Pilot study of etanercept in patients with relapsed cutaneous T-cell lymphomas.

BACKGROUND: Tumor necrosis factor (TNF)-alpha has been implicated in the pathogenesis of cutaneous T-cell lymphoma (CTCL). OBJECTIVE: To assess the toxicity, safety, and efficacy of etanercept (soluble TNF receptor) in patients with relapsed CTCL. METHODS: Etanercept was administered twice weekly at a dose of 25 mg subcutaneously. Patients with improvement after two months could be continued on treatment. RESULTS: Twelve out of the 13 patients enrolled on study were evaluable (Stage I-IIA, 3 patients; Stage IIB-IV disease, 9 patients). The median number of previous therapies was 7 (range, 3-12). Etanercept induced partial remission in one patient (8%) and minor response in one patient (8%), both of whom had Stage IB disease. Most patients experienced no side effects. CONCLUSION: This pilot study suggests that etanercept is safe and generally well tolerated in patients with CTCL. The effect of etanercept in a larger cohort of patients with early disease merits investigation.