Table:
Demographics and clinical characteristics of patients in the MD Anderson cohort
| Training Cohort |
Validation Cohort |
p value* | Testing Cohort |
p value† | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Patients alive at data cutoff (n=294) | Patients who died (n=270) | p value‡ | Patients alive at data cutoff (n=40) | Patients who died (n=38) | p value‡ | Patients alive at data cutoff (n=140) | Patients who died (n=134) | p value‡ | |||
| Mean age, years | 64·9 (10·8) | 65·3 (9·6) | 0·46 | 62·9 (10·5) | 65·4 (10·3) | 0·17 | 0·61 | 65·8 (9·5) | 65·9 (8·9) | 0·50 | 0·51 |
| Sex | ·· | ·· | 1·0 | ·· | ·· | 0·17 | 0·78 | ·· | ·· | 0·44 | 0·92 |
| Female | 133 (45%) | 125 (46%) | ·· | 22 (55%) | 15 (39%) | ·· | ·· | 66 (47%) | 57 (43%) | ·· | ·· |
| Male | 161 (55%) | 145 (54%) | ·· | 18 (45%) | 23 (61%) | ·· | ·· | 74 (53%) | 77 (57%) | ·· | ·· |
| Histology | ·· | ·· | 0·25 | ·· | ·· | 0·098 | 0·78 | ·· | ·· | 0·31 | 0·47 |
| Adenocarcinoma | 242 (82%) | 209 (77%) | ·· | 36 (90%) | 29 (76%) | ·· | ·· | 108 (77%) | 100 (75%) | ·· | ·· |
| Squamous cell carcinoma | 41 (14%) | 44 (16%) | ·· | 2 (5%) | 8 (21%) | ·· | ·· | 25 (18%) | 21 (16%) | ·· | ·· |
| Other | 11 (4%) | 17 (6%) | ·· | 2 (5%) | 1 (3%) | ·· | ·· | 7 (5%) | 13 (10%) | ·· | ·· |
| Smoking history | ·· | ·· | 0·32 | ·· | ·· | 0·80 | 0·25 | ·· | ·· | 0·023 | 0·33 |
| Current | 44 (15%) | 43 (16%) | ·· | 7 (18%) | 7 (18%) | ·· | ·· | 36 (26%) | 17 (13%) | ·· | ·· |
| Former | 191 (65%) | 186 (69%) | ·· | 28 (70%) | 28 (74%) | ·· | ·· | 84 (60%) | 93 (69%) | ·· | ·· |
| Never | 59 (20%) | 41 (15%) | ·· | 5 (13%) | 3 (8%) | ·· | ·· | 20 (14%) | 24 (18%) | ·· | ·· |
| Stage immune checkpoint inhibitors started | ·· | ·· | <0·0001 | ·· | ·· | 0·014 | 0·79 | ·· | ·· | 0·034 | 0·96 |
| IVA | 130 (44%) | 74 (27%) | ·· | 19 (48%) | 8 (21%) | ·· | ·· | 59 (42%) | 40 (30%) | ·· | ·· |
| IVB | 164 (56%) | 196 (73%) | ·· | 21 (53%) | 30 (79%) | ·· | ·· | 81 (58%) | 94 (70%) | ·· | ·· |
| Liver metastasis | ·· | ·· | 0·021 | ·· | ·· | 0·31 | 0·76 | ·· | ·· | 0·15 | 0·39 |
| No | 259 (88%) | 219 (81%) | ·· | 35 (88%) | 30 (79%) | ·· | ·· | 127 (91%) | 114 (85%) | ·· | ·· |
| Yes | 35 (12%) | 51 (19%) | ·· | 5 (13%) | 8 (21%) | ·· | ·· | 13 (9%) | 20 (15%) | ·· | ·· |
| Adrenal metastasis | ·· | ·· | 0·071 | ·· | ·· | 0·92 | 0·84 | ·· | ·· | 0·34 | 0·94 |
| No | 252 (86%) | 216 (80%) | ·· | 33 (83%) | 31 (82%) | ·· | ·· | 118 (84%) | 107 (80%) | ·· | ·· |
| Yes | 42 (14%) | 54 (20%) | ·· | 7 (18%) | 7 (18%) | ·· | ·· | 22 (16%) | 27 (20%) | ·· | ·· |
| Bone metastasis | ·· | ·· | 0·0021 | ·· | ·· | 0·013 | 0·68 | ·· | ·· | 0·023 | 0·63 |
| No | 191 (65%) | 141 (52%) | ·· | 28 (70%) | 16 (42%) | ·· | ·· | 87 (62%) | 65 (49%) | ·· | ·· |
| Yes | 103 (35%) | 129 (48%) | ·· | 12 (30%) | 22 (58%) | ·· | ·· | 53 (38%) | 69 (51%) | ·· | ·· |
| Brain metastasis | ·· | ·· | 0·40 | ·· | ·· | 0·48 | 0·18 | ·· | ·· | 0·12 | 0·39 |
| No | 204 (69%) | 196 (73%) | ·· | 30 (75%) | 31 (82%) | ·· | ·· | 105 (75%) | 89 (66%) | ·· | ·· |
| Yes | 90 (31%) | 74 (27%) | ·· | 10 (25%) | 7 (18%) | ·· | ·· | 35 (25%) | 45 (34%) | ·· | ·· |
| Line of immune checkpoint inhibitor therapy | ·· | ·· | <0·0001 | ·· | ·· | 0·27 | 0·73 | ·· | ·· | 0·0049 | 0·89 |
| 1 | 212 (72%) | 138 (51%) | ·· | 28 (70%) | 22 (58%) | ·· | ·· | 100 (71%) | 74 (55%) | ·· | ·· |
| ≥2 | 82 (28%) | 132 (49%) | ·· | 12 (30%) | 16 (42%) | ·· | ·· | 40 (29%) | 60 (45%) | ·· | ·· |
| Therapy regimen | ·· | ·· | <0·0001 | ·· | ·· | 0·15 | 0·61 | ·· | ·· | 0·14 | 0·87 |
| Anti-PD-1 immune checkpoint inhibitor monotherapy | 119 (40%) | 154 (57%) | ·· | 17 (43%) | 18 (47%) | ·· | ·· | 68 (49%) | 66 (49%) | ·· | ·· |
| Anti-PD-L1 immune checkpoint inhibitor monotherapy | 14 (5%) | 17 (6%) | ·· | 0 | 5 (13%) | ·· | ·· | 4 (3%) | 11 (8%) | ·· | ·· |
| <1 immune checkpoint inhibitor combination | 39 (13%) | 23 (9%) | ·· | 3 (8%) | 2 (5%) | ·· | ·· | 20 (14%) | 12 (9%) | ·· | ·· |
| Immune checkpoint inhibitor plus chemotherapy | 119 (40%) | 69 (26%) | ·· | 19 (48%) | 12 (32%) | ·· | ·· | 46 (33%) | 40 (30%) | ·· | ·· |
| Immune checkpoint inhibitor plus other therapy | 3 (1%) | 7 (3%) | ·· | 1 (3%) | 1 (3%) | ·· | ·· | 2 (1%) | 5 (4%) | ·· | ·· |
| PD-L1 expression (tumour proportion score) | ·· | ·· | <0·0001 | ·· | ·· | 0·43 | 0·49 | ·· | ·· | <0·0001 | 0·51 |
| Low (<1%) | 75 (26%) | 62 (23%) | ·· | 10 (25%) | 11 (29%) | ·· | ·· | 27 (19%) | 32 (24%) | ·· | ·· |
| Intermediate (1–49%) | 88 (30%) | 61 (23%) | ·· | 10 (25%) | 8 (21%) | ·· | ·· | 34 (24%) | 29 (22%) | ·· | ·· |
| High (50–100%) | 74 (25%) | 51 (19%) | ·· | 9 (23%) | 4 (11%) | ·· | ·· | 46 (33%) | 18 (13%) | ·· | ·· |
| Unknown | 57 (19%) | 96 (36%) | ·· | 11 (28%) | 15 (39%) | ·· | ·· | 33 (24%) | 55 (41%) | ·· | ·· |
| Imaging type | ·· | ·· | 0·91 | ·· | ·· | 0·51 | 0·76 | ·· | ·· | 0·96 | 0·74 |
| CT | 222 (76%) | 203 (75%) | ·· | 32 (80%) | 28 (74%) | ·· | ·· | 109 (78%) | 104 (78%) | ·· | ·· |
| PET–CT | 72 (24%) | 67 (25%) | ·· | 8 (20%) | 10 (26%) | ·· | ·· | 31 (22%) | 30 (22%) | ·· | ·· |
| Image resources | ·· | ·· | 0·0010 | ·· | ·· | 0·42 | 0·23 | ·· | ·· | 0·37 | 0·23 |
| MD Anderson cohort | 156 (53%) | 180 (67%) | ·· | 25 (63%) | 27 (71%) | ·· | ·· | 76 (54%) | 80 (60%) | ·· | ·· |
| External | 138 (47%) | 90 (33%) | ·· | 15 (38%) | 11 (29%) | ·· | ·· | 64 (46%) | 54 (40%) | ·· | ·· |
| Median progression-free survival, months | 8·4 (3·5–20·6) | 4·1 (2·0–8·7) | ·· | 15·7 (6·2–30·5) | 4·2 (2·0–7·7) | ·· | 0·24 | 11·6 (4·4–23·2) | 6·4 (2·5–16·0) | ·· | 0·22 |
| Median overall survival, months | 18·1 (9·4–28·9) | 11·4 (6·3–18·7) | ·· | 21·1 (9·7–36·3) | 9·7 (5·0–14·8) | ·· | 0·87 | 19·8 (10·7–31·8) | 10·1 (6·3–18·2) | ·· | 0·86 |
Data are mean (SD), n (%), or median (IQR).
*
Comparison between training and validation cohorts.
†
Comparison between training, validation, and testing cohorts.
‡
Derived from the comparison of patients alive at data cutoff and patients who died within a cohort.