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/m²) 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.

Keywords::

• Rituximab
• interferon-α2a
• indolent lymphoma
• follicular lymphoma
• biologic therapy
• long-term survival

Acknowledgements

We acknowledge the patients who participated in the study and all the study staff. We also thank the employees of Roche who contributed to the implementation of the trial and data analysis.

The study was supported by research grants from F. Hoffman-La Roche Ltd in collaboration with the Nordic Lymphoma Group (NLG) and was also supported in part by research funding from the Nordic Cancer Union (NCU) and a joint grant from Karolinska Institutet and Stockholm County Council.

Special thanks are given to all collaborative investigators: Sweden: Dr. Anders Aldrin, Visby, Dr. Lars Andreassen, Örebro, Dr. Kristina Arnljots, Malmö, Dr. Ulf Bandmann, Eskilstuna, Dr. Margaretha S. Carlsson, Växjö, Dr. Susanne Fredén, Jönköping, Dr. Louise Hellquist, Halmstad, Dr. Mikael Köhler, Falun, Dr. Birgitta Lauri, Luleå, Dr. Jack Lindh, Umeå, Dr. Olof Lindquist, Uddevalla, Dr. Gerd Lärfars, Stockholm, Dr. Marie Nordström, Stockholm, Dr. Eva Mrazek , Karlstad, Dr. Anders Rådlund, Linköping, Dr. Maria Strandberg, Sundsvall, Dr. Ulf Petersson, Västerås, Dr. Lars Timberg, Kristianstad. Denmark: Dr. Mads Hansen and Dr. Lisbeth Enggaard, Copenhagen. Norway: Dr. Roald Ekanger, Bergen, Dr. Martin Maisenhølder, Tromsö, Dr. Peter Meyer, Stavanger, Dr. Ragnar Telhaug, Trondheim.

Potential conflict of interest

Disclosure forms provided by the authors are available with the full text of this article at www.informahealthcare.com/lal.