Abstract
BACKGROUND:
Novel therapies are needed to improve outcomes in Tβcell lymphomas. The authors report the interim results of a prospective multicenter trial evaluating lenalidomide in Tβcell lymphomas.
METHODS:
Patients with recurrent and refractory Tβcell 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 28βday cycle until disease progression, death, or unacceptable toxicity. The primary endpoint was overall response rate. Secondary endpoints were progressionβfree survival (PFS), overall survival (OS), and safety. The 2βstage 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 β₯5 cycles. Responses were seen in anaplastic, angioimmunoblastic, and peripheral Tβcell unspecified histologies. Median PFS was 96 days (range, 8β696+ days). Median OS was 241 days (range, 8β696+ 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 Tβcell 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. Β© 2010 American Cancer Society.