Table 2.
Case no. | Pt sex | Age | cGVHD dx to study entry (Wks) | No. prior lines tx | Sites involved and cGVHD severity at study entry | LD IL-2 course (Wks) | Response at Week 8 or Week 12 | Best overall response | Reason for d/c IL-2 | IL-2 stop to last f/u (Wks) | cGVHD status at last f/u | Systemic IS at last f/u |
---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | M | 48 | 161 | 1 | Skin, JMF; severe | 74 | PR | PR | Plateaued response | 599 | Improving subcutaneous fibrosis | None |
2 | M | 65 | 72 | 3 | Skin, JMF; moderate | 132 | PR | PR | Plateaued response, difficulty finding injection sites | 191 | Stable thickened skin | sirolimus, LD prednisone |
3 | F | 22 | 70 | 3 | Skin, eyes, JMF; severe | 86 | PR | PR | Plateaued response | 204 | No active disease; hyperpigmented skin | None |
4 | F | 46 | 13 | 2 | Mouth, eyes, liver, GU; moderate | 258 | PR | CR (liver); PR (eyes and mouth) | Stabilized disease, mild fatigue and difficulty picking up IL-2 supply | 234 | Mild oral and ocular GVHD | None |
5 | M | 29 | 27 | 1 | Skin, lung, liver, GI, JMF; moderate | 244 | PR | PR | Plateaued response | 244 | No active disease | None |
6 | F | 50 | 71 | 2 | Skin, mouth, JMF; severe | 138 | PR | PR | Stabilized disease, difficulty picking up IL-2 supply | 190 | Stable minimal skin cGVHD | None |
7 | M | 61 | 17 | 2 | Skin, eyes, JMF; moderate | 24 | SD/MR | SD/MR | Difficulty with daily injections | 442 | Minimal cGVHD of the eyes, well-controlled | None |
8 | F | 22 | 50 | 2 | Skin, mouth, eyes, lung, liver, GU; moderate | 102 | PR | PR | Patient decision | 227* | Stable respiratory status on trach/vent#, active skin cGVHD | Tacrolimus, prednisone |
9 | M | 68 | 226 | 1 | Mouth, eyes, lung; moderate | 57 | SD/MR | SD/MR | Plateaued response | 383 | No active disease | None |
10 | F | 70 | 32 | 2 | Skin, mouth, eyes, lung, liver, JMF; moderate | 94 | SD/MR | SD/MR | Plateaued response, side effects (anorexia and fatigue) | 343 | Continued sclerodermatous skin | Ruxolitinib, LD prednisone |
11 | F | 45 | 10 | 1 | Skin, mouth, eyes, liver, GU; moderate | 21 | PR | PR | Plateaued response | 432 | Persistent dry eyes, dry mouth; mild skin involvement | Ruxolitinib |
12 | F | 34 | 34 | 2 | Skin, eyes, lung, JMF; moderate | 80 | SD/MR | SD/MR | Stabilized disease, difficulty picking up IL-2 supply | 92 | No active disease | None |
13 | M | 48 | 116 | 2 | Skin, mouth, eyes, JMF; moderate | 84 | SD/MR | SD/MR | Plateaued response | 141 | Persistent mild skin and JMF involvement | None |
14 | M | 44 | 241 | 7 | Skin, JMF; severe | 104 | SD/MR | SD/MR | Plateaued response | 206 | Persistent severe cGVHD of skin and JMF | Sirolimus, ibrutinib |
15 | F | 59 | 29 | 2 | Skin, JMF; severe | 106 | PR | CR | Resolved cGVHD | 148 | No residual disease | None |
16 | M | 57 | 26 | 3 | Skin, mouth, liver; moderate | 83 | PR | PR | Patient decision | 201 | Residual scleroderma | None |
17 | F | 59 | 30 | 3 | Skin, eyes, lung, JMF; moderate | 177 | SD/MR | PR | Plateaued response, side effects | 119 | Some residual tightness of skin | None |
18 | F | 76 | 128 | 3 | Skin, eyes, JMF; severe | 121 | SD/MR | SD/MR | Plateaued response; CLL relapse | 196 | Residual scleroderma | Ibrutinib |
19 | F | 65 | 41 | 2 | Skin, lung, JMF; moderate | 57 | SD | PR | Plateaued response | 238 | No active disease | None |
20 | F | 21 | 121 | 2 | Mouth, eyes, GI; moderate | 123 | Mixed | PR | Plateaued response | 137 | Persistent eye involvement | None |
21 | M | 12 | 41 | 2 | Skin, mouth, lung; moderate | 141 | PR | CR | Plateaued response | 100 | No active disease; hyperpigmented skin | None |
22 | M | 2 | 16 | 2 | Skin, mouth, liver, JMF; moderate | 139 | PR | PR | Plateaued response | 101 | No active disease; residual hyperpigmented skin and joint contractures | None |
*Patient died of multisystem organ failure after a prolonged hospitalization for appendicitis.
# Patient had progression of lung cGVHD after an infection and underwent tracheostomy with ventilator dependence.
cGVHD, chronic graft-versus-host disease; CLL, chronic lymphocytic leukemia; CR, complete response; Dx, diagnosis; D/c, discontinue; F/u, follow up; GI, gastrointestinal tract; GU, genitourinary tract; IS, immunosuppression; JMF, joint/muscle/fascia; LD, low dose; No., number; PR, partial response; Pt, patient; SD/MR, stable disease with minor response; Trach, tracheostomy; Tx, treatment; Vent, ventilator; Wks, weeks.