TY - JOUR
T1 - Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours
T2 - final results of the CLARINET open-label extension study
AU - on behalf of the CLARINET Investigators
AU - Caplin, Martyn E.
AU - Pavel, Marianne
AU - Phan, Alexandria T.
AU - Ćwikła, Jarosław B.
AU - Sedláčková, Eva
AU - Thanh, Xuan Mai Truong
AU - Wolin, Edward M.
AU - Ruszniewski, Philippe
N1 - Funding Information:
The authors thank all patients involved in the study, as well as their caregivers, care team, investigators and research staff in participating institutions. We thank Dr. Edda Gomez-Panzani of Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ, USA, for her contribution to this work before her passing. We also thank Torkia Grira, contracted to Ipsen prior to manuscript development, for her assistance with the statistical analyses. The authors thank Nicky French Ph.D., contracted to Watermeadow Medical, an Ashfield company, part of UDG Healthcare, for providing medical writing support, which was sponsored by Ipsen in accordance with Good Publication Practice guidelines. All authors were involved in the preparation of the manuscript and approved the final version before submission. The focus for each author is as follows: M.E.C.: study design, patient recruitment, data collection and data interpretation. M.P. and E.S.: patient recruitment and data interpretation. A.T.P. and J.B.Ć.: patient recruitment, data collection and data interpretation. X-M.T.T.: data analysis and data interpretation. E.M.W.: study design, patient recruitment, data collection, data analysis and data interpretation. P.R.: study design, patient recruitment, data analysis and data interpretation. This work was sponsored by Ipsen. Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results reported in this article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available. Proposals should be submitted to DataSharing@Ipsen.com and will be assessed by a scientific review board. Data are available beginning 6 months and ending 5 years after publication; after this time, only raw data may be available.
Funding Information:
This work was sponsored by Ipsen.
Publisher Copyright:
© 2020, The Author(s).
PY - 2021/2
Y1 - 2021/2
N2 - 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.
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.
KW - Lanreotide autogel
KW - Lanreotide depot
KW - Neuroendocrine tumours
KW - Progression-free survival
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=85092563674&partnerID=8YFLogxK
U2 - 10.1007/s12020-020-02475-2
DO - 10.1007/s12020-020-02475-2
M3 - Article
C2 - 33052555
AN - SCOPUS:85092563674
VL - 71
SP - 502
EP - 513
JO - Endocrine
JF - Endocrine
SN - 1355-008X
IS - 2
ER -