First insights from phase II, open-label, single-arm study on efficacy of extracorporeal photopheresis (ECP) in early-stage mycosis fungoides

Summary: Abstract Body: We aimed to evaluate the efficacy of extracorporeal photopheresis (ECP) therapy among early-stage cutaneous T-cell lymphoma (CTCL) patients with minor peripheral blood involvement using mSWAT, flow cytometry, and quality of life (QoL) questionnaires. ECP has a favorable side effect profile but is currently used for patients with advanced CTCL. Patients received 2 ECP treatments every 2 weeks for at least 3 months, with mSWAT assessed monthly for the first 3 months and then bi-monthly. After 3 months, patients could decrease to monthly ECP treatments. Every 3 months throughout the study, blood involvement was assessed via flow cytometry, and the Skindex-29, FACT-G, and SF-36 QOL questionnaires were completed. Three patients completed the study, with average follow-up time of 14.3 months (range: 12.4 - 18.2 months). Two patients were stage 1A; one was 1B. On enrollment, mSWAT ranged from 1.7 to 11 and the number of CD4+/CD26- cells ranged from 150 to 890. From initial study visit to last follow-up, mSWAT decreased on average by 97% (range: 90%-100%). At three months, mSWAT had decreased by 64% on average (range: -37.7% to -95.45%). Flow cytometry over 9 months showed an average reduction in the number of CD4+/CD26- cells of 44.4% (range: 26.67-69.44%). Over 9 months, FACT-G scores increased on average by 14%, demonstrating slight improvement in overall QoL. Importantly, ECP did not negatively affect patients’ QoL. Our preliminary results provide a comprehensive and granular investigation of ECP’s effectiveness and impact on quality of life for patients with early-stage disease, suggesting a promising use case for this well-studied and well-tolerated treatment. Sara Suhl¹, Julie Sung², Alexander Kaminsky¹, Brigit Lapolla², Oleg Akilov³, Michael Girardi⁴, Ellen Kim⁵, Sima Rozati⁶, Larisa J. Geskin² 1. Columbia University Vagelos College of Physicians and Surgeons, New York, NY, United States. 2. New York-Presbyterian/Columbia University Irving Medical Center, New York, NY, United States. 3. UPMC, Pittsburgh, PA, United States. 4. Yale New Haven Health, New Haven, CT, United States. 5. Penn Medicine, Philadelphia, PA, United States. 6. Johns Hopkins Medicine, Baltimore, MD, United States. Clinical Research: Interventional Research