Table 1.
Baseline demographics | Arm A (G/NP+P) N=24 |
Arm B (G/NP) N=13 |
Total N=37 |
Age group | |||
18–64 years | 10 (41.7%) | 8 (61.5%) | 18 (48.6%) |
65–74 years | 10 (41.7%) | 4 (30.8%) | 14 (37.8%) |
≥75 years | 4 (16.7%) | 1 (7.7%) | 5 (13.5%) |
Median | 67 | 62 | 66 |
Sex | |||
Male | 8 (33.3%) | 6 (46.2%) | 14 (37.8%) |
Female | 16 (66.7%) | 7 (53.8%) | 23 (62.2%) |
BMI (kg/m2) | |||
Mean (SD) | 25.27 (4.303) | 26.69 (4.757) | 25.77 (4.455) |
Median | 25.5 | 28.3 | 25.7 |
Min, max | (18.4 to 37.5) | (19.3 to 33.8) | (18.4 to 37.5) |
ECOG | |||
Grade 0 | 9 (37.5%) | 7 (53.8%) | 16 (43.2%) |
Grade 1 | 15 (62.5%) | 6 (46.2%) | 21 (56.8%) |
TNM stage | |||
T3 N0 M0 | 6 (25.0%) | 0 | 6 (16.2%) |
T3 N1 M0 | 0 | 2 (15.4%) | 2 (5.4%) |
T4 N0 M0 | 14 (58.3%) | 7 (53.8%) | 21 (56.8%) |
T4 N1 M0 | 3 (12.5%) | 4 (30.8%) | 7 (18.9%) |
T4 NX M0 | 1 (4.2%) | 0 | 1 (2.7%) |
Location of the tumour in the pancreas* | |||
Head | 18 (75.0%) | 11 (84.6%) | 29 (78.4%) |
Body | 7 (29.2%) | 2 (15.4%) | 9 (24·.3%) |
Tail | 1 (4.2%) | 2 (15.4%) | 3 (8.1%) |
Median tumour size (mm) | 37 | 38 | 37 |
Non-resectability per NCCN criterion* | |||
>180° SMA encasement | 11 (45.8%) | 3 (23.1%) | 14 (37.8%) |
Any coeliac abutment | 9 (37.5%) | 6 (46.2%) | 15 (40.5%) |
Inferior vena cava invasion or encasement | 1 (4.2%) | 1 (7.7%) | 2 (5.4%) |
Unreconstructible SMV/portal occlusion | 9 (37.5%) | 5 (38.5%) | 14 (37.8%) |
Aortic invasion and encasement | 1 (4.2%) | 0 | 1 (2.7%) |
OK as is
*Not mutually exclusive.
BMI, body mass index; ECOG, Eastern Cooperative Oncology Group; G, gemcitabine; n, number of subjects; NCCN, National Comprehensive Cancer Network; NP, nab paclitaxel; P, pamrevlumab; PV, portal vein; SMA, superior mesenteric artery; SMV, superior mesenteric vein.