The aim of this study was to evaluate the efficacy and safety of 177LuLu-DOTAGA.Glu.(FAPi)2 therapy in patients with sarcoma, a cohort of individuals with limited treatment options and significant disease burden. Methods: This retrospective analysis involved 10 patients with histologically confirmed sarcoma. Patients received a median cumulative activity of 17.5 GBq (range, 6.3–55.5 GBq) of 177LuLu-DOTAGA.Glu.(FAPi)2 administered over a median of 3 treatment cycles (range, 1–6 cycles). Patient responses were assessed using PERCIST in 6 patients and RECIST 1.1 in 9 patients. The primary endpoint was the disease control rate, defined as complete response, partial response, or stable disease, evaluated through morphologic, molecular, or clinical criteria. Secondary endpoints included progression-free survival, overall survival, and safety. Results: 177LuLu-DOTAGA.Glu.(FAPi)2 was generally well tolerated. Response assessment using PERCIST indicated a partial response in 33.3% of patients, whereas no objective response was observed in the response assessed with RECIST. Disease control rates were 50% and 22.3% with PERCIST and RECIST, respectively. Disease progression was documented in 7 patients, 3 of whom succumbed to disease-related complications. The median progression-free survival was approximately 5 mo (95% CI, 2.9–7.1 mo), and the median overall survival was 8 mo (95% CI, 5.5–10.5 mo). Conclusion: 177LuLu-DOTAGA.Glu.(FAPi)2 demonstrated clinical antitumor activity with a manageable safety profile in patients with sarcoma. Further studies with larger cohorts and combination therapies are warranted to optimize therapeutic efficacy and improve outcomes.
Ballal et al. (Thu,) studied this question.