Konference: 2014 39th Congress ESMO - účast ČR
Kategorie: Gastrointestinální nádory
Číslo abstraktu: 1136PD
Autoři: Prof. M.D. Philippe B. Ruszniewski; Prof. M.D. Martyn E. Caplin, FRCP; Prof. Dr. Marianne E. Pavel, M.D.; Prof. M.D. Jaroslaw B. Cwikla; Prof. M.D. Alexandria T. Phan; M.D. Markus Raderer; MUDr. Eva Sedláčková, MBA; Prof. M.D. Guillaume Cadiot, Ph.D.; M.D. Lucy R. Wall ; M.D. Guido Rindi, Ph.D.; Alison Langley; Joelle Blumberg
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.
Datum přednesení příspěvku: 29. 9. 2014