)In: Leukemia and Lymphoma, ISSN 1042-8194, E-ISSN 1029-2403, Vol. 56, no 9, 2598-2607 p.Article in journal (Refereed) Published
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.
Place, publisher, year, edition, pages
2015. Vol. 56, no 9, 2598-2607 p.
Rituximab; interferon-alpha 2a; indolent lymphoma; follicular lymphoma; biologic therapy; long-term survival
Cancer and Oncology Hematology
Research subject Pathology
IdentifiersURN: urn:nbn:se:uu:diva-278835DOI: 10.3109/10428194.2015.1014363ISI: 000369812100020PubMedID: 25686644OAI: oai:DiVA.org:uu-278835DiVA: diva2:906999