Japanese Journal of
Gastroenterology Research


Case Report - Open Access, Volume 2

Statements for peptide receptor radionuclide therapy from JNETS

Tetsuhide Ito1,2*; Toshihiko Masui3; Masafumi Ikeda4; Noritoshi Kobayashi5; Izumi Komoto6; Makoto Hosono7; Shinji Uemoto3

1 Neuroendocrine Tumor Centre, Fukuoka Sanno Hospital, Fukuoka, Japan.

2 Department of Gastroenterology, Graduate School of Medical Sciences, Internal University of Health and Welfare, Fukuoka, Japan.

3 Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

4 Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan.

5 Department of Oncology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.

6 Neuroendorine Tumor Center, Kansai Electric Power Hospital, Osaka, Japan.

7 Department of Radiology, Kindai University Faculty of Medicine, Osaka, Japan.

*Corresponding Author : Tetsuhide Ito
Neuroendocrine Tumor Centre, Fukuoka Sanno Hospital, 3-6-45 Momochihama, Sawara-ku, Fukuoka, 814-0001, Japan.
Email: itopapa@kouhoukai.or.jp

Received : Feb 14, 2022

Accepted : Mar 14, 2022

Published : Mar 18, 2022

Archived : www.jjgastro.com

Copyright : © Ito T (2022).

Citation: Ito T, Masui T, Ikeda M, Kobayashi N, Komoto I, et al. Statements for peptide receptor radionuclide therapy from JNETS. Japanese J Gastroenterol Res. 2021; 2(5): 1070.

Editorial

Lutetium oxodotreotide, one of the peptide receptor radionuclide therapy (PRRT) [1,2], was approved in Japan on June 23, 2021 for patients with somatostatin receptor-positive neuroendocrine tumors (NETs). We would like to make statements regarding appropriate use of PRRT in Japan from the Japan Neuroendocrine Tumor Society (JNETS).

Lutetium oxodotreotide is used in an environment where patients can be admitted to a “radiation therapy” room “or” a room with special measures “for at least one day after administration to prevent exposure to caregivers and the public. Appropriate patient care such as radiation protection measures including excrement management is required. Thus, the management of lutetium oxodotreotide is strict, In addition, the number of patients who can be accepted even in a manageable facility will be limited because the treatment is repeated 4 times every 8 weeks and some patients require treatment with radionuclides other than NETs.

Recently, JNETS has revised the clinical practice guidelines [3] in response to PRRT’s insurance coverage in Japan. Added recommendations for PRRT to the clinical question “Is radiation therapy recommended for pancreatic and gastrointestinal NETs?” Peptide receptor radionuclide therapy (PRRT) is recommended as an alternative treatment for somatostatin receptorpositive pancreatic and gastrointestinal NETs and for patients who are refractory to other drugs after second-line treatment. (Grade A, agreement rate 100%).

As such, we need to be fully aware of the followings: Due to the limited number of patients who can provide lutetium oxodotreotide treatment, PRRT has been established as an alternative treatment for patients who are refractory to other drugs after the second-line treatment, and its efficacy for neuroendocrine cancer (NEC) has not been established.

In the future, patients who are ineffective after the secondline treatment and require urgent lutetium oxodotreotide treatment should be given priority, and for that purpose, it is necessary to build a network with facilities that can carry out the treatment. Information on Lutetium oxodotreotide is listed in the (Table 1).

Table 1: Lutetium oxodotreotide.

1. Efficacy or effect

Somatostatin receptor-positive neuroendocrine tumor

2. Usage and dosage

In general, for adults, administer 7.4 GBq of lutetium oxodotreotide (177 Lu) once over 30 minutes by intravenous drip infusion up to 4 times at 8-week intervals. The dose may be reduced as appropriate depending on the patient’s condition.

3. Precautions related to usage and dosage

To reduce renal exposure due to administration of this drug, administer an infusion solution containing only 25 g each of L-lysine hydrochloride and L-arginine hydrochloride as amino acids in 1000 mL from 30 minutes before administration of this drug.

4. Serious side effecta [4,5,6].

(1) Bone marrow suppression

Lymphocytopenia (28.3%), thrombocytopenia (22.8%), anemia (11.8%), etc. may occur.

(2) Renal dysfunction

Acute renal failure (4.7%), increased blood creatinine (3.1%), etc. may occur.

(3) Myelodysplastic syndrome (1.6%), acute myeloid leukemia (incidence unknown)

References

  1. Bodei L, Cremonesi M, Grana CM, et al. Peptide receptor radionuclide therapy with 177Lu-DOTATATE: the IEO phase I-II study. Eur J Nucl Med Mol Imaging. 2011; 38: 2125-35.
  2. Hicks RJ, Kwekkeboom DJ, Krenning E, et al. ENETS consensus guidelines for the standards of care in neuroendocrine neoplasia: Peptide receptor radionuclide therapy with radiolabeled somatostatin analogues. Neuroendocrinology. 2017; 105: 295- 309.
  3. Ito T, Masui T, Komoto I, et al. JNETS clinical practice guidelines for gastroenteropancreatic neuroendocrine neoplasms: diagnosis, treatment, and follow-up: a synopsis. J Gastroenterol. 2021; 56: 1033-44.
  4. Strosberg J, El-Haddad G, Wolin E, et al. Phase 3 trial of 177LuDotatate for midgut neuroendocrine tumors. N Engl J Med. 2017; 376: 125-135.
  5. Kobayashi N, Takano S, Ito K, et al. Safety and efficacy of peptide receptor radionuclide therapy with 177 Lu-DOTA 0 -Tyr 3 -octreotate in combination with amino acid solution infusion in Japanese patients with somatostatin receptor-positive, progressive neuroendocrine tumors. Ann Nucl Med. 2021; 35: 1332–41.
  6. Kudo A, Tateishi U, Yoshimura R, et al. Safety and response after peptide receptor radionuclide therapy with 177 Lu-DOTATATE for neuroendocrine tumors in phase 1/2 prospective Japanese trial. J Hepatobiliary Pancreat Sci. 2021 Dec 14. doi: 10.1002/ jhbp.1101. Online ahead of print.