Utility Of Photography To Confirm Skin Lesion Response Assessed Using A Severity Weighted Assessment Tool (Swat) In Cutaneous T-Cell Lymphoma (Ctcl)

6579 Background: In Oct 2006, FDA approved vorinostat for treatment of cutaneous manifestations of CTCL–based on response rate and duration of response observed in CTCL skin lesions. Response was determined by change in SWAT score at follow up compared to the baseline score. SWAT Score: sum of % Body Surface Area weighted by factor 1, 2, or 4 for patch (no elevation from normal skin), plaque (< 5 mm elevation) and tumor (= 5 mm elevation), respectively. All responses but one were partial. A partial response required = 50% reduction in whole body SWAT score lasting = 4 weeks. FDA also reviewed serial photographs of all patients (standard whole body views and close-ups of skin lesions), submitted as supportive evidence. Methods: An expert external reviewer, blind to SWAT scores, adjudicated responses by examining photographs and response determinations by photographs and by SWAT scores were compared. Results: Based on SWAT scores, skin lesions in 18 of 61 stage = IIB CTCL patients responded to vorinostat; there were 17 partial and 1 complete responses. Blinded reviewer adjudicated 4 photographs not evaluable (reasons: blurred image, color or light problem, wrong label), easily confirmed 7 responses, and called 7 responses equivocal. Responses seemed easier to determine in skin lesions with tumors or ulcers. Predominantly patch or plaque lesions were harder to evaluate: patches due to poor color reproduction and plaques due to inability to palpate. A response from plaque to patch morphology decreases SWAT score 50%, but the change may not manifest adequately in a photograph. Small sample size did not allow a reliable statistical analysis for correlation between different lesion types and ability to confirm objective responses (based on SWAT scores) by photography. Conclusions: Photography allows a limited evaluation of skin lesions in CTCL: inability to measure lesion thickness in photographs limits direct confirmation of SWAT scores. Photography complements SWAT evaluation: in half the cases in the vorinostat pivotal trial, a response by SWAT score was easily confirmed by the reviewer blind to SWAT scores. Further experience and technological advances in photography may reduce the number of not evaluable photographs. No significant financial relationships to disclose.