1135PD - Quality of life (QoL) associated with lanreotide autogel (LAN) treatment for carcinoid syndrome (CS) in gastroenteropancreatic neuroendocrine tumou...

Date 29 September 2014
Event ESMO 2014
Session Neuroendocrine & endocrine tumours and CUP
Topics Neuroendocrine Cancers
Supportive Care
Presenter Edda Gomez-Panzani
Citation Annals of Oncology (2014) 25 (suppl_4): iv394-iv405. 10.1093/annonc/mdu345
Authors E. Gomez-Panzani1, A.I. Vinik2, E.M. Wolin3, H. Audry4
  • 1Medical Development, Ipsen, 92100 - Boulogne-Billancourt/FR
  • 2Neuroendocrine Unit, Eastern Virginia Medical School, Norfolk/US
  • 3Samuel Oschin Cancer Center, Cedars-Sinai Medical Center, Los Angeles/US
  • 4Biostatistics, Ipsen, Boulogne-Billancourt/FR

Abstract

Aim

QoL is an important consideration for CS treatment. This analysis evaluated QoL in GEP-NET patients treated for CS in the ELECT study.

Methods

ELECT was a 16-week, randomised, double-blind (DB) phase III study (NCT00774930). Patients with GEP-NETs and a history of CS were treated with LAN 120 mg (n = 59) or placebo (n = 56) every 4 weeks. It was followed by 32-week and ≥2-year open-label extensions (OLEs). The primary endpoint was % of days of rescue medication use (SC octreotide) during DB study. Safety evaluations focused on adverse events (AEs). QoL was assessed using the EORTC QLQ-C30 and the EORTC QLQ-GI.NET21. Scores for global health status score (QLQ-C30) and endocrine and gastrointestinal subscales (QLQ-GI.NET21) were secondary endpoints; other scores were exploratory.

Results

Mean [95% CI] % of days of rescue medication use was significantly lower with LAN (34% [25, 42%]) than placebo (49% [40, 57%]); difference –15% [–27, –3%], p = 0.02. Treatment-related AEs occurred in 15 (26%) LAN vs. 11 (19%) placebo patients: most common AEs were gastrointestinal. The global health status score (QLQ-C30) remained similar after 12 weeks of DB treatment with LAN and placebo. Treatment differences in endocrine and gastrointestinal subscale scores are shown in the table. For all functional scales of the QLQ-C30, scores remained stable/slightly improved in the LAN group, while there were small deteriorations in the placebo group; however CIs were wide. For the other subscales of the QLQ-GI.NET21, changes in scores were similar in both treatment groups.

Conclusions

LAN 120 mg treatment for CS symptoms was not associated with a deterioration in QoL in GEP-NET patients. In fact, despite the relatively short duration of the study, there was evidence of initial improvements in some aspects of QoL. Results of QoL scores in OLE may provides more information. Table: Effect of LAN on QoL secondary endpoints.

Values are mean (SD) unless otherwise stated. P-value tested at a significance level of 0.05. A hierarchical testing procedure was applied for secondary endpoints. 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

Lanreotide Autogel Placebo LS mean treatment difference in change from baseline [95% CI] p-value
QLQ-C30 Global health status/QoL
Baseline 59.89 (20.15) [n = 59] 62.58 (20.28) [n = 55] 4.05 [–2.09, 10.20] 0.1931
Week 12 64.93 (19.37) [n = 48] 61.19 (18.07) [n = 35] 4.05 [–2.09, 10.20] 0.1931
QLQ-GI.NET21 Endocrine symptoms
Baseline 25.89 (22.83) [n = 59] 33.54 (23.92) [n = 53] –7.04 [–14.80, 0.73] 0.0750
Week 12 18.06 (20.06) [n = 48] 29.84 (22.51) [n = 35] –7.04 [–14.80, 0.73] 0.0750
QLQ-GI.NET21 Gastrointestinal symptoms
Baseline 22.40 (16.95) [n = 59] 24.84 (20.09) [n = 53] –4.68 [–9.63, 0.26] 0.0632
Week 12 17.64 (14.32) [n = 48] 23.62 (15.45) [n = 35] –4.68 [–9.63, 0.26] 0.0632

Disclosure

E. Gomez-Panzani: Ipsen: employee; A.I. Vinik: Ipsen: Research grant, advisory board member; E.M. Wolin: Research grant from Ipsen. Advisory board member for Ipsen, Novartis and Celgene; H. Audry: Received consulting fee (contract statistician) from Ipsen.