Haematologica (Jan 2019)

A phase 2 study of rituximab, bendamustine, bortezomib and dexamethasone for first-line treatment of older patients with mantle cell lymphoma

  • Rémy Gressin,
  • Nicolas Daguindau,
  • Adrian Tempescul,
  • Anne Moreau,
  • Sylvain Carras,
  • Emmanuelle Tchernonog,
  • Anna Schmitt,
  • Roch Houot,
  • Caroline Dartigeas,
  • Jean Michel Pignon,
  • Selim Corm,
  • Anne Banos,
  • Christiane Mounier,
  • Jehan Dupuis,
  • Margaret Macro,
  • Joel Fleury,
  • Fabrice Jardin,
  • Clementine Sarkozy,
  • Ghandi Damaj,
  • Pierre Feugier,
  • Luc Matthieu Fornecker,
  • Cecile Chabrot,
  • Veronique Dorvaux,
  • Krimo Bouadallah,
  • Sandy Amorin,
  • Reda Garidi,
  • Laurent Voillat,
  • Bertrand Joly,
  • Philippe Solal Celigny,
  • Nadine Morineau,
  • Marie Pierre Moles,
  • Hacene Zerazhi,
  • Jean Fontan,
  • Yazid Arkam,
  • Magda Alexis,
  • Vincent Delwail,
  • Jean Pierre Vilque,
  • Loic Ysebaert,
  • Steven Le Gouill,
  • Mary B. Callanan,
  • for the Lymphoma Study Association

DOI
https://doi.org/10.3324/haematol.2018.191429
Journal volume & issue
Vol. 104, no. 1

Abstract

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We present results of a prospective, multicenter, phase II study evaluating rituximab, bendamustine, bortezomib and dexamethasone as first-line treatment for patients with mantle cell lymphoma aged 65 years or older. A total of 74 patients were enrolled (median age, 73 years). Patients received a maximum of six cycles of treatment at 28-day intervals. The primary objective was to achieve an 18-month progression-free survival rate of 65% or higher. Secondary objectives were to evaluate toxicity and the prognostic impact of mantle cell lymphoma prognostic index, Ki67 expression, [18F]fluorodeoxyglucose-positron emission tomography and molecular minimal residual disease, in peripheral blood or bone marrow. With a median follow-up of 52 months, the 24-month progression-free survival rate was 70%, hence the primary objective was reached. After six cycles of treatment, 91% (54/59) of responding patients were analyzed for peripheral blood residual disease and 87% of these (47/54) were negative. Four-year overall survival rates of the patients who did not have or had detectable molecular residual disease in the blood at completion of treatment were 86.6% and 28.6%, respectively (P