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Poster Display session 2

5458 - Baseline characteristics from CLARINET FORTE: Evaluating lanreotide autogel (LAN) 120 mg every 14 days in patients with progressive pancreatic or midgut neuroendocrine tumours during a standard first-line LAN regimen.

Date

29 Sep 2019

Session

Poster Display session 2

Presenters

Philippe Ruszniewski

Citation

Annals of Oncology (2019) 30 (suppl_5): v564-v573. 10.1093/annonc/mdz256

Authors

P. Ruszniewski1, J. Ćwikła2, C. Lombard-Bohas3, I. Borbath4, T. Shah5, U. Pape6, X. Truong Thanh7, A. Houchard8, M.E. Pavel9

Author affiliations

  • 1 Gastroenterology, University of Paris, Beaujon Hospital, 92110 - Clichy/FR
  • 2 Department Of Radiology, University of Warmia and Mazury, 11-041 - Olsztyn/PL
  • 3 Medical Oncology, Hopital Edouard Herriot, 69437 - Lyon/FR
  • 4 Medical Oncology, Cliniques Universitaires St. Luc, 1200 - Brussels/BE
  • 5 Birmingham Neuroendocrine Tumour Centre, Queen Elizabeth Hospital Birmingham, B15 2TH - Birmingham/GB
  • 6 Innere Medizin Und Gastroenterologie, Charité – Universitätsmedizin Berlin, 10117 - Berlin/DE
  • 7 Onco-endocrinology, Ipsen, 92100 - Boulogne-Billancourt/FR
  • 8 Clinical Statistics, Ipsen, 92100 - Boulogne-Billancourt/FR
  • 9 Gastroenterology And Hepatology, Endocrinology & Metabolic Diseases, Universitätsklinik Erlangen, 91054 - Erlangen/DE
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Resources

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*, %--
122.954.9
277.145.1
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)
Missing01
Hepatic tumour load, n (%) >25% ≤25% Missing- 6 (13.3) 39 (86.7) 3- 9 (17.6) 42 (82.4) 0
Previous primary tumour surgery18 (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 8.341.7 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.

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