Table 2. Clinical characteristics of patients (test and independent sets).
| Study Set | Primary Location | |||||||||
| Test Set ( n = 63) % | Lung | Stomach | Pancreas$ | SI | Appendix | Colorectal | CUP | |||
| 3 (5%) | 4 (6%) | 3 (5%) | 39 (62%) | 8 (13%) | 6 (9%) | 0 (0%) | ||||
| Grade * | ||||||||||
| G1 | G2 | G3 | ND | |||||||
| 30 (48%) | 18 (28%) | 2 (3%) | 13 (21%) | |||||||
| Metastases ** | ||||||||||
| No | Yes | ND | ||||||||
| 12 (19%) | 46 (73%) | 5 (8%) | ||||||||
| Study Set | Primary Location & | |||||||||
| Independent Validation Set 1 ( n = 72) % | Lung | Stomach | Pancreas$ | SI | Appendix | Colorectal | CUP | |||
| 0 (0%) | 0 (0%) | 18 (25%) | 46 (64%) | 3 (4%) | 5 (7%) | 0 (0%) | ||||
| Grade * | ||||||||||
| G1 | G2 | G3 | ND | |||||||
| 44 (61%) | 20 (28%) | 0 (0%) | 8 (11%) | |||||||
| Metastases ** | ||||||||||
| No | Yes | ND | ||||||||
| 10 (14%) | 61 (85%) | 1 (1%) | ||||||||
| Study Set | Primary Location & | |||||||||
| Independent Validation Set 2 ( n = 71) % | Lung | Stomach | Pancreas$ | SI | Appendix | Colorectal | CUP | |||
| 0 (0%) | 2 (3%) | 25 (35%) | 36 (51%) | 0 (0%) | 2 (3%) | 6 (8%) | ||||
| Grade * | ||||||||||
| G1 | G2 | G3 | ND | |||||||
| 30 (42%) | 9 (13%) | 2 (4%) | 30 (42%) | |||||||
| Metastases ** # | ||||||||||
| No | Yes | ND | ||||||||
| 1 (1%) | 60 (85%) | 10 (14%) | ||||||||
CUP = carcinoid of unknown primary, ND = no data available, SI = small intestine.
Grade: based on Ki67 or mitotic index (from WHO201029).
Metastases: any tumor disease identified in lymph nodes, mesentery, liver, lung, bone, ovary (or any combination thereof). Methodologies including octreoscan, identification at surgery, identification at pathology e.g. positive lymph nodes, etc.
p<0.05 vs. Test set (Chi-square). This reflects the higher proportion (25–35%) of Pancreatic NENs included in the validation sets.
p<0.05 vs. Test and Validation set 1 (Chi-square). This reflects the higher proportion ∼10% of patients with no metastases.
A comparison of these clinical sets with the spectrum of disease included in the Surveillance Epidemiology and End Results (SEER) database for GEP-NENs32,33 identifies no significant differences. Patient characteristics also provide a reasonable reflection of the clinical spectrum of disease that is pari passu for NEN patients.
Details regarding Age and Sex for patients are included in Table 1.
Forty six of the samples were collected from pancreas, with the following break-down: ACTH (n = 1), gastrinoma (n = 2), glucagonoma (n = 1), insulinoma (n = 4), VIP (n = 3), Functional (no characterization of hormone, n = 8), non-functional (n = 27).