TY - JOUR
T1 - Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma
AU - Wiernik, Peter H.
AU - Lossos, Izidore S.
AU - Tuscano, Joseph M.
AU - Justice, Glen
AU - Vose, Julie M.
AU - Cole, Craig E.
AU - Lam, Wendy
AU - McBride, Kyle
AU - Wride, Kenton
AU - Pietronigro, Dennis
AU - Takeshita, Kenichi
AU - Ervin-Haynes, Annette
AU - Zeldis, Jerome B.
AU - Habermann, Thomas M.
PY - 2008/10/20
Y1 - 2008/10/20
N2 - Purpose: The major cause of death in aggressive lymphoma is relapse or nonresponse to initial therapy. Lenalidomide has activity in a variety of hematologic malignancies, including non-Hodgkin's lymphoma (NHL). We report the results of a phase II, single-arm, multicenter trial evaluating the safety and efficacy of lenalidomide oral monotherapy in patients with relapsed or refractory aggressive NHL. Patients and Methods: Patients were treated with oral lenalidomide 25 mg once daily on days 1 to 21, every 28 days, for 52 weeks, until disease progression or intolerance. The primary end point was response; secondary end points included duration of response, progression-free survival (PFS), and safety. Results: Forty-nine patients with a median age of 65 years received lenalidomide in this study. The most common histology was diffuse large B-cell lymphoma (53%), and patients had received a median of four prior treatment regimens for NHL. An objective response rate of 35% was observed in 49 treated patients, including a 12% rate of complete response/unconfirmed complete response. Responses were observed in each aggressive histologic subtype tested (diffuse large B-cell, follicular center grade 3, mantle cell, and transformed lymphomas). Of patients with stable disease or partial response at first assessment, 25% improved with continued treatment. Estimated median duration of response was 6.2 months, and median PFS was 4.0 months. The most common grade 4 adverse events were neutropenia (8.2%) and thrombocytopenia (8.2%); the most common grade 3 adverse events were neutropenia (24.5%), leukopenia (14.3%), and thrombocytopenia (12.2%). Conclusion: Oral lenalidomide monotherapy is active in relapsed or refractory aggressive NHL, with manageable side effects.
AB - Purpose: The major cause of death in aggressive lymphoma is relapse or nonresponse to initial therapy. Lenalidomide has activity in a variety of hematologic malignancies, including non-Hodgkin's lymphoma (NHL). We report the results of a phase II, single-arm, multicenter trial evaluating the safety and efficacy of lenalidomide oral monotherapy in patients with relapsed or refractory aggressive NHL. Patients and Methods: Patients were treated with oral lenalidomide 25 mg once daily on days 1 to 21, every 28 days, for 52 weeks, until disease progression or intolerance. The primary end point was response; secondary end points included duration of response, progression-free survival (PFS), and safety. Results: Forty-nine patients with a median age of 65 years received lenalidomide in this study. The most common histology was diffuse large B-cell lymphoma (53%), and patients had received a median of four prior treatment regimens for NHL. An objective response rate of 35% was observed in 49 treated patients, including a 12% rate of complete response/unconfirmed complete response. Responses were observed in each aggressive histologic subtype tested (diffuse large B-cell, follicular center grade 3, mantle cell, and transformed lymphomas). Of patients with stable disease or partial response at first assessment, 25% improved with continued treatment. Estimated median duration of response was 6.2 months, and median PFS was 4.0 months. The most common grade 4 adverse events were neutropenia (8.2%) and thrombocytopenia (8.2%); the most common grade 3 adverse events were neutropenia (24.5%), leukopenia (14.3%), and thrombocytopenia (12.2%). Conclusion: Oral lenalidomide monotherapy is active in relapsed or refractory aggressive NHL, with manageable side effects.
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U2 - 10.1200/JCO.2007.15.3429
DO - 10.1200/JCO.2007.15.3429
M3 - Article
C2 - 18606983
AN - SCOPUS:54449095901
SN - 0732-183X
VL - 26
SP - 4952
EP - 4957
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 30
ER -