Health-Related Quality of Life for Long-Acting Octreotide versus Placebo in Patients with Metastatic Midgut Neuroendocrine Tumors in the Phase 3 PROMID Trial.

BACKGROUND:In the phase IIIb PROMID study, octreotide long-acting significantly extended time to tumor progression compared with placebo in treatment-naïve patients with well-differentiated metastatic midgut neuroendocrine tumors. We report post hoc analyses for health-related quality of life (HRQoL). METHODS:HRQoL was measured with EORTC QLQ-C30, a 30-item self-report questionnaire (5 functional, 1 global, 9 symptom scales). Assessments were completed at baseline and every 12 weeks until tumor progression. Time to definitive deterioration (TDD; worsening of ≥10 points without further improvement) was analyzed with the Kaplan-Meier method. Linear mixed models were fit to assess change from baseline in QLQ-C30 scores by treatment arm over time. RESULTS:Among 85 patients, 82 (96%) completed the QLQ-C30 at baseline. There were few events of definitive deterioration for many scales. Significantly longer TDD was reported for long-acting octreotide versus placebo for fatigue (median 18.5 months vs. 6.8; p = 0.0006), pain (not reached [NR] vs. 18.2; p = 0.0435) and insomnia (NR vs. 16.4; p = 0.0046). Change from baseline to week 24 fatigue scores were stable for long-acting octreotide (mean 0.78; 95% CI -6.3 to 7.8) but worsened for placebo (mean 9.1; 95% CI 1.9-16.4), and for diarrhea there were improvements for long-acting octreotide (mean -8.0; 95% CI -19.6 to 3.5) and worsening for placebo (mean 11.2; 95% CI -0.7 to 23.1). CONCLUSIONS:HRQoL was maintained with few deteriorations in long-acting octreotide patients, whereas there was earlier and/or more deterioration in placebo patients. In long-acting octreotide patients, HRQoL was maintained or improved for the clinically important neuroendocrine tumor symptoms such as fatigue, insomnia, diarrhea and pain, whereas placebo patients experienced a deterioration of HRQoL scores for these symptoms.