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OtherClinical Investigations (Human)
Open Access

Symptom Diaries of Patients with Midgut Neuroendocrine Tumors Treated with 177Lu-DOTATATE

Jonathan R. Strosberg, Rajaventhan Srirajaskanthan, Ghassan El-Haddad, Edward M. Wolin, Beth R. Chasen, Matthew H. Kulke, David L. Bushnell, Martyn E. Caplin, Richard P Baum, Andrew E. Hendifar, Kjell Öberg, Philippe Ruszniewski, Paola Santoro, Per Broberg, Oscar R. Leeuwenkamp and Eric P. Krenning
Journal of Nuclear Medicine March 2021, jnumed.120.258897; DOI: https://doi.org/10.2967/jnumed.120.258897
Jonathan R. Strosberg
1 H. Lee Moffitt Cancer Center & Research Institute;
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Rajaventhan Srirajaskanthan
2 Neuroendocrine Tumour Unit, Department of Gastroenterology, King's College Hospital, United Kingdom;
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Ghassan El-Haddad
3 H. Lee Moffitt Center & Research Institute;
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Edward M. Wolin
4 Center for Carcinoid and Neuroendocrine Tumors, Tish Cancer Institute at Mount Sinai, United States;
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Beth R. Chasen
5 Department of Nuclear Medicine, Division of Diagnostic Imaging, MD Anderson Cancer Center, The University of Texas, United States;
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Matthew H. Kulke
6 Section of Hematology and Medical Oncology, Boston University and Boston Medical Center, United States;
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David L. Bushnell
7 Department of Radiology, University of Iowa, United States;
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Martyn E. Caplin
8 Neuroendocrine Tumour Unit, Royal Free Hospital, United Kingdom;
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Richard P Baum
9 CURANOSTICUM Wiesbaden-Frankfurt, DKD HELIOS Clinic, Germany;
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Andrew E. Hendifar
10 Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, United States;
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Kjell Öberg
11 Department of Medical Sciences, Uppsala University, Sweden;
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Philippe Ruszniewski
12 Division of Gastroenterology and Pancreatology, Hôpital Beaujon, France;
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Paola Santoro
13 Advanced Accelerator Applications, United States;
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Per Broberg
13 Advanced Accelerator Applications, United States;
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Oscar R. Leeuwenkamp
14 Advanced Accelerator Applications,, Switzerland;
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Eric P. Krenning
15 Cyclotron Rotterdam BV, Erasmus University Medical Center, Netherlands
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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, 1.35–4.88; 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.

  • Neuroendocrine
  • Oncology: Endocrine
  • Radionuclide Therapy
  • NETTER-1
  • lutetium-177
  • neuroendocrine
  • symptom diary
  • Copyright © 2021 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

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Journal of Nuclear Medicine: 62 (4)
Journal of Nuclear Medicine
Vol. 62, Issue 4
April 1, 2021
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Symptom Diaries of Patients with Midgut Neuroendocrine Tumors Treated with 177Lu-DOTATATE
Jonathan R. Strosberg, Rajaventhan Srirajaskanthan, Ghassan El-Haddad, Edward M. Wolin, Beth R. Chasen, Matthew H. Kulke, David L. Bushnell, Martyn E. Caplin, Richard P Baum, Andrew E. Hendifar, Kjell Öberg, Philippe Ruszniewski, Paola Santoro, Per Broberg, Oscar R. Leeuwenkamp, Eric P. Krenning
Journal of Nuclear Medicine Mar 2021, jnumed.120.258897; DOI: 10.2967/jnumed.120.258897

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Symptom Diaries of Patients with Midgut Neuroendocrine Tumors Treated with 177Lu-DOTATATE
Jonathan R. Strosberg, Rajaventhan Srirajaskanthan, Ghassan El-Haddad, Edward M. Wolin, Beth R. Chasen, Matthew H. Kulke, David L. Bushnell, Martyn E. Caplin, Richard P Baum, Andrew E. Hendifar, Kjell Öberg, Philippe Ruszniewski, Paola Santoro, Per Broberg, Oscar R. Leeuwenkamp, Eric P. Krenning
Journal of Nuclear Medicine Mar 2021, jnumed.120.258897; DOI: 10.2967/jnumed.120.258897
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Keywords

  • Neuroendocrine
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  • Radionuclide Therapy
  • NETTER-1
  • Lutetium-177
  • symptom diary
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