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
5612 - Evaluation of germ line mutational status among women with triple-negative breast cancer in Russia
Presenter: Elena Shagimardanova
Session: Poster Display session 2
Resources:
Abstract
4142 - Association of derived neutrophil-to-lymphocyte ratio (dNLR) with pathological complete response (pCR) after neoadjuvant chemotherapy (CT)
Presenter: Alberto Ocaña
Session: Poster Display session 2
Resources:
Abstract
1733 - Competing nomogram for late-period breast cancer-specific death in patients with early-stage hormone receptor-positive breast cancer
Presenter: Jianfei Fu
Session: Poster Display session 2
Resources:
Abstract
1978 - A Nomogram to Predict Pathologic Complete Response of Neoadjuvant Chemotherapy in Triple-Negative Breast Cancer Based on Simple Blood Indicators
Presenter: Fanrong Zhang
Session: Poster Display session 2
Resources:
Abstract
3062 - Identification of GSTP1 transferred by extracellular vesicles responsible for adriamycin-resistance in breast cancer cells
Presenter: Sujin Yang
Session: Poster Display session 2
Resources:
Abstract
5274 - Expression of X-linked Inhibitor of Apoptosis Protein (XIAP) and its Association with Clinicopathological Parameters in Invasive Breast Cancers
Presenter: Gayathri Devi
Session: Poster Display session 2
Resources:
Abstract
1324 - The prognostic significance of preoperative tumor marker (CEA, CA15-3) elevation in breast cancer patients
Presenter: Soo Youn Bae
Session: Poster Display session 2
Resources:
Abstract
4877 - Correlation of clinical and pathological features with the tumour microenvironment in DCIS. An institutional experience
Presenter: Ann Eapen
Session: Poster Display session 2
Resources:
Abstract
2471 - Correlation between radiologic complete response (rCR) in contrast-enhanced magnetic resonance imaging (CE-MRI) after neoadjuvant chemotherapy for early breast cancer and pathologic complete response and their impact in recurrence-free survival
Presenter: Ariadna Gasol Cudos
Session: Poster Display session 2
Resources:
Abstract
2632 - Ring-like uptake appearance on dedicated breast positron emission tomography before chemotherapy predicts outcome of neoadjuvant chemotherapy in breast cancer
Presenter: Norio Masumoto
Session: Poster Display session 2
Resources:
Abstract