caa a22 4500 445333561 CHVBK 20180317142745.0 cr unu---uuuuu 170323e20110601xx s 000 0 eng 10.1245/s10434-011-1631-5 doi (NATIONALLICENCE)springer-10.1245/s10434-011-1631-5 Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Improves Survival of Patients with Peritoneal Carcinomatosis from Gastric Cancer: Final Results of a Phase III Randomized Clinical Trial [Elektronische Daten] [Xiao-Jun Yang, Chao-Qun Huang, Tao Suo, Lie-Jun Mei, Guo-Liang Yang, Fu-Lin Cheng, Yun-Feng Zhou, Bin Xiong, Yutaka Yonemura, Yan Li] Background: This randomized phase III study was to evaluate the efficacy and safety of cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) for the treatment of peritoneal carcinomatosis (PC) from gastric cancer. Methods: Sixty-eight gastric PC patients were randomized into CRS alone (n=34) or CRS+HIPEC (n=34) receiving cisplatin 120mg and mitomycin C 30mg each in 6000ml of normal saline at 43±0.5°C for 60-90min. The primary end point was overall survival, and the secondary end points were safety profiles. Results: Major clinicopathological characteristics were balanced between the 2 groups. The PC index was 2-36 (median 15) in the CRS+HIPEC and 3-23 (median 15) in the CRS groups (P=0.489). The completeness of CRS score (CC 0-1) was 58.8% (20 of 34) in the CRS and 58.8% (20 of 34) in the CRS+HIPEC groups (P=1.000). At a median follow-up of 32months (7.5-83.5months), death occurred in 33 of 34 (97.1%) cases in the CRS group and 29 of 34 (85.3%) cases of the CRS+HIPEC group. The median survival was 6.5months (95% confidence interval 4.8-8.2months) in CRS and 11.0months (95% confidence interval 10.0-11.9months) in the CRS+HIPEC groups (P=0.046). Four patients (11.7%) in the CRS group and 5 (14.7%) patients in the CRS+HIPEC group developed serious adverse events (P=0.839). Multivariate analysis found CRS+HIPEC, synchronous PC, CC 0-1, systemic chemotherapy≥6 cycles, and no serious adverse events were independent predictors for better survival. Conclusions: For synchronous gastric PC, CRS+HIPEC with mitomycin C 30mg and cisplatin 120mg may improve survival with acceptable morbidity. The Author(s), 2011 Yang Xiao-Jun Department of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China aut Huang Chao-Qun Department of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China aut Suo Tao Department of General Surgery, Zhongshan Hospital of Fudan University, Shanghai, China aut Mei Lie-Jun Department of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China aut Yang Guo-Liang Department of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China aut Cheng Fu-Lin Department of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China aut Zhou Yun-Feng Department of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China aut Xiong Bin Department of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China aut Yonemura Yutaka NPO Organization to Support Peritoneal Dissemination Treatment, Kishiwada, Osaka, Japan aut Li Yan Department of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China aut Annals of Surgical Oncology Springer-Verlag 18/6(2011-06-01), 1575-1581 1068-9265 18:6<1575 2011 18 10434 https://doi.org/10.1245/s10434-011-1631-5 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1245/s10434-011-1631-5 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Yang Xiao-Jun Department of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China aut NATIONALLICENCE 700 1- Huang Chao-Qun Department of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China aut NATIONALLICENCE 700 1- Suo Tao Department of General Surgery, Zhongshan Hospital of Fudan University, Shanghai, China aut NATIONALLICENCE 700 1- Mei Lie-Jun Department of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China aut NATIONALLICENCE 700 1- Yang Guo-Liang Department of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China aut NATIONALLICENCE 700 1- Cheng Fu-Lin Department of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China aut NATIONALLICENCE 700 1- Zhou Yun-Feng Department of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China aut NATIONALLICENCE 700 1- Xiong Bin Department of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China aut NATIONALLICENCE 700 1- Yonemura Yutaka NPO Organization to Support Peritoneal Dissemination Treatment, Kishiwada, Osaka, Japan aut NATIONALLICENCE 700 1- Li Yan Department of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China aut NATIONALLICENCE 773 0- Annals of Surgical Oncology Springer-Verlag 18/6(2011-06-01), 1575-1581 1068-9265 18:6<1575 2011 18 10434 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer