Characteristics and outcome of immune checkpoint inhibition therapy for non-resectable skin cancer
| MM | cSCC | MCC | |||||||
| Hemato Mal N (%) | No Hemato Mal N (%) | P value | Hemato Mal N (%) | No Hemato Mal N (%) | P value | Hemato Mal N (%) | No Hemato Mal N (%) | P value | |
| Total | 44 (100%) | 257 (100%) | 15 (100%) | 59 (100%) | 16 (100%) | 76 (100%) | |||
| Therapy type | <0.001 | 0.84 | 0.58 | ||||||
| Anti-PD-1 | 32 (72.7%) | 178 (69.3%) | 15 (100%) | 57 (96.6%) | 8 (50.0%) | 30 (39.5% | |||
| Anti-PD-L1 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 8 (50.0%) | 46 (60.5%) | |||
| Anti-CTLA-4 | 5 (11.4%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |||
| Combinations | 7 (15.9%) | 79 (30.7%) | 0 (0.0%) | 2 (3.4%) | 0 (0.0%) | 0 (0.0%) | |||
| Best overall response | 0.17 | 0.46 | 0.77 | ||||||
| CR | 2 (4.5%) | 23 (8.9%) | 1 (6.7%) | 8 (13.6%) | 0 (0.0%) | 19 (25.0%) | |||
| PR | 12 (27.3%) | 47 (18.3%) | 3 (20.0%) | 12 (20.3%) | 3 (18.8%) | 20 (26.3%) | |||
| SD | 11 (25.0%) | 59 (23.0%) | 4 (26.7%) | 12 (20.3%) | 4 (25.0%) | 11 (14.5%) | |||
| PD | 14 (31.8%) | 128 (49.8%) | 7 (46.7%) | 15 (25.4%) | 8 (50.0%) | 26 (34.2%) | |||
| NE | 5 (11.4%) | 0 (0.0%) | 0 (0.0%) | 12 (20.3%) | 1 (6.3%) | 0 (0.0%) | |||
| Objective response | 14 (31.8%) | 70 (27.2%) | 0.66 | 4 (26.7%) | 20 (33.8%) | 0.82 | 3 (18.8%) | 39 (51.3%) | 0.035 |
| Disease control | 25 (56.8%) | 129 (50.2%) | 0.52 | 8 (53.3%) | 32 (54.2%) | 0.82 | 7 (43.8%) | 50 (65.7%) | 0.17 |
| Disease progression | 0.056 | 0.032 | 0.95 | ||||||
| Yes | 29 (65.9%) | 126 (49.0%) | 11 (73.3%) | 18 (30.5%) | 10 (62.5%) | 44 (57.9%) | |||
| No | 15 (34.1%) | 131 (50.9%) | 4 (26.7%) | 30 (50.8%) | 6 (37.5%) | 32 (42.1%) | |||
| NE | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 11 (18.6%) | 0 (0.0%) | 0 (0.0%) | |||
| Consecutive therapy | 0.10 | 0.26 | 0.076 | ||||||
| None | 28 (63.6%) | 136 (52.9%) | 8 (53.3%) | 28 (47.5%) | 8 (50.0%) | 38 (50.0%) | |||
| Immunotherapy | 11 (25.0%) | 66 (25.7%) | 1 (6.7%) | 3 (5.1%) | 5 (31.2%) | 5 (6.5%) | |||
| Targeted therapy | 1 (2.3%) | 28 (10.9%) | 1 (6.7%) | 3 (5.1%) | 0 (0.0%) | 0 (0.0%) | |||
| Chemotherapy | 2 (4.5%) | 22 (8.6%) | 5 (33.3%) | 4 (6.8%) | 2 (12.5%) | 13 (17.1%) | |||
| Other/NE | 3 (6.8%) | 5 (1.9%) | 0 (0.0%) | 21 (35.5%) | 1 (6.2%) | 20 (26.2%) | |||
| Death | 0.056 | 0.38 | 0.88 | ||||||
| Yes | 13 (29.5%) | 119 (46.3%) | 5 (33.3%) | 11 (18.6%) | 7 (43.8%) | 31 (40.8%) | |||
| No | 31 (70.5%) | 138 (53.7%) | 10 (66.7%) | 48 (81.4%) | 10 (56.3%) | 45 (59.2%) | |||
| Cause of death | – | 0.95 | 0.70 | ||||||
| Skin cancer | 4 (30.8%) | nr | 3 (50.0%) | 10 (90.9%) | 4 (57.1%) | 18 (58.1%) | |||
| Hematological malignancy | 2 (15.4%) | nr | 1 (20.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |||
| Other/unknown | 7 (53.8%) | nr | 1 (20.0%) | 1 (9.1%) | 3 (42.9%) | 13 (41.9%) | |||
| PFS | 0.96 | 0.002 | 0.42 | ||||||
| Median (95% CI) | 8.4 mo (3.9 to 12.8) | 5.8 mo (3.9 to 7.8) | 4.0 mo (0.3 to 7.9) | Not reached | 5.7 mo (0.7 to 10.7) | 11.9 mo (6.2 to 17.8) | |||
| 1-year PFS rate (95% CI) | 34.7% (19.3 to 50.1) | 38.5% (32.2 to 44.7) | 11.8% (0 to 31.9) | 60.4% (44.7 to 76.1) | 35.3% (9.4 to 61.8) | 48.3% (36.5 to 60.6) | |||
| OS | 0.27 | 0.12 | 0.61 | ||||||
| Median (95% CI) | Not reached | 27.5 mo (18.1 to 36.8) | 14.9 mo (0.1 to 31.2) | Not reached | 11.7 mo (10.3 to 22.4) | 21.1 mo (16.2 to 25.9) | |||
| 1-year OS rate (95% CI) | 78.4% (65.1 to 91.7) | 70.6% (64.5 to 76.6) | 65.8% (38.2 to 93.4) | 74.6% (60.5 to 88.7) | 47.4% (16.1 to 78.7) | 69.3% (58.0 to 80.8) | |||
Data for immune checkpoint inhibition (ICI) therapy, outcome and follow-up are given for each skin cancer entity in n=75 patients with and n=392 patients without concomitant hematological malignancy (Hemato Mal). Treatment response is presented as best response recorded from the start of treatment until disease progression.
anti-CTLA-4, ipilimumab; anti-PD-1, nivolumab or pembrolizumab; anti-PD-L1, avelumab; CR, complete response; CR+PR, objective response; CR+PR+SD, disease control; cSCC, cutaneous squamous cell carcinoma; MCC, Merkel cell carcinoma; MM, malignant melanoma; mo, months; NE, not evaluable; nr, not reported; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease.