Anti-tumour effects of lanreotide for pancreatic and intestinal neuroendocrine tumours: the CLARINET open-label extension study

Endocrine-Related Cancer - Tập 23 Số 3 - Trang 191-199 - 2016
Martyn Caplin1, Marianne Pavel2, Jarosław B. Ćwikła, Alexandria T. Phan3, Markus Raderer4, Eva Sedláčková5, Guillaume Cadiot6, Edward M. Wolin7, Jaume Capdevila8, Lucy Wall9, Guido Rindi10, Alison Langley11, Séverine Martinez11, Edda Gomez-Panzani12, Philippe Ruszniewski13,14, _ _
1Royal Free Hospital, London, UK
2Charite University Medicine Berlin, Berlin, Germany
3University of Texas MD Anderson Cancer Center, Houston, Texas, USA
4University Hospital Vienna, Austria
5Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic
6Robert-Debre ´Hospital, Reims, France
7Markey Cancer Center, University of Kentucky, Lexington, Kentucky, USA
8Vall d'Hebron University Hospital, Barcelona, Spain
9Western General Hospital, Edinburgh, UK
10Universita Cattolica del Sacro Cuore, Rome, Italy
11IPSEN, Les Ulis, FRANCE
12Ipsen, Basking Ridge, New Jersey, USA
13Beaujon Hospital, Clichy, France
14Paris Diderot University, Paris, France

Tóm tắt

In the CLARINET study, lanreotide Autogel (depot in USA) significantly prolonged progression-free survival (PFS) in patients with metastatic pancreatic/intestinal neuroendocrine tumours (NETs). We report long-term safety and additional efficacy data from the open-label extension (OLE). Patients with metastatic grade 1/2 (Ki-67 ≤10%) non-functioning NET and documented baseline tumour-progression status received lanreotide Autogel 120 mg (n=101) or placebo (n=103) for 96 weeks or until death/progressive disease (PD) in CLARINET study. Patients with stable disease (SD) at core study end (lanreotide/placebo) or PD (placebo only) continued or switched to lanreotide in the OLE. In total, 88 patients (previously: lanreotide, n=41; placebo, n=47) participated: 38% had pancreatic, 39% midgut and 23% other/unknown primary tumours. Patients continuing lanreotide reported fewer adverse events (AEs) (all and treatment-related) during OLE than core study. Placebo-to-lanreotide switch patients reported similar AE rates in OLE and core studies, except more diarrhoea was considered treatment-related in OLE (overall diarrhoea unchanged). Median lanreotide PFS (core study randomisation to PD in core/OLE; n=101) was 32.8 months (95% CI: 30.9, 68.0). A sensitivity analysis, addressing potential selection bias by assuming that patients with SD on lanreotide in the core study and not entering the OLE (n=13) had PD 24 weeks after last core assessment, found median PFS remaining consistent: 30.8 months (95% CI: 30.0, 31.3). Median time to further PD after placebo-to-lanreotide switch (n=32) was 14.0 months (10.1; not reached). This OLE study suggests long-term treatment with lanreotide Autogel 120 mg maintained favourable safety/tolerability. CLARINET OLE data also provide new evidence of lanreotide anti-tumour benefits in indolent and progressive pancreatic/intestinal NETs.

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Tài liệu tham khảo

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Endocrine-Related Cancer

Tập 23 Số 3

191-199

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