Table 4.
PFS for lanreotide autogel/depot 120 mg from the CLARINET core study and the OLE and PFS for placebo from the core study across subgroups defined according to baseline characteristics in the core study
| Subgroup | Number of events/patients | Median PFS [95% CI] (months) | ||
|---|---|---|---|---|
| LAN (core and OLE) N = 101 |
PBO (core) N = 103 |
LAN (core and OLE) | PBO (core) | |
| Tumour origin | ||||
| Midgut | 15/33 | 21/40 | 61.5 [30.9, NR] | 21.1 [17.0, NR] |
| Pancreas | 24/42 | 32/49 | 29.7 [12.0, 38.5] | 12.1 [9.4, 18.3] |
| Hindgut | 5/11 | 2/3 | 55.0 [2.9, NR] | 24.4 [12.0, 24.4] |
| Other/unknown | 7/15 | 6/11 | 59.4 [32.8, 74.8] | 15.0 [6.3, NR] |
| Tumour gradea | ||||
| G1 (Ki-67 0–2%) | 32/69 | 41/72 | 50.8 [31.3, 74.8] | 18.2 [12.1; 24.0] |
| G2 (Ki-67 3–10%) | 19/32 | 19/29 | 31.2 [16.6, 32.8] | 12.1 [9.0; 18.0] |
| Missing | 0/0 | 1/2 | – | – |
| Hepatic tumour load | ||||
| ≤25% | 28/62 | 42/75 | 50.8 [31.3, 74.8] | 18.6 [17.0; 24.4] |
| >25% | 23/39 | 19/28 | 24.1 [9.3, 49.0] | 9.4 [6.3; 12.0] |
| Progressive disease at baseline of core study | ||||
| Yes | 3/4 | 3/5 | 3.1 [3.0, 3.2] | 6.2 [3.0, NR] |
| No | 48/97 | 58/98 | 38.7 [31.2, 61.5] | 18.0 [12.1, 21.1] |
| Previous therapy for non-functioning NET | ||||
| Yesb | 12/16 | 9/16 | 29.7 [6.0, 31.3] | 12.0 [3.3, NR] |
| No | 39/85 | 52/87 | 50.8 [32.4, 74.8] | 18.0 [12.1, 24.0] |
| Geographical region | ||||
| USA | 6/16 | 9/14 | 61.5 [12.0, NR] | 9.4 [9.0, NR] |
| Outside of the USA | 45/85 | 52/89 | 37.1 [29.7, 55.0] | 18.0 [12.1, 24.0] |
PFS progression-free survival, OLE open-label extension, LAN lanreotide autogel/depot 120 mg, PBO placebo, NET neuroendocrine tumour, NR not reached, SD stable disease
aTumour 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%;
bNumber of patients who received previous chemotherapy: LAN n = 14, PBO n = 15; Yttrium (90Y) compounds: LAN n = 4, PBO n = 0; proton pump inhibitors: LAN n = 2, PBO n = 2; octreotide: LAN n = 2, PBO n = 1; interferons, LAN n = 1, PBO, n = 1; monoclonal antibodies, LAN n = 1, PBO n = 0; opioids: LAN n = 0, PBO n = 2 (patients could have more than one previous therapy). Data are from the intention-to-treat population with months approximated based on 4 weeks per month and were for subgroups defined a priori except for tumour grade and hepatic tumour load. Core-study data are from all patients randomly allocated to double-blind treatment (lanreotide autogel/depot or placebo). The OLE data are only for patients originally randomly allocated to lanreotide in the core study who then continued into the OLE. The PFS data previously reported for placebo were based on 60 events overall [1]; this was because 1 patient was erroneously reported as having centrally assessed SD at the time of database lock in the core study. This has been revised in the analysis of the OLE data.