Table 3. Impact of immune-related adverse events on response to PD-1 inhibitors therapy.
| Total (n=93) | Number of irAEs | irAEs grade | |||||
| Any (n=54) | None (n=39) | 1-2 (n=31) | ≥3 (n=23) | 1-2 (n=46) | 3-4 (n=8) | ||
| CR, n (%) | 2(2.2) | 2(3.7) | 0(0.0) | 0(0.0) | 2(8.7) | 2(4.3) | 0(0.0) |
| PR, n (%) | 19(20.4) | 16(29.6) | 3(7.7) | 6(19.4) | 10(43.5) | 15(32.6) | 1(12.5) |
| SD, n (%) | 17(18.3) | 11(20.4) | 6(15.4) | 5(16.1) | 6(26.1) | 8(17.4) | 3(37.5) |
| PD, n (%) | 55(59.1) | 25(46.3) | 30(76.9) | 20(64.5) | 5(21.7) | 21(45.7) | 4(50.0) |
| ORR, % (95% CI) | 22.6 (14.0-32.3) | 33.3 (20.4-46.3) | 7.7 (0.0-17.9) | 19.4 (6.5-35.5) | 42.2 (30.4-69.6) | 40.0 (23.9-50.0) | 12.5 (0.0-37.5) |
| P1 | 0.004a | 0.148a | <0.001a | 0.002a | 0.657a 0.176c | ||
| DCR, % (95% CI) | 40.9 (31.2-51.6) | 53.7 (38.9-66.7) | 23.1 (10.3-38.5) | 35.5 (19.4-51.6) | 78.3 (60.9-95.7) | 54.3 (41.3-69.6) | 50.0 (12.5-87.5) |
| P2 | 0.003a | 0.254a | <0.001a <0.001b | 0.003a | 0.121a 0.820c | ||
Abbreviations: irAEs, immune-related adverse events; CR, complete remission; PR, partial remission; SD, stable disease; PD, progressive disease; ORR, objective response rate; DCR, Disease control rate
a Versus no immune-related adverse events.
b Versus 1-2 immune-related adverse events.
c Versus Grade 1-2 immune-related adverse events.