Table 1.
Demographic and disease characteristics for patients participating in the OLE
| LAN–LAN group (n = 42) |
PBO–LAN group (n = 47) |
Total (n = 89) |
|
|---|---|---|---|
| Men | 19 (45.2) | 25 (53.2) | 44 (49.4) |
| Age, mean (SD) in yearsa | 64.8 (10.8) | 61.3 (10.2) | 62.9 (10.6) |
| Time since diagnosis, mean (SD) in months | 36.1 (58.1) | 41.8 (46.5) | 39.1 (52.1) |
| WHO performance status scorea | |||
| 0—normal activity | 36 (85.7) | 34 (72.3) | 70 (78.7) |
| 1—restricted activity | 6 (14.3) | 12 (25.5) | 18 (20.2) |
| 2—in bed ≤50% of the time | 0 | 1 (2.1) | 1 (1.1) |
| Prior NET treatment | 6 (14.3) | 9 (19.1) | 15 (16.9) |
| NET origin | |||
| Pancreas | 12 (28.6) | 22 (46.8) | 34 (38.2) |
| Midgut | 17 (40.5) | 17 (36.2) | 34 (38.2) |
| Hindgut | 5 (11.9) | 2 (4.3) | 7 (7.9) |
| Other/unknown | 8 (19.0) | 6 (12.8) | 14 (15.7) |
| Tumour progression at: | |||
| Core study baseline | 0 | 4 (8.5) | 4 (4.5) |
| OLE baseline | 1 (2.3)b | 32 (68.1) | 33 (37.1) |
| Tumour gradec | |||
| G1 (Ki-67 0–2%) | 30 (71.4) | 32 (68.1) | 62 (69.7) |
| G2 (Ki-67 3–10%) | 12 (28.6) | 15 (31.9) | 27 (30.3) |
| Hepatic tumour load | |||
| 0% | 9 (21.4) | 12 (25.5) | 21 (23.6) |
| >0–10% | 19 (45.2) | 19 (40.4) | 38 (42.7) |
| >10–25% | 2 (4.8) | 7 (14.9) | 9 (10.1) |
| >25–50% | 10 (23.8) | 5 (10.6) | 15 (16.9) |
| >50% | 2 (4.8) | 4 (8.5) | 6 (6.7) |
Data are n (%), unless stated otherwise, from the Safety population and for assessments at either the CLARINET core-study baseline or aCLARINET OLE baseline. Treatment groups are for patients receiving lanreotide autogel/depot 120 mg in both the CLARINET core study and the OLE (LAN–LAN group) and patients receiving placebo in the CLARINET core study and crossing over to lanreotide in the OLE (PBO–LAN group)
bEnroled by the investigator before communication of the results of the central assessment (PD) in the core study; patient withdrawn from the OLE on receipt of the assessment result
cTumour grades based on WHO 2010 classification [15] (G1, mitotic count <2 mitoses/10 HPF and/or Ki-67 ≤ 2%; G2, mitotic count 2–20 mitoses/10 HPF and Ki-67 > 2–20%)—note that none of the patients had tumours with Ki-67 > 10%. OLE open-label extension, LAN–LAN group patients receiving lanreotide autogel/depot in core study as well as the OLE study, PBO–LAN group patients receiving placebo in the core study before crossing over to lanreotide in the OLE study, WHO World Health Organization, NET neuroendocrine tumour, PD progressive disease