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Combination of lenalidomide and rituximab in elderly patients with relapsed or refractory diffuse large B-cell lymphoma: a phase 2 trial.

AbstractBACKGROUND:
Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of aggressive non-Hodgkin lymphoma and despite recent chemotherapeutic advances up to half of all patients relapse. Here we report the results from a phase 2, single-arm, single-center trial evaluating the safety and efficacy of lenalidomide plus rituximab in elderly patients with relapsed or refractory DLBCL.
PATIENTS AND METHODS:
Between March and June 2009, elderly patients (65 years of age or older) with relapsed/refractory DLBCL who had been heavily pretreated were recruited. Oral lenalidomide (20 mg/d for 21 days of each 28-day cycle) was initiated for four cycles and rituximab (375 mg/m(2)) was administered on day 1 and day 21 of each 28-day cycle for four cycles. After this induction phase, patients achieving a complete response (CR), partial response (PR), or stable disease (SD) were given lenalidomide maintenance therapy at the same schedule for another 8 months.
RESULTS:
A total of 23 patients with a median of three prior treatments (range, 2 to 8) were included. The overall response rate (CR + PR) at the end of the induction phase was 35% (n = 8). Ten patients (7 CR, 1 PR, and 2 SD patients) were eligible for lenalidomide maintenance and 8 of these patients achieved a CR. Adverse events were manageable and the most common included neutropenia and thrombocytopenia.
CONCLUSION:
Oral lenalidomide in combination with rituximab is active in elderly patients with relapsed/refractory DLBCL with a high percentage of patients achieving a continuous CR after lenalidomide maintenance.
AuthorsPier Luigi Zinzani, Cinzia Pellegrini, Letizia Gandolfi, Vittorio Stefoni, Federica Quirini, Enrico Derenzini, Alessandro Broccoli, Lisa Argnani, Stefano Pileri, Michele Baccarani
JournalClinical lymphoma, myeloma & leukemia (Clin Lymphoma Myeloma Leuk) Vol. 11 Issue 6 Pg. 462-6 (Dec 2011) ISSN: 2152-2669 [Electronic] United States
PMID21859554 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2011 Elsevier Inc. All rights reserved.
Chemical References
  • Antibodies, Monoclonal, Murine-Derived
  • Rituximab
  • Thalidomide
  • Lenalidomide
Topics
  • Age Factors
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal, Murine-Derived (administration & dosage, adverse effects)
  • Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
  • Drug Resistance, Neoplasm
  • Female
  • Humans
  • Lenalidomide
  • Lymphoma, Large B-Cell, Diffuse (drug therapy, pathology)
  • Male
  • Recurrence
  • Rituximab
  • Thalidomide (administration & dosage, adverse effects, analogs & derivatives)

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