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Thalidomide May Not be Effective As Single-Agent Therapy for Recurrent Non-Hodgkin Lymphoma and Hodgkin Disease

Thalidomide appears to have only minimal activity as a single-agent therapy for patients with recurrent/refractory non-Hodgkin lymphoma and Hodgkin disease, based on the findings of a recent study.

Thalidomide has been shown to produce an overall response rate of 30% in patients with recurrent and refractory multiple myeloma. A recent study used a combination of thalidomide and rituximab to achieve a high response rate in a small number of patients with recurrent mantle cell lymphoma. However, the single-agent activity of thalidomide in patients with recurrent lymphoma has not been determined.

To address this issue, Barbara Pro, MD, of the University of Texas M.D. Anderson Cancer Center, Houston, United States, and colleagues examined the efficacy of thalidomide as single-agent therapy for patients with recurrent and refractory non-Hodgkin lymphoma (NHL) and Hodgkin disease.

Nineteen patients (median age, 62, 30-78) with a median of 5 previous treatments (range, 2-7) participated in the study, including 17 with NHL and 2 with Hodgkin disease. Thalidomide was administered orally at a starting dosage of 200 mg per day and escalated every 2 weeks up to a maximum of 800 mg per day. Treatment was continued at the maximum tolerated dose until disease progression or intolerable toxicity.

Thalidomide was discontinued during the first 2 weeks for 3 patients, 1 due to pancytopaenia and 2 to rapidly progressing disease. All other patients received at least 8 weeks of therapy with a median thalidomide dose of 400 mg.

Only 1 patient, a male with recurrent mucosa-associated lymphoid tissue lymphoma of the stomach, achieved a pathologic complete response in the study. Treatment was continued for a total of 9 months, and the patient remains in remission 19 months after his initial response was documented (at month 2). Three other patients achieved stable disease, 2 with large cell histology and 1 with small lymphocytic lymphoma.

The researchers note that the low response rate observed in the present study differs strikingly from the results of the previous rituximab/thalidomide combination study. As a potential explanation for this difference, they suggest that thalidomide may have enhanced rituximab activity by modulating the immune response. Alternatively, thalidomide may have made mantle cell lymphoma cells more sensitive to rituximab by modulating intracellular resistance pathways.

"Our data certainly do not support the use of thalidomide as a single agent in patients with recurrent and refractory lymphoma," they conclude, and suggest that it is too early to conclude whether thalidomide-based therapy will be of clinical value for patients with recurrent lymphoma.

Cancer 2004 Mar 15;100:6:1186-9. "Thalidomide for patients with recurrent lymphoma"

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