Table 1.
Baseline characteristics and details on treatment administered and patient outcomes. To compare the demographic and diagnostic cohorts, T-Tests and Chi square of Fish were utilised (excluding missing values). Abbreviations: CisGem, cisplatin Capecitabine; CI, confidence interval; ECOG PS, Eastern Cooperative Oncology Group Performance Status; FOLFOX, Foloni acid, fluorouracil and oxaliplatin; GemCap, gemcitabine capecitabine; GemNabPaclitaxel, Gemcitabine Nab-paclitaxel; Ki67, nuclear protein 67; NET, neuroendocrine tumour; SSA, somatostatin analogue; TemCap, Temozolomide-capecitabine. * other types of chemotherapy combinations.
| Demographic Cohort (n = 50) | Diagnostic Cohort (n = 25) | Demographic vs. Diagnostic Cohort | Joint Demographic and Diagnostic Cohorts (n = 75) | Full Follow-Up Cohort (n = 37) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| n | % | n | % | p-Value | n | % | n | % | ||
| Baseline Characteristics | ||||||||||
| Age at study entry | Median (range) (95% CI) | 65.63 (25.56–87.53) (60–68) | 69.63 (50.98–84.68) (64–72) | 0.2259 | 65.87 (25.56–87.53) (62–68) | 70.57 (44–85.11) (65–72) | ||||
| Gender | Female | 27 | 54.0 | 11 | 44.0 | 0.414 | 38 | 50.67 | 17 | 45.95 |
| Male | 23 | 46.0 | 14 | 56.0 | 37 | 49.33 | 20 | 54.05 | ||
| Comorbidities | None | 20 | 40.0 | 17 | 68.0 | 0.116 | 37 | 49.33 | 13 | 35.14 |
| Mild | 19 | 38.0 | 4 | 16.0 | 23 | 30.67 | 18 | 48.65 | ||
| Moderate | 7 | 14.0 | 2 | 8.0 | 9 | 12.0 | 5 | 13.51 | ||
| Severe | 4 | 8.0 | 2 | 8.0 | 6 | 8.0 | 1 | 2.7 | ||
| Localisation primary pancreatic tumour | Head/neck | 25 | 50.0 | 13 | 52.0 | 0.713 | 38 | 50.67 | 20 | 54.05 |
| Body | 16 | 32.0 | 6 | 24.0 | 22 | 29.33 | 10 | 27.03 | ||
| Tail | 9 | 18.0 | 6 | 24.0 | 15 | 20.0 | 6 | 16.22 | ||
| Biopsy confirmed cancer | No | 1 | 2.0 | 0 | 0.0 | 1.000 | 1 | 1.33 | 0 | 0.0 |
| Yes | 49 | 98.0 | 25 | 100.0 | 74 | 98.67 | 37 | 100.0 | ||
| Type of pancreatic cancer | Adenocarcinoma | 44 | 88.0 | 20 | 80.0 | 0.064 | 64 | 85.33 | 33 | 89.19 |
| NET | 6 | 12.0 | 2 | 8.0 | 8 | 10.67 | 2 | 5.41 | ||
| Other | 0 | 0.0 | 3 | 12.0 | 3 | 4.0 | 2 | 5.41 | ||
| Differentiation (if NET) | Grade 1 | 1 | 2.0 | 0 | 0.0 | 1.000 | 1 | 1.33 | 1 | - |
| Grade 2 | 3 | 6.0 | 1 | 4.0 | 4 | 5.33 | 0 | - | ||
| Grade 3 | 2 | 4.0 | 1 | 4.0 | 3 | 4.0 | 1 | - | ||
| Not NET | 44 | 88.0 | 23 | 92.0 | 67 | 89.33 | 35 | - | ||
| Ki 67 (if NET) | Median (range) (ki67) | 10 (2–80) (0–56.45) | 17.5 (3–32) (0–100) | 0.7777 | 10 (2–80) (0.12–45.38) | 14 (1–27) (0–100) | ||||
| Functional (if NET) | Yes | 0 | 0.0 | 0 | 0.0 | n/a | 0 | 0.0 | 0 | - |
| No | 6 | 12.0 | 2 | 8.0 | 8 | 10.67 | 2 | - | ||
| Not NET | 44 | 88.0 | 23 | 92.0 | 67 | 89.33 | 35 | - | ||
| ECOG PS at study entry | 0 | 7 | 14.0 | 9 | 36.0 | 0.230 | 16 | 21.33 | 6 | 16.22 |
| 1 | 28 | 56.0 | 11 | 44.0 | 39 | 52.0 | 21 | 56.76 | ||
| 2 | 12 | 24.0 | 5 | 20.0 | 17 | 22.67 | 7 | 18.92 | ||
| 3 | 2 | 4.0 | 0 | 0.0 | 2 | 2.67 | 3 | 8.11 | ||
| 4 | 1 | 2.0 | 0 | 0.0 | 1 | 1.33 | 0 | 0.0 | ||
| Stage at study entry | Localised | 0 | - | 0 | - | 0 | - | 1 | 2.7 | |
| Locally advanced | 16 | 32.0 | 7 | 28.0 | 0.723 | 23 | 30.67 | 18 | 48.65 | |
| Metastatic | 34 | 68.0 | 18 | 72.0 | 52 | 69.33 | 18 | 48.65 | ||
| Treatment and outcomes | ||||||||||
| Treatment intention | Palliative | 50 | 100.0 | 25 | 100.0 | n/a | 75 | 100.0 | 37 | 100.0 |
| Did patient received systemic treatment | No | 13 | 26.0 | 4 | 16.0 | 0.386 | 17 | 22.67 | 11 | 29.73 |
| Yes | 37 | 74.0 | 21 | 84.0 | 58 | 77.34 | 26 | 70.27 | ||
| Line of treatment | First-line | 35 | 70.0 | 21 | 84.0 | 0.263 | 56 | 74.67 | 25 | 67.57 |
| Other line | 2 | 4.0 | 0 | 0.0 | 2 | 2.67 | 1 | 2.7 | ||
| None | 13 | 26.0 | 4 | 16.0 | 17 | 22.67 | 11 | 29.73 | ||
| Type of systemic treatment | Gemcitabine | 6 | 12.0 | 3 | 12.0 | 0.834 | 9 | 12.0 | 7 | 18.92 |
| FOLFIRINOX | 9 | 18.0 | 6 | 24.0 | 15 | 20.0 | 5 | 13.51 | ||
| GemCap | 5 | 10.0 | 4 | 16.0 | 9 | 12.0 | 7 | 18.92 | ||
| GemNabPaclitaxel | 6 | 12.0 | 4 | 16.0 | 10 | 13.33 | 5 | 13.51 | ||
| Sunitinib | 0 | 0.0 | 1 | 4.0 | 1 | 1.33 | 0 | 0.0 | ||
| SSA | 2 | 4.0 | 0 | 0.0 | 2 | 2.67 | 1 | 2.7 | ||
| TemCap | 3 | 6.0 | 0 | 0.0 | 3 | 4.0 | 0 | 0.0 | ||
| Carboplatin and Etoposide | 1 | 2.00 | 1 | 4.0 | 2 | 2.67 | 0 | 0.0 | ||
| Other * | 5 | 10.0 | 2 | 8.0 | 7 | 9.33 | 1 | 2.7 | ||
| None | 13 | 26.0 | 4 | 16.0 | 17 | 22.67 | 11 | 29.73 | ||
| * If Other (which) | NUC1031 | 2 | - | 0 | - | n/a | 2 | - | 0 | - |
| CisGem | 0 | - | 1 | - | 1 | - | 1 | - | ||
| FOLFOX + NabPaclitaxel | 3 | - | 1 | - | 4 | - | 0 | - | ||
| Chemotherapy dose intensity (%) | Median (range) (95% CI) | 68.5 (11.1–100) (58.96–77.37) | 80.6 (11.1–100) (55.06–84.28) | 0.8514 | 73.9 (11.1–100) (61.10–76.28); 54 observations | 52.6 (11.1–100) (40.88–58.84) | ||||
| Best radiological response | Progressive disease | 4 | 8.0 | 2 | 8.0 | 0.350 | 6 | 8.0 | 3 | 8.11 |
| Stable disease | 12 | 24.0 | 8 | 32.0 | 20 | 26.67 | 12 | 32.43 | ||
| Partial response | 14 | 28.0 | 3 | 12.0 | 17 | 22.67 | 4 | 10.81 | ||
| Not documented or no treatment received | 20 (13 never started treatment) | 40.0 | 12 | 48.0 | 32 (17 never started treatment) | 42.67 | 18 | 48.65 | ||
| Radiological progression documented at time of last data lock | Yes | 22 | 44.0 | 5 | 20.0 | 0.009 | 27 | 36.0 | 5 | 13.51 |
| Death documented at time of last data lock | Yes | 41 | 82.0 | 10 | 40.0 | <0.001 | 51 | 68.0 | 15 | 40.54 |
| Overall survival (estimated) | Median (95% CI) | 7.39 (1.14–9.95) | 5.85 (4.11-nr) | 0.79784 (log rank) | 7.29 (4.37–9.49) | 4.27 (2.17–nr) | ||||
| Follow-up | Median (range) (95% CI) | 7.23 (0.16–21.59) | 3.28 (0.46–9.03) | 0.014 | 4.50 (0.16–21.55) (5.39–8.01) | 2.49 (0–13.21) (1.75–3.27) | ||||