4171 Background: The Phase 3 COMPETE trial demonstrated a significant treatment effect in favor of 177 Lu-edotreotide over everolimus in patients with Grade 1/2, well-differentiated, gastroenteropancreatic neuroendocrine tumors; 177 Lu-edotreotide significantly improved progression-free survival (primary endpoint) and objective response rate (secondary endpoint) compared to everolimus. Nowadays, treatment choice also considers the impact of therapy on patients’ quality of life (QoL); here, we present QoL results from the COMPETE trial. Methods: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 and EORTC QLQ-gastrointestinal neuroendocrine tumors (GI.NET) were completed by patients at baseline, each month during the first year, and every 3 months thereafter until disease progression or end of study. Mean change from baseline, duration of maximum health-related quality of life (HRQoL) improvement (until deterioration), and time to deterioration were calculated. Between-group comparisons were conducted using repeated measure analysis with factors for treatment, randomization stratification factors, visit, baseline value, and treatment-by-visit interaction; all HRQoL analyses were prespecified and exploratory. Results: Based on repeated measure analysis, mean change from baseline was in favor of 177 Lu-edotreotide: overall mean change (95% confidence interval CI) in global health score was 0.9 (-2.7, 4.4) in the 177 Lu-edotreotide arm vs -9.9 (-13.9, -6.0) in the everolimus arm (nominal p<0.0001) (positive change corresponds to improvement). Time to deterioration in global health status/QoL was longer in the 177 Lu-edotreotide arm vs the everolimus arm (Table 1). Similar trends were observed in the EORTC QLQ-C30 and EORTC QLQ-GI.NET subdomains. In the 177 Lu-edotreotide arm, 90/207 (43.5%) participants had a clinically meaningful improvement (≥10 points) in global HRQoL score, vs 31/102 (30.4%) participants in the everolimus arm. Among these participants, the median duration of improvement was 22.0 (95%CI: 10.1, not evaluable NE) vs 10.2 (95%CI: 3.3, NE) months in the 177 Lu-edotreotide and everolimus arm, respectively. Conclusions: Consistent with the overall COMPETE outcomes, this analysis demonstrated clinically meaningful and durable HRQoL benefits for 177 Lu-edotreotide compared with everolimus. Clinical trial information: NCT03049189 . Time to deterioration in global health status/QoL (≥10 points). Parameter / Statistics 177 Lu-edotreotide(N=207) Everolimus(N=102) Patients with ≥10 points deterioration, n (%) 114 (55.1) 78 (76.5) Median, months (95% CI) a 10.251 (7.359, 15.901) 2.267 (2.004, 3.253) Nominal stratified p-value b <0.0001 Stratified hazard ratio (95% CI) 0.392 (0.292, 0.527) a Estimated via Kaplan-Meier method. b Derived from a two-sided test between the two groups.
Capdevila et al. (Wed,) studied this question.