Introduction Fibroblast activation protein (FAP) is a member of the serine protease family and has a high expression in the stroma of approximately 90% of epithelial malignancies. The present investigation aimed to assess the feasibility, safety, and dosimetry data of 177Lu-FAPI-46 in diverse malignancies. Patients and Methods Patients with advanced cancers with nonoperable tumors, or tumors refractory to conventional therapies, were enrolled. Treatment included escalating doses of 177Lu-FAPI-46 (1.85–4.44 GBq) per cycle using a combination of clinical and statistical expertise design, and intervals of 4 to 6 weeks were considered between the cycles. Biodistribution and dosimetry were examined by whole-body scans. We applied the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 to measure peptide-targeted radionuclide therapy (PTRT)–associated toxicity. Results A total of 21 patients (11 females and 10 males) with a median age of 50 years (range, 6–79 years) were investigated. Of 21 participants, 18 cases were selected for PTRT. 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. The 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. The therapy was well tolerated in almost all patients. Conclusions 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.

Introduction: Although weekly paclitaxel and carboplatin regimen is as effective as the standard method for treatment of advanced ovarian cancer, it has less frequently been used as neoadjuvant therapy. Objectives: To reduce the side effects of typical every three-week chemotherapy and increase progression-free survival (PFS) rate, this study aimed to evaluate the feasibility of using weekly paclitaxel as neoadjuvant therapy in patients with epithelial ovarian cancer. Patients and Methods: This pre-post clinical trial was conducted on 14 patients with stage IIIC (8 patients) and IV (6 patients) advanced ovarian carcinoma. All the patients received the three courses of treatment and then underwent interval debulking surgery. After the surgery, patients received three or five courses based on their stages. Every neoadjuvant chemotherapy course consisted of weekly paclitaxel (80 mg/m2 ) and carboplatin (AUC=6) every 3 weeks. After every 21 days of treatment course, the patients were evaluated to investigate their response to treatment and side effects. Patients were followed up for at least 6 months. Results: The mean (SD) age of the patients was 64±8 years. After three courses of neoadjuvant chemotherapy, one patient (7%) had a complete response and 13 patients (93%) had a partial response. During the treatment period, two patients (14%) developed anemia, one patient (7%) developed neutropenia, two patients (14%) developed thrombocytopenia, and six patients (43%) developed neuropathy. The median (interquartile range) of PFS was 13 months (9.5-16.25). Conclusion: The findings showed that a weekly paclitaxel and carboplatin regimen as neoadjuvant therapy could be effective in the treatment of advanced ovarian cancer. However, it is necessary to conduct multicenter studies with larger sample sizes. Trial registration: Registration of trial protocol has been approved in Iranian Registry of Clinical Trial (identifier: IRCT2017050333789N1; http://en.irct.ir/trial/25978)

No abstract