RT Journal Article SR Electronic T1 Symptom Diaries of Patients with Midgut Neuroendocrine Tumors Treated with 177Lu-DOTATATE JF Journal of Nuclear Medicine JO J Nucl Med FD Society of Nuclear Medicine SP jnumed.120.258897 DO 10.2967/jnumed.120.258897 A1 Jonathan R. Strosberg A1 Rajaventhan Srirajaskanthan A1 Ghassan El-Haddad A1 Edward M. Wolin A1 Beth R. Chasen A1 Matthew H. Kulke A1 David L. Bushnell A1 Martyn E. Caplin A1 Richard P Baum A1 Andrew E. Hendifar A1 Kjell Öberg A1 Philippe Ruszniewski A1 Paola Santoro A1 Per Broberg A1 Oscar R. Leeuwenkamp A1 Eric P. Krenning YR 2021 UL http://jnm.snmjournals.org/content/early/2021/03/26/jnumed.120.258897.abstract AB We report the impact of 177Lu DOTATATE treatment on abdominal pain, diarrhea, and flushing, symptoms that patients with advanced midgut neuroendocrine tumors (NETs) often find burdensome. Methods: All patients enrolled in the international randomized phase 3 Neuroendocrine Tumors Therapy (NETTER-1) trial (177Lu-DOTATATE plus standard-dose octreotide long-acting repeatable [LAR], n = 117; high-dose octreotide LAR, n = 114) were asked to record the occurrence of predefined symptoms in a daily diary. Change from baseline in symptom scores (mean number of days with a symptom) was analyzed using a mixed model for repeated measures. Results: Patients (intent-to-treat) who received 177Lu-DOTATATE experienced a significantly greater decline from baseline in symptom scores than patients who received high-dose octreotide LAR. For 177Lu-DOTATATE, the mean decline in days with abdominal pain, diarrhea, and flushing was 4.10, 4.55, and 4.52 days per 4 weeks, respectively, compared with 0.99, 1.44, and 2.54 days for high-dose octreotide LAR. The mean differences were 3.11 days (95% confidence interval, 1.35–4.88; P = 0.0007) for abdominal pain, 3.11 days (1.18–5.04; P = 0.0017) for diarrhea, and 1.98 days (0.08–3.88; P = 0.0413) for flushing, favoring 177Lu-DOTATATE. A positive repeated measures correlation was found between diary-recorded symptom scores and questionnaire-recorded pain, diarrhea, and flushing. Conclusion: In addition to efficacy and quality of life benefits, symptom diaries from NETTER-1 demonstrated that treatment with 177Lu DOTATATE was associated with statistically significant reductions in abdominal pain, diarrhea, and flushing, constituting the core symptoms of patients with progressive midgut NETs, compared with high-dose octreotide LAR, supporting a beneficial effect of 177Lu DOTATATE on HRQoL.