ECE2014 Poster Presentations Endocrine tumours and neoplasia (99 abstracts)
Antiproliferative effects of lanreotide Autogel in patients with enteropancreatic neuroendocrine tumours: results of CLARINET, a large international phase 3 study
Martyn Caplin 1 , Philippe Ruszniewski 2 , Marianne Pavel 3 , Jaroslaw Cwikla 4 , Alexandria Phan 5 , Markus Raderer 6 , Eva Sedlackova 7 , Guillaume Cadiot 8 , Lucy Wall 9 , Guido Rindi 10 , Alison Langley 11 & Joelle Blumberg 11
1Royal Free Hospital, London, UK; 2Beaujon Hospital, Clichy, France; 3Charité University Medicine Berlin, Berlin, Germany; 4University of Varmia and Masuria, Olsztyn, Poland; 5University of Texas MD Anderson Cancer Center, Houston, Texas, USA; 6University Hospital, Vienna, Austria; 7First Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic; 8Robert-Debré Hospital, Reims, France; 9Western General Hospital, Edinburgh, UK; 10Universita Cattolica del Sacro Cuore, Rome, Italy; 11Ipsen, Les Ulis, France.
Introduction: Data demonstrating antiproliferative effects of somatostatin analogs (SSAs) in enteropancreatic NETs are limited; only one prospective trial so far has shown this for patients with midgut tumors and low hepatic tumor load (HTL). CLARINET is the first large phase 3, randomized, placebo-controlled trial evaluating such effects for the SSA lanreotide in patients with non-functioning enteropancreatic NETs.
Methods: Patients who had well/moderately differentiated, with Ki67<10%, non-functioning enteropancreatic NETs, and no SSA or other medical therapy within the last 6 months, received lanreotide Autogel 120 mg (n=101) or placebo (n=103) every 4 weeks for 96 weeks or until progression/death. The primary endpoint was progression-free survival (i.e., time to progression using RECIST, or death) based on centrally assessed CT scans.
EudraCT: 2005-004904-35; ClinicalTrials.gov: NCT00353496.
Results: At enrolment, primary tumor locations included pancreas (44%) and midgut (36%); 96% had stable disease and 84% were treatment-naïve; 30% had Ki67 3–10% (WHO grade 2); and 33% had HTL>25%. Lanreotide treatment significantly prolonged PFS vs placebo (stratified logrank P=0.0002): median PFS was not reached with lanreotide vs 18 months with placebo (HR 0.47; 95% CI 0.30–0.73). At 2 years, 62% on lanreotide vs 22% on placebo had not progressed or died. Similar results for lanreotide vs placebo were seen in patients with HTL>25% (logrank P=0.017; median PFS 24.1 vs 9.4 months; HR 0.45; 95% CI 0.23–0.88) and in those with grade 2 tumors (logrank P=0.024; median PFS not reached vs 12.1 months; HR 0.45; 95% CI 0.22–0.91). Lanreotide showed favorable safety/tolerability consistent with its known safety profile: treatment-related AEs occurred in 50% on lanreotide vs 28% on placebo (most frequent event was diarrhea, 26 vs 9%).
Conclusions: This new evidence demonstrates the antiproliferative effects of lanreotide Autogel as shown by a clinically significant increase in PFS in enteropancreatic NET patients.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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