Phase II Study of ¹⁷⁷Lu-DOTATATE for Progressive Metastatic Pheochromocytomas and Paragangliomas: Interim Analysis of Efficacy, Safety, and Biomarkers.

ABSTRACT:

Purpose

¹⁷⁷Lu-DOTA(0)-Tyr(3)-octreotate (¹⁷⁷Lu-DOTATATE) is a somatostatin receptor (SSTR)-targeting radiopharmaceutical that shows promise for treating metastatic pheochromocytomas/paragangliomas (PPGLs), a rare SSTR-expressing tumor.

Methods

In the first stage of this two-stage Simon phase II trial, 36 PPGL patients with RECIST 1.1 progression within 12 months were prospectively recruited into two genetic cohorts (succinate dehydrogenase [SDHx]-mutated v apparent sporadic, 18 per cohort) and treated with four cycles of ¹⁷⁷Lu-DOTATATE. The primary end point was progression-free survival (PFS) rate at 6 months (from initiation of treatment). Secondary end points included safety, overall survival (OS), response rate, imaging/seru

SUBMITTER: Lin FI 

PROVIDER: S-EPMC12367064 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature