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
1933 - A national comparative effectiveness study to assess definitive chemoradiation regimens in proximal oesophageal squamous cell cancer
Presenter: Judith de Vos-Geelen
Session: Poster Display session 2
Resources:
Abstract
2860 - Prognostic value of metabolic response assessed by 18FDG-PET after induction chemotherapy and after chemoradiotherapy (CRT) in localized esophageal squamous cell carcinoma (ESCC) patients (pts) receiving definite CRT (dCRT)
Presenter: Yeonghak Bang
Session: Poster Display session 2
Resources:
Abstract
3881 - Comprehensive genomic profiling of early-stage esophageal squamous cell carcinoma
Presenter: Jing Zuo
Session: Poster Display session 2
Resources:
Abstract
3944 - A novel nomogram and risk classification system predicting radiation pneumonitis in patients with esophageal cancer receiving radiotherapy
Presenter: Lu Wang
Session: Poster Display session 2
Resources:
Abstract
1956 - Drinking alcohol, smoking, multiple dysplastic lesions and the risk of field cancerization of squamous cell carcinoma in the esophagus and head and neck region
Presenter: Chikatoshi Katada
Session: Poster Display session 2
Resources:
Abstract
2144 - Neoadjuvant chemotherapy can eliminate the negative impact of postoperative infectious complications on recurrence in patients with esophageal cancer
Presenter: Kazuki Kano
Session: Poster Display session 2
Resources:
Abstract
2403 - Comparison of chemoradiotherapy (CRT) followed by consolidation with cisplatin and 5-fluorouracil (CF) versus definitive CRT with carboplatin and paclitaxel (CP) in esophageal cancer
Presenter: Marcelle Cesca
Session: Poster Display session 2
Resources:
Abstract
3247 - Paclitaxel in Combination with Cisplatin and 5-fluorouracil(TPF) Induction Chemotherapy for Locally Advanced Borderline-resectable Esophageal Squamous cell Carcinoma: A Phase II Clinical Trial
Presenter: Yuhong Li
Session: Poster Display session 2
Resources:
Abstract
4293 - Prognosis of esophageal squamous cell carcinoma based on local immunity evaluation
Presenter: Elena Zlatnik
Session: Poster Display session 2
Resources:
Abstract
5419 - Impact of Sarcopenia and adiposity in survival of metastatic esophageal cancer (MEC)
Presenter: Aline Fares
Session: Poster Display session 2
Resources:
Abstract