Phase II trial of interferon‐α‐2a plus psolaren with ultraviolet light A in patients with cutaneous T‐cell lymphoma

Abstract

PURPOSE To evaluate the efficacy and side effects of psolaren with ultraviolet light A (PUVA) and interferon‐alpha‐2a (IFN‐α‐2a) in patients with mycosis fungoides (MF) and Sézary syndrome (SS). PATIENTS AND METHODS From May 1993 to January 1999, 63 symptomatic patients with all stages of MF and SS were treated in a prospective Phase II trial with systemic escalating doses of IFN‐α‐2a combined with PUVA for 1 year, followed by indefinite PUVA maintenance in complete responding patients. RESULTS Sixty‐three patients were enrolled (Stage IA, n = 6; IB, n = 37; IIA, n = 3; IIB, n = 3; III, n = 12; IVA, n = 2). Ten patients had received previous therapy. The median follow‐up duration for the entire cohort is 37 months. Of 63 patients, 51 achieved a complete response (CR; 74.6%) or partial response (PR; 6%) to therapy. The median response duration is 32 months. The 5‐year overall survival rate is 91% and the 5‐year disease‐free survival rate is 75%. No life‐threatening side effects were observed. Five patients stopped IFN‐α‐2a therapy due to toxicity. Eighty‐four percent of the patients received more than 75% of the planned dose (12 million units three times a week). CONCLUSIONS This combination of IFN‐α‐2a and phototherapy is an effective and safe therapy for patients with symptomatic MF. Cancer 2002;95:569–75. © 2002 American Cancer Society. DOI 10.1002/cncr.10706