Haematologica (Feb 2016)

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

DOI
https://doi.org/10.3324/haematol.2015.128710
Journal volume & issue
Vol. 101, no. 2

Abstract

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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