1136PD - Quality of life (QoL) with lanreotide autogel (LAN) vs. placebo in patients with enteropancreatic neuroendocrine tumours (EP-NETs): results from th...

Date 29 September 2014
Event ESMO 2014
Session Neuroendocrine & endocrine tumours and CUP
Topics Neuroendocrine Cancers
Supportive Care
Presenter Philippe Ruszniewski
Citation Annals of Oncology (2014) 25 (suppl_4): iv394-iv405. 10.1093/annonc/mdu345
Authors P. Ruszniewski1, M. Caplin2, M. Pavel3, J. Ćwikła4, A. Phan5, M. Raderer6, E. Sedlackova7, G. Cadiot8, L. Wall9, G. Rindi10, A. Langley11, J. Blumberg11, E. Gomez-Panzani11
  • 1Pancreatology & Gastroenterology, Beaujon Hospital, 92110 - Clichy/FR
  • 2Neuroendocrine Tumour Unit, Royal Free Hospital, London/GB
  • 3Hepatology And Gastroenterology, Endocrinology And Diabetes, Charité University Medicine, Berlin/DE
  • 4Faculty Of Medical Science, University of Varmia and Masuria, Olsztyn, Olsztyn/PL
  • 5Gi Medical Oncology, The Methodist Hospital, Houston/US
  • 6Oncology, University Hospital, Vienna/AT
  • 7Oncology, First Faculty of Medicine and General Teaching Hospital, Prague/CZ
  • 8Gastro-entérologie Et Hépatologie, Hôpital Robert Debré, Reims/FR
  • 9Edinburgh Cancer Centre, Western General Hospital, Edinburgh/GB
  • 10Institute Of Pathology, Università Cattolica del Sacro Cuore, Rome/IT
  • 11Ipsen, Ipsen, Les Ulis/FR



QoL in patients with gastroenteropancreatic-NETs can be affected by the symptom burden, but also treatment efficacy and safety. To better evaluate this, the EORTC developed a NET-specific QoL questionnaire (QLQ-GI.NET21), to be used in combination with its more generic questionnaire, EORTC QLQ-C30. Here, we examine the impact of LAN vs. placebo on QoL from the CLARINET study.


CLARINET was a 96-week randomized double-blind phase III study, in which patients with well/moderately differentiated, non-functioning EP-NETs were treated with LAN 120 mg (n = 101) or placebo (n = 103) deep SC injections every 4 weeks (NCT00353496). The primary endpoint was progression-free survival (PFS). Safety was a key secondary endpoint. QoL (also a secondary endpoint) was assessed at each study visit using the EORTC QLQ-C30 and the EORTC QLQ-GI.NET21.


LAN significantly prolonged PFS vs. placebo (stratified log rank, p = 0.0002; hazard ratio 0.47 [95% CI: 0.30, 0.73]). Treatment-related adverse events (AEs) occurred in 50% of patients in the LAN group vs. 28% in the placebo group. Gastrointestinal disorders were the most common AEs (37% vs. 19%). The QLQ-C30 global health status scores and the QLQ-GI.NET21 endocrine and gastrointestinal subscale scores were similar in the two treatment groups at baseline and throughout treatment, though inter-individual variation was high (Table). Results for the other subscale scores of the QLQ-C30 and QLQ-GI.NET21 questionnaires were also similar between LAN and placebo.


Overall, patients on LAN 120 mg had a significantly improved PFS and a good safety/tolerability profile that did not compromise patients' QoL vs. placebo. Further analyses are ongoing to evaluate QoL based on patient characteristics and treatment response. Table: Effect of LAN treatment on patients' QoL.

Values are mean (SD); LVA, last post-baseline value available Data shown are for the transformed scores, which can range from 0 to 100. A higher transformed score for global health status represents a better QoL. A higher transformed score for Endocrine and GI symptoms represents a higher level of symptomatology/problems

Baseline Week 48 Week 96 LVA
QLQ-C30 Global health status/QoL
LAN 70.2 (19.9) [n = 98] 70.9 (17.3) [n = 71] 66.4 (22.1) [n = 57] 64.5 (23.2) [n = 98]
Placebo 73.6 (19.6) [n = 99] 72.0 (14.9) [n = 59] 70.1 (22.2) [n = 34] 67.0 (22.4) [n = 102]
QLQ-GI.NET21 Endocrine symptoms
LAN 10.9 (15.0) [n = 98] 11.0 (15.5) [n = 71] 11.1 (15.1) [n = 56] 11.7 (14.9) [n = 97]
Placebo 12.0 (16.9) [n = 98] 13.2 (18.0 [n = 48] 11.8 (11.3) [n = 34] 13.9 (19.0) [n = 102]
QLQ-GI.NET21 Gastrointestinal symptoms
LAN 17.1 (16.4) [n = 98] 19.9 (17.6) [n = 71] 15.3 (13.8) [n = 56] 18.2 (16.5) [n = 97]
Placebo 18.3 (18.0) [n = 98] 16.0 (14.3) [n = 58] 17.4 (17.3) [n = 34] 19.8 (18.5) [n = 102]


P. Ruszniewski: Ipsen: Consultant/advisory role; honoraria; research funding; partner is Ipsen employee. Novartis: honoraria and research funding; M. Caplin: IPSEN: honoraria for consultant/advisory role. NOVARTIS: Consulting fee, Advisory Committees or Review Panels; LEXICON: Consulting fee, Advisory Committees or Review Panel; M. Pavel: Ipsen: Consulting & Speaker role fee. Pfizer, Inc.: Consulting & Speaker role fee. Novartis Pharmaceuticals: Consulting & Speaker role fee, research funding. Lexicon Pharmaceuticals, Inc.: Consulting & Speaker role fee; J. Ćwikła: Ipsen: Research Funding; A. Phan: Ipsen: Research Funding; M. Raderer: Speaker fee from: Ipsen, Novartis Pharmaceuticals, Roche Pharmaceuticals, Pfizer, Inc., Bayer, Inc., Celgene; G. Cadiot: Ipsen: Consultant and Speaker fee. Novartis Pharmaceuticals: Consultant and Speaker fee. Keocyt: Consultant and Speaker fee; G. Rindi: Ipsen: Consultant and Speaker fee. Novartis Pharmaceuticals: Consultant and Speaker fee. Pfizer, Inc.: Consultant and Speaker fee. Advanced Accelerator Applications: Consultant fee; A. Langley: Ipsen: Consultant fee; J. Blumberg: Ipsen: employee; E. Gomez-Panzani: Ipsen: employee. All other authors have declared no conflicts of interest.