{"title":"腹腔热化疗联合SOX化疗与单独SOX化疗治疗胃癌伴腹膜转移的II期随机临床试验","authors":"Lijie Luo, Zijing Zhang, Haiping Zeng, Yuting Xu, Yaohui Peng, Haipeng Huang, Zeyu Lin, Wenjun Xiong, Wei Wang","doi":"10.21037/jgo-24-807","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The prognosis of patients with gastric cancer with peritoneal metastasis (GCPM) is exceedingly poor. This study evaluated the efficacy and safety of hyperthermic intraperitoneal chemotherapy (HIPEC) with paclitaxel combined with S-1 and oxaliplatin (SOX) in the treatment of GCPM.</p><p><strong>Methods: </strong>Patients with pathologically confirmed primary gastric adenocarcinoma and laparoscopy-confirmed peritoneal metastasis were enrolled and randomized to receive either HIPEC plus SOX (HIPEC group) or SOX alone (SOX group). The primary endpoint was progression-free survival (PFS), and the secondary endpoints were 1-year survival rate, overall survival (OS), and safety.</p><p><strong>Results: </strong>Among the included patients, 30 were assigned to the HIPEC group and 29 to the SOX group. Compared to the HIPEC group, the SOX group had a significantly higher median PFS (SOX: median 8.5 months, IQR, 3.8-21.8 months; HIPEC: median 6.1 months, IQR, 3.3-10.8 months; P=0.004) and OS (SOX: median 13.0 months, IQR, 6.3-16.6 months; HIPEC: median 10.0 months, IQR, 5.2-24.0 months; P=0.02). The 1-year survival rate was 50.0% in the SOX group and 37.9% in HIPEC group, but the difference was not statistically significant. No serious adverse events related to the protocol treatment occurred in any patients.</p><p><strong>Conclusions: </strong>This trial failed to show the superiority of HIPEC with SOX over SOX alone. Further research into this regimen is needed.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03604614.</p>","PeriodicalId":15841,"journal":{"name":"Journal of gastrointestinal oncology","volume":"16 1","pages":"17-26"},"PeriodicalIF":2.0000,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11921333/pdf/","citationCount":"0","resultStr":"{\"title\":\"Hyperthermic intraperitoneal chemotherapy plus SOX chemotherapy versus SOX chemotherapy alone in patients with gastric cancer and peritoneal metastasis: a phase II randomized clinical trial.\",\"authors\":\"Lijie Luo, Zijing Zhang, Haiping Zeng, Yuting Xu, Yaohui Peng, Haipeng Huang, Zeyu Lin, Wenjun Xiong, Wei Wang\",\"doi\":\"10.21037/jgo-24-807\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The prognosis of patients with gastric cancer with peritoneal metastasis (GCPM) is exceedingly poor. This study evaluated the efficacy and safety of hyperthermic intraperitoneal chemotherapy (HIPEC) with paclitaxel combined with S-1 and oxaliplatin (SOX) in the treatment of GCPM.</p><p><strong>Methods: </strong>Patients with pathologically confirmed primary gastric adenocarcinoma and laparoscopy-confirmed peritoneal metastasis were enrolled and randomized to receive either HIPEC plus SOX (HIPEC group) or SOX alone (SOX group). The primary endpoint was progression-free survival (PFS), and the secondary endpoints were 1-year survival rate, overall survival (OS), and safety.</p><p><strong>Results: </strong>Among the included patients, 30 were assigned to the HIPEC group and 29 to the SOX group. Compared to the HIPEC group, the SOX group had a significantly higher median PFS (SOX: median 8.5 months, IQR, 3.8-21.8 months; HIPEC: median 6.1 months, IQR, 3.3-10.8 months; P=0.004) and OS (SOX: median 13.0 months, IQR, 6.3-16.6 months; HIPEC: median 10.0 months, IQR, 5.2-24.0 months; P=0.02). The 1-year survival rate was 50.0% in the SOX group and 37.9% in HIPEC group, but the difference was not statistically significant. No serious adverse events related to the protocol treatment occurred in any patients.</p><p><strong>Conclusions: </strong>This trial failed to show the superiority of HIPEC with SOX over SOX alone. Further research into this regimen is needed.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03604614.</p>\",\"PeriodicalId\":15841,\"journal\":{\"name\":\"Journal of gastrointestinal oncology\",\"volume\":\"16 1\",\"pages\":\"17-26\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2025-02-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11921333/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of gastrointestinal oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.21037/jgo-24-807\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/9 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of gastrointestinal oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.21037/jgo-24-807","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/9 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Hyperthermic intraperitoneal chemotherapy plus SOX chemotherapy versus SOX chemotherapy alone in patients with gastric cancer and peritoneal metastasis: a phase II randomized clinical trial.
Background: The prognosis of patients with gastric cancer with peritoneal metastasis (GCPM) is exceedingly poor. This study evaluated the efficacy and safety of hyperthermic intraperitoneal chemotherapy (HIPEC) with paclitaxel combined with S-1 and oxaliplatin (SOX) in the treatment of GCPM.
Methods: Patients with pathologically confirmed primary gastric adenocarcinoma and laparoscopy-confirmed peritoneal metastasis were enrolled and randomized to receive either HIPEC plus SOX (HIPEC group) or SOX alone (SOX group). The primary endpoint was progression-free survival (PFS), and the secondary endpoints were 1-year survival rate, overall survival (OS), and safety.
Results: Among the included patients, 30 were assigned to the HIPEC group and 29 to the SOX group. Compared to the HIPEC group, the SOX group had a significantly higher median PFS (SOX: median 8.5 months, IQR, 3.8-21.8 months; HIPEC: median 6.1 months, IQR, 3.3-10.8 months; P=0.004) and OS (SOX: median 13.0 months, IQR, 6.3-16.6 months; HIPEC: median 10.0 months, IQR, 5.2-24.0 months; P=0.02). The 1-year survival rate was 50.0% in the SOX group and 37.9% in HIPEC group, but the difference was not statistically significant. No serious adverse events related to the protocol treatment occurred in any patients.
Conclusions: This trial failed to show the superiority of HIPEC with SOX over SOX alone. Further research into this regimen is needed.
期刊介绍：
ournal of Gastrointestinal Oncology (Print ISSN 2078-6891; Online ISSN 2219-679X; J Gastrointest Oncol; JGO), the official journal of Society for Gastrointestinal Oncology (SGO), is an open-access, international peer-reviewed journal. It is published quarterly (Sep. 2010- Dec. 2013), bimonthly (Feb. 2014 -) and openly distributed worldwide.
JGO publishes manuscripts that focus on updated and practical information about diagnosis, prevention and clinical investigations of gastrointestinal cancer treatment. Specific areas of interest include, but not limited to, multimodality therapy, markers, imaging and tumor biology.
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