PMID- 33052555
OWN - NLM
STAT- MEDLINE
DCOM- 20210708
LR  - 20210708
IS  - 1559-0100 (Electronic)
IS  - 1355-008X (Print)
IS  - 1355-008X (Linking)
VI  - 71
IP  - 2
DP  - 2021 Feb
TI  - Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: 
      final results of the CLARINET open-label extension study.
PG  - 502-513
LID - 10.1007/s12020-020-02475-2 [doi]
AB  - PURPOSE: In the phase III CLARINET study (NCT00353496), lanreotide autogel/depot 
      (lanreotide) significantly improved progression-free survival (PFS) vs placebo in 
      patients with non-functioning intestinal or pancreatic neuroendocrine tumours 
      (NETs). The aim of CLARINET open-label extension (OLE) (NCT00842348) was to 
      evaluate long-term safety and efficacy of lanreotide in these patients. METHODS: 
      Patients from the CLARINET study were eligible for the OLE if they had stable 
      disease (irrespective of treatment group) or progressive disease (PD) 
      (placebo-treated patients only). All patients in the OLE received lanreotide 
      120 mg every 28 days. Computed tomography or magnetic resonance imaging scans 
      were conducted every 6 months and assessed locally for PD (the final scan was 
      also assessed centrally). RESULTS: Overall, 89 patients took part in the OLE 
      (lanreotide, n = 42; placebo, n = 47). Median (range) exposure to lanreotide in 
      patients who received lanreotide in the core study and OLE (LAN-LAN group) was 
      59.0 (26.0-102.3) months. In this group, the overall incidences of adverse events 
      (AEs) and treatment-related AEs were lower in the OLE than in the core study. 
      Median [95% CI] PFS in the LAN-LAN group was 38.5 [30.9; 59.4] months. In 
      placebo-treated patients with PD at the end of the core study, time to death or 
      subsequent PD during the OLE was 19 [10.1; 26.7] months. CONCLUSIONS: This study 
      provides new evidence on the long-term safety profile and sustained anti-tumour 
      effects of lanreotide autogel/depot in indolent and progressive metastatic 
      intestinal or pancreatic NETs.
FAU - Caplin, Martyn E
AU  - Caplin ME
AD  - Department of Gastroenterology and Tumour Neuroendocrinology, Royal Free 
      Hospital, London, UK. m.caplin@ucl.ac.uk.
FAU - Pavel, Marianne
AU  - Pavel M
AD  - Department of Medicine, Division of Endocrinology and Diabetology, 
      Universitatsklinikum Erlangen, Friedrich Alexander University Erlangen-Nurnberg, 
      Erlangen, Germany.
FAU - Phan, Alexandria T
AU  - Phan AT
AD  - Department of Hematology-Oncology, University of Texas Health Science Center at 
      Tyler, Tyler, TX, USA.
AD  - Cancer Treatment Centers of America at South Eastern Regional Center, Atlanta, 
      GA, USA.
FAU - Cwikla, Jaroslaw B
AU  - Cwikla JB
AD  - Department of Cardiology and Cardiac Surgery, School of Medicine, University of 
      Warmia and Mazury, Olsztyn, Poland.
AD  - Diagnostic and Therapeutic Center - Gammed, Warsaw, Poland.
FAU - Sedlackova, Eva
AU  - Sedlackova E
AD  - Department of Oncology, First Faculty of Medicine and General Teaching Hospital, 
      Prague, Czech Republic.
FAU - Thanh, Xuan-Mai Truong
AU  - Thanh XT
AD  - Medical Affairs, Ipsen Pharma, Boulogne-Billancourt, France.
FAU - Wolin, Edward M
AU  - Wolin EM
AD  - Tisch Cancer Institute at Mount Sinai and Icahn School of Medicine at Mount 
      Sinai, New York, NY, USA.
AD  - Center for Carcinoid and Neuroendocrine Tumors, New York, NY, USA.
FAU - Ruszniewski, Philippe
AU  - Ruszniewski P
AD  - Division of Gastroenterology and Pancreatology, Beaujon Hospital, Clichy, France.
AD  - Universite de Paris, Paris, France.
CN  - CLARINET Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT00353496
SI  - ClinicalTrials.gov/NCT00842348
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20201014
PL  - United States
TA  - Endocrine
JT  - Endocrine
JID - 9434444
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Peptides, Cyclic)
RN  - 0G3DE8943Y (lanreotide)
RN  - 51110-01-1 (Somatostatin)
SB  - IM
MH  - *Antineoplastic Agents/adverse effects
MH  - Humans
MH  - *Neuroendocrine Tumors/drug therapy
MH  - *Pancreatic Neoplasms/drug therapy
MH  - Peptides, Cyclic/therapeutic use
MH  - Somatostatin/analogs & derivatives
PMC - PMC7881960
OTO - NOTNLM
OT  - Lanreotide autogel
OT  - Lanreotide depot
OT  - Neuroendocrine tumours
OT  - Progression-free survival
OT  - Safety
COIS- M.E.C.: Advisory board and speaker honoraria-Ipsen, Novartis, AAA, ITM and 
      Pfizer. M.P.: Honoraria for presentation and advisory boards-Ipsen; research 
      grants-Ipsen to former institution (Charite University Medicine, Berlin). A.T.P.: 
      Research funding-Ipsen, Sanofi and Incyte; consulting/advisory fees-Ipsen and 
      Roche; speaker fees-Lexicon, Novartis and Ipsen. JBC: Research funding and travel 
      grant-Ipsen. E.S.: Travel grants and speaker fees-Ipsen and Novartis. E.M.W.: 
      Consultancy/advisory fees-Ipsen, Novartis, Lexicon and Progenics. P.R.: Research 
      funding-Ipsen; speaker fees - Ipsen, Novartis, AAA, ITM; consultancy-Ipsen, 
      Novartis, AAA, ITM. X-MTT: Ipsen employee.
EDAT- 2020/10/15 06:00
MHDA- 2021/07/09 06:00
PMCR- 2020/10/14
CRDT- 2020/10/14 12:46
PHST- 2020/05/07 00:00 [received]
PHST- 2020/08/23 00:00 [accepted]
PHST- 2020/10/15 06:00 [pubmed]
PHST- 2021/07/09 06:00 [medline]
PHST- 2020/10/14 12:46 [entrez]
PHST- 2020/10/14 00:00 [pmc-release]
AID - 10.1007/s12020-020-02475-2 [pii]
AID - 2475 [pii]
AID - 10.1007/s12020-020-02475-2 [doi]
PST - ppublish
SO  - Endocrine. 2021 Feb;71(2):502-513. doi: 10.1007/s12020-020-02475-2. Epub 2020 Oct 
      14.