Abstract 5458
Background
Lanreotide autogel (LAN) is a long-acting somatostatin analogue used to treat somatostatin receptor-positive (SSTR+), gastroenteropancreatic neuroendocrine tumours (GEP-NETs).1 In the CLARINET study, LAN 120 mg every (q)28 days significantly improved progression-free survival (PFS) versus placebo in patients with metastatic, SSTR+ GEPNETs. CLARINET FORTE is an ongoing phase II study assessing the safety and efficacy (centrally assessed median PFS) of increasing the frequency of LAN 120 mg dosing (q14 days) in patients with progressive pancreatic NETs (panNETs) or midgut NETs.
Methods
Eligible patients had well-differentiated, metastatic or locally advanced, unresectable, G1/G2, panNETs or midgut NETs with a proliferation index (Ki-67) ≤20%. Patients had radiological progressive disease within 2 years prior to study inclusion as assessed by central review, while receiving first-line treatment with LAN 120 mg with standard treatment intervals (q28) days for ≥24 weeks. Following a 28-day screening interval, LAN 120 mg was administered q14 days. In total, 99 enrolled patients from 10 countries received treatment.
Results
Table: 1388P
Baseline characteristics | ||
---|---|---|
panNET (n = 48) | Midgut NET (n = 51) | |
Age, mean (SD) | 63.3 (10.6) | 67.1 (8.2) |
Male, n (%) | 20 (41.7) | 29 (56.9) |
Tumour grading*, % | - | - |
1 | 22.9 | 54.9 |
2 | 77.1 | 45.1 |
Proliferation index Ki-67, mean (SD) | 6.2 (4.6) | 3.5 (3.8) |
Proliferation index Ki-67 category, n (%) | - | - |
≥10% | 9 (18.8) | 4 (8.0) |
<10% | 39 (81.3) | 46 (92.0) |
≤2%† | 11 (28.2) | 28 (60.9) |
2–10%† | 28 (71.8) | 18 (39.1) |
Missing | 0 | 1 |
Hepatic tumour load, n (%) >25% ≤25% Missing | - 6 (13.3) 39 (86.7) 3 | - 9 (17.6) 42 (82.4) 0 |
Previous primary tumour surgery | 18 (37.5) | 12 (23.5) |
Krenning scale, n (%) Grade 1 Grade 2 Grade 3 Grade 4 N/A‡ Missing | - 0 6 (12.5) 10 (20.8) 28 (58.3) 4 (8.3) 0 | - 4 (8.5) 4 (8.5) 15 (31.9) 21 (44.7) 3 (6.4) 4 |
Duration of LAN treatment (standard dosing interval) prior to study enrolment in months, median (range) | 21.7 (5–103) | 16.4 (5–198) |
Diarrhoea presence, % Flushing presence, % | 16.7 8.3 | 41.7 28.0 |
WHO classification
†Percentages are based on the number of subjects with a Ki-67 <10 %.
‡Patients who had a PET scan with gallium.
Conclusions
Baseline CLARINET FORTE data highlight the high rate of G1 in progressive midgut NET and of G2 in panNET. The cohort is representative of typical patients requiring treatment intensification due to progressive panNET or midgut NET. Final analyses are expected in Q1 2020, which will provide efficacy and safety data on use of LAN 120 mg at an increased dosing frequency. 1. Somatuline autogel SmPC. November 2018.
Clinical trial identification
NCT02651987.
Editorial acknowledgement
Editorial assistance was provided by Louise Cully of Ashfield Healthcare and funded by Ipsen.
Legal entity responsible for the study
Ipsen.
Funding
Ipsen.
Disclosure
P. Ruszniewski: Advisory / Consultancy: Novartis; Advisory / Consultancy: Ipsen; Advisory / Consultancy: AAA; Advisory / Consultancy: Keocyt. J. Ćwikła: Advisory / Consultancy, PI in Poland for this study: Ipsen. C. Lombard-Bohas: Advisory / Consultancy, Research grant / Funding (self): Ipsen; Research grant / Funding (self): Pfizer ; Advisory / Consultancy, Research grant / Funding (self): Novartis. I. Borbath: Advisory / Consultancy: Pfizer ; Advisory / Consultancy, Research grant / Funding (self): Novartis; Advisory / Consultancy, Research grant / Funding (self): Ipsen; Research grant / Funding (self): Bayer; Research grant / Funding (self): Celgene. T. Shah: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Ipsen. U. Pape: Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Ipsen; Research grant / Funding (self): Novartis. X. Truong Thanh: Full / Part-time employment: Ipsen. A. Houchard: Full / Part-time employment: Ipsen. M.E. Pavel: Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Lexicon.
Resources from the same session
3240 - Efficacy and safety of trifluridine/tipiracil (FTD/TPI) in European patients with heavily pretreated metastatic gastric cancer (mGC): an analysis of the TAGS study
Presenter: Maria Alsina
Session: Poster Display session 2
Resources:
Abstract
733 - Clinical experience: ramucirumab with FOLFIRI/XELIRI as a second line for patients with metastatic gastric cancer
Presenter: Tatiana Titova
Session: Poster Display session 2
Resources:
Abstract
2186 - Efficacy and safety of apatinib for the treatment of AFP-producing gastric cancer
Presenter: Ningning Li
Session: Poster Display session 2
Resources:
Abstract
3172 - Apatinib in combination with docetaxol and S1 chemotherapy in the first line treatment of metastatic gastric cancer
Presenter: Ling Xia
Session: Poster Display session 2
Resources:
Abstract
3982 - Parameters of local cellular immunity in metastatic gastric cancer
Presenter: Aleksandr Sagakyants
Session: Poster Display session 2
Resources:
Abstract
5102 - Germline pathogenic mutations in Chinese patients with gastric cancer identified by next-generation sequencing (NGS)
Presenter: Xiaotian Zhang
Session: Poster Display session 2
Resources:
Abstract
5012 - Inhibition of the PI3K pathway in HER2-positive gastric cancer
Presenter: Sinead Toomey
Session: Poster Display session 2
Resources:
Abstract
4803 - Investigation on gastric cancer susceptibility genes in Chinese early-onset diffuse gastric cancer
Presenter: Yi Feng
Session: Poster Display session 2
Resources:
Abstract
4778 - A correlation analysis between survival rate and the characteristic gene of gastric cancer based on bioinformatics analysis
Presenter: Yi-wen Zhang
Session: Poster Display session 2
Resources:
Abstract
4805 - Phase I study of apatinib combined with POF (paclitaxel plus FOLFOX) in patients (pts) with treatment-naïve advanced gastric cancer (TNAGC)
Presenter: Rongbo LIN
Session: Poster Display session 2
Resources:
Abstract