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• W2972639654 abstract "Treatment of unresectable, locally advanced pancreatic cancer (LAPC) is challenging. Current treatment options include chemotherapy alone or followed by chemoradiation or SBRT. However, the prognosis of LAPC remains poor, with a median overall survival less than 1 year. Therefore, novel treatment approaches are needed. Phosphorus-32 (P-32) is a brachytherapy device that carries the radioactive beta-emitter P-32 microparticles and is implanted directly into the pancreatic tumor under endoscopic ultrasound (EUS) guidance. This data represents early results of a multi-institutional, single-arm, pilot study (OncoPac-1, NCT03076216) assessing the feasibility, safety, and efficacy of P-32 brachytherapy in conjunction with standard chemotherapy in patients with unresectable LAPC. Eligible patients were enrolled in the study and received gemcitabine +/- nab-paclitaxel chemotherapy. During the 4th or 5th week of the chemotherapy regimen, P-32 was implanted into the pancreatic tumor under EUS guidance using a 22-gauge FNA needle. The dose of P-32 was calculated based on each patient’s respective tumor volume so that the absorbed radiation dose equaled 100Gy (±20%). Chemotherapy regimen was resumed following P-32 implantation. Bremsstrahlung SPECT/CT imaging was performed to assess the intra-tumoral and any potential extra-tumoral distribution of the P-32 microparticles at 4 hours and 7 days after P-32 implantation. Centrally-read CT scans were performed every 8 weeks from enrollment to assess tumor response defined as complete response (CR), partial response (PR), and stable disease (SD) according to RECIST 1.1 criteria. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade and report adverse events (AEs). A total of 9 patients with a median age of 65 years (range 57-87) were enrolled in the study. The local disease control rate at week 16 was 88%, with PR or SD reported in 7/8 patients. Median change in tumor volume at week 16 was -9% (range +61 to -80%). P-32 was successfully implanted in all cases without any procedure-related AEs. P-32 localization to the implantation site was confirmed by SPECT/CT Bremsstrahlung imaging in eight patients at 4 hours (89%) and in nine patients at 7 days (100%). One grade 4 AE and 23 grade 3 AEs were reported as possibly or probably related to chemotherapy and/or P-32. The majority of grade 3/4 AE were hematologic toxicities: neutropenia (15), anemia (3), and thrombocytopenia (1). Early results from the OncoPaC-1 pilot study showed that P-32 brachytherapy in conjunction with standard chemotherapy is technically feasible and has an acceptable safety profile in patients with unresectable LAPC. Preliminary data shows evidence of local disease control, however further evaluation is needed to confirm these findings." @default.
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• W2972639654 date "2019-09-01" @default.
• W2972639654 modified "2023-09-23" @default.
• W2972639654 title "OncoPaC-1: An Open-label, Single-Arm Pilot Study of Phosphorus-32 Microparticles Brachytherapy in Combination with Gemcitabine +/- Nab-Paclitaxel in Unresectable Locally Advanced Pancreatic Cancer" @default.
• W2972639654 doi "https://doi.org/10.1016/j.ijrobp.2019.06.2010" @default.
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