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

Pier Luigi Zinzani, Cinzia Pellegrini, Letizia Gandolfi, Vittorio Stefoni, Federica Quirini, Enrico Derenzini, Alessandro Broccoli, Lisa Argnani, Stefano Pileri, Michele Baccarani

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Abstract

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. We conducted a phase two trial: 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. Background: 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.

Original languageEnglish
Pages (from-to)462-466
Number of pages5
JournalClinical Lymphoma, Myeloma and Leukemia
Volume11
Issue number6
DOIs
Publication statusPublished - Dec 2011

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Lymphoma, Large B-Cell, Diffuse
Maintenance
lenalidomide
Rituximab
Non-Hodgkin's Lymphoma
Recurrence
Neutropenia
Thrombocytopenia
Appointments and Schedules

Keywords

  • Diffuse large B-cell lymphoma
  • Elderly patients
  • Lenalidomide
  • Relapsed/refractory
  • Rituximab

ASJC Scopus subject areas

  • Cancer Research
  • Hematology
  • Oncology

Cite this

Combination of lenalidomide and rituximab in elderly patients with relapsed or refractory diffuse large B-cell lymphoma : A phase 2 trial. / Zinzani, Pier Luigi; Pellegrini, Cinzia; Gandolfi, Letizia; Stefoni, Vittorio; Quirini, Federica; Derenzini, Enrico; Broccoli, Alessandro; Argnani, Lisa; Pileri, Stefano; Baccarani, Michele.

In: Clinical Lymphoma, Myeloma and Leukemia, Vol. 11, No. 6, 12.2011, p. 462-466.

Research output: Contribution to journalArticle

Zinzani, PL, Pellegrini, C, Gandolfi, L, Stefoni, V, Quirini, F, Derenzini, E, Broccoli, A, Argnani, L, Pileri, S & Baccarani, M 2011, 'Combination of lenalidomide and rituximab in elderly patients with relapsed or refractory diffuse large B-cell lymphoma: A phase 2 trial', Clinical Lymphoma, Myeloma and Leukemia, vol. 11, no. 6, pp. 462-466. https://doi.org/10.1016/j.clml.2011.02.001
Zinzani, Pier Luigi ; Pellegrini, Cinzia ; Gandolfi, Letizia ; Stefoni, Vittorio ; Quirini, Federica ; Derenzini, Enrico ; Broccoli, Alessandro ; Argnani, Lisa ; Pileri, Stefano ; Baccarani, Michele. / Combination of lenalidomide and rituximab in elderly patients with relapsed or refractory diffuse large B-cell lymphoma : A phase 2 trial. In: Clinical Lymphoma, Myeloma and Leukemia. 2011 ; Vol. 11, No. 6. pp. 462-466.
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AU - Gandolfi, Letizia

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AU - Quirini, Federica

AU - Derenzini, Enrico

AU - Broccoli, Alessandro

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AU - Pileri, Stefano

AU - Baccarani, Michele

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N2 - 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. We conducted a phase two trial: 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. Background: 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.

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KW - Relapsed/refractory

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