Multicenter Trial of Photopheresis in Early Stage Mycosis Fungoides

Extracorporeal photopheresis (ECP) has been approved for 20 years for patients with erythrodermic MF or Sézary syndrome (SS) with circulating atypical T-cells. The response rate of 54% was based on 25% improvement in erythema. ECP has not widely been used to treat patients with early stage MF. The objective of this multicenter single-arm open-label study was to determine the efficacy of UVAR^® XTSÔ Photopheresis System in early stage MF with measurable skin lesions. Patients were eligible at stage IA if there was with minor blood involvement (B1), or at IB- IIA MF with or without minor blood involvement (B1). Patients had to be refractory to at least one treatment for early MF such as PUVA, electron beam, oral or topical high potency steroids, topical mustragen, oral methotrexate, alpha interferon, or bexarotene. Two photopheresis treatments were given on successive days every 4 weeks for six months. There were 13 evaluable patients treated with ECP (4 males/9 females; 12 Caucasians, 1 African-American) whose median age was 61 yrs (range 46–85). Their stages were IA (n=3), IB (n=8) and IIA (n=2). Patients received a median of 12 ECP sessions (range 4–42+) over a median of 6 months (range 5–22). The overall response rate of 54% (7 of 13) required a ≥50% improvement in the baseline body surface area involved with patches or plaques. The median time to response was 6 months (range 3–8 months) and median duration of response was 6 mos (range 2–30 mos). The protocol allowed additional therapy if patients failed to improve by month 3. ECP alone was effective in four of ten patients (40%) and the other three patients had partial response with combined therapy: two with low dose bexarotene (150 mg) added at 4 or 6 mos and a third with bexarotene, interferon, and PUVA at 6 mos. Only 2 of 13 patients progressed and four had stable disease. There were no photopheresis related adverse events other than mild post-ECP erythema in one patient. One patient developed central right arterial occlusion with left eye visual defect unrelated to the ECP. In conclusion, photopheresis had a 54% response rate for all 13 patients and a 40% response rate to ECP alone in 10 early stage MF patients without adverse side effects suggesting it could be successfully used to treat early MF patients.