- Email: [email protected]
Quality of Life (Qol) with Lanreotide Autogel (Lan) Vs. Placebo in Patients with Enteropancreatic Neuroendocrine Tumours (Ep-Nets): Results from the Clarinet Phase III Study
Annals of Oncology 25 (Supplement 4): iv394–iv405, 2014 doi:10.1093/annonc/mdu345.5
neuroendocrine & endocrine tumours and cup 1136PD
P. Ruszniewski1, M. Caplin2, M. Pavel3, J. C´wikła4, A. Phan5, M. Raderer6, E. Sedlackova7, G. Cadiot8, L. Wall9, G. Rindi10, A. Langley11, J. Blumberg11, E. Gomez-Panzani11 1 Pancreatology & Gastroenterology, Beaujon Hospital, Clichy, FRANCE 2 Neuroendocrine Tumour Unit, Royal Free Hospital, London, UK 3 Hepatology and Gastroenterology, Endocrinology and Diabetes, Charité University Medicine, Berlin, GERMANY 4 Faculty of Medical Science, University of Varmia and Masuria, Olsztyn, Olsztyn, POLAND 5 GI Medical Oncology, The Methodist Hospital, Houston, USA 6 Oncology, University Hospital, Vienna, AUSTRIA 7 Oncology, First Faculty of Medicine and General Teaching Hospital, Prague, CZECH REPUBLIC 8 Gastro-entérologie et Hépatologie, Hôpital Robert Debré, Reims, FRANCE 9 Edinburgh Cancer Centre, Western General Hospital, Edinburgh, UK 10 Institute of Pathology, Università Cattolica del Sacro Cuore, Rome, ITALY 11 IPSEN, Les Ulis, FRANCE
abstracts
Aim: 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.
Table: 1136PD 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
70.2 (19.9) [n = 98] 73.6 (19.6) [n = 99]
70.9 (17.3) [n = 71] 72.0 (14.9) [n = 59]
66.4 (22.1) [n = 57] 70.1 (22.2) [n = 34]
64.5 (23.2) [n = 98] 67.0 (22.4) [n = 102]
10.9 (15.0) [n = 98] 12.0 (16.9) [n = 98]
11.0 (15.5) [n = 71] 13.2 (18.0 [n = 48]
11.1 (15.1) [n = 56] 11.8 (11.3) [n = 34]
11.7 (14.9) [n = 97] 13.9 (19.0) [n = 102]
17.1 (16.4) [n = 98] 18.3 (18.0) [n = 98]
19.9 (17.6) [n = 71] 16.0 (14.3) [n = 58]
15.3 (13.8) [n = 56] 17.4 (17.3) [n = 34]
18.2 (16.5) [n = 97] 19.8 (18.5) [n = 102]
QLQ-C30 Global health status/QoL LAN Placebo QLQ-GI.NET21 Endocrine symptoms LAN Placebo QLQ-GI.NET21 Gastrointestinal symptoms LAN Placebo
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/iv396/2241871 by guest on 25 October 2019
QUALITY OF LIFE (QOL) WITH LANREOTIDE AUTOGEL (LAN) VS. PLACEBO IN PATIENTS WITH ENTEROPANCREATIC NEUROENDOCRINE TUMOURS (EP-NETS): RESULTS FROM THE CLARINET PHASE III STUDY
Methods: 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. Results: 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. Conclusions: 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. Disclosure: 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.
neuroendocrine & endocrine tumours and cup 1136PD
P. Ruszniewski1, M. Caplin2, M. Pavel3, J. C´wikła4, A. Phan5, M. Raderer6, E. Sedlackova7, G. Cadiot8, L. Wall9, G. Rindi10, A. Langley11, J. Blumberg11, E. Gomez-Panzani11 1 Pancreatology & Gastroenterology, Beaujon Hospital, Clichy, FRANCE 2 Neuroendocrine Tumour Unit, Royal Free Hospital, London, UK 3 Hepatology and Gastroenterology, Endocrinology and Diabetes, Charité University Medicine, Berlin, GERMANY 4 Faculty of Medical Science, University of Varmia and Masuria, Olsztyn, Olsztyn, POLAND 5 GI Medical Oncology, The Methodist Hospital, Houston, USA 6 Oncology, University Hospital, Vienna, AUSTRIA 7 Oncology, First Faculty of Medicine and General Teaching Hospital, Prague, CZECH REPUBLIC 8 Gastro-entérologie et Hépatologie, Hôpital Robert Debré, Reims, FRANCE 9 Edinburgh Cancer Centre, Western General Hospital, Edinburgh, UK 10 Institute of Pathology, Università Cattolica del Sacro Cuore, Rome, ITALY 11 IPSEN, Les Ulis, FRANCE
abstracts
Aim: 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.
Table: 1136PD 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
70.2 (19.9) [n = 98] 73.6 (19.6) [n = 99]
70.9 (17.3) [n = 71] 72.0 (14.9) [n = 59]
66.4 (22.1) [n = 57] 70.1 (22.2) [n = 34]
64.5 (23.2) [n = 98] 67.0 (22.4) [n = 102]
10.9 (15.0) [n = 98] 12.0 (16.9) [n = 98]
11.0 (15.5) [n = 71] 13.2 (18.0 [n = 48]
11.1 (15.1) [n = 56] 11.8 (11.3) [n = 34]
11.7 (14.9) [n = 97] 13.9 (19.0) [n = 102]
17.1 (16.4) [n = 98] 18.3 (18.0) [n = 98]
19.9 (17.6) [n = 71] 16.0 (14.3) [n = 58]
15.3 (13.8) [n = 56] 17.4 (17.3) [n = 34]
18.2 (16.5) [n = 97] 19.8 (18.5) [n = 102]
QLQ-C30 Global health status/QoL LAN Placebo QLQ-GI.NET21 Endocrine symptoms LAN Placebo QLQ-GI.NET21 Gastrointestinal symptoms LAN Placebo
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/iv396/2241871 by guest on 25 October 2019
QUALITY OF LIFE (QOL) WITH LANREOTIDE AUTOGEL (LAN) VS. PLACEBO IN PATIENTS WITH ENTEROPANCREATIC NEUROENDOCRINE TUMOURS (EP-NETS): RESULTS FROM THE CLARINET PHASE III STUDY
Methods: 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. Results: 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. Conclusions: 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. Disclosure: 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.