An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma

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BlankAn international phase II trial of single-agent lenalidomide for relapsed

or refractory aggressive B-cell non-Hodgkin’s lymphoma

1.. T. E. Witzig1,*,

2.. J. M. Vose2,

3.. P. L. Zinzani3,

4.. C. B. er4,

5.. R. Buckstein5,

6.. J. A. Polikoff6,

7.. R. Bouabdallah7,

8.. C. Haioun8,

9.. H. Tilly9,

10.. P. Guo10,

11.. D. Pietronigro10,

12.. A. L. Ervin-Haynes10 and

13.. M. S. Czuczman11

+ Author Affiliations

1.. 1Department of Medicine, Division of Hematology, Mayo Clinic, Rochester

2.. 2Section of Hematology/Oncology, University of Nebraska, Omaha, USA

3.. 3Institute of Hematology and Oncology Seragnoli, University of Bologna,

Bologna, Italy

4.. 4Department of Medicine, Division of Hematology, Mayo Clinic, sdale,

USA

5.. 5Department of Hematology, Sunnybrook Odette Cancer Center, Toronto,

Canada

6.. 6Department of Hematology/Oncology, Kaiser Permanente Medical Group, San

Diego, USA

7.. 7Department of Hematology, Institut Paoli Calmettes, Marseilles

8.. 8Department of Hôpital Henri Mondor-AP-HP, Créteil

9.. 9Department of Centre Henri Becquerel, Rouen, France

10.. 10Department of Celgene Corporation, Summit

11.. 11Department of Medicine, Lymphoma/Myeloma Service, Roswell Park Cancer

Institute, Buffalo, USA

1.. ?*Correspondence to: Dr T. E. Witzig, Hematology, Mayo Clinic, Stabile

628, 200 First Street SW, Rochester, MN 55905 USA. Tel: +1-507-266-2040; Fax:

+1-507-266-9277; E-mail: witzig@...

a.. Received March 17, 2010.

b.. Revision received July 1, 2010.

c.. Accepted September 22, 2010.

Abstract

Background: Lenalidomide is an immunomodulatory agent with antitumor activity in

B-cell malignancies. This phase II trial aimed to demonstrate the safety and

efficacy of lenalidomide in patients with relapsed or refractory diffuse large

B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), follicular grade 3 lymphoma

(FL-III), or transformed lymphoma (TL).

Methods: Patients received oral lenalidomide 25 mg on days 1–21 every 28 days as

tolerated or until progression. The primary end point was overall response rate

(ORR).

Results: Two hundred and seventeen patients enrolled and received lenalidomide.

The ORR was 35% (77/217), with 13% (29/217) complete remission (CR), 22%

(48/217) partial remission, and 21% (45/217) with stable disease. The ORR for

DLBCL was 28% (30/108), 42% (24/57) for MCL, 42% (8/19) for FL-III, and 45%

(15/33) for TL. Median progression-free survival for all 217 patients was 3.7

months [95% confidence interval (CI) 2.7–5.1]. For 77 responders, the median

response duration lasted 10.6 months (95% CI 7.0–NR). Median response duration

was not reached in 29 patients who achieved a CR and in responding patients with

FL-III or MCL. The most common adverse event was myelosuppression with grade 4

neutropenia and thrombocytopenia in 17% and 6%, respectively.

Conclusion: Lenalidomide is well tolerated and produces durable responses in

patients with relapsed or refractory aggressive non-Hodgkin’s lymphoma.