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

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.

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.

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

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.

Plný text abstraktu v časopise Ann Oncol (2014) 25 (suppl 4)