Table 1 Baseline demographic and disease characteristics of study cohort
Characteristic | Total | Observation | CC-486 |
|---|---|---|---|
(N = 49) | (N = 25) | (N = 24) | |
Eligibility criteria, N(%) | |||
CA19-9 | 24 (49%) | 12 (48%) | 12 (50%) |
R1 | 10 (20%) | 2 (9%) | 8 (33%) |
Positive lymph nodes | 36 (73%) | 20 (80%) | 16 (67%) |
Age at randomization, Median (1st–3rd Q) | 66 (60, 71) | 64 (50, 73) | 66 (61, 68) |
Female, N(%) | 23 (47%) | 10 (40%) | 13 (54%) |
Race | |||
White | 46 (94%) | 24 (96%) | 22 (92%) |
Asian | 2 (4%) | 1 (4%) | 1 (4%) |
Other | 1 (2%) | 0 (0%) | 1 (4%) |
ECOG at randomization, N(%) | |||
0 | 40 (82%) | 19 (76%) | 21 (88%) |
1 | 9 (18%) | 6 (24%) | 3 (12%) |
CA 19–9 at randomization, Median (1st–3rd Q) | 37.3 (15.4, 83.9) | 37.3 (13.6, 77.8) | 36.9 (18.9, 90.7) |
Time from surgery to randomization (months), Median (1st–3rd Q) | 9.6 (7.8, 12.0) | 9.6 (7.8, 12.2) | 9.8 (8.1, 10.9) |
Surgical Resection Margin Status, N(%) | |||
R0 | 39 (80%) | 23 (92%) | 16 (67%) |
R1 | 10 (20%) | 2 (8%) | 8 (33%) |
Histologic grade, N(%) | |||
Well differentiated | 3 (6%) | 2 (8%) | 1 (4%) |
Moderately differentiated | 36 (74%) | 17 (68%) | 19 (79%) |
Poorly differentiated | 10 (20%) | 6 (24%) | 4 (17%) |
T stage, N(%) | |||
T1 (≤ 2 cm) | 13 (27%) | 6 (24%) | 7 (29%) |
T2 (> 2 cm) | 16 (33%) | 10 (40%) | 6 (25%) |
T3 (> 4 cm) | 19 (39%) | 9 (36%) | 10 (42%) |
T4 (involves celiac axis, SM or common hepatic artery) | 1 (2%) | 0 (0%) | 1 (4%) |
Positive lymph nodes, N(%) | 36 (73%) | 20 (80%) | 16 (67%) |
Lymphovascular invasion (LVI), N(%) | |||
No | 17 (39%) | 6 (27%) | 11 (50%) |
Yes | 27 (61%) | 16 (73%) | 11 (50%) |
Missing | 5 (10%) | 3 (12%) | 2 (8%) |
Perineural spread/invasion (PNS), N(%) | 43 (88%) | 23 (92%) | 20 (83%) |
Pre-trial Radiation Therapy, N(%) | |||
None | 18 (37%) | 10 (40%) | 8 (33%) |
Neo-adjuvant only | 11 (22%) | 3 (12%) | 8 (33%) |
Adjuvant only | 20 (41%) | 12 (48%) | 8 (33%) |
Pre-trial Systemic Therapy, N(%) | |||
Neo-adjuvant only | 1 (2%) | 1 (4%) | 0 (0%) |
Adjuvant only* | 30 (61%) | 18 (72%) | 12 (50%) |
Both neo-adjuvant and adjuvant | 18 (37%) | 6 (24%) | 12 (50%) |
Neo-adjuvant Systemic Therapy, N(%) | |||
None | 30 (61%) | 18 (72%) | 12 (50%) |
5-FU-based combination | 15 (31%) | 6 (24%) | 9 (38%) |
Gemcitabine-based combination | 2 (4%) | 0 (0%) | 2 (8%) |
Other | 2 (4%) | 1 (4%) | 1 (4%) |
Adjuvant Systemic Therapy, N(%) | |||
None | 1 (2%) | 1 (4%) | 0 (0%) |
5-FU-based combination | 15 (31%) | 4 (16%) | 11 (46%) |
Gemcitabine-based combination | 10 (20%) | 6 (24%) | 4 (17%) |
Gemcitabine alone | 10 (20%) | 6 (24%) | 4 (17%) |
Gemcitabine/Xeloda | 9 (18%) | 5 (20%) | 4 (17%) |
Other | 4 (8%) | 3 (12%) | 1 (4%) |