Table 1.

Demographics, disease, and treatment history among participants who received at least one treatment.

CharacteristicsAll participants, N = 82Arm A, N = 40Arm B, N = 42
Age at randomization (years), median (1st–3rd Q)61 (56–68)60 (55–65)62 (58–70)
Male, N (%)49 (60%)23 (57%)26 (62%)
Caucasian, N (%)71 (87%)35 (88%)36 (86%)
Months since stage IV diagnosis, median (1st–3rd Q)6 (5–8)6 (5–8)7 (5–8)
Initial stage, N (%)
 IB–IIB24 (29%)12 (30%)12 (29%)
 III2 (2%)0 (0%)2 (5%)
 IV56 (68%)28 (70%)28 (67%)
ECOG 031 (38%)12 (30%)19 (45%)
Histologic grade, N (%)a
 Well differentiated/moderately differentiated39 (48%)20 (48%)19 (45%)
 Poorly differentiated22 (36%)10 (33%)12 (39%)
 Unknown21 (26%)10 (25%)11 (26%)
Pancreatic tumor location, N (%)
 Head40 (49%)18 (45%)22 (52%)
 Body27 (33%)11 (28%)16 (38%)
 Tail22 (27%)14 (35%)8 (19%)
 Neck1 (1%)1 (2%)
Metastatic sites at randomization, N (%)b
 Liver58 (71%)27 (68%)31 (74%)
 Lung19 (23%)10 (25%)9 (21%)
 Lymph nodes5 (6%)2 (5%)3 (7%)
 Peritoneum15 (18%)11 (28%)4 (10%)
 Otherc3 (4%)2 (5%)1 (2%)
CA19-9 secretors (elevated either on study or prior to enrollment), N (%)63 (76.8%)32 (80%)31 (73.8%)
CA19-9 at baseline – normal11 (17.5%)5 (15.6%)6 (19.4%)
CA19-9 at baseline - elevated, <59xULN44 (69.8%)20 (62.5%)24 (77.4%)
CA19-9 at baseline - elevated, ≥59xULN8 (12.7%)7 (21.9%)1 (3.2%)
Albumin at randomization, median (1st–3rd Q)4 (3.7–4.2)3.9 (3.6–4.2)4 (3.7–4.1)
Prior pancreatectomy22 (27%)10 (25%)12 (29%)
Prior radiotherapy16 (20%)8 (20%)8 (19%)
Number of cycles of FFX, median (1st–3rd Q)10 (8–12)10 (8–12)10 (8–12)
  • Abbreviations: FFX, FOLFIRINOX; Q, quartile; ULN, upper limit of normal.

  • aPercent missing is computed out of the total number of participants. Percent within each category is calculated out of the number with available data.

  • bThe numbers will total more than 100% because patients could have more than one disease location.

  • cOther includes 1 patient each with the following: chest wall and paraspinal, inferior vena cava and right perirenal mass, and bone.