Eficacia de lutecio-177 DOTATATE/TOC en pacientes con tumores neuroendocrinos bien diferenciados en estado avanzado. Ensayo clínico fase II

Abstract

ABSTRACT Objectives: The National Cancer Institute first developed the 177Lu-DOTATATE/TOC in 2009. The purpose of this study was to prove the efficacy of these radiopeptides in the palliative treatment of patients with progressive advanced inoperable neuroendocrine tumors (NETs). Methods: A single-arm phase II open-label clinical trial was conducted in 13 adult patients with Grade 1 or 2 NETs, with somatostatin receptor expression in target lesions proven by Krenning Score 3 or 4 uptake at 99mTc-HYNIC TOC. Patients were treated with 177Lu-DOTATATE or 177Lu-DOTATOC (depending on availability) at a projected cumulative activity of 600-800 mCi divided into 3-4 doses every 6-9 weeks, always beginning with a fixed activity of 200 mCi and dosimetry with the first dose. The primary outcome was an objective response to therapy. Results: 13 patients (7 women) aged 63 ± 11.6 years with inoperable advanced NETs were included. The final therapeutic activity administered was 800 mCi, 600 mCi, 400 mCi, and 200 mCi in 4, 7, 1 and 1 patients, respectively. The disease control rate at 6 and 12 months was 69.2% and 45.5%, respectively, achievieng only a stable disease. Seven patients died, 2 of them within the first 6 months. The median overall survival rate was 15.7 months from the last treatment dose. Conclusions: The efficacy of the treatment with 177Lu-DOTATATE or 177Lu-DOTATOC radiopeptides developed in-house was confirmed, becoming a management alternative for patients with advanced NETs.