Table 1.
Patient and tumour characteristics
| Characteristic | Gemcitabine | Nab‐paclitaxel + gemcitabine | FOLFIRINOX | All regimens | ||||
|---|---|---|---|---|---|---|---|---|
| (n = 272) | (n = 489) | (n = 284) | (n = 1,174) | |||||
| Median | Min‐Max | Median | Min‐Max | Median | Min‐Max | Median | Min‐Max | |
| Age at start of therapy, years | 78 | 45–94 | 71 | 40–87 | 60 | 39–79 | 70 | 39–94 |
| n | % | n | % | n | % | n | % | |
| Age ≥ 70 | 230 | 84.6% | 276 | 56.4% | 42 | 14.8% | 616 | 52.5% |
| Age ≥ 75 | 189 | 69.5% | 153 | 31.3% | 12 | 4.2% | 400 | 34.1% |
| Mean | StD | Mean | StD | Mean | StD | Mean | StD | |
| BMI at enrolment, kg/m2 | 24.3 | 4.4 | 24.7 | 4.2 | 24.7 | 4.4 | 24.6 | 4.3 |
| Sex | n | % | n | % | n | % | n | % |
| Female | 151 | 55.5% | 219 | 44.8% | 109 | 38.4% | 535 | 45.6% |
| Male | 121 | 44.5% | 270 | 55.2% | 175 | 61.6% | 639 | 54.4% |
| Patients with comorbidity1 , 2 | ||||||||
| Any comorbidity | 244 | 89.7% | 407 | 83.2% | 208 | 73.2% | 968 | 82.5% |
| CCI = 03 | 170 | 62.5% | 352 | 72.0% | 230 | 81.0% | 843 | 71.8% |
| CCI ≥ 13 | 102 | 37.5% | 137 | 28.0% | 54 | 19.0% | 331 | 28.2% |
| Hypertension | 170 | 62.5% | 266 | 54.4% | 116 | 40.8% | 625 | 53.2% |
| Diabetes mellitus | 98 | 36.0% | 147 | 30.1% | 66 | 23.2% | 358 | 30.5% |
| Coronary heart disease | 30 | 11.0% | 35 | 7.2% | 15 | 5.3% | 97 | 8.3% |
| Thyroid disorders | 21 | 7.7% | 47 | 9.6% | 26 | 9.2% | 103 | 8.8% |
| Chronic GI disorders | 25 | 9.2% | 44 | 9.0% | 22 | 7.7% | 100 | 8.5% |
| Performance status1 | ||||||||
| ECOG = 0 | 74 | 27.2% | 175 | 35.8% | 136 | 47.9% | 425 | 36.2% |
| ECOG = 1 | 145 | 53.3% | 263 | 53.8% | 136 | 47.9% | 623 | 53.1% |
| ECOG = 2 | 53 | 19.5% | 51 | 10.4% | 12 | 4.2% | 126 | 10.7% |
| Pancreatic tumour location | ||||||||
| Head | 159 | 58.5% | 256 | 52.4% | 149 | 52.5% | 635 | 54.1% |
| Body | 59 | 21.7% | 111 | 22.7% | 52 | 18.3% | 246 | 21.0% |
| Tail | 37 | 13.6% | 92 | 18.8% | 66 | 23.2% | 218 | 18.6% |
| Unknown | 18 | 6.6% | 30 | 6.1% | 17 | 6.0% | 75 | 6.4% |
| Metastases at start of therapy 4 | ||||||||
| Yes | 244 | 89.7% | 439 | 89.8% | 256 | 90.1% | 1,057 | 90.0% |
| Bilirubin | ||||||||
| ≤1.5 × ULN | 173 | 63.6% | 341 | 69.7% | 206 | 72.5% | 720 | 68.9% |
| 1.5–3 × ULN | 18 | 6.6% | 32 | 6.5% | 15 | 5.3% | 65 | 6.2% |
| >3 × ULN | 16 | 5.9% | 16 | 3.3% | 6 | 2.1% | 38 | 3.6% |
| Missing | 65 | 23.9% | 100 | 20.4% | 57 | 20.0% | 222 | 21.2% |
| Previous treatment5 | ||||||||
| Any prior treatment | 43 | 15.8% | 106 | 21.7% | 64 | 22.5% | 253 | 21.6% |
| Adjuvant chemotherapy | 7 | 2.6% | 68 | 14.0% | 47 | 16.5% | 154 | 13.2% |
| Radiotherapy | 1 | 0.4% | 8 | 1.6% | 6 | 2.1% | 16 | 1.4% |
| Surgery | 42 | 15.6% | 95 | 19.5% | 57 | 20.1% | 230 | 19.7% |
Abbreviations: BMI, body mass index; GI, gastrointestinal; Max, maximum; Min, minimum; StD, standard deviation; ULN: upper limit of normal.
1
At enrolment.
2
Comorbidity according to Charlson or additional concomitant diseases.
4
All metastases documented in the period of 8 weeks before until 4 weeks after start of first‐line treatment.
5
Multiple entries possible.