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Interim report of a phase 2 clinical trial of lenalidomide for T‐cell non‐Hodgkin lymphoma
Author(s) -
Dueck Greg,
Chua Neil,
Prasad Angeli,
Finch Daygen,
Stewart Doug,
White Darrell,
van der Jagt Richard,
Johnston James,
Belch Andrew,
Reiman Tony
Publication year - 2010
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.25377
Subject(s) - medicine , lenalidomide , neutropenia , interim analysis , clinical endpoint , rash , febrile neutropenia , adverse effect , gastroenterology , phases of clinical research , oncology , surgery , clinical trial , chemotherapy , multiple myeloma
BACKGROUND: Novel therapies are needed to improve outcomes in T‐cell lymphomas. The authors report the interim results of a prospective multicenter trial evaluating lenalidomide in T‐cell lymphomas. METHODS: Patients with recurrent and refractory T‐cell lymphomas other than mycosis fungoides and untreated patients ineligible for combination chemotherapy were prescribed oral lenalidomide (25 mg daily) on Days 1 to 21 of each 28‐day cycle until disease progression, death, or unacceptable toxicity. The primary endpoint was overall response rate. Secondary endpoints were progression‐free survival (PFS), overall survival (OS), and safety. The 2‐stage design allows for up to 40 patients. RESULTS: At the time of this interim analysis, 24 patients were enrolled in this study, and 23 were evaluable for response. The median age was 65 years. The overall response rate was 7 (30%) of 23; all were partial responses. Two patients had stable disease for ≥5 cycles. Responses were seen in anaplastic, angioimmunoblastic, and peripheral T‐cell unspecified histologies. Median PFS was 96 days (range, 8‐696+ days). Median OS was 241 days (range, 8‐696+ days). The most common grade 4 adverse event was thrombocytopenia (33%). The most common grade 3 adverse events were neutropenia (21%), febrile neutropenia (17%), and pain not otherwise specified (17%). Rash correlated with response to therapy ( P = .003). CONCLUSIONS: In patients with recurrent and refractory T‐cell lymphomas, oral lenalidomide monotherapy has clinical activity, and toxicity is consistent with the known safety profile of lenalidomide. Further study of lenalidomide in these diseases is warranted. Cancer 2010. © 2010 American Cancer Society.