PMID- 26743120
OWN - NLM
STAT- MEDLINE
DCOM- 20161024
LR  - 20231111
IS  - 1479-6821 (Electronic)
IS  - 1351-0088 (Print)
IS  - 1351-0088 (Linking)
VI  - 23
IP  - 3
DP  - 2016 Mar
TI  - Anti-tumour effects of lanreotide for pancreatic and intestinal neuroendocrine 
      tumours: the CLARINET open-label extension study.
PG  - 191-9
LID - 10.1530/ERC-15-0490 [doi]
AB  - 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.
CI  - (c) 2016 The authors.
FAU - Caplin, Martyn E
AU  - Caplin ME
AD  - Royal Free HospitalLondon, UKCharite University Medicine BerlinBerlin, 
      GermanyUniversity of Warmia and MazuryOlsztyn, PolandUniversity of Texas MD 
      Anderson Cancer CenterHouston, Texas, USAUniversity HospitalVienna, 
      AustriaDepartment of Oncology of the First Faculty of Medicine and General 
      Teaching HospitalPrague, Czech RepublicRobert-Debre HospitalReims, FranceMarkey 
      Cancer CenterUniversity of Kentucky, Lexington, Kentucky, USAVall d'Hebron 
      University HospitalBarcelona, SpainWestern General HospitalEdinburgh, 
      UKUniversita Cattolica del Sacro CuoreRome, ItalyIpsenLes Ulis, 
      FranceIpsenBasking Ridge, New Jersey, USABeaujon HospitalClichy, FranceParis 
      Diderot UniversityParis, France m.caplin@ucl.ac.uk.
FAU - Pavel, Marianne
AU  - Pavel M
AD  - Royal Free HospitalLondon, UKCharite University Medicine BerlinBerlin, 
      GermanyUniversity of Warmia and MazuryOlsztyn, PolandUniversity of Texas MD 
      Anderson Cancer CenterHouston, Texas, USAUniversity HospitalVienna, 
      AustriaDepartment of Oncology of the First Faculty of Medicine and General 
      Teaching HospitalPrague, Czech RepublicRobert-Debre HospitalReims, FranceMarkey 
      Cancer CenterUniversity of Kentucky, Lexington, Kentucky, USAVall d'Hebron 
      University HospitalBarcelona, SpainWestern General HospitalEdinburgh, 
      UKUniversita Cattolica del Sacro CuoreRome, ItalyIpsenLes Ulis, 
      FranceIpsenBasking Ridge, New Jersey, USABeaujon HospitalClichy, FranceParis 
      Diderot UniversityParis, France.
FAU - Cwikla, Jaroslaw B
AU  - Cwikla JB
AD  - Royal Free HospitalLondon, UKCharite University Medicine BerlinBerlin, 
      GermanyUniversity of Warmia and MazuryOlsztyn, PolandUniversity of Texas MD 
      Anderson Cancer CenterHouston, Texas, USAUniversity HospitalVienna, 
      AustriaDepartment of Oncology of the First Faculty of Medicine and General 
      Teaching HospitalPrague, Czech RepublicRobert-Debre HospitalReims, FranceMarkey 
      Cancer CenterUniversity of Kentucky, Lexington, Kentucky, USAVall d'Hebron 
      University HospitalBarcelona, SpainWestern General HospitalEdinburgh, 
      UKUniversita Cattolica del Sacro CuoreRome, ItalyIpsenLes Ulis, 
      FranceIpsenBasking Ridge, New Jersey, USABeaujon HospitalClichy, FranceParis 
      Diderot UniversityParis, France.
FAU - Phan, Alexandria T
AU  - Phan AT
AD  - Royal Free HospitalLondon, UKCharite University Medicine BerlinBerlin, 
      GermanyUniversity of Warmia and MazuryOlsztyn, PolandUniversity of Texas MD 
      Anderson Cancer CenterHouston, Texas, USAUniversity HospitalVienna, 
      AustriaDepartment of Oncology of the First Faculty of Medicine and General 
      Teaching HospitalPrague, Czech RepublicRobert-Debre HospitalReims, FranceMarkey 
      Cancer CenterUniversity of Kentucky, Lexington, Kentucky, USAVall d'Hebron 
      University HospitalBarcelona, SpainWestern General HospitalEdinburgh, 
      UKUniversita Cattolica del Sacro CuoreRome, ItalyIpsenLes Ulis, 
      FranceIpsenBasking Ridge, New Jersey, USABeaujon HospitalClichy, FranceParis 
      Diderot UniversityParis, France.
FAU - Raderer, Markus
AU  - Raderer M
AD  - Royal Free HospitalLondon, UKCharite University Medicine BerlinBerlin, 
      GermanyUniversity of Warmia and MazuryOlsztyn, PolandUniversity of Texas MD 
      Anderson Cancer CenterHouston, Texas, USAUniversity HospitalVienna, 
      AustriaDepartment of Oncology of the First Faculty of Medicine and General 
      Teaching HospitalPrague, Czech RepublicRobert-Debre HospitalReims, FranceMarkey 
      Cancer CenterUniversity of Kentucky, Lexington, Kentucky, USAVall d'Hebron 
      University HospitalBarcelona, SpainWestern General HospitalEdinburgh, 
      UKUniversita Cattolica del Sacro CuoreRome, ItalyIpsenLes Ulis, 
      FranceIpsenBasking Ridge, New Jersey, USABeaujon HospitalClichy, FranceParis 
      Diderot UniversityParis, France.
FAU - Sedlackova, Eva
AU  - Sedlackova E
AD  - Royal Free HospitalLondon, UKCharite University Medicine BerlinBerlin, 
      GermanyUniversity of Warmia and MazuryOlsztyn, PolandUniversity of Texas MD 
      Anderson Cancer CenterHouston, Texas, USAUniversity HospitalVienna, 
      AustriaDepartment of Oncology of the First Faculty of Medicine and General 
      Teaching HospitalPrague, Czech RepublicRobert-Debre HospitalReims, FranceMarkey 
      Cancer CenterUniversity of Kentucky, Lexington, Kentucky, USAVall d'Hebron 
      University HospitalBarcelona, SpainWestern General HospitalEdinburgh, 
      UKUniversita Cattolica del Sacro CuoreRome, ItalyIpsenLes Ulis, 
      FranceIpsenBasking Ridge, New Jersey, USABeaujon HospitalClichy, FranceParis 
      Diderot UniversityParis, France.
FAU - Cadiot, Guillaume
AU  - Cadiot G
AD  - Royal Free HospitalLondon, UKCharite University Medicine BerlinBerlin, 
      GermanyUniversity of Warmia and MazuryOlsztyn, PolandUniversity of Texas MD 
      Anderson Cancer CenterHouston, Texas, USAUniversity HospitalVienna, 
      AustriaDepartment of Oncology of the First Faculty of Medicine and General 
      Teaching HospitalPrague, Czech RepublicRobert-Debre HospitalReims, FranceMarkey 
      Cancer CenterUniversity of Kentucky, Lexington, Kentucky, USAVall d'Hebron 
      University HospitalBarcelona, SpainWestern General HospitalEdinburgh, 
      UKUniversita Cattolica del Sacro CuoreRome, ItalyIpsenLes Ulis, 
      FranceIpsenBasking Ridge, New Jersey, USABeaujon HospitalClichy, FranceParis 
      Diderot UniversityParis, France.
FAU - Wolin, Edward M
AU  - Wolin EM
AD  - Royal Free HospitalLondon, UKCharite University Medicine BerlinBerlin, 
      GermanyUniversity of Warmia and MazuryOlsztyn, PolandUniversity of Texas MD 
      Anderson Cancer CenterHouston, Texas, USAUniversity HospitalVienna, 
      AustriaDepartment of Oncology of the First Faculty of Medicine and General 
      Teaching HospitalPrague, Czech RepublicRobert-Debre HospitalReims, FranceMarkey 
      Cancer CenterUniversity of Kentucky, Lexington, Kentucky, USAVall d'Hebron 
      University HospitalBarcelona, SpainWestern General HospitalEdinburgh, 
      UKUniversita Cattolica del Sacro CuoreRome, ItalyIpsenLes Ulis, 
      FranceIpsenBasking Ridge, New Jersey, USABeaujon HospitalClichy, FranceParis 
      Diderot UniversityParis, France.
FAU - Capdevila, Jaume
AU  - Capdevila J
AD  - Royal Free HospitalLondon, UKCharite University Medicine BerlinBerlin, 
      GermanyUniversity of Warmia and MazuryOlsztyn, PolandUniversity of Texas MD 
      Anderson Cancer CenterHouston, Texas, USAUniversity HospitalVienna, 
      AustriaDepartment of Oncology of the First Faculty of Medicine and General 
      Teaching HospitalPrague, Czech RepublicRobert-Debre HospitalReims, FranceMarkey 
      Cancer CenterUniversity of Kentucky, Lexington, Kentucky, USAVall d'Hebron 
      University HospitalBarcelona, SpainWestern General HospitalEdinburgh, 
      UKUniversita Cattolica del Sacro CuoreRome, ItalyIpsenLes Ulis, 
      FranceIpsenBasking Ridge, New Jersey, USABeaujon HospitalClichy, FranceParis 
      Diderot UniversityParis, France.
FAU - Wall, Lucy
AU  - Wall L
AD  - Royal Free HospitalLondon, UKCharite University Medicine BerlinBerlin, 
      GermanyUniversity of Warmia and MazuryOlsztyn, PolandUniversity of Texas MD 
      Anderson Cancer CenterHouston, Texas, USAUniversity HospitalVienna, 
      AustriaDepartment of Oncology of the First Faculty of Medicine and General 
      Teaching HospitalPrague, Czech RepublicRobert-Debre HospitalReims, FranceMarkey 
      Cancer CenterUniversity of Kentucky, Lexington, Kentucky, USAVall d'Hebron 
      University HospitalBarcelona, SpainWestern General HospitalEdinburgh, 
      UKUniversita Cattolica del Sacro CuoreRome, ItalyIpsenLes Ulis, 
      FranceIpsenBasking Ridge, New Jersey, USABeaujon HospitalClichy, FranceParis 
      Diderot UniversityParis, France.
FAU - Rindi, Guido
AU  - Rindi G
AD  - Royal Free HospitalLondon, UKCharite University Medicine BerlinBerlin, 
      GermanyUniversity of Warmia and MazuryOlsztyn, PolandUniversity of Texas MD 
      Anderson Cancer CenterHouston, Texas, USAUniversity HospitalVienna, 
      AustriaDepartment of Oncology of the First Faculty of Medicine and General 
      Teaching HospitalPrague, Czech RepublicRobert-Debre HospitalReims, FranceMarkey 
      Cancer CenterUniversity of Kentucky, Lexington, Kentucky, USAVall d'Hebron 
      University HospitalBarcelona, SpainWestern General HospitalEdinburgh, 
      UKUniversita Cattolica del Sacro CuoreRome, ItalyIpsenLes Ulis, 
      FranceIpsenBasking Ridge, New Jersey, USABeaujon HospitalClichy, FranceParis 
      Diderot UniversityParis, France.
FAU - Langley, Alison
AU  - Langley A
AD  - Royal Free HospitalLondon, UKCharite University Medicine BerlinBerlin, 
      GermanyUniversity of Warmia and MazuryOlsztyn, PolandUniversity of Texas MD 
      Anderson Cancer CenterHouston, Texas, USAUniversity HospitalVienna, 
      AustriaDepartment of Oncology of the First Faculty of Medicine and General 
      Teaching HospitalPrague, Czech RepublicRobert-Debre HospitalReims, FranceMarkey 
      Cancer CenterUniversity of Kentucky, Lexington, Kentucky, USAVall d'Hebron 
      University HospitalBarcelona, SpainWestern General HospitalEdinburgh, 
      UKUniversita Cattolica del Sacro CuoreRome, ItalyIpsenLes Ulis, 
      FranceIpsenBasking Ridge, New Jersey, USABeaujon HospitalClichy, FranceParis 
      Diderot UniversityParis, France.
FAU - Martinez, Severine
AU  - Martinez S
AD  - Royal Free HospitalLondon, UKCharite University Medicine BerlinBerlin, 
      GermanyUniversity of Warmia and MazuryOlsztyn, PolandUniversity of Texas MD 
      Anderson Cancer CenterHouston, Texas, USAUniversity HospitalVienna, 
      AustriaDepartment of Oncology of the First Faculty of Medicine and General 
      Teaching HospitalPrague, Czech RepublicRobert-Debre HospitalReims, FranceMarkey 
      Cancer CenterUniversity of Kentucky, Lexington, Kentucky, USAVall d'Hebron 
      University HospitalBarcelona, SpainWestern General HospitalEdinburgh, 
      UKUniversita Cattolica del Sacro CuoreRome, ItalyIpsenLes Ulis, 
      FranceIpsenBasking Ridge, New Jersey, USABeaujon HospitalClichy, FranceParis 
      Diderot UniversityParis, France.
FAU - Gomez-Panzani, Edda
AU  - Gomez-Panzani E
AD  - Royal Free HospitalLondon, UKCharite University Medicine BerlinBerlin, 
      GermanyUniversity of Warmia and MazuryOlsztyn, PolandUniversity of Texas MD 
      Anderson Cancer CenterHouston, Texas, USAUniversity HospitalVienna, 
      AustriaDepartment of Oncology of the First Faculty of Medicine and General 
      Teaching HospitalPrague, Czech RepublicRobert-Debre HospitalReims, FranceMarkey 
      Cancer CenterUniversity of Kentucky, Lexington, Kentucky, USAVall d'Hebron 
      University HospitalBarcelona, SpainWestern General HospitalEdinburgh, 
      UKUniversita Cattolica del Sacro CuoreRome, ItalyIpsenLes Ulis, 
      FranceIpsenBasking Ridge, New Jersey, USABeaujon HospitalClichy, FranceParis 
      Diderot UniversityParis, France.
FAU - Ruszniewski, Philippe
AU  - Ruszniewski P
AD  - Royal Free HospitalLondon, UKCharite University Medicine BerlinBerlin, 
      GermanyUniversity of Warmia and MazuryOlsztyn, PolandUniversity of Texas MD 
      Anderson Cancer CenterHouston, Texas, USAUniversity HospitalVienna, 
      AustriaDepartment of Oncology of the First Faculty of Medicine and General 
      Teaching HospitalPrague, Czech RepublicRobert-Debre HospitalReims, FranceMarkey 
      Cancer CenterUniversity of Kentucky, Lexington, Kentucky, USAVall d'Hebron 
      University HospitalBarcelona, SpainWestern General HospitalEdinburgh, 
      UKUniversita Cattolica del Sacro CuoreRome, ItalyIpsenLes Ulis, 
      FranceIpsenBasking Ridge, New Jersey, USABeaujon HospitalClichy, FranceParis 
      Diderot UniversityParis, France Royal Free HospitalLondon, UKCharite University 
      Medicine BerlinBerlin, GermanyUniversity of Warmia and MazuryOlsztyn, 
      PolandUniversity of Texas MD Anderson Cancer CenterHouston, Texas, USAUniversity 
      HospitalVienna, AustriaDepartment of Oncology of the First Faculty of Medicine 
      and General Teaching HospitalPrague, Czech RepublicRobert-Debre HospitalReims, 
      FranceMarkey Cancer CenterUniversity of Kentucky, Lexington, Kentucky, USAVall 
      d'Hebron University HospitalBarcelona, SpainWestern General HospitalEdinburgh, 
      UKUniversita Cattolica del Sacro CuoreRome, ItalyIpsenLes Ulis, 
      FranceIpsenBasking Ridge, New Jersey, USABeaujon HospitalClichy, FranceParis 
      Diderot UniversityParis, France.
CN  - CLARINET Investigators
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20160107
PL  - England
TA  - Endocr Relat Cancer
JT  - Endocrine-related cancer
JID - 9436481
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Peptides, Cyclic)
RN  - 0G3DE8943Y (lanreotide)
RN  - 51110-01-1 (Somatostatin)
SB  - IM
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Disease-Free Survival
MH  - Humans
MH  - Intestinal Neoplasms/*drug therapy
MH  - Neuroendocrine Tumors/*drug therapy
MH  - Pancreatic Neoplasms/*drug therapy
MH  - Peptides, Cyclic/adverse effects/*therapeutic use
MH  - Somatostatin/adverse effects/*analogs & derivatives/therapeutic use
MH  - Treatment Outcome
PMC - PMC4740728
OTO - NOTNLM
OT  - anti-tumour effects
OT  - lanreotide Autogel
OT  - neuroendocrine tumours
OT  - open-label extension
FIR - Raderer, M
IR  - Raderer M
FIR - Borbath, I
IR  - Borbath I
FIR - Ysebaert, D
IR  - Ysebaert D
FIR - Sedlackova, E
IR  - Sedlackova E
FIR - Vitek, P
IR  - Vitek P
FIR - Gronbaek, H
IR  - Gronbaek H
FIR - Adenis, A
IR  - Adenis A
FIR - Buscail, L
IR  - Buscail L
FIR - Cadiot, G
IR  - Cadiot G
FIR - Dominguez, S
IR  - Dominguez S
FIR - Ducreux, M
IR  - Ducreux M
FIR - Lombard-Bohas, C
IR  - Lombard-Bohas C
FIR - Mitry, E
IR  - Mitry E
FIR - Ruszniewski, P
IR  - Ruszniewski P
FIR - Seitz, J F
IR  - Seitz JF
FIR - Begum, N
IR  - Begum N
FIR - Harsch, I
IR  - Harsch I
FIR - Pavel, M
IR  - Pavel M
FIR - Schofl, C
IR  - Schofl C
FIR - Weber, M
IR  - Weber M
FIR - Wiedenmann, B
IR  - Wiedenmann B
FIR - Mallath, M
IR  - Mallath M
FIR - Patil, P
IR  - Patil P
FIR - Sambasivaiah, K
IR  - Sambasivaiah K
FIR - Saxena, R
IR  - Saxena R
FIR - Bajetta, E
IR  - Bajetta E
FIR - Buonadonna, A
IR  - Buonadonna A
FIR - Buzzoni, R
IR  - Buzzoni R
FIR - Cannizzaro, R
IR  - Cannizzaro R
FIR - Colao, A
IR  - Colao A
FIR - De Angelis, C
IR  - De Angelis C
FIR - Tomassetti, P
IR  - Tomassetti P
FIR - Cwikla, J
IR  - Cwikla J
FIR - Kos-Kudla, B
IR  - Kos-Kudla B
FIR - Salek, T
IR  - Salek T
FIR - Capdevila, J
IR  - Capdevila J
FIR - Soler, G
IR  - Soler G
FIR - Tabernero, J M
IR  - Tabernero JM
FIR - Ahlman, H
IR  - Ahlman H
FIR - Kjellman, M
IR  - Kjellman M
FIR - Aithal, G
IR  - Aithal G
FIR - Anthoney, A
IR  - Anthoney A
FIR - Caplin, M
IR  - Caplin M
FIR - Grossman, A
IR  - Grossman A
FIR - Newell-Price, J
IR  - Newell-Price J
FIR - Ramage, J
IR  - Ramage J
FIR - Reed, N
IR  - Reed N
FIR - Rees, A
IR  - Rees A
FIR - Steward, W
IR  - Steward W
FIR - Wall, L
IR  - Wall L
FIR - Choti, M
IR  - Choti M
FIR - Phan, T
IR  - Phan T
FIR - Wolin, E M
IR  - Wolin EM
EDAT- 2016/01/09 06:00
MHDA- 2016/10/25 06:00
PMCR- 2016/03/01
CRDT- 2016/01/09 06:00
PHST- 2016/01/06 00:00 [accepted]
PHST- 2016/01/09 06:00 [entrez]
PHST- 2016/01/09 06:00 [pubmed]
PHST- 2016/10/25 06:00 [medline]
PHST- 2016/03/01 00:00 [pmc-release]
AID - ERC-15-0490 [pii]
AID - ERC150490 [pii]
AID - 10.1530/ERC-15-0490 [doi]
PST - ppublish
SO  - Endocr Relat Cancer. 2016 Mar;23(3):191-9. doi: 10.1530/ERC-15-0490. Epub 2016 
      Jan 7.