Adjuvant therapy with gemcitabine and stereotactic body radiation therapy versus gemcitabine alone for resected stage II pancreatic cancer: a prospective, randomized, open-label, single center trial
Abstract Background The role of adjuvant radiation in pancreatic adenocarcinoma (PDAC) remains unclear. We aimed to investigate the efficacy of gemcitabine combined with stereotactic body radiation therapy (SBRT) as adjuvant therapy for resected stage II PDAC. Methods In this single-center randomize...
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BMC
2022-08-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-022-09974-7 |
| _version_ | 1811215519745835008 |
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| author | Tao Ma Xueli Bai Qichun Wei Yongjie Shui Mengyi Lao Wen Chen Bingfeng Huang Risheng Que Shunliang Gao Yun Zhang Wei Chen Ji Wang Tingbo Liang |
| author_facet | Tao Ma Xueli Bai Qichun Wei Yongjie Shui Mengyi Lao Wen Chen Bingfeng Huang Risheng Que Shunliang Gao Yun Zhang Wei Chen Ji Wang Tingbo Liang |
| author_sort | Tao Ma |
| collection | DOAJ |
| description | Abstract Background The role of adjuvant radiation in pancreatic adenocarcinoma (PDAC) remains unclear. We aimed to investigate the efficacy of gemcitabine combined with stereotactic body radiation therapy (SBRT) as adjuvant therapy for resected stage II PDAC. Methods In this single-center randomized controlled trial, patients with stage II PDAC that underwent margin-negative resection were randomly assigned to gemcitabine-alone adjuvant chemotherapy or adjuvant SBRT followed by gemcitabine chemotherapy. The primary endpoint was recurrence-free survival (RFS). Secondary endpoints included locoregional recurrence-free survival (LRFS), overall survival (OS), and incidence of adverse events. Results Forty patients were randomly assigned to treatment between Sep 1, 2015 and Mar 31, 2018. Of these, 38 were included in the intention-to-treat analysis (20 in gemcitabine arm and 18 in gemcitabine plus SBRT arm). The median RFS and OS were 9.70, 28.0 months in the gemcitabine arm and 5.30, 15.0 months in the gemcitabine plus SBRT arm (RFS, P = 0.53; OS, P = 0.20), respectively. The median LRFS in both arms was unreached (P = 0.81). Grade 3 or 4 adverse events were all comparable between the two arms. Evaluation of data from the enrolled patients indicated that the addition of adjuvant SBRT was not associated with either better local disease control or recurrence-free survival. Conclusions Adjuvant SBRT neither provided a survival benefit nor improved local disease control in resected stage II PDAC. Trial registration ClinicalTrials.gov, NCT02461836 . Registered 03/06/2015 |
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| format | Article |
| id | doaj.art-b7e9daef588b4d7cb3afb7204b9412f3 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-04-12T06:23:57Z |
| publishDate | 2022-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-b7e9daef588b4d7cb3afb7204b9412f32022-12-22T03:44:14ZengBMCBMC Cancer1471-24072022-08-012211710.1186/s12885-022-09974-7Adjuvant therapy with gemcitabine and stereotactic body radiation therapy versus gemcitabine alone for resected stage II pancreatic cancer: a prospective, randomized, open-label, single center trialTao Ma0Xueli Bai1Qichun Wei2Yongjie Shui3Mengyi Lao4Wen Chen5Bingfeng Huang6Risheng Que7Shunliang Gao8Yun Zhang9Wei Chen10Ji Wang11Tingbo Liang12Department of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of MedicineDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of MedicineDepartment of Radiation Oncology, the Second Affiliated Hospital of Zhejiang University School of MedicineDepartment of Radiation Oncology, the Second Affiliated Hospital of Zhejiang University School of MedicineDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of MedicineDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of MedicineDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of MedicineDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of MedicineDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of MedicineDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of MedicineDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of MedicineDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of MedicineDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of MedicineAbstract Background The role of adjuvant radiation in pancreatic adenocarcinoma (PDAC) remains unclear. We aimed to investigate the efficacy of gemcitabine combined with stereotactic body radiation therapy (SBRT) as adjuvant therapy for resected stage II PDAC. Methods In this single-center randomized controlled trial, patients with stage II PDAC that underwent margin-negative resection were randomly assigned to gemcitabine-alone adjuvant chemotherapy or adjuvant SBRT followed by gemcitabine chemotherapy. The primary endpoint was recurrence-free survival (RFS). Secondary endpoints included locoregional recurrence-free survival (LRFS), overall survival (OS), and incidence of adverse events. Results Forty patients were randomly assigned to treatment between Sep 1, 2015 and Mar 31, 2018. Of these, 38 were included in the intention-to-treat analysis (20 in gemcitabine arm and 18 in gemcitabine plus SBRT arm). The median RFS and OS were 9.70, 28.0 months in the gemcitabine arm and 5.30, 15.0 months in the gemcitabine plus SBRT arm (RFS, P = 0.53; OS, P = 0.20), respectively. The median LRFS in both arms was unreached (P = 0.81). Grade 3 or 4 adverse events were all comparable between the two arms. Evaluation of data from the enrolled patients indicated that the addition of adjuvant SBRT was not associated with either better local disease control or recurrence-free survival. Conclusions Adjuvant SBRT neither provided a survival benefit nor improved local disease control in resected stage II PDAC. Trial registration ClinicalTrials.gov, NCT02461836 . Registered 03/06/2015https://doi.org/10.1186/s12885-022-09974-7Pancreatic adenocarcinomaAdjuvant therapyGemcitabineSBRTRandomized controlled trial |
| spellingShingle | Tao Ma Xueli Bai Qichun Wei Yongjie Shui Mengyi Lao Wen Chen Bingfeng Huang Risheng Que Shunliang Gao Yun Zhang Wei Chen Ji Wang Tingbo Liang Adjuvant therapy with gemcitabine and stereotactic body radiation therapy versus gemcitabine alone for resected stage II pancreatic cancer: a prospective, randomized, open-label, single center trial BMC Cancer Pancreatic adenocarcinoma Adjuvant therapy Gemcitabine SBRT Randomized controlled trial |
| title | Adjuvant therapy with gemcitabine and stereotactic body radiation therapy versus gemcitabine alone for resected stage II pancreatic cancer: a prospective, randomized, open-label, single center trial |
| title_full | Adjuvant therapy with gemcitabine and stereotactic body radiation therapy versus gemcitabine alone for resected stage II pancreatic cancer: a prospective, randomized, open-label, single center trial |
| title_fullStr | Adjuvant therapy with gemcitabine and stereotactic body radiation therapy versus gemcitabine alone for resected stage II pancreatic cancer: a prospective, randomized, open-label, single center trial |
| title_full_unstemmed | Adjuvant therapy with gemcitabine and stereotactic body radiation therapy versus gemcitabine alone for resected stage II pancreatic cancer: a prospective, randomized, open-label, single center trial |
| title_short | Adjuvant therapy with gemcitabine and stereotactic body radiation therapy versus gemcitabine alone for resected stage II pancreatic cancer: a prospective, randomized, open-label, single center trial |
| title_sort | adjuvant therapy with gemcitabine and stereotactic body radiation therapy versus gemcitabine alone for resected stage ii pancreatic cancer a prospective randomized open label single center trial |
| topic | Pancreatic adenocarcinoma Adjuvant therapy Gemcitabine SBRT Randomized controlled trial |
| url | https://doi.org/10.1186/s12885-022-09974-7 |
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