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Efficacy and Safety of Lu-177 DOTATATE Peptide Receptor Radionuclide Therapy in Patients with Unresectable or Metastatic Neuroendocrine Tumors in Korea

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Abstract

Background

Lutetium (Lu)-177 peptide receptor radionuclide therapy (PRRT) is one of the standard treatments for somatostatin receptor-positive well-differentiated neuroendocrine tumors (NETs). However, limited Asian representation in the pivotal NETTER-1 trial and a lack of real-world data for Lu-177 PRRT from Asian regions exist.

Objective

This retrospective study aimed to evaluate the efficacy and safety of Lu-177 PRRT in Korean patients with advanced NETs.

Patients and Methods

This study analyzed 64 patients treated with Lu-177 DOTATATE PRRT at the Asan Medical Center, Seoul, Korea, between November 2019 and December 2022. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included overall survival (OS), objective response rate (ORR), and safety profile.

Results

The median age of patients was 55 years. Prior to PRRT, patients received a median of two lines (range 0–6) of systemic therapy. Fifty (78%) patients received the planned four cycles of Lu-177 DOTATATE PRRT. The median PFS was 21.7 months (95% confidence interval 16.7–not available) and the ORR was 20%. With a median follow-up of 15.7 months (range 1.0–39.3), the median OS was not reached and the 1-year OS rate was 88%. The median PFS was better in patients with grade 1–2 NETs than in those with grade 3 NET (not reached vs. 14.2 months; hazard ratio 3.15; p = 0.0058). Hematological toxicities were the common adverse events, including grade ≥ 3 anemia (7.8%), neutropenia (10.9%), and thrombocytopenia (9.4%).

Conclusions

In Korean patients with advanced NETs, Lu-177 DOTATATE PRRT showed efficacy and safety outcomes, consistent with those in the NETTER-1 trial and previous Western real-world studies.

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Authors and Affiliations

  1. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea

    Yeokyeong Shin, Baek-Yeol Ryoo, Heung-Moon Chang, Kyu-pyo Kim, Yong Sang Hong, Tae Won Kim & Changhoon Yoo

  2. Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

    Bo Hyun Moon

  3. Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea

    Jin-Sook Ryu & Yong-il Kim

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  1. Yeokyeong Shin
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Corresponding authors

Correspondence to Yong-il Kim or Changhoon Yoo.

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Funding

This study was supported in part by the Asan Institute for Life Sciences, Asan Medical Center, Seoul, Korea [grant numbers 2021IF0022]. The funder had no role in the design, analysis, or interpretation of the study.

Conflict of interest

Yeokyeong Shin, Bo Hyun Moon, Baek-Yeol Ryoo, Heung-Moon Chang, Kyu-pyo Kim, Yong Sang Hong, Tae Won Kim, Jin-Sook Ryu, Yong-il Kim, and Changhoon Yoo declare that they have no conflicts of interest that might be relevant to the contents of this manuscript.

Availability of data and material

All data supporting the findings of this study are available within the paper and its electronic supplementary material.

Ethics approval

This retrospective study was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization Guidelines for Good Clinical Practice. The protocol was approved by the Institutional Review Board of Asan Medical Center (#2022-1065).

Consent to participate

Informed consent from all patients was waived.

Consent for publication

As this article did not contain any identifiable patient data, additional informed consent from the patients was waived.

Code availability

Not applicable.

Author contributions

CY contributed to the study conception and design. Material preparation and data collection were performed by YS, BHM, B-YR, H-MC, K-PK, YSH, TWK, J-SR, Y-IK and CY. Data analysis was performed by YS, Y-IK and CY. The first draft of the manuscript was written by YS, Y-IK, and CY, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Shin, Y., Moon, B.H., Ryoo, BY. et al. Efficacy and Safety of Lu-177 DOTATATE Peptide Receptor Radionuclide Therapy in Patients with Unresectable or Metastatic Neuroendocrine Tumors in Korea. Targ Oncol 19, 41–49 (2024). https://doi.org/10.1007/s11523-023-01022-z

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  • DOI: https://doi.org/10.1007/s11523-023-01022-z

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