Table 1.
Patient characteristics and treatment at inclusion (N = 243).
| Characteristic | Total |
|---|---|
| Gender | |
| Men | 155 (63.8%) |
| Women | 88 (36.2%) |
| Age at start of treatment (years) | |
| Median (min–max) | 60.0 (30.0–86.0) |
| ECOG PS | |
| 0 | 95 (39.1%) |
| 1 | 148 (60.9%) |
| Body mass index (kg/m2) | |
| Median (min–max) | 23.6 (14.5–45.2) |
| Indication for FOLFIRINOX | |
| From the outset (locally advanced or metastatic disease) | 192 (79.0%) |
| After recurrence | 51 (21.0%) |
| Previous adjuvant chemotherapy with gemcitabine (n = 50, MD = 1) | |
| No | 9 (18.0%) |
| Yes | 41 (82.0%) |
| Location of the primary pancreatic tumor (MD = 1) | |
| Head | 128 (52.9%) |
| Isthmus | 21 (8.7%) |
| Body/tail | 93 (38.4%) |
| Number of metastatic sites at inclusion | |
| 0 | 65 (26.7%) |
| 1–2 | 169 (69.5%) |
| 3 or more | 9 (3.7%) |
| Metastatic sites | |
| Hepatic | 138 (56.8%) |
| Pulmonary | 38 (15.6%) |
| Peritoneal and/or carcinoma cells in ascites | 36 (14.8%) |
| Other | 22 (9.1%) |
| CA19-9 at inclusion >normal (MD = 35) | |
| No | 32 (13.2%) |
| Yes | 176 (72.4%) |
| Number of cycles of FOLFIRINOX before first reassessment | |
| 3 | 28 (11.5%) |
| 4 | 96 (39.5%) |
| 5 | 38 (15.6%) |
| ⩾6 | 81 (33.3%) |
| Continuation of treatment beyond first reassessment | |
| Yes | 177 (72.8%) |
| No | 66 (27.2%) |
| Reason for treatment discontinuation (n = 62, MD = 4) | |
| Progression | 51 (77.3%) |
| Deterioration in overall health | 7 (10.6%) |
| Toxicity | 1 (1.5%) |
| Other | 3 (4.5%) |
| Duration of treatment with FOLFIRINOX up to reassessment (days) | |
| Median (min–max) | 70 (38–134) |
| G-CSF prophylaxis from cycle 1 of FOLFIRINOX | |
| No | 177 (72.8%) |
| Yes | 66 (27.2%) |
| Cumulative relative dose intensity (%) | |
| csRDI oxaliplatin, median (min–max) | 80.8 (23.8–102.5) |
| csRDI irinotecan, median (min–max) | 79.3 (8.5–102.1) |
| csRDI 5FU bolus, median (min–max) | 74.9 (0–102.5) |
| csRDI 5FU continuous infusion, median (min–max) | 84.6 (23.8–102.5) |
| cmRDI FOLFIRINOX, median (min–max) | 80.3 (22.8–102.2) |
| Tumor response at first evaluation (RECIST v 1.1) | |
| Complete response | 5 (2.1%) |
| Partial response | 44 (18.1%) |
| Stable disease | 131 (53.9%) |
| Disease progression | 63 (25.9%) |
| Progression-free survival (PFS) | |
| Median PFS duration, months | 9.2 (7.9–10.2) |
| Overall survival (OS) | |
| Median OS duration, months | 13.2 (11.5–15.7) |
CA19-9, carbohydrate antigen 19-9; cmRDI, cumulative multi-drug relative dose intensity; csRDI, cumulative single-agent relative dose intensity; ECOG, Eastern Cooperative Oncology Group; G-CSF, granulocyte colony-stimulating factor; MD, missing data; PS, performance status; RECIST, response evaluation criteria in solid tumors.