Long-term efficacy and safety of peptide receptor radionuclide therapy (PRRT) in Japanese patients with unresectable neuroendocrine tumour: Japanese phase I and phase I/II extension study

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Introduction: PRRT with 177Lu-DOTATATE has been approved in Japan according to Japanese phase I and Phase I/II clinical trials. Primary end point of these clinical studies was safety and response rate, therefore, long-term efficacy and safety of PRRT for Japanese patients with NET are uncertain.

Aim(s): We conducted a record-based analysis of Japanese phase I and Phase I/II clinical trials on PRRT and evaluate the time to treatment failure (TTF), overall survival (OS) and long duration safety.

Materials and methods: We recruited Japanese patients who participated in the phase I and phase I/II clinical trial of 177Lu-DOTATATE for somatostatin receptor-positive NETs. Original phase I and phase I/II studies finished in March 2021; therefore, we investigated date of death occurrence, progressive disease, and severe disease after PRRT until December 2023 according to recorded data base.

Conference:

Presenting Author: Ichikawa Y

Authors: Kobayashi N, Ono H, Okubo N, Akahoshi K, Kudo A,

Keywords: Neuroendocrine tumour, Peptide receptor radionuclide therapy, Japanese patients,