FROM THE LITERATURE

A New Treatment Option for Relapsed or Refractory
Aggressive NHL

The major cause of death in patients with aggressive histology NHL is relapse or nonresponse to initial therapy. These patients are heavily-pretreated with chemoimmunotherapy, stem-cell transplantation, and/or radioimmunotherapy that leaves them with very little bone marrow reserves. Consequently, they are left with few or no further treatment options. Lenalidomide(Revlimid^®) has activity in a variety of hematologic malignancies, including NHL. The results of a phase II, single-arm, safety/efficacy trial of lenalidomide oral monotherapy (25mg once daily on days 1 to 21, every 28 days for 52 weeks) in this patient population were recently published. The 49 patients had aggressive histology NHL as follows: diffuse large B-cell in 53% of them, follicular center lymphoma, grade 3 (10%), mantle-cell (31%), and transformed low-grade (6%). For the primary endpoint of response, the overall response rate (ORR) of the entire group of 49 patients was 35%, including a 12% rate of CR/CRu. The ORR of the 4 different histology groups were: diffuse B-cell 19%, follicular center grade 3 was 60%, mantle-cell (MCL) 53%, and transformed low-grade 33%. The 53% ORR in MCL along with a manageable toxicity profile suggests that lenalidomide is a potential treatment option for these patients. Estimates for median duration of response and PFS were 6.2 and 4.0 months, respectively. Lenalidomide, an immunomodulatory agent, may control aggressive NHL by enhancing the immune system. It has been reported that when used in combination, lenalidomide and rituximab produce a robust response rate in relapsed or refractory MCL.

These results demonstrate the activity of lenalidomide in this relapsed/refractory patient population and warrant further investigation alone or as a component combination therapy.

J Clin Oncol 26: 4952-4957, 2008

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