Table 1.
Cohort description, demographic and clinicopathological parameters data from test and validation cohorts
| Glasgow Cohort | Pisa Cohort | Sydney Cohort | ICGC Cohort | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
|
|||||||||
| n = 189 | Median OS | P value | n = 69 | Median OS | P value | n = 249 | Median OS | P value | n = 179 | Median OS | P value | |
| Variables | No. (%) | (months) | (Log rank) | No. (%) | (months) | (Log rank) | No. (%) | (months) | (Log rank) | No. (%) | (month) | (Log rank) |
| Gender | ||||||||||||
| Male | 101 (58.7) | 17.6 | 31 (44.9) | 20.9 | 125 (50.2) | 16.8 | 88 (49.2) | 16.8 | ||||
| Female | 88 (41.3) | 20.1 | 0.48 | 38 (55.1) | 17 | 0.8 | 124 (49.8) | 16 | 0.296 | 91 (50.8) | 28.7 | 0.082 |
| Age (years) | ||||||||||||
| Mean | 62.2 | 65.1 | 67.1 | 66.5 | ||||||||
| Median | 63.4 | 65 | 69 | 67.0 | ||||||||
| Range | 37.4-86.1 | 42.0-82.0 | 28.0-87.1 | 36.2-88.1 | ||||||||
| Outcome | ||||||||||||
| Follow-up (months) | 0.8-79.0 | 3.8-129.1 | 0.4-120 | 3.0-79.0 | ||||||||
| Median follow-up | 22 | 19.8 | 16.7 | 19.6 | ||||||||
| Death PDAC | 61 (76.3) | 69 (100) | 198 (79.5) | 85 (47.4) | ||||||||
| Death other | 7 (8.7) | 0 (0) | 10 (4.1) | 6 (3.5) | ||||||||
| Death unknown | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||||||||
| Alive | 12 (6.3) | 0 (0) | 41 (16.4) | 88 (49.1) | ||||||||
| Stage | ||||||||||||
| I | 5 (2.7) | 90.3 | 1 (1.4) | - | 19 (7.6) | 70 | 12 (6.7) | 60.1 | ||||
| II | 32 (16.9) | 22.6 | 9 (13.1) | 21.5 | 75 (30.1) | 17.5 | 160 (89.3) | 30.1 | ||||
| III | 152 (80.4) | 18.1 | 0.049 | 59 (85.5) | 19 | 0.057 | 155 (62.2) | 16.4 | 0.045 | 0.013 | ||
| IV | 7 (4.0) | 17.6 | ||||||||||
| T Stage | ||||||||||||
| T1/T2 | 15 (7.9) | 33.4 | 2 (2.8) | - | 39 (15.7) | 31 | 21 (11.7) | 61.7 | ||||
| T3/T4 | 174 (92.1) | 18.1 | 0.031 | 67 (97.2) | 19.5 | 0.032 | 210 (84.3) | 16.4 | 0.002 | 158 (88.3) | 28.6 | 0.312 |
| N Stage | ||||||||||||
| N0 | 36 (19.0) | 31 | 11 (15.9) | 24 | 94 (37.8) | 20 | 50 (27.9) | 61.8 | ||||
| N1 | 153 (81.0) | 18.5 | 0.003 | 58 (84.1) | 18 | 0.044 | 155 (62.2) | 16.7 | 0.05 | 129 (72.1) | 25.6 | 0.041 |
| Grade | ||||||||||||
| Low | 128 (67.7) | 23.1 | 39 (56.5) | 20.9 | 189 (75.9) | 16.7 | 140 (78.2) | 28.3 | ||||
| High | 61 (32.3) | 13.4 | 0.021 | 30 (43.5) | 18 | 0.079 | 60 (24.1) | 18.3 | 0.572 | 39 (21.8) | 16.3 | 0.008 |
| Tumour size | ||||||||||||
| ≤ 30 mm | 94 (49.7) | 23.1 | 30 (43.7) | 22.9 | 50 (15.7) | 36.5 | 84 (46.9) | 38.1 | ||||
| > 30 mm | 95 (50.3) | 16.1 | 0.01 | 39 (46.3) | 18 | 0.041 | 199 (84.3) | 16 | < 0.0001 | 95 (53.1) | 21.6 | < 0.0001 |
| Margins | ||||||||||||
| R0 | 49 (25.9) | 28.5 | 60 (86.9) | 19.5 | 148 (59.4) | 22.4 | 127 (71.0) | 33.4 | ||||
| R1 | 140 (74.1) | 16.4 | < 0.0001 | 9 (13.1) | 21.5 | 0.33 | 101 (40.6) | 13.2 | < 0.0001 | 52 (29.0) | 20.3 | 0.001 |
| Perineural Invasion | ||||||||||||
| Negative | 15 (7.9) | 18.2 | 0 (0) | - | 57 (22.9) | 25.6 | 32 (18.1) | 41.9 | ||||
| Positive | 174 (92.1) | 20 | 0.33 | 69 (100.0) | 19.9 | - | 184 (73.9) | 16.7 | 0.275 | 144 (81.9) | 25.6 | 0.047 |
| Venous Invasion | ||||||||||||
| Negative | 97 (51.3) | 24 | 50 (72.4) | 19.9 | 123 (49.4) | 20.7 | 73 (42.1) | 40.1 | ||||
| Positive | 92 (48.7) | 16.3 | 0.004 | 19 (27.6) | 16.8 | 0.382 | 111 (44.6) | 16.2 | 0.008 | 100 (57.9) | 23.8 | 0.013 |
| Chemotherapy | ||||||||||||
| Adjuvant | 83 (43.9) | 23.1 | 69 (100) | 19.5 | 52 (20.9) | 25.2 | 41 (23.6) | 31.4 | ||||
| No Adjuvant | 106 (56.1) | 16.3 | 0.04 | 0 (0) | - | - | 196 (79.1) | 16.3 | 0.013 | 138 (76.4) | 17.4 | 0.007 |
| miR-21 Expression (median histoscore 45) | ||||||||||||
| Low | 94 (49.7) | 26.5 | 37 (53.6) | 23.7 | 126 (50.6 | 29.3 | 85 (47.4) | 36.8 | ||||
| High | 95 (50.3) | 14.7 | < 0.0001 | 32 (46.3) | 15.5 | 0.002 | 123 (49.4) | 12.8 | < 0.0001 | 94 (52.6) | 20.3 | < 0.0001 |
| miR-21 & Lymph Node Status | ||||||||||||
| Mir21 low/LN Neg | 16 (8.5) | 90.3 | 7 (10.2) | 25.7 | 62 (6.3) | 26 | 26 (14.5) | 61.8 | ||||
| Mir21 high/LN Neg | 20 (10.6) | 13.6 | 3 (4.3) | 21.5 | 32 (10.0) | 13 | 24 (13.5) | 21.6 | ||||
| Mir21 low/LN Pos | 77 (40.7) | 24.7 | 30 (43.4) | 23.1 | 64 (43.7) | 29.6 | 59 (32.9) | 34.9 | ||||
| Mir21 High/LN Pos | 76 (40.2) | 14.7 | < 0.0001 | 29 (42.0) | 15.2 | 0.002 | 91 (40.0) | 12.6 | < 0.0001 | 70 (39.1) | 20.2 | < 0.0001 |
| miR-21 & Resection Margin Status | ||||||||||||
| Mir21 low/R0 | 16 (8.5) | 90.3 | 33 (47.8) | 23.0 | 80 (32.1) | 33.6 | 67 (37.4) | 41.9 | ||||
| Mir21 high/R0 | 20 (10.6) | 13.6 | 26 (37.6) | 15.5 | 68 (27.3) | 15.1 | 60 (33.5) | 26.5 | ||||
| Mir21 low/R1 | 77 (40.7) | 24.7 | 3 (4.3) | 23.7 | 46 (18.4) | 19.5 | 18 10.0) | 23.9 | ||||
| Mir21 High/R1 | 76 (40.2) | 14.7 | < 0.0001 | 6 (8.6) | 13.2 | 0.002 | 55 (22.1) | 10.1 | < 0.0001 | 34 (18.9) | 15.8 | 0.001 |