The addition of rituximab to fludarabine and cyclophosphamide chemotherapy results in a significant improvement in overall survival in patients with newly diagnosed mantle cell lymphoma: results of a randomized UK National Cancer Research Institute trial
Simon Rule,
Paul Smith,
Peter W.M. Johnson,
Simon Bolam,
George Follows,
Joanne Gambell,
Peter Hillmen,
Andrew Jack,
Stephen Johnson,
Amy A Kirkwood,
Anton Kruger,
Christopher Pocock,
John F. Seymour,
Milena Toncheva,
Jan Walewski,
David Linch
Affiliations
Simon Rule
Derriford Hospital, Plymouth, UK
Paul Smith
Cancer Reasearch UK and UCL Cancer Trials Centre, London, UK
Peter W.M. Johnson
University of Southampton, Southampton, UK
Simon Bolam
Musgrove Park Hospital, Taunton, UK
George Follows
Addenbrookes Hospital, Cambridge, UK
Joanne Gambell
Cancer Reasearch UK and UCL Cancer Trials Centre, London, UK
Peter Hillmen
St. James’s University Hospital, Leeds, UK
Andrew Jack
HMDS, Leeds General Infirmary, UK
Stephen Johnson
Musgrove Park Hospital, Taunton, UK
Amy A Kirkwood
Cancer Reasearch UK and UCL Cancer Trials Centre, London, UK
Anton Kruger
Royal Cornwall Hospital, Truro, UK
Christopher Pocock
Kent and Canterbury Hospital, Canterbury, UK
John F. Seymour
The Peter MacCallum Cancer Centre, Melbourne, Australia
Milena Toncheva
Cancer Reasearch UK and UCL Cancer Trials Centre, London, UK
Jan Walewski
Maria Sklodowska-Curie Institute and Oncology Centre, Gilwice, Poland
Mantle cell lymphoma is an incurable and generally aggressive lymphoma that is more common in elderly patients. Whilst a number of different chemotherapeutic regimens are active in this disease, there is no established gold standard therapy. Rituximab has been used widely to good effect in B-cell malignancies but there is no evidence that it improves outcomes when added to chemotherapy in this disease. We performed a randomized, open-label, multicenter study looking at the addition of rituximab to the standard chemotherapy regimen of fludarabine and cyclophosphamide in patients with newly diagnosed mantle cell lymphoma. A total of 370 patients were randomized. With a median follow up of six years, rituximab improved the median progression-free survival from 14.9 to 29.8 months (P