PMID- 35135467
OWN - NLM
STAT- MEDLINE
DCOM- 20220517
LR  - 20230217
IS  - 1874-4729 (Electronic)
IS  - 1874-4710 (Print)
IS  - 1874-4710 (Linking)
VI  - 15
IP  - 2
DP  - 2022
TI  - Toxicity and Tolerability of (177)Lu-DOTA-TATE PRRT with a Modified Administered 
      Activity Protocol in NETs of Variable Origin - A Phase 2 Registry Study.
PG  - 123-133
LID - 10.2174/1874471014666210810100435 [doi]
AB  - BACKGROUND: Peptide receptor radionuclide therapy (PRRT) has been recently 
      approved for advanced, metastatic, or progressive neuroendocrine tumors (NETs). 
      OBJECTIVE: This study reports the adverse events (AEs) observed with 
      patient-tailored administered activity. METHODS: Fifty-two PRRT naive patients 
      were treated with 177Lu-DOTATATE. The administered activity ranges between 2.78 
      and 5.55 GBq/cycle using the patient's unique characteristics (age, symptoms, 
      blood work, and biomarkers). RESULTS: The protocol was well tolerated with the 
      overwhelming majority of participants being forty- six (88%), completing all 4 
      induction therapy cycles. The median cumulative administered activity was 19.6 
      GBq (ranged 3.8-22.3 GBq). A total of 42/52 (81%) reported at least one symptom, 
      and 43/52 (83%) had evidence of biochemical abnormality at enrollment that would 
      meet grade 1 or 2 criteria for AEs. These symptoms only slightly increase with 
      treatment to 50/52 (96%) and 51/52 (98%), respectively. The most common symptoms 
      were mild fatigue (62%), shortness of breath (50%), nausea (44%), abdominal pain 
      (38%), and musculoskeletal pain (37%). The most common biomarker abnormalities 
      were mild anemia (81%), reduced estimated glomerular filtration rate (eGFR) 
      (58%), increased alkaline phosphatase (ALP) (50%), and leukopenia (37%). Of 
      critical importance, no 177Lu-DOTATATE related grade 3 or 4 AEs were observed. 
      CONCLUSION: Tailoring the administered activity of 177Lu-DOTATATE to the 
      individual patient with a variety of NETs is both safe and well-tolerated. No 
      patient developed severe grade 3 or 4 AEs. Most patients exhibit symptoms or 
      biochemical abnormality before treatment and this only slightly worsens following 
      induction therapy.
CI  - Copyright(c) Bentham Science Publishers; For any queries, please email at 
      epub@benthamscience.net.
FAU - Khatami, Alireza
AU  - Khatami A
AD  - Division of Nuclear Medicine, Department of Medical Imaging, Western University, 
      London, ON N645C1, Canada.
FAU - Sistani, Golmehr
AU  - Sistani G
AD  - Division of Nuclear Medicine, Department of Medical Imaging, Western University, 
      London, ON N645C1, Canada.
AD  - Division of Radiology, Department of Medical Imaging, Western University, London, 
      ON, Canada.
FAU - Sutherland, Duncan E K
AU  - Sutherland DEK
AD  - Division of Nuclear Medicine, Department of Medical Imaging, Western University, 
      London, ON N645C1, Canada.
FAU - DeBrabandere, Sarah
AU  - DeBrabandere S
AD  - Division of Nuclear Medicine, Department of Medical Imaging, Western University, 
      London, ON N645C1, Canada.
FAU - Reid, Robert H
AU  - Reid RH
AD  - Division of Nuclear Medicine, Department of Medical Imaging, Western University, 
      London, ON N645C1, Canada.
FAU - Laidley, David T
AU  - Laidley DT
AD  - Division of Nuclear Medicine, Department of Medical Imaging, Western University, 
      London, ON N645C1, Canada.
LA  - eng
GR  - 172567/Cancer Care Ontario CCO Canada/
PT  - Clinical Trial Protocol
PT  - Journal Article
PL  - United Arab Emirates
TA  - Curr Radiopharm
JT  - Current radiopharmaceuticals
JID - 101468718
RN  - 0 (Heterocyclic Compounds, 1-Ring)
RN  - 0 (Organometallic Compounds)
RN  - 0 (Radiopharmaceuticals)
RN  - 0 (copper dotatate CU-64)
RN  - 1HTE449DGZ (1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid)
RN  - RWM8CCW8GP (Octreotide)
SB  - IM
MH  - Clinical Trials, Phase II as Topic
MH  - Heterocyclic Compounds, 1-Ring
MH  - Humans
MH  - *Neuroendocrine Tumors/radiotherapy
MH  - Octreotide/adverse effects
MH  - *Organometallic Compounds/adverse effects
MH  - Positron-Emission Tomography
MH  - Radionuclide Imaging
MH  - Radiopharmaceuticals/adverse effects
MH  - Registries
PMC - PMC9900697
OTO - NOTNLM
OT  - DOTATAE
OT  - Lu-177
OT  - NET
OT  - PRRT
OT  - Toxicity
OT  - neuroendocrine tumor
OT  - peptide receptor radionuclide therapy
OT  - safety
EDAT- 2022/02/10 06:00
MHDA- 2022/05/18 06:00
PMCR- 2023/02/06
CRDT- 2022/02/09 05:39
PHST- 2021/03/04 00:00 [received]
PHST- 2021/05/21 00:00 [revised]
PHST- 2021/05/24 00:00 [accepted]
PHST- 2022/02/10 06:00 [pubmed]
PHST- 2022/05/18 06:00 [medline]
PHST- 2022/02/09 05:39 [entrez]
PHST- 2023/02/06 00:00 [pmc-release]
AID - CRP-EPUB-117222 [pii]
AID - CRP-15-123 [pii]
AID - 10.2174/1874471014666210810100435 [doi]
PST - ppublish
SO  - Curr Radiopharm. 2022;15(2):123-133. doi: 10.2174/1874471014666210810100435.