Figure 1. Regression of cutaneous Kaposi sarcoma in 2 participants after treatment with pembrolizumab.


Modified AIDS Clinical Trials Group Criteria for Kaposi sarcoma assessment of cutaneous lesions includes measures of the total number of lesions, number of nodular lesions, and sum of the area of five marker lesions. When more than 50 lesions are present, a representative area of the body is identified, and lesions are counted and measured only within this area. Panel A shows photos of the right lower extremity of a 33-year-old participant with baseline CD4+ T cell count of 526 cells/μL and T1 Kaposi sarcoma (KS) involving the lungs and skin previously treated with liposomal doxorubicin, pomalidomide, and paclitaxel. Panel B shows a reduction in the number of lesions in the right lower extremity after 4 cycles of pembrolizumab. Panel C shows the percent change from baseline in total number of lesions, number of nodular lesions, total area of the five marker lesions, CD4+ T-cell counts, and CD8+ T-cell counts with pembrolizumab treatment. At baseline, the participant had more than 50 lesions and a representative area on the arms and legs was identified. Within the representative area, 28 total lesions, 9 nodular lesions, and five marker lesions with total area of 760 mm3 were identified. At cycle 13 day 1, the total number of lesions had reduced to 10 and the total area had reduced to 480 mm3. Panels D and E show photos of the plantar surface of the feet of a 53-year-old man with baseline CD4+ T cell count of 169 cells/μL and T1 KS previously treated with liposomal doxorubicin, paclitaxel, and pomalidomide. Panels E and F show the same participant’s feet with a reduction in the number and nodularity of the cutaneous KS lesions after 8 cycles of pembrolizumab. Panel H shows the percent change from baseline of the total number of lesions, number of nodular lesions, total area of the 5 marker lesions, and CD4+ and CD8+ T-cell counts. At baseline, the participant had more than 50 lesions and a representative area on the arms and torso was identified. Within the representative area, 27 total lesions, 18 nodular lesions, and five marker lesions with total area of 2250 mm3 were identified. At cycle 9 day 1, the total number of lesions had reduced to 11 and there were zero nodular lesions in the representative area.