The Polish radioligand therapy (RLT) Registry: initial real-world evidence in neuroendocrine tumors.

Abstract

Background: Radioligand therapy (RLT) with [177Lu]Lu-DOTA-TATE has become a key treatment option for advanced gastroenteropancreatic neuroendocrine tumors (NETs). In Poland, RLT has been reimbursed since March 2023 within the national drug program B.139. In order to monitor real-world data and patient characteristics, the Polish RLT Registry was established under the auspices of the Polish Society of Endocrinology.

Material and methods: This first report summarizes two years of data collection in six major clinical centers. The Registry includes retrospective and prospective data on demographics, primary tumor site, hormonal activity, prior therapies, type of progression leading to qualification, as well as the safety of administered RLT.

Results: The analyzed cohort reflects the real-world population of Polish patients referred for RLT. Most patients presented with advanced, progressive NETs after multiple treatment lines. Registry data allowed characterization of referral patterns, disease progression leading to qualification, and the patient care pathway from initial diagnosis to RLT. Due to the short observation period, survival outcomes such as progression-free survival (PFS) and overall survival (OS) are not yet available.

Conclusions: This is the first national real-world evidence report on RLT for NET in Poland. The Registry provides unique insight into patient characteristics and clinical practice in the early phase of therapy implementation. Collected data will serve as a basis for the development of national recommendations and optimization of NET management.