Safety and efficacy of intraoperative radiation therapy using a low-energy X-ray source for resectable pancreatic cancer: an interim evaluation of an ongoing prospective phase II study

Objective: The role of intraoperative radiation therapy (IORT) in the management of resectable pancreatic cancer (RPC) remains unclear. To date, the application of IORT using a low-energy X-ray source has not been extensively investigated. Therefore, this study was conducted to evaluate the safety a...

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Main Authors: Xingyun Chen, Shuo Li, Chuntao Gao, Wei Wang, Haorui Li, Yuxiao Liu, Rui Liu, Jihui Hao
Format: Article
Language:English
Published: China Anti-Cancer Association 2025-01-01
Series:Cancer Biology & Medicine
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Online Access:https://www.cancerbiomed.org/content/22/1/67
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author Xingyun Chen
Shuo Li
Chuntao Gao
Wei Wang
Haorui Li
Yuxiao Liu
Rui Liu
Jihui Hao
author_facet Xingyun Chen
Shuo Li
Chuntao Gao
Wei Wang
Haorui Li
Yuxiao Liu
Rui Liu
Jihui Hao
author_sort Xingyun Chen
collection DOAJ
description Objective: The role of intraoperative radiation therapy (IORT) in the management of resectable pancreatic cancer (RPC) remains unclear. To date, the application of IORT using a low-energy X-ray source has not been extensively investigated. Therefore, this study was conducted to evaluate the safety and efficacy of IORT using a 50 kV X-ray source in treating RPC. Methods: Patients with RPC who underwent radical pancreatectomy and IORT were enrolled. The primary endpoint was time to treatment failure (TTF) survival, whereas the secondary endpoints were safety and overall survival (OS). Results: By November 2023, 35 patients with RPC were treated according to the study protocol. The median TTF was 11.67 months, whereas the median OS for the cohort was 22.2 months. The local recurrence rate was 20%. The most common postoperative complication was pancreatic fistula. The incidence of delayed gastric emptying was 20%. Within 30 days after surgery, one patient experienced abdominal pain, another experienced vomiting, and one died because of abdominal infection and a grade C pancreatic fistula. Carcinoembryonic antigen (CEA) and D-dimer levels significantly correlated with TTF and OS in multivariate analyses. The carbohydrate antigen 19-9 (CA19-9) level was another prognostic factor significantly associated with OS. Patients with low D-dimer and normal CA19-9 levels showed prolonged OS with an IORT dose ≤ 15 Gy. Conclusions: This study supports use of IORT with a 50 kV X-ray source in treating RPC. IORT using a low-energy X-ray source was well-tolerated and feasible. Additionally, D-dimer, CEA, and CA19-9 levels may help identify patient profiles potentially benefitting from IORT.
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spelling doaj-art-eb0d3817a14942d1a62984ba368d84a42025-02-05T11:20:48ZengChina Anti-Cancer AssociationCancer Biology & Medicine2095-39412025-01-01221677610.20892/j.issn.2095-3941.2024.0287Safety and efficacy of intraoperative radiation therapy using a low-energy X-ray source for resectable pancreatic cancer: an interim evaluation of an ongoing prospective phase II studyXingyun Chen0Shuo Li1Chuntao Gao2Wei Wang3Haorui Li4Yuxiao Liu5Rui Liu6Jihui Hao7Department of Pancreatic Cancer, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin 300060, ChinaDepartment of Pancreatic Cancer, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin 300060, ChinaDepartment of Pancreatic Cancer, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin 300060, ChinaDepartment of Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin 300060, ChinaDepartment of Pancreatic Cancer, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin 300060, ChinaDepartment of Pancreatic Cancer, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin 300060, ChinaDepartment of Gastrointestinal Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin Key Laboratory of Digestive Cancer, Tianjin 300060, ChinaDepartment of Pancreatic Cancer, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin 300060, ChinaObjective: The role of intraoperative radiation therapy (IORT) in the management of resectable pancreatic cancer (RPC) remains unclear. To date, the application of IORT using a low-energy X-ray source has not been extensively investigated. Therefore, this study was conducted to evaluate the safety and efficacy of IORT using a 50 kV X-ray source in treating RPC. Methods: Patients with RPC who underwent radical pancreatectomy and IORT were enrolled. The primary endpoint was time to treatment failure (TTF) survival, whereas the secondary endpoints were safety and overall survival (OS). Results: By November 2023, 35 patients with RPC were treated according to the study protocol. The median TTF was 11.67 months, whereas the median OS for the cohort was 22.2 months. The local recurrence rate was 20%. The most common postoperative complication was pancreatic fistula. The incidence of delayed gastric emptying was 20%. Within 30 days after surgery, one patient experienced abdominal pain, another experienced vomiting, and one died because of abdominal infection and a grade C pancreatic fistula. Carcinoembryonic antigen (CEA) and D-dimer levels significantly correlated with TTF and OS in multivariate analyses. The carbohydrate antigen 19-9 (CA19-9) level was another prognostic factor significantly associated with OS. Patients with low D-dimer and normal CA19-9 levels showed prolonged OS with an IORT dose ≤ 15 Gy. Conclusions: This study supports use of IORT with a 50 kV X-ray source in treating RPC. IORT using a low-energy X-ray source was well-tolerated and feasible. Additionally, D-dimer, CEA, and CA19-9 levels may help identify patient profiles potentially benefitting from IORT.https://www.cancerbiomed.org/content/22/1/67resectable pancreatic cancerintraoperative radiationsurvivalcomplicationsbenefit group
spellingShingle Xingyun Chen
Shuo Li
Chuntao Gao
Wei Wang
Haorui Li
Yuxiao Liu
Rui Liu
Jihui Hao
Safety and efficacy of intraoperative radiation therapy using a low-energy X-ray source for resectable pancreatic cancer: an interim evaluation of an ongoing prospective phase II study
Cancer Biology & Medicine
resectable pancreatic cancer
intraoperative radiation
survival
complications
benefit group
title Safety and efficacy of intraoperative radiation therapy using a low-energy X-ray source for resectable pancreatic cancer: an interim evaluation of an ongoing prospective phase II study
title_full Safety and efficacy of intraoperative radiation therapy using a low-energy X-ray source for resectable pancreatic cancer: an interim evaluation of an ongoing prospective phase II study
title_fullStr Safety and efficacy of intraoperative radiation therapy using a low-energy X-ray source for resectable pancreatic cancer: an interim evaluation of an ongoing prospective phase II study
title_full_unstemmed Safety and efficacy of intraoperative radiation therapy using a low-energy X-ray source for resectable pancreatic cancer: an interim evaluation of an ongoing prospective phase II study
title_short Safety and efficacy of intraoperative radiation therapy using a low-energy X-ray source for resectable pancreatic cancer: an interim evaluation of an ongoing prospective phase II study
title_sort safety and efficacy of intraoperative radiation therapy using a low energy x ray source for resectable pancreatic cancer an interim evaluation of an ongoing prospective phase ii study
topic resectable pancreatic cancer
intraoperative radiation
survival
complications
benefit group
url https://www.cancerbiomed.org/content/22/1/67
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