{"title":"一项随机、开放标签、非劣效性、3期、多中心、对照试验，比较腹腔镜手术与开放手术治疗有症状的、无法治愈的IV期结直肠癌（JCOG1107）。","authors":"Tomonori Akagi, Masafumi Inomata, Ryo Kanzaka, Hiroshi Katayama, Haruhiko Fukuda, Akio Shiomi, Masaaki Ito, Jun Watanabe, Kohei Murata, Yasumitsu Hirano, Manabu Shimomura, Shunsuke Tsukamoto, Tetsuya Hamaguchi, Seigo Kitano, Yukihide Kanemitsu","doi":"10.1097/AS9.0000000000000580","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To confirm noninferiority of laparoscopic (LAP) to open surgery (OP) for progression-free survival (PFS) of patients with non-curable stage IV colorectal cancer (CRC).</p><p><strong>Background: </strong>Benefits of LAP versus OP are suggested, but long-term survival following LAP for symptomatic, noncurable CRC remains unclear.</p><p><strong>Methods: </strong>In this open-label, multicenter, randomized controlled trial, only accredited surgeons from 42 Japanese institutions participated. Eligibility criteria included pathologically proven adenocarcinoma or adenosquamous carcinoma; primary tumor anywhere in the colon causing bowel stenosis and/or bleeding; and at least 1 to 3 noncurable factors. Patients received mFOLFOX6+bevacizumab or CapeOX+bevacizumab postoperatively and were randomly assigned 1:1 to the OP or LAP group. The primary endpoint was PFS, with noninferiority margin for the hazard ratio (HR) set at 1.38.</p><p><strong>Results: </strong>Between January 2013 and January 2021, 195 patients were randomized (OP, n = 95, LAP, n = 100). Ninety-two patients received OP and 98 LAP, with 82 OP and 86 LAP patients receiving postoperative chemotherapy. Median PFS was 9.7 months (95% CI = 8.7-11.3) for OP and 10.4 months (9.1-12.4) for LAP. Noninferiority of LAP was confirmed [HR = 1.02; 91.4% CI = 0.79-1.32 (<1.38), <i>P</i> for noninferiority = 0.021]. Median overall survival was 23.9 months (95% CI = 18.6-29.4) for OP and 25.4 months (19.4-29.0) for LAP (HR = 0.99; 95% CI, 0.72-1.36). In-hospital mortality was 1.1% (OP) and 0% (LAP). Postoperative complications (Grade 2-4) included ileus (OP = 12.0%; LAP = 5.1%), wound infection (OP = 2.2%; LAP = 2.0%), and anastomotic leakage (OP = 0%; LAP = 2.0%).</p><p><strong>Conclusions: </strong>LAP appears to be an acceptable standard treatment for symptomatic, noncurable stage IV CRC.</p><p><strong>Trial registration: </strong>UMIN-CTR, number UMIN000009715.</p>","PeriodicalId":72231,"journal":{"name":"Annals of surgery open : perspectives of surgical history, education, and clinical approaches","volume":"6 2","pages":"e580"},"PeriodicalIF":0.0000,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12185070/pdf/","citationCount":"0","resultStr":"{\"title\":\"A Randomized Open-Label, Noninferiority, Phase 3, Multicenter, Controlled Trial to Compare Laparoscopic Surgery With Open Surgery for Symptomatic, Noncurable Stage IV Colorectal Cancer (JCOG1107).\",\"authors\":\"Tomonori Akagi, Masafumi Inomata, Ryo Kanzaka, Hiroshi Katayama, Haruhiko Fukuda, Akio Shiomi, Masaaki Ito, Jun Watanabe, Kohei Murata, Yasumitsu Hirano, Manabu Shimomura, Shunsuke Tsukamoto, Tetsuya Hamaguchi, Seigo Kitano, Yukihide Kanemitsu\",\"doi\":\"10.1097/AS9.0000000000000580\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To confirm noninferiority of laparoscopic (LAP) to open surgery (OP) for progression-free survival (PFS) of patients with non-curable stage IV colorectal cancer (CRC).</p><p><strong>Background: </strong>Benefits of LAP versus OP are suggested, but long-term survival following LAP for symptomatic, noncurable CRC remains unclear.</p><p><strong>Methods: </strong>In this open-label, multicenter, randomized controlled trial, only accredited surgeons from 42 Japanese institutions participated. Eligibility criteria included pathologically proven adenocarcinoma or adenosquamous carcinoma; primary tumor anywhere in the colon causing bowel stenosis and/or bleeding; and at least 1 to 3 noncurable factors. Patients received mFOLFOX6+bevacizumab or CapeOX+bevacizumab postoperatively and were randomly assigned 1:1 to the OP or LAP group. The primary endpoint was PFS, with noninferiority margin for the hazard ratio (HR) set at 1.38.</p><p><strong>Results: </strong>Between January 2013 and January 2021, 195 patients were randomized (OP, n = 95, LAP, n = 100). Ninety-two patients received OP and 98 LAP, with 82 OP and 86 LAP patients receiving postoperative chemotherapy. Median PFS was 9.7 months (95% CI = 8.7-11.3) for OP and 10.4 months (9.1-12.4) for LAP. Noninferiority of LAP was confirmed [HR = 1.02; 91.4% CI = 0.79-1.32 (<1.38), <i>P</i> for noninferiority = 0.021]. Median overall survival was 23.9 months (95% CI = 18.6-29.4) for OP and 25.4 months (19.4-29.0) for LAP (HR = 0.99; 95% CI, 0.72-1.36). In-hospital mortality was 1.1% (OP) and 0% (LAP). Postoperative complications (Grade 2-4) included ileus (OP = 12.0%; LAP = 5.1%), wound infection (OP = 2.2%; LAP = 2.0%), and anastomotic leakage (OP = 0%; LAP = 2.0%).</p><p><strong>Conclusions: </strong>LAP appears to be an acceptable standard treatment for symptomatic, noncurable stage IV CRC.</p><p><strong>Trial registration: </strong>UMIN-CTR, number UMIN000009715.</p>\",\"PeriodicalId\":72231,\"journal\":{\"name\":\"Annals of surgery open : perspectives of surgical history, education, and clinical approaches\",\"volume\":\"6 2\",\"pages\":\"e580\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-06-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12185070/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of surgery open : perspectives of surgical history, education, and clinical approaches\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1097/AS9.0000000000000580\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/6/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of surgery open : perspectives of surgical history, education, and clinical approaches","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1097/AS9.0000000000000580","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/6/1 0:00:00","PubModel":"eCollection","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
目的：探讨腹腔镜手术（LAP）对IV期结直肠癌（CRC）患者无进展生存（PFS）的非低效性。背景：LAP相对于OP的益处已被提出，但对于有症状的、无法治愈的结直肠癌，LAP后的长期生存仍不清楚。方法：在这项开放标签、多中心、随机对照试验中，只有来自42家日本机构的经认证的外科医生参与。入选标准包括病理证实的腺癌或腺鳞癌；结肠任何部位的原发肿瘤，引起肠狭窄和/或出血；至少有1到3个不可治愈的因素。患者术后接受mFOLFOX6+贝伐单抗或CapeOX+贝伐单抗治疗，按1:1随机分为OP组或LAP组。主要终点为PFS，风险比（HR）的非劣效性边际为1.38。结果：2013年1月至2021年1月，195例患者随机入选（OP, n = 95， LAP, n = 100）。OP 92例，LAP 98例，OP 82例，LAP 86例，术后化疗。OP的中位PFS为9.7个月（95% CI = 8.7-11.3）， LAP为10.4个月（9.1-12.4）。证实LAP的非劣效性[HR = 1.02；91.4% CI = 0.79-1.32（非劣效性P = 0.021）。OP的中位总生存期为23.9个月（95% CI = 18.6-29.4）， LAP的中位总生存期为25.4个月（19.4-29.0）(HR = 0.99；95% ci, 0.72-1.36)。住院死亡率分别为1.1% （OP）和0% （LAP）。术后并发症（2-4级）包括肠梗阻(OP = 12.0%；LAP = 5.1%)，伤口感染(OP = 2.2%；LAP = 2.0%)，吻合口漏(OP = 0%；圈= 2.0%)。结论：LAP似乎是一种可接受的标准治疗有症状的，无法治愈的IV期结直肠癌。试验注册号：UMIN-CTR，编号：UMIN000009715。
A Randomized Open-Label, Noninferiority, Phase 3, Multicenter, Controlled Trial to Compare Laparoscopic Surgery With Open Surgery for Symptomatic, Noncurable Stage IV Colorectal Cancer (JCOG1107).
Objective: To confirm noninferiority of laparoscopic (LAP) to open surgery (OP) for progression-free survival (PFS) of patients with non-curable stage IV colorectal cancer (CRC).
Background: Benefits of LAP versus OP are suggested, but long-term survival following LAP for symptomatic, noncurable CRC remains unclear.
Methods: In this open-label, multicenter, randomized controlled trial, only accredited surgeons from 42 Japanese institutions participated. Eligibility criteria included pathologically proven adenocarcinoma or adenosquamous carcinoma; primary tumor anywhere in the colon causing bowel stenosis and/or bleeding; and at least 1 to 3 noncurable factors. Patients received mFOLFOX6+bevacizumab or CapeOX+bevacizumab postoperatively and were randomly assigned 1:1 to the OP or LAP group. The primary endpoint was PFS, with noninferiority margin for the hazard ratio (HR) set at 1.38.
Results: Between January 2013 and January 2021, 195 patients were randomized (OP, n = 95, LAP, n = 100). Ninety-two patients received OP and 98 LAP, with 82 OP and 86 LAP patients receiving postoperative chemotherapy. Median PFS was 9.7 months (95% CI = 8.7-11.3) for OP and 10.4 months (9.1-12.4) for LAP. Noninferiority of LAP was confirmed [HR = 1.02; 91.4% CI = 0.79-1.32 (<1.38), P for noninferiority = 0.021]. Median overall survival was 23.9 months (95% CI = 18.6-29.4) for OP and 25.4 months (19.4-29.0) for LAP (HR = 0.99; 95% CI, 0.72-1.36). In-hospital mortality was 1.1% (OP) and 0% (LAP). Postoperative complications (Grade 2-4) included ileus (OP = 12.0%; LAP = 5.1%), wound infection (OP = 2.2%; LAP = 2.0%), and anastomotic leakage (OP = 0%; LAP = 2.0%).
Conclusions: LAP appears to be an acceptable standard treatment for symptomatic, noncurable stage IV CRC.
Trial registration: UMIN-CTR, number UMIN000009715.
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