Table 1.
Demographic and clinical characteristics of individuals with NSCLC receiving ICI therapy overall and by irAE status by 1 year.
| Overall (n = 114) |
Neg-irAE (n = 62) |
Pos-irAE (n = 52) |
P-value | |
|---|---|---|---|---|
| Age, years | .171 | |||
| <65 | 54 (47.4) | 33 (53.2) | 21 (40.4) | |
| 65+ | 60 (52.6) | 29 (46.8) | 31 (59.6) | |
| Sex | .629 | |||
| Male | 62 (54.4) | 35 (56.5) | 27 (51.9) | |
| Female | 52 (45.6) | 27 (43.6) | 25 (48.1) | |
| Race | 1.000 | |||
| White | 92 (80.7) | 50 (80.7) | 42 (80.8) | |
| Black | 20 (17.5) | 11 (17.7) | 9 (17.3) | |
| Asian | 2 (1.8) | 1 (1.6) | 1 (1.9) | |
| Race | .987 | |||
| White | 92 (80.7) | 50 (80.7) | 42 (80.8) | |
| Non-White | 22 (19.3) | 12 (19.4) | 10 (19.2) | |
| Smoking status | .018 | |||
| Current | 13 (11.4) | 4 (6.5) | 9 (17.3) | |
| Former | 81 (71.1) | 51 (82.3) | 30 (57.7) | |
| Never | 20 (17.5) | 7 (11.3) | 13 (25.0) | |
| Marital status | .826 | |||
| Married | 87 (79.8) | 50 (82.0) | 37 (77.1) | |
| Single | 12 (11.0) | 6 (9.8) | 6 (12.5) | |
| Divorced | 10 (9.2) | 5 (8.2) | 5 (10.4) | |
| ECOG | .857 | |||
| 0 | 22 (19.3) | 12 (19.4) | 10 (19.2) | |
| 1 | 83 (72.8) | 46 (74.2) | 37 (71.2) | |
| 2+ | 9 (7.9) | 4 (6.5) | 5 (9.6) | |
| Stage at start of IO | .725 | |||
| III (III, IIIA, and IIIB) | 14 (12.3) | 7 (11.3) | 7 (13.5) | |
| IV | 100 (87.7) | 55 (88.7) | 45 (86.5) | |
| Sites of metastasis | ||||
| Brain | 18 (15.8) | 13 (21.0) | 5 (9.6) | .125 |
| Liver | 17 (14.9) | 9 (14.5) | 8 (15.4) | .897 |
| Tumor histology | .264 | |||
| Squamous | 30 (26.3) | 17 (27.4) | 13 (25.0) | |
| Adenocarcinoma | 76 (66.7) | 43 (69.4) | 33 (63.5) | |
| Large cell neuroendocrine | 3 (2.6) | 0 (0.0) | 3 (5.8) | |
| Poorly differentiated carcinoma | 3 (2.6) | 1 (1.6) | 2 (3.9) | |
| Sarcomatoid | 1 (0.9) | 1 (1.6) | 0 (0) | |
| Adenosquamous | 1 (0.9) | 0 (0.0) | 1 (1.9) | |
| Oncogenic driver mutations | ||||
| EGFR | 4 (4.3) | 4 (7.8) | 0 (0) | .122 |
| ROS-1 | 2 (3.9) | 2 (7.7) | 0 (0) | .255 |
| KRAS | 32 (36.8) | 23 (50.0) | 9 (22.0) | .007 |
| BRAF | 4 (5.3) | 1 (2.6) | 3 (8.3) | .345 |
| RET | 2 (4.8) | 2 (10.5) | 0 (0) | .199 |
| MET | 3 (7.3) | 0 (0.0) | 3 (13.0) | .243 |
| PD-L1 status | .658 | |||
| Unknown | 69 (60.5) | 37 (59.7) | 32 (61.5) | |
| 0% | 13 (11.4) | 6 (9.7) | 7 (13.5) | |
| 1%-49% | 8 (7.0) | 4 (6.5) | 4 (7.7) | |
| 50+% | 24 (21.1) | 15 (24.2) | 9 (17.3) | |
| Treatment type | .682 | |||
| SOC | 59 (51.8) | 31 (50.0) | 28 (53.9) | |
| Clinical trial | 55 (48.3) | 31 (50.0) | 24 (46.2) | |
| Number of doses, median (IQR) | 13 (19) | 12.5 (19) | 14.5 (17) | .853 |
| Duration of therapy, median (IQR) | 251 (362) | 258 (542) | 246 (304) | .975 |
| Number of prior systemic therapies | .015 | |||
| 0 | 39 (34.2) | 14 (22.6) | 25 (48.1) | |
| 1 | 55 (48.3) | 36 (58.1) | 19 (36.5) | |
| 2+ | 20 (17.5) | 12 (19.4) | 8 (15.4) | |
| Prior chemotherapy | 75 (65.8) | 48 (77.4) | 27 (51.9) | .004 |
| Prior targeted therapy | 5 (4.4) | 5 (8.1) | 0 (0) | .062 |
| Prior other systemic therapy | 4 (3.5) | 2 (3.2) | 2 (3.9) | 1.000 |
| Number of subsequent systemic therapies | .424 | |||
| 0 | 55 (48.2) | 27 (43.6) | 28 (53.9) | |
| 1 | 23 (20.2) | 12 (19.4) | 11 (21.2) | |
| 2 | 24 (21.1) | 14 (22.6) | 10 (19.2) | |
| 3-9 | 12 (10.5) | 9 (14.5) | 3 (5.8) | |
| Monotherapy | .707 | |||
| Nivolumab | 44 (58.7) | 27 (60.0) | 17 (56.7) | |
| Pembrolizumab | 21 (28.0) | 11 (24.4) | 10 (33.3) | |
| Durvalumab | 8 (10.7) | 5 (11.1) | 3 (10.0) | |
| MDX-1105 | 2 (2.7) | 2 (4.4) | 0 (0) | |
| Combination therapy | 1.000 | |||
| Dual IO | 14 (35.9) | 6 (35.3) | 8 (36.4) | |
| IO + chemotherapy | 12 (30.8) | 5 (29.4) | 7 (31.8) | |
| IO + other | 13 (33.3) | 6 (35.3) | 7 (31.8) | |
| Best response to IO | .007 | |||
| Progressive disease | 10 (8.8) | 10 (16.1) | 0 (0) | |
| Complete response | 7 (6.1) | 2 (3.2) | 5 (9.6) | |
| Partial response | 48 (42.1) | 25 (40.3) | 23 (44.2) | |
| Stable disease | 49 (43.0) | 25 (40.3) | 24 (46.2) |