Table 1.
Patient and tumor characteristics.
| Variable | FOLFIRINOX (n=83)* | Gem-Abx (n=37)* | p |
|---|---|---|---|
| Age | |||
| mean ± SD, in years | 62.4 ± 7.6 | 70.6 ± 7.5 | <0.001 |
| <75 years | 79 (95.2) | 27 (73.0) | <0.001 |
| ≥75 years | 4 (4.8) | 10 (27.0) | |
| Male gender | 46 (55.4) | 14 (37.8) | 0.075 |
| BMI, mean ± SD, in kg/m2 | 24.4 ± 5.8 | 25.6 ± 4.9 | 0.250 |
| ECOG performance status | |||
| ≥1 (vs 0) | 44 (53.0) | 27 (73.0) | 0.040 |
| 0 | 39 (47.0) | 10 (27.0) | 0.031 |
| 1 | 43 (51.8) | 24 (64.9) | |
| 2 | 1 (1.2) | 3 (8.1) | |
| Diabetes mellitus | |||
| None | 61 (73.5) | 25 (67.6) | 0.672 |
| Non-insulin | 7 (8.4) | 5 (13.5) | |
| Insulin | 15 (18.1) | 7 (18.9) | |
| Hypertension | 28 (33.7) | 26 (70.3) | <0.001 |
| Creatinine | |||
| mean ± SD in mg/dL | 0.8 ± 0.2 | 0.9 ± 0.4 | 0.003 |
| Elevated creatinine (>1.1 mg/dL) | 7 (8.4) | 8 (21.6) | 0.044 |
| Albumin | |||
| mean ± SD in mg/dL | 3.8 ± 0.6 | 3.7 ± 0.6 | 0.525 |
| Low albumin (<3.5 g/dL) | 20 (24.1) | 12 (32.4) | 0.340 |
| CA19-9, median (range), in U/mLa | 314 (10.8-9147.0) | 390.9 (20.4-9067) | 0.691 |
| Tumor Location | |||
| Head/uncinate | 72 (86.8) | 26 (70.3) | 0.031 |
| Body/tail | 11 (13.3) | 11 (29.7) | |
| NCCN Resectability Status | |||
| Borderline resectable | 57 (68.7) | 22 (59.5) | 0.326 |
| Locally advanced | 26 (31.3) | 15 (40.5) | |
| Tumor size >3 cm | 47 (56.6) | 26 (70.3) | 0.157 |
| Clinical T-stage | |||
| T3 | 54 (65.1) | 18 (48.7) | 0.090 |
| T4 | 29 (34.9) | 19 (51.4) | |
| Clinical N-stage | |||
| N0 | 45 (54.2) | 19 (51.4) | 0.771 |
| N1 | 38 (45.8) | 18 (48.7) | |
| Completed Treatments, median (range) | 4 (1-12) | 6 (1-18) | <0.001 |
| Dose reduction | |||
| No | 49 (59.0) | 19 (51.4) | 0.691 |
| Yes | 27 (32.5) | 15 (40.5) | |
| Hyperbilirubinemia | 3/27 (11.1) | 2 (13.3) | |
| Failure to thrive | 8/27 (29.6) | 1/15 (6.7) | |
| Neutropenia | 7/27 (25.9) | 5/15 (33.3) | |
| Thrombocytopenia | 1/27 (3.7) | 2/15 (13.3) | |
| Pancytopenia | 0/27 (0) | 2/15 (13.3) | |
| Neuropathy | 6/27 (22.2) | 1/15 (6.7) | |
| Mucositis | 1/27 (3.7) | 0/15 (0) | |
| Infection | 1/27 (3.7) | 0/15 (0) | |
| Unknown | 0/27 (0) | 2/15 (13.3) | |
| Unknown | 7 (8.4) | 3 (8.1) | |
| Patient’s with side effects requiring hospitalization | 18 (21.7) | 5 (13.5) | 0.294 |
| Change to different chemotherapy regimen | 10 (12.1) | 4 (10.8) | 0.845 |
| Gemcitabine alone | 0/10 (0) | 2/4 (50.0) | |
| FOLFIRINOX | - | 1/4 (25.0) | |
| Gemcitabine/abraxane | 6/10 (60.0) | - | |
| FOLFOX | 4/10 (40.0) | 1/4 (25.0) | |
| Adherence to chemotherapy protocol | |||
| Completed number of treatments as planned | 60 (72.3) | 28 (75.7) | 0.514 |
| Fewer treatments completed than planned | 10 (12.1) | 2 (5.4) | |
| More treatments completed than planned | 13 (15.6) | 7 (18.9) | |
| Neoadjuvant Radiation | 56 (67.5) | 28 (75.7) | 0.365 |
| Response to neoadjuvant therapy (RECIST criteria) | |||
| Partial | 21 (25.3) | 3 (8.1) | 0.001 |
| Stable | 51 (61.5) | 19 (51.4) | |
| Complete | 0 (0) | 0 (0) | |
| Progression | 11 (13.3) | 15 (40.5) | |
| Outcome | |||
| Non-surgical candidate | 19 (22.9) | 18 (48.7) | 0.002 |
| Local | 5 (26.3) | 6 (33.3) | 0.262 |
| Distant | 5 (26.3) | 8 (44.4) | |
| Both | 9 (47.4) | 4 (22.2) | |
| Unresectable at time of operation | 9 (10.8) | 7 (18.9) | |
| Local | 5 (55.6) | 4 (57.1) | 0.949 |
| Distant | 4 (44.4) | 3 (42.9) | |
| Both | 0 (0) | 0 (0) | |
| Surgically resected | 55 (66.3) | 12 (32.4) |
Gem-Abx gemcitabine and abraxane
a
Median CA19-9 among patients with a total bilirubin <2 mg/dL at time of CA19-9 evaluation excluding non-secretors (CA19-9 <1) (n=48)
*
n (%) unless stated otherwise