Efficacy and safety of S-1 based adjuvant chemoradiotherapy for resected pancreatic ductal adenocarcinoma with high-risk pathological feature: a prospective, single-arm, interventional study
Abstract. Objective:. It remains unclear whether adjuvant chemoradiotherapy (CRT) improves survival outcome of pancreatic ductal adenocarcinoma (PDAC) patients after surgery. This study aimed to investigate the efficacy and safety of tegafur/gimeracil/oteracil (S-1)-based adjuvant concurrent chemor...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer Health/LWW
2022-03-01
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| Series: | Journal of Pancreatology |
| Online Access: | http://journals.lww.com/10.1097/JP9.0000000000000084 |
| _version_ | 1811183553682079744 |
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| author | Lili Wu Yaolin Xu Zhaochong Zeng Yixing Chen Yuhong Zhou Dansong Wang Jing Sun Minzhi Lv Shisuo Du Wenhui Lou |
| author_facet | Lili Wu Yaolin Xu Zhaochong Zeng Yixing Chen Yuhong Zhou Dansong Wang Jing Sun Minzhi Lv Shisuo Du Wenhui Lou |
| author_sort | Lili Wu |
| collection | DOAJ |
| description | Abstract.
Objective:. It remains unclear whether adjuvant chemoradiotherapy (CRT) improves survival outcome of pancreatic ductal adenocarcinoma (PDAC) patients after surgery. This study aimed to investigate the efficacy and safety of tegafur/gimeracil/oteracil (S-1)-based adjuvant concurrent chemoradiotherapy in resected PDAC patients with defined high-risk pathological features.
Methods:. We conducted a single-arm, prospective, and interventional study at Zhongshan Hospital Fudan University from December 2012 to December 2019 and the last follow-up was conducted in December 2021. This study was approved by the Ethics Committee of Zhongshan Hospital Fudan University on December 27, 2012 (approval No. B2012-139). Resected PDAC patients with high-risk pathological features, including positive resection margin, pathological T3-4N1-2M0 disease, peripancreatic fat invasion, microvascular invasion, and perineural invasion, were recruited. Primary endpoint was overall survival and secondary endpoints were disease-free survival, treatment toxicity, and 2-, 5-year survival rates.
Results:. A total of 54 patients were recruited. Mean age was 63.6 years old (±7.2). The distribution of T and N stages were 24.1% for T1, 46.3% for T2, 27.8% for T3, 1.9% for T4, 33.3% for N1, and 11.1% for N2. Seven patients had R1 resection. The median overall survival and disease-free survival were 27.1 and 13.7 months, respectively, while no fatal adverse events were recorded. Subgroup analyses showed differences in survival outcomes among patients with microvascular invasion, different N stages, and preoperative CA 19-9 levels. Further, a Cox proportional hazard model demonstrated associations of lymph node metastases, CA 19-9 level, and microvascular invasion with overall survival and disease-free survival.
Conclusion:. S-1-based adjuvant CRT showed promising efficacy and manageable toxicity in resected PDAC patients with high-risk pathological features. |
| first_indexed | 2024-04-11T09:48:42Z |
| format | Article |
| id | doaj.art-786c3846e49a40a597e40512af2fadee |
| institution | Directory Open Access Journal |
| issn | 2096-5664 2577-3577 |
| language | English |
| last_indexed | 2024-04-11T09:48:42Z |
| publishDate | 2022-03-01 |
| publisher | Wolters Kluwer Health/LWW |
| record_format | Article |
| series | Journal of Pancreatology |
| spelling | doaj.art-786c3846e49a40a597e40512af2fadee2022-12-22T04:30:53ZengWolters Kluwer Health/LWWJournal of Pancreatology2096-56642577-35772022-03-0151182610.1097/JP9.0000000000000084202203000-00003Efficacy and safety of S-1 based adjuvant chemoradiotherapy for resected pancreatic ductal adenocarcinoma with high-risk pathological feature: a prospective, single-arm, interventional studyLili WuYaolin XuZhaochong ZengYixing ChenYuhong ZhouDansong WangJing SunMinzhi LvShisuo DuWenhui LouAbstract. Objective:. It remains unclear whether adjuvant chemoradiotherapy (CRT) improves survival outcome of pancreatic ductal adenocarcinoma (PDAC) patients after surgery. This study aimed to investigate the efficacy and safety of tegafur/gimeracil/oteracil (S-1)-based adjuvant concurrent chemoradiotherapy in resected PDAC patients with defined high-risk pathological features. Methods:. We conducted a single-arm, prospective, and interventional study at Zhongshan Hospital Fudan University from December 2012 to December 2019 and the last follow-up was conducted in December 2021. This study was approved by the Ethics Committee of Zhongshan Hospital Fudan University on December 27, 2012 (approval No. B2012-139). Resected PDAC patients with high-risk pathological features, including positive resection margin, pathological T3-4N1-2M0 disease, peripancreatic fat invasion, microvascular invasion, and perineural invasion, were recruited. Primary endpoint was overall survival and secondary endpoints were disease-free survival, treatment toxicity, and 2-, 5-year survival rates. Results:. A total of 54 patients were recruited. Mean age was 63.6 years old (±7.2). The distribution of T and N stages were 24.1% for T1, 46.3% for T2, 27.8% for T3, 1.9% for T4, 33.3% for N1, and 11.1% for N2. Seven patients had R1 resection. The median overall survival and disease-free survival were 27.1 and 13.7 months, respectively, while no fatal adverse events were recorded. Subgroup analyses showed differences in survival outcomes among patients with microvascular invasion, different N stages, and preoperative CA 19-9 levels. Further, a Cox proportional hazard model demonstrated associations of lymph node metastases, CA 19-9 level, and microvascular invasion with overall survival and disease-free survival. Conclusion:. S-1-based adjuvant CRT showed promising efficacy and manageable toxicity in resected PDAC patients with high-risk pathological features.http://journals.lww.com/10.1097/JP9.0000000000000084 |
| spellingShingle | Lili Wu Yaolin Xu Zhaochong Zeng Yixing Chen Yuhong Zhou Dansong Wang Jing Sun Minzhi Lv Shisuo Du Wenhui Lou Efficacy and safety of S-1 based adjuvant chemoradiotherapy for resected pancreatic ductal adenocarcinoma with high-risk pathological feature: a prospective, single-arm, interventional study Journal of Pancreatology |
| title | Efficacy and safety of S-1 based adjuvant chemoradiotherapy for resected pancreatic ductal adenocarcinoma with high-risk pathological feature: a prospective, single-arm, interventional study |
| title_full | Efficacy and safety of S-1 based adjuvant chemoradiotherapy for resected pancreatic ductal adenocarcinoma with high-risk pathological feature: a prospective, single-arm, interventional study |
| title_fullStr | Efficacy and safety of S-1 based adjuvant chemoradiotherapy for resected pancreatic ductal adenocarcinoma with high-risk pathological feature: a prospective, single-arm, interventional study |
| title_full_unstemmed | Efficacy and safety of S-1 based adjuvant chemoradiotherapy for resected pancreatic ductal adenocarcinoma with high-risk pathological feature: a prospective, single-arm, interventional study |
| title_short | Efficacy and safety of S-1 based adjuvant chemoradiotherapy for resected pancreatic ductal adenocarcinoma with high-risk pathological feature: a prospective, single-arm, interventional study |
| title_sort | efficacy and safety of s 1 based adjuvant chemoradiotherapy for resected pancreatic ductal adenocarcinoma with high risk pathological feature a prospective single arm interventional study |
| url | http://journals.lww.com/10.1097/JP9.0000000000000084 |
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