PMID- 34907652
OWN - NLM
STAT- MEDLINE
DCOM- 20220502
LR  - 20220502
IS  - 1868-6982 (Electronic)
IS  - 1868-6974 (Linking)
VI  - 29
IP  - 4
DP  - 2022 Apr
TI  - Safety and response after peptide receptor radionuclide therapy with (177) 
      Lu-DOTATATE for neuroendocrine tumors in phase 1/2 prospective Japanese trial.
PG  - 487-499
LID - 10.1002/jhbp.1101 [doi]
AB  - BACKGROUND: The present prospective phase 1/2 study aimed to elucidate the 
      efficacy and safety of (177) Lu-DOTATATE (four cycles of 7.4 GBq) in Japanese 
      patients with unresectable, progressive neuroendocrine tumors (NETs). METHODS: 
      From April 2018 to October 2020, 15 patients with advanced NETs (five midgut, 
      eight pancreatic, and two lung NETs) were enrolled. Objective response rate 
      (ORR), progression-free survival (PFS), and adverse events (AEs) were evaluated. 
      Pharmacokinetics and dosimetry were also evaluated in three midgut patients. 
      RESULTS: The mean absorbed doses of (177) Lu-DOTATATE to the kidneys 
      (20.7 Gy/29.6 GBq) and the bone marrow (0.631 Gy/29.6 GBq) were within the 
      radiation tolerance doses. The ORR of the whole population was 53% (90% CI, 
      30%-76%). ORRs of the midgut and non-midgut NETs were 60% (90% CI, 19%-92%) and 
      50% (90% CI, 22%-78%), respectively. There was no difference in the maximum 
      reduction rate of the sum of the target lesion diameters between patients with 
      midgut and non-midgut NET. The median PFS was not reached; the PFS rate at 
      52 weeks was 80% (90% CI, 56.1%-91.7%). AEs of Grade 3 or higher were lymphopenia 
      (47%) and leukopenia (7%). CONCLUSION: (177) Lu-DOTATATE demonstrated remarkable 
      tumor shrinkage and tolerability in Japanese patients with advanced NETs.
CI  - (c) 2021 Japanese Society of Hepato-Biliary-Pancreatic Surgery.
FAU - Kudo, Atsushi
AU  - Kudo A
AUID- ORCID: 0000-0002-5301-3847
AD  - Department of Hepatobiliary and Pancreatic Surgery, Tokyo Medical and Dental 
      University, Tokyo, Japan.
FAU - Tateishi, Ukihide
AU  - Tateishi U
AD  - Department of Diagnostic Radiology, Graduate School of Medicine, Tokyo Medical 
      and Dental University, Tokyo, Japan.
FAU - Yoshimura, Ryoichi
AU  - Yoshimura R
AUID- ORCID: 0000-0001-9435-1503
AD  - Department of Radiation Therapeutics and Oncology, Graduate School of Medical and 
      Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.
FAU - Tsuchiya, Junichi
AU  - Tsuchiya J
AD  - Department of Diagnostic Radiology, Graduate School of Medicine, Tokyo Medical 
      and Dental University, Tokyo, Japan.
FAU - Yokoyama, Kota
AU  - Yokoyama K
AD  - Department of Diagnostic Radiology, Graduate School of Medicine, Tokyo Medical 
      and Dental University, Tokyo, Japan.
FAU - Takano, Shoko
AU  - Takano S
AD  - Department of Radiation Oncology, Yokohama City University Graduate School of 
      Medicine, Yokohama, Japan.
FAU - Kobayashi, Noritoshi
AU  - Kobayashi N
AUID- ORCID: 0000-0002-9181-3722
AD  - Department of Oncology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Utsunomiya, Daisuke
AU  - Utsunomiya D
AUID- ORCID: 0000-0002-1723-1724
AD  - Department of Diagnostic Radiology, Yokohama City University Graduate School of 
      Medicine, Yokohama, Japan.
FAU - Hata, Masaharu
AU  - Hata M
AUID- ORCID: 0000-0002-4133-2592
AD  - Department of Radiation Oncology, Yokohama City University Graduate School of 
      Medicine, Yokohama, Japan.
FAU - Ichikawa, Yasushi
AU  - Ichikawa Y
AD  - Department of Oncology, Yokohama City University Graduate School of Medicine, 
      Yokohama, Japan.
FAU - Tanabe, Minoru
AU  - Tanabe M
AUID- ORCID: 0000-0003-4875-1471
AD  - Department of Hepatobiliary and Pancreatic Surgery, Tokyo Medical and Dental 
      University, Tokyo, Japan.
FAU - Hosono, Makoto
AU  - Hosono M
AUID- ORCID: 0000-0001-8040-3245
AD  - Department of Radiation Oncology, Faculty of Medicine, Kindai University, 
      Osakasayama, Japan.
FAU - Kinuya, Seigo
AU  - Kinuya S
AD  - Department of Nuclear Medicine, Institute of Medical, Pharmaceutical and Health 
      Sciences, Kanazawa University, Kanazawa, Japan.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20211227
PL  - Japan
TA  - J Hepatobiliary Pancreat Sci
JT  - Journal of hepato-biliary-pancreatic sciences
JID - 101528587
RN  - 0 (Radioisotopes)
RN  - 0 (Radiopharmaceuticals)
RN  - 0 (Receptors, Peptide)
RN  - 0 (copper dotatate CU-64)
SB  - IM
MH  - Humans
MH  - Japan
MH  - *Neuroendocrine Tumors/drug therapy/radiotherapy
MH  - Positron-Emission Tomography
MH  - Prospective Studies
MH  - Radioisotopes/adverse effects
MH  - Radionuclide Imaging
MH  - Radiopharmaceuticals/adverse effects/pharmacokinetics
MH  - Receptors, Peptide/therapeutic use
OTO - NOTNLM
OT  - lung
OT  - lymphopenia
OT  - midgut
OT  - pancreas
OT  - pharmacokinetics of 177Lu-DOTATATE
EDAT- 2021/12/16 06:00
MHDA- 2022/05/03 06:00
CRDT- 2021/12/15 07:41
PHST- 2021/11/11 00:00 [revised]
PHST- 2021/10/04 00:00 [received]
PHST- 2021/11/29 00:00 [accepted]
PHST- 2021/12/16 06:00 [pubmed]
PHST- 2022/05/03 06:00 [medline]
PHST- 2021/12/15 07:41 [entrez]
AID - 10.1002/jhbp.1101 [doi]
PST - ppublish
SO  - J Hepatobiliary Pancreat Sci. 2022 Apr;29(4):487-499. doi: 10.1002/jhbp.1101. 
      Epub 2021 Dec 27.