The incidence of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) has been increasing over recent decades. Lutetium therapy is now established as a treatment with benefit towards progression-free survival (PFS) in patients with metastatic GEP-NETs with median PFS of up to 36 months. However, the effect of 177Lu-DOTATATE on quality of life (QoL) is not yet well understood with few studies evaluating the impact on symptom control and patient function. Our study sought to evaluate the change in QoL for patients with progressive GEP-NETs treated with 177Lu-DOTATATE.
Our study was conducted as a part of the Phase II open label clinical trial at the Cross Cancer Institute in Edmonton. Patient enrollment started in March of 2014 and is ongoing. Treatment consisted of induction phase of 5.55 GBq administered at four treatments, 10 weeks apart. For patients without toxicity or progression on treatment, a maintenance phase was entered consisting of 2.78 GBq every 6 months for up to 4 years and maximum of 12 total treatments. QoL over 177Lu-DOTATATE treatment was assessed with EORTC QLQ-C30 and QLQ-GI.NET 21 QoL questionnaires at baseline and subsequent to each treatment. Planned interim analysis of QoL was completed in all patients having completed induction therapy. Repeated measures ANOVA was performed. A p value of < 0.05 was considered significant and change in EORTC score of ≥ 5 points was considered to be clinically significant.
In total 85 patients met inclusion criteria for interim analysis: tumor of gastroenteric or pancreatic origin and completion of four 177Lu-DOTATATE treatments. Primary analysis revealed statistically significant change and clinically significant improvement in mean insomnia (36.43 to 25.58), endocrine symptom (20.37 to 14.81) and GI symptom scores (22.28 to 16.67) from baseline to post fourth treatment. Overall global health status was maintained over treatment course with no improvement but also no statistically significant deterioration in QoL.
177Lu-DOTATATE is not only effective in improving PFS for patients with metastatic GEP-NETs but also maintains overall quality of life and importantly provides patients with improvement in specific symptoms such as insomnia, endocrine and GI symptoms.
Clinical trial identification
Legal entity responsible for the study
Alberta Health Services.
Alberta Cancer Foundation, Alberta Heritage Foundation for Medical Research, Canadian Institutes of Health Research, Canada Foundation for Innovation.
All authors have declared no conflicts of interest.