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In the search for a magic bullet for the radiopharmaceutical treatment of refractory cancers, in this issue, Majid Assadi and colleagues present “Feasibility and Therapeutic Potential of 177Lu–Fibroblast Activation Protein Inhibitor–46 for Patients With Relapsed or Refractory Cancers​"

Fibroblast activation protein (FAP) is a serine protease with high expression in the stroma of approximately 90% of epithelial malignancies. Authors assessed the feasibility, safety, and dosimetry for 177Lu-FAPI-46 in diverse advanced cancers that are not surgically addressable and are refractory to conventional therapies. Treated cancers included bile duct, breast, cervical, colon, lung, ovarian, pancreatic, prostate, sarcoma and thyroid cancer. Treatment included escalating doses of 177Lu-FAPI-46 (1.85–4.44 GBq) per cycle based on clinical and statistical expertise design, delivered at intervals of 4 to 6 weeks. Biodistribution and dosimetry were evaluated by body scans.

NCI Common Terminology Criteria for Adverse Events version 4.03 criteria were applied to quantitate peptide-targeted radionuclide therapy (PTRT)–associated toxicity in 18 of 21 patients (11 females and 10 males) with a median age of 50 years (range, 6–79 years). Overall, 36 PTRT cycles were performed.

The median number of PTRT cycles and the median injected amount of activity in each cycle were 2 and 3.7 GBq, respectively. Dosimetric analysis revealed median absorbed doses of 0.026, 0.136, 0.886, and 0.02 with ranges of 0.023–0.034, 0.001–0.2, 0.076–1.39, and 0.002–0.2 mGy/MBq for the whole body, liver, kidneys, and spleen, respectively. Treatments were well tolerated in almost all patients.

Authors conclude that the findings of this preliminary investigation might indicate the potential feasibility and safety of PTRT using 177Lu-FAPI-46 for different aggressive tumors. Moreover, the current study could be beneficial in determining the suitable amount of activity for a phase 2 study.

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Feasibility and Therapeutic Potential of 177Lu–Fibroblast Activation Protein Inhibitor–46 for Patients With Relapsed or Refractory Cancers: A Preliminary Study

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