Lenalidomide In Patients with Relapsed or Refractory Hodgkin Lymphoma.

Abstract 2828

The immunomodulatory compound lenalidomide induces apoptosis in tumor cells, exerts antiangiogenic effects and activates immune effector cells. Apoptosis resistance, increased neoangiogenesis and impaired immunity critically contribute to Hodgkin‘s Lymphoma (HL). However, the activity of lenalidomide in HL is unknown so far.

42 patients with multiple relapsed or refractory HL were treated with 25 mg oral lenalidomide for 21 days of a 28-day cycle in a named patient program in 18 different german hospitals. Participants gave written informed consent, had no curative treatment options, an ECOG performance status ≤ 2, and normal organ functions including peripheral blood counts within the normal range. Patients were staged and restaged with computed tomography (CT) of the initially involved sites; the use of PET was optional. Response was defined according to the “Cheson-criteria” from 1999 and evaluated after two to three cycles and every other cycle thereafter. Treatment was continued until disease progression or in case of intolerable toxicity occurred. Concomitant anti-thrombotic prophylaxis with 100 mg daily oral acetylsalicylic acid was mandatory. Patients with a history of thrombosis or thrombembolic events received low molecular heparin.

To date, in the 24 patients who are eligible for analysis, treatment was well tolerated. No hematological or other toxicities above CTC grade-2 were reported; adverse events included diarrhea, constipation, neuropathy, and mild dyspnea. At restaging, eight of the analyzed patients had stable disease and twelve patients achieved clinical responses (11× PR, 1× CR) as measured by CT-scan. However, five of the heavily pretreated patients had progressive disease. Results on the remaining patients are currently being analyzed and will be presented at the ASH meeting.

In conclusion, these first clinical observations indicate that lenalidomide is well tolerated and effective in patients with relapsed or refractory HL. Consequently, international clinical trials evaluating the role of lenalidomide in HL are in preparation and a phase I/II trial evaluating lenalidomide with AVD (Adriamycine, Vinblastine and Dacarbacine) in elderly HL patients is currently recruiting.