345 - The Endoscopy Results of Recombinant Human Superoxide Dismutase in Radical Concurrent Chemoradiotherapy for Cervical Cancer to Prevent and Treat Radiation-Induced Acute Rectal Injury: A Multi-Center, Randomized, Open-Label, Prospective Trial
Presenter(s)
J. Zhu1, X. F. Li2, M. Huang3, X. He4, Z. Sun4, H. Zhu5, Y. Tan6, P. Xie7, H. Cheng8, L. Zhu9, X. Cao10, F. Li11, P. Jiang12, G. Ke13, H. Lou14, J. Yan1, and F. Zhang1; 1Department of Radiation Oncology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China, 2Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing, China, 3Department of Gynecological Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, 4Department of Radiation Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, Jiangsu, China, 5Department of Oncology, Xiangya Hospital, Central South University, Changsha, Hunan, China, 6adiation Oncology Key Laboratory of Sichuan Province, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Affiliated Cancer Hospital of University of Electronic Science and Technology of China, Chengdu, Sichuan, China, 7Department of Gynecologic Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China, 8The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, Henan, China, 9Radiotherapy center,Beijing Obstetrics and Gynecology Hospital, Capital Medical University. Beijing Maternal and Child Health Care Hospital, Beijing, China, 10Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China, 11Department of Oncology, The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, China, 12Department of Radiation Oncology, Peking University Third Hospital, Beijing, China, 13Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China, 14Department of Gynecologic Oncology,Zhejiang Cancer hospital,Hangzhou,China, Beijing, China
Purpose/Objective(s): To evaluate the efficacy of recombinant human superoxide dismutase (rhSOD) enema through endoscopy in radiation-induced acute rectal injury (RARI) for patients with locally advanced cervical cancer (LACC).
Materials/Methods: This was a phase III, multicenter, randomized, open-label trial (NCT04819685) in China. All patients received concurrent chemoradiotherapy (CCRT). The experimental group was treated with rhSOD enema during CCRT, and the control group received no placebo enema. A colorectoscope was performed at baseline and within 3 months after finishing CCRT. The endoscopy appearance was assessed according to the Vienna Rectoscopy Score (VRS) and was compared using the Mann-Whitney U test. Ordered logistic regression analysis was performed to identify independent risk factors, including rhSOD enema, age, body mass index (BMI), Federation International of Gynecology and Obstetrics (FIGO) stage, and D2cc of the rectum.
Results: Five hundred and fifteen patients were enrolled and randomized to the experimental (n = 263) and control group (n = 255) after finishing the colorectoscope at baseline. There were no differences in the pre-treatment VRS grades of endoscopy between the two groups (P = 0.70). Two hundred and eighteen patients in the experimental group and two hundred one patients in the control group finished the post-treatment colorectoscope (completion rate 81%, P = 0.24). The post-treatment endoscopy showed that the VRS grades of RARI in the experimental group were lower than those in the control group (Grade N: 80.3% vs. 66.2%, Grade 0: 15.1% vs. 25.4%, Grade 1: 3.2% vs. 6.0%, Grade 2: 0.9% vs. 1.5%, P = 0.001). In ordered logistic regression, rhSOD enema was found to be the only factor associated with lower VRS grades (P = 0.002).
Conclusion: Using rhSOD enema in LACC patients who underwent CCRT was associated with lower VRS grades, indicating it could protect the rectal mucosa.