Intraoperative Radiotherapy for Resectable Pancreatic Cancer Using a Low-Energy X-Ray Source: Postoperative Complications and Early Outcomes
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Purpose: We evaluated the safety, feasibility, and early treatment outcomes of intraoperative radiotherapy (IORT) using a lowenergyX-ray source. Materials and Methods: Patients with resectable pancreatic cancer were enrolled in this single-institution, prospective, singlearm,phase II trial. Patients underwent surgery and IORT with 10 Gy prescribed at a 5-mm depth from the tumor bed using a 50 kVX-ray source (Intrabeam, Carl Zeiss). Six cycles of adjuvant gemcitabine-based chemotherapy were administered 8–12 weeks aftersurgery. Results: A total of 41 patients were included. Thirty-one patients (75.6%) underwent wide R0 resection, while 5 (12.2%) underwentR1 resection and 5 (12.2%) underwent narrow R0 resection (retroperitoneal margin <1 mm). Grade 3 postoperative complicationswere reported in only one patient (4.9%) who needed additional surgery due to ulcer perforation. At a median follow-up of 9 months,four patients showed local-only recurrence, nine had distant metastases, and two showed both local and distant recurrence. The1-year local control rate was 76.4%. Conclusion: Our preliminary report suggests that IORT is well-tolerated and feasible in patients with resectable pancreatic cancer. Further follow-up is needed to confirm the clinical benefits of IORT in terms of local control and overall survival. Trial Registration: Clinical trial registration No. (NCT03273374).
Abstract
Purpose: We evaluated the safety, feasibility, and early treatment outcomes of intraoperative radiotherapy (IORT) using a lowenergyX-ray source. Materials and Methods: Patients with resectable pancreatic cancer were enrolled in this single-institution, prospective, singlearm,phase II trial. Patients underwent surgery and IORT with 10 Gy prescribed at a 5-mm depth from the tumor bed using a 50 kVX-ray source (Intrabeam, Carl Zeiss). Six cycles of adjuvant gemcitabine-based chemotherapy were administered 8–12 weeks aftersurgery. Results: A total of 41 patients were included. Thirty-one patients (75.6%) underwent wide R0 resection, while 5 (12.2%) underwentR1 resection and 5 (12.2%) underwent narrow R0 resection (retroperitoneal margin <1 mm). Grade 3 postoperative complicationswere reported in only one patient (4.9%) who needed additional surgery due to ulcer perforation. At a median follow-up of 9 months,four patients showed local-only recurrence, nine had distant metastases, and two showed both local and distant recurrence. The1-year local control rate was 76.4%. Conclusion: Our preliminary report suggests that IORT is well-tolerated and feasible in patients with resectable pancreatic cancer. Further follow-up is needed to confirm the clinical benefits of IORT in terms of local control and overall survival. Trial Registration: Clinical trial registration No. (NCT03273374).
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