학술논문
Symptom Diaries of Patients with Midgut Neuroendocrine Tumors Treated with 177 Lu-DOTATATE.
Document Type
Academic Journal
Author
Strosberg JR; H. Lee Moffitt Cancer Center & Research Institute.; Srirajaskanthan R; Neuroendocrine Tumour Unit, Department of Gastroenterology, King's College Hospital, United Kingdom.; El-Haddad G; H. Lee Moffitt Center & Research Institute.; Wolin EM; Center for Carcinoid and Neuroendocrine Tumors, Tish Cancer Institute at Mount Sinai, United States.; Chasen BR; Department of Nuclear Medicine, Division of Diagnostic Imaging, MD Anderson Cancer Center, The University of Texas, United States.; Kulke MH; Section of Hematology and Medical Oncology, Boston University and Boston Medical Center, United States.; Bushnell DL; Department of Radiology, University of Iowa, United States.; Caplin ME; Neuroendocrine Tumour Unit, Royal Free Hospital, United Kingdom.; Baum RP; CURANOSTICUM Wiesbaden-Frankfurt, DKD HELIOS Clinic, Germany.; Hendifar AE; Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, United States.; Öberg K; Department of Medical Sciences, Uppsala University, Sweden.; Ruszniewski P; Division of Gastroenterology and Pancreatology, Hôpital Beaujon, France.; Santoro P; Advanced Accelerator Applications, United States.; Broberg P; Advanced Accelerator Applications, United States.; Leeuwenkamp OR; Advanced Accelerator Applications,, Switzerland.; Krenning EP; Cyclotron Rotterdam BV, Erasmus University Medical Center, Netherlands.
Source
Publisher: Society of Nuclear Medicine Country of Publication: United States NLM ID: 0217410 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1535-5667 (Electronic) Linking ISSN: 01615505 NLM ISO Abbreviation: J Nucl Med Subsets: MEDLINE
Subject
Language
English
Abstract
We report the impact of 177 Lu 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 ( 177 Lu-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 177 Lu-DOTATATE experienced a significantly greater decline from baseline in symptom scores than patients who received high-dose octreotide LAR. For 177 Lu-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 177 Lu-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 177 Lu 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 177 Lu DOTATATE on HRQoL.
(Copyright © 2021 by the Society of Nuclear Medicine and Molecular Imaging, Inc.)
(Copyright © 2021 by the Society of Nuclear Medicine and Molecular Imaging, Inc.)