Does Tumor Response Correlate With Quality of Life Changes Following LU177 DOTATATE Therapy for Neuroendocrine Tumors? Observations From a Multicenter Prospective Study (NCT02743741)
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Overview
abstract
Purpose/objective(s)
The objective of this report is to explore the relationship between response to therapy and quality of life experience.
Materials/methods
Key study eligibility criteria include progressive metastatic NET, Ki67 index ≤30%, ECOG ≤2, any primary site of origin, creatinine clearance (or measured GFR) > 30ml/min and Ga68 DOTATATE PET avid disease. Pts are planned to receive 4 cycles of Lu177 DOTATATE with individualized dosimetry to guide activity prescription. First post treatment clinical, radiological and QoL evaluation is scheduled for 5 months post last cycle. Response is assessed using cross-sectional CT imaging. Quality of life (QoL) is captured using EQ5D, EORTC QLQ30 and EORTC GINET21. Wilcoxon signed rank test is used to compare mean QoL change scores (cs) [post treatment (PT) minus baseline (BL)]. (+cs for summary scores and functional scales and -cs for symptom scales = improve) For scales with significant improvements, we explored the relationship between clinical response and QoL.
Results
In this ongoing study, 119 pts have reached first PT evaluation. Excluding 3 pts where response was unavailable, 95 pts with QoL and response formed the analysis cohort (QoL response compliance was 83% [95/115]). The mean EORTCQLQ30 overall summary score at BL vs PT; cs was 83 (SD14) vs 85 (SD12), -2.7 cs; P = 0.055) respectively. Statistically significant Improvement was observed in 3 symptom scales including Fatigue (F) (-4.73cs; P = 0.04); Endocrine Symptoms (ES) (-3.1cs; P = 0.017); Financial Difficulties (FD) (-6.7cs; P = 0.003) and one functional scale: Social Functioning (SF) (+4.8cs; P = 0.031). There was no significant difference in EQ5D, and the remaining EORTC QLQ30 and GINET subscales. When QoL subscales were compared across responses, there was a correlation between QoL change and tumor response for Endocrine Symptoms (cs: -1.5; -4.5; +2.2 for PR, SD, and PD); and Fatigue (cs: -12; -3.7; -2.2) for PR, SD, and PD, respectively. In contrast, improvement for Social Functioning and Financial Difficulties were independent (SF cs: +6, 7; +3.1; +10 and FD cs: -7.1; -6.7; -6.7 for PR, SD, and PD respectively).
Conclusion
Lu177 DOTATATE therapy resulted in improvement of QoL especially in Fatigue, Endocrine Symptoms, Financial Difficulties as well as Social Functioning. FD and SC improvements were independent of response while physical symptoms (F, ES) were correlated with PR and SD. Upon validation with larger datasets, Information is valuable in patient education and treatment decision-making.
