RT Journal Article
SR Electronic
T1 Symptom Diaries of Patients with Midgut Neuroendocrine Tumors Treated with <sup>177</sup>Lu-DOTATATE
JF Journal of Nuclear Medicine
JO J Nucl Med
FD Society of Nuclear Medicine
SP 1712
OP 1718
DO 10.2967/jnumed.120.258897
VO 62
IS 12
A1 Strosberg, Jonathan R.
A1 Srirajaskanthan, Rajaventhan
A1 El-Haddad, Ghassan
A1 Wolin, Edward M.
A1 Chasen, Beth A.
A1 Kulke, Matthew H.
A1 Bushnell, David L.
A1 Caplin, Martyn E.
A1 Baum, Richard P.
A1 Hendifar, Andrew E.
A1 Öberg, Kjell
A1 Ruszniewski, Philippe
A1 Santoro, Paola
A1 Broberg, Per
A1 Leeuwenkamp, Oscar R.
A1 Krenning, Eric P.
A1 for the NETTER-1 study group
YR 2021
UL http://jnm.snmjournals.org/content/62/12/1712.abstract
AB We report the impact of 177Lu-DOTATATE treatment on abdominal pain, diarrhea, and flushing, symptoms that patients with advanced midgut neuroendocrine tumors 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 d per 4 wk, respectively, compared with 0.99, 1.44, and 2.54 d for high-dose octreotide LAR. The mean differences were 3.11 d (95% CI, 1.35–4.88; P = 0.0007) for abdominal pain, 3.11 d (1.18–5.04; P = 0.0017) for diarrhea, and 1.98 d (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 neuroendocrine tumors, compared with high-dose octreotide LAR, supporting a beneficial effect of 177Lu-DOTATATE on health-related quality of life.