@article {Strosbergjnumed.120.258897, author = {Jonathan R. Strosberg and Rajaventhan Srirajaskanthan and Ghassan El-Haddad and Edward M. Wolin and Beth R. Chasen and Matthew H. Kulke and David L. Bushnell and Martyn E. Caplin and Richard P Baum and Andrew E. Hendifar and Kjell {\"O}berg and Philippe Ruszniewski and Paola Santoro and Per Broberg and Oscar R. Leeuwenkamp and Eric P. Krenning}, title = {Symptom Diaries of Patients with Midgut Neuroendocrine Tumors Treated with 177Lu-DOTATATE}, elocation-id = {jnumed.120.258897}, year = {2021}, doi = {10.2967/jnumed.120.258897}, publisher = {Society of Nuclear Medicine}, abstract = {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{\textendash}4.88; P = 0.0007) for abdominal pain, 3.11 days (1.18{\textendash}5.04; P = 0.0017) for diarrhea, and 1.98 days (0.08{\textendash}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.}, issn = {0161-5505}, URL = {https://jnm.snmjournals.org/content/early/2021/03/26/jnumed.120.258897}, eprint = {https://jnm.snmjournals.org/content/early/2021/03/26/jnumed.120.258897.full.pdf}, journal = {Journal of Nuclear Medicine} }