Baseline characteristics | Melanoma cohort | Modified melanoma cohort | NSCLC cohort | ||||||
ICI+COXi (n=32) | ICI alone (n=58) | P value | ICI+COXi (n=26) | ICI alone (n=43) | P value | ICI+COXi (n=20) | ICI alone (n=17) | P value | |
Age (years) | |||||||||
Mean (SD) | 69.1 (11.4) | 63.2 (11) | 0.017 | 69.4 (11.5) | 64.8 (11.6) | 0.12 | 68 (9.9) | 66.2 (9.5) | 0.585 |
Median (range) | 69 (34–91) | 60 (41–89) | 0.006 | 69 (34–91) | 62 (41–69) | 0.049 | 65.5 (55–86) | 67 (50–82) | 0.737 |
Pretreatment NLR | |||||||||
High (>5) | 10 (32.3) | 18 (34) | 1 | 8 (30.8) | 16 (38.1) | 0.608 | 5 (25) | 10 (62.5) | 0.041 |
Low (≤5) | 21 (67.7) | 35 (66) | 18 (69.2) | 26 (61.9) | 15 (75) | 6 (37.5) | |||
Gender | |||||||||
Female | 10 (31.3) | 22 (37.9) | 0.647 | 9 (34.6) | 16 (37.2) | 1 | 16 (80) | 12 (70.6) | 0.703 |
Male | 22 (68.7) | 36 (62.1) | 17 (65.4) | 27 (62.8) | 4 (20) | 5 (29.4) | |||
BRAF mutation | |||||||||
WT | 21 (65.6) | 36 (62.1) | 0.672 | 18 (69.2) | 25 (58.2) | 0.576 | – | – | – |
Mutant | 7 (21.9) | 17 (29.3) | 5 (19.3) | 13 (30.2) | – | – | |||
Unknown | 4 (12.5) | 5 (8.6) | 3 (11.5) | 5 (11.6) | – | – | |||
Histology | |||||||||
Adenocarcinoma | – | – | – | – | – | – | 16 (80) | 12 (70.6) | 0.703 |
SCC | – | – | – | – | 4 (20) | 5 (29.4) | |||
Tumor mutation burden | |||||||||
High (≥10 mut/Mb) | 9 (28.1) | 12 (20.7) | – | 8 (30.8) | 10 (23.3) | – | 11 (55) | 7 (41.2) | – |
Low (<10 mut/Mb) | 6 (18.8) | 8 (13.8) | 6 (23.1) | 7 (16.3) | 1 (5) | 5 (29.4) | |||
Unknown | 17 (53.1) | 38 (65.5) | 12 (46.2) | 26 (60.5) | 8 (40) | 5 (29.4) | |||
ECOG | |||||||||
0 | 20 (62.5) | 31 (53.5) | 0.317 | 17 (65.4) | 22 (51.2) | 0.203 | 0 (0) | 1 (6.2) | 0.381 |
1 | 11 (34.4) | 19 (32.8) | 8 (30.8) | 13 (30.2) | 19 (95) | 13 (81.3) | |||
2 | 1 (3.1) | 8 (13.8) | 1 (3.8) | 8 (18.6) | 1 (5) | 2 (12.5) | |||
Type of ICI | |||||||||
αCTLA-4 | 8 (25) | 22 (37.9) | 0.126 | 6 (23.1) | 11 (25.6) | 0.509 | 0 (0) | 0 (0) | – |
αPD-(L)1 | 20 (62.5) | 23 (40) | 16 (61.5) | 21 (48.8) | 20 (100) | 17 (100) | |||
αCTLA-4 + αPD-1 | 4 (12.5) | 13 (22.4) | 4 (15.4) | 11 (25.6) | 0 (0) | 0 (0) | |||
Type of COXi | |||||||||
Aspirin | 21 (65.6) | – | – | 16 (61.5) | – | – | 6 (30) | – | – |
NSAIDs | 7 (21.9) | – | 6 (23.1) | – | 12 (60) | – | |||
Combination | 4 (12.5) | – | 4 (15.4) | – | 2 (10) | – | |||
Reason for COXi use | |||||||||
Cardiovascular | 25 (78.1) | – | – | 20 (76.9) | – | – | 8 (40) | – | – |
Chronic pain/arthritis | 3 (9.4) | – | 3 (11.5) | – | 4 (20) | – | |||
Cancer pain | 3 (9.4) | – | 2 (7.7) | – | 6 (30) | – | |||
Ulcerative colitis | 0 (0) | – | 0 (0) | – | 1 (5) | – | |||
Unknown | 1 (3.1) | – | 1 (3.8) | – | 1 (5) | – | |||
COXi duration with ICI | |||||||||
<8 weeks | 3 (9.4) | – | – | 2 (7.7) | – | – | 2 (10) | – | – |
8–26 weeks | 15 (46.9) | – | 12 (46.2) | – | 6 (30) | – | |||
>26 weeks | 14 (43.8) | – | 12 (46.2) | – | 12 (60) | – | |||
Aspirin dose | |||||||||
81 mg daily | 19 (76) | – | – | 14 (70) | – | – | 8 (100) | – | – |
162 mg daily | 2 (8) | – | 2 (10) | – | 0 (0) | – | |||
325 mg daily | 2 (8) | – | 2 (10) | – | 0 (0) | – | |||
Other/unknown | 2 (8) | – | 2 (10) | – | 0 (0) | – | |||
Steroid use | |||||||||
Yes | 16 (50) | 32 (56.1) | 0.66 | 14 (53.9) | 26 (60.5) | 0.623 | 8 (40) | 10 (58.8) | 0.33 |
No | 16 (50) | 25 (43.9) | 12 (46.1) | 17 (39.5) | 12 (60) | 7 (41.2) | |||
Prior IT treatment | |||||||||
Yes | 4 (12.5) | 8 (13.8) | 1 | 4 (15.4) | 6 (14) | 1 | 1 (5) | 0 (0) | 1 |
No | 28 (87.5) | 50 (86.2) | 22 (84.6) | 37 (86) | 19 (95) | 17 (100) | |||
Reason for stopping ICI | |||||||||
POD | 9 (28.1) | 36 (62.1) | 0.007 | 8 (30.8) | 28 (65.1) | 0.015 | 12 (60) | 13 (76.5) | 0.474 |
irAE | 6 (18.8) | 5 (8.6) | 4 (15.4) | 5 (11.6) | 2 (10) | 0 (0) | |||
Completed/ongoing | 17 (53.1) | 17 (29.3) | 14 (53.8) | 10 (23.3) | 6 (30) | 4 (23.5) | |||
ICI-related toxicity | |||||||||
None | 7 (21.9) | 16 (28.1) | 0.222 | 4 (15.4) | 12 (27.9) | 0.187 | 11 (55) | 9 (52.9) | 0.15 |
Grade 1 | 7 (21.9) | 18 (31.6) | 7 (26.9) | 15 (34.9) | 0 (0) | 3 (17.7) | |||
Grade 2 | 15 (46.9) | 14 (24.6) | 12 (46.2) | 9 (20.9) | 9 (45) | 5 (29.4) | |||
Grade 3/4 | 3 (9.4) | 9 (15.8) | 3 (11.5) | 7 (16.3) | 0 (0) | 0 (0) |
Data are given as No. (%).
COXi, cyclo-oxygenase inhibitors; αCTLA-4, cytotoxic T-lymphocyte-associated protein 4 antibody; ECOG, Eastern Cooperative Oncology Group; ICI, immune checkpoint inhibitor; irAE, immune-related adverse events; IT, immunotherapy; NLR, neutrophil-to-lymphocyte ratio; NSAIDs, non-steroidal anti-inflammatory drugs; NSCLC, non-small cell lung cancer; αPD-(L)1, programmed cell death protein (ligand) 1 antibody; POD, progression of disease; SCC, squamous cell carcinoma; WT, wild-type.