Sheraz Markar, Christophe Mariette, Frank Bonnetain, Lars Lundell, Riccardo Rosati, Giovanni de Manzoni, Luigi Bonavina, Olga Tucker, Patrick Plum, Xavier Benoit D'Journo, Daniel Van Daele, Geoff Cogill, Stefano Santi, Leandres Farran, Vega Iranzo, Manuel Pera, Julie Veziant, Guillaume Piessen
{"title":"免疫营养提高手术前新辅助治疗（NEOIMMUNE）上消化道肿瘤患者生活质量：双盲随机对照多中心临床试验","authors":"Sheraz Markar, Christophe Mariette, Frank Bonnetain, Lars Lundell, Riccardo Rosati, Giovanni de Manzoni, Luigi Bonavina, Olga Tucker, Patrick Plum, Xavier Benoit D'Journo, Daniel Van Daele, Geoff Cogill, Stefano Santi, Leandres Farran, Vega Iranzo, Manuel Pera, Julie Veziant, Guillaume Piessen","doi":"10.1093/dote/doae113","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Malnutrition is common with esophagogastric cancers and is associated with negative outcomes. We aimed to evaluate if immunonutrition during neoadjuvant treatment improves patient's health-related quality of life (HRQOL) and reduces postoperative morbidity and toxicities during neoadjuvant treatment.</p><p><strong>Methods: </strong>A multicenter double-blind randomized controlled trial (RCT) was undertaken. Included patients had untreated nonmetastatic esophagogastric tumor, aged 18 ≥ years with a life expectancy of >3 months. The study was powered for 80% power to detect a clinically relevant difference in EORTC-QLQC30 with standard deviation of 15 between groups. Primary end point was the quality of life as measured by the global health status at 30 days after surgery. An intention-to-treat analysis was employed.</p><p><strong>Results: </strong>The study was terminated at the interim analysis stage. About 300 patients were randomized: 149 to the IMPACT group and 151 to the control-formula group. Patient groups were well-balanced in terms of age, sex, body mass index, WHO performance status, and clinical tumor stage. Analysis of the primary end point for the study of global health status at 30-day postoperatively failed to show any significant differences between the groups (55.4 ± 18.6 [IMPACT] vs. 55.9 ± 19.8 [control]; P = 0.345). No significant differences between the groups were detected in the majority of domains from EORTC QLQC30 and OG25 tools after neoadjuvant therapy and 30 days postoperatively. Finally, no significant differences were seen between groups in neoadjuvant therapy or postoperative complications, or tumor response.</p><p><strong>Conclusion: </strong>The results of this multicenter double-blind RCT fail to demonstrate any HRQOL benefits to the utilization of immunonutrition during neoadjuvant therapy in patients with esophagogastric cancer.</p>","PeriodicalId":54277,"journal":{"name":"Diseases of the Esophagus","volume":"38 1","pages":""},"PeriodicalIF":2.6000,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Immunonutrition to improve the quality of life of upper gastrointestinal cancer patients undergoing neoadjuvant treatment prior to surgery (NEOIMMUNE): double-blind randomized controlled multicenter clinical trial.\",\"authors\":\"Sheraz Markar, Christophe Mariette, Frank Bonnetain, Lars Lundell, Riccardo Rosati, Giovanni de Manzoni, Luigi Bonavina, Olga Tucker, Patrick Plum, Xavier Benoit D'Journo, Daniel Van Daele, Geoff Cogill, Stefano Santi, Leandres Farran, Vega Iranzo, Manuel Pera, Julie Veziant, Guillaume Piessen\",\"doi\":\"10.1093/dote/doae113\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Malnutrition is common with esophagogastric cancers and is associated with negative outcomes. We aimed to evaluate if immunonutrition during neoadjuvant treatment improves patient's health-related quality of life (HRQOL) and reduces postoperative morbidity and toxicities during neoadjuvant treatment.</p><p><strong>Methods: </strong>A multicenter double-blind randomized controlled trial (RCT) was undertaken. Included patients had untreated nonmetastatic esophagogastric tumor, aged 18 ≥ years with a life expectancy of >3 months. The study was powered for 80% power to detect a clinically relevant difference in EORTC-QLQC30 with standard deviation of 15 between groups. Primary end point was the quality of life as measured by the global health status at 30 days after surgery. An intention-to-treat analysis was employed.</p><p><strong>Results: </strong>The study was terminated at the interim analysis stage. About 300 patients were randomized: 149 to the IMPACT group and 151 to the control-formula group. Patient groups were well-balanced in terms of age, sex, body mass index, WHO performance status, and clinical tumor stage. Analysis of the primary end point for the study of global health status at 30-day postoperatively failed to show any significant differences between the groups (55.4 ± 18.6 [IMPACT] vs. 55.9 ± 19.8 [control]; P = 0.345). No significant differences between the groups were detected in the majority of domains from EORTC QLQC30 and OG25 tools after neoadjuvant therapy and 30 days postoperatively. Finally, no significant differences were seen between groups in neoadjuvant therapy or postoperative complications, or tumor response.</p><p><strong>Conclusion: </strong>The results of this multicenter double-blind RCT fail to demonstrate any HRQOL benefits to the utilization of immunonutrition during neoadjuvant therapy in patients with esophagogastric cancer.</p>\",\"PeriodicalId\":54277,\"journal\":{\"name\":\"Diseases of the Esophagus\",\"volume\":\"38 1\",\"pages\":\"\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2025-01-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Diseases of the Esophagus\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/dote/doae113\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diseases of the Esophagus","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/dote/doae113","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
背景：营养不良在食管胃癌中很常见，并与不良预后相关。我们的目的是评估新辅助治疗期间免疫营养是否能改善患者健康相关生活质量（HRQOL），并降低新辅助治疗期间的术后发病率和毒性。方法：采用多中心双盲随机对照试验（RCT）。纳入未经治疗的非转移性食管胃肿瘤患者，年龄≥18岁，预期寿命为30个月。本研究检测EORTC-QLQC30临床相关差异的功率为80%，组间标准差为15。主要终点是术后30天总体健康状况衡量的生活质量。采用意向治疗分析。结果：研究在中期分析阶段终止。约300例患者随机分为：IMPACT组149例，对照配方组151例。患者组在年龄、性别、体重指数、WHO表现状态和临床肿瘤分期等方面平衡良好。术后30天总体健康状况研究的主要终点分析未显示两组之间有任何显著差异(55.4±18.6 [IMPACT] vs. 55.9±19.8 [control]；p = 0.345)。在新辅助治疗后和术后30天，两组之间在EORTC、QLQC30和OG25工具的大多数域上没有发现显著差异。最后，两组在新辅助治疗、术后并发症或肿瘤反应方面没有显著差异。结论：这项多中心双盲随机对照试验的结果未能证明免疫营养在食管胃癌患者新辅助治疗期间的使用有任何HRQOL益处。
Immunonutrition to improve the quality of life of upper gastrointestinal cancer patients undergoing neoadjuvant treatment prior to surgery (NEOIMMUNE): double-blind randomized controlled multicenter clinical trial.
Background: Malnutrition is common with esophagogastric cancers and is associated with negative outcomes. We aimed to evaluate if immunonutrition during neoadjuvant treatment improves patient's health-related quality of life (HRQOL) and reduces postoperative morbidity and toxicities during neoadjuvant treatment.
Methods: A multicenter double-blind randomized controlled trial (RCT) was undertaken. Included patients had untreated nonmetastatic esophagogastric tumor, aged 18 ≥ years with a life expectancy of >3 months. The study was powered for 80% power to detect a clinically relevant difference in EORTC-QLQC30 with standard deviation of 15 between groups. Primary end point was the quality of life as measured by the global health status at 30 days after surgery. An intention-to-treat analysis was employed.
Results: The study was terminated at the interim analysis stage. About 300 patients were randomized: 149 to the IMPACT group and 151 to the control-formula group. Patient groups were well-balanced in terms of age, sex, body mass index, WHO performance status, and clinical tumor stage. Analysis of the primary end point for the study of global health status at 30-day postoperatively failed to show any significant differences between the groups (55.4 ± 18.6 [IMPACT] vs. 55.9 ± 19.8 [control]; P = 0.345). No significant differences between the groups were detected in the majority of domains from EORTC QLQC30 and OG25 tools after neoadjuvant therapy and 30 days postoperatively. Finally, no significant differences were seen between groups in neoadjuvant therapy or postoperative complications, or tumor response.
Conclusion: The results of this multicenter double-blind RCT fail to demonstrate any HRQOL benefits to the utilization of immunonutrition during neoadjuvant therapy in patients with esophagogastric cancer.
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