TABLE 1.
Baseline demography and clinical characteristics
| Characteristic | Patients (N = 50) |
|---|---|
| Mean (SD) age, years | 63.4 (8.6) |
| Male, n (%) | 27 (54.0) |
| Race, n (%) | |
| Caucasian/White | 45 (90.0) |
| Black/African‐American | 3 (6.0) |
| Asian | 2 (4.0) |
| Median (95% CI) time since NET diagnosis, months a | 4.50 (2.80; 6.58) |
| Primary tumour, n (%) | |
| Ileum | 24 (48.0) |
| Caecum | 5 (10.0) |
| Jejunum | 4 (8.0) |
| Small bowel | 3 (6.0) |
| Duodenum (second part) b | 1 (2.0) |
| Ascending/right colon | 1 (2.0) |
| Appendix | 1 (2.0) |
| Other | 5 (10.0) |
| Unknown c | 6 (12.0) |
| Positive somatostatin‐receptor imaging, n (%) | 50 (100) |
| ENETS disease stage, n (%) | |
| Missing | 14 |
| IIa | 1 (2.8) |
| IIb | 2 (5.6) |
| IIIa | 1 (2.8) |
| IIIb | 4 (11.1) |
| IV | 28 (77.8) |
| Proliferation index, n (%) | |
| ≤2% | 31 (62.0) |
| >2 to ≤5% | 11 (22.0) |
| >5 to <10% | 4 (8.0) |
| ≥10% | 4 (8.0) |
| Previous SSA treatment | |
| Octreotide d | 11 (22.0) |
| LAN | 7 (14.0) |
| Median (95% CI) number of diarrhoea episodes per day e | 1.3 (0.6; 2.7) |
| Median (95% CI) number of flushing episodes per day e | 2.4 (1.5; 3.1) |
| Mode severity of flushing, n (%) | |
| None | 7 (14.0) |
| Mild | 19 (38.0) |
| Moderate | 23 (46.0) |
| Severe | 1 (2.0) |
| CTC status, n (%) | |
| Missing | 2 |
| Positive | 22 (45.8) |
| Negative | 26 (54.2) |
| CTC+ by ENETS disease stage, n (%) | |
| Missing | 8 |
| Stage IV | 11 (78.6) |
| Other stages f | 3 (21.4) |
Abbreviations: 5‐HIAA, 5‐hydroxyindoleacetic acid; CI, confidence interval; CTC, circulating tumour cell; ENETS, European Neuroendocrine Tumour Society; LAN, lanreotide autogel; NET, neuroendocrine tumour; SD, standard deviation; SSA somatostatin analogue.
At study entry.
Although the tumour was not of midgut origin, it was 5‐HIAA secreting, and the patient was included in the study and is part of the analysis.
Location of the primary tumour in the midgut was not documented; however, all patients had a documented diagnosis of midgut NET.
Eight patients had received previous treatment with subcutaneous octreotide, two patients with octreotide LAR, and one patient had been treated previously with both. No other prior treatments for NETs beyond SSA, were recorded in eligible patients.
Average number of episodes in 7 days before first study treatment.
CTC status missing for one patient.