Safety of intraoperative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection: a randomized, multicenter, prospective, phase III IOCCRC trial (IOCCRC)
Safety of intraoperative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection: a randomized, multicenter, prospective, phase III IOCCRC trial (IOCCRC)
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DOI：
10.1007/s00432-017-2489-0
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发表时间：
2017-12-01
影响因子：
3.6
通讯作者：
Pan, Zhi-zhong
中科院分区：
文献类型：
--
作者：
Zhang, Rong-xin;Lin, Jun-zhong;Pan, Zhi-zhong
结直肠癌术中化疗的安全性和有效性尚未得到广泛研究。本随机对照试验旨在比较术中化疗联合手术切除与单纯传统手术切除的安全性和有效性。 2011年1月至2016年1月，共纳入696例结直肠癌患者：其中341例患者被随机分配至术中化疗（包括门静脉化疗、腔内化疗和腹腔化疗加手术组），而344例患者被随机分配至对照组单纯手术治疗。 11名患者退出同意。术中化疗并未增加手术并发症的发生率，也没有观察到严重的化疗相关副作用。术中化疗组和对照组各有 4 例患者出现吻合口瘘并接受了第二次手术（1.2% vs. 1.2%，P = 0.99）。化疗组术后90天内无死亡病例，而对照组有1例患者死亡。术中化疗并没有降低术中组和对照组接受术后化疗的患者比例（29.3% vs. 30.2%，P = 0.795）。术中化疗可以在结直肠手术期间安全进行；然而，为了更好地评估其疗效，有必要进行随访。ClinicalTrial.gov 注册号：NCT01465451。
The safety and efficacy of intraoperative chemotherapy in colorectal cancer have not yet been extensively investigated. This randomized control trial was designed to compare the safety and efficacy of intraoperative chemotherapy in combination with surgical resection to those of traditional surgical resection alone.From January 2011 to January 2016, 696 colorectal cancer patients were enrolled in this study: 341 patients were randomly assigned to the intraoperative chemotherapy, which consist of portal vein chemotherapy, intraluminal chemotherapy and intraperitoneal chemotherapy, plus surgery group, whereas 344 patients were randomized to the control group to undergo surgery alone. Eleven patients withdrew consent.Intraoperative chemotherapy did not increase the rate of surgical complications, and no severe chemotherapy-associated side effects were observed. Four patients in each of the intraoperative chemotherapy and the control groups experienced anastomotic leakage and underwent a second operation (1.2 vs. 1.2%, P = 0.99). There were no deaths within 90 days after surgery in the chemotherapy group, whereas one patient died in the control group. Intraoperative chemotherapy did not decrease the rate of patients who received postoperative chemotherapy between the intraoperative group and control group (29.3 vs. 30.2%, P = 0.795).Intraoperative chemotherapy can be safely performed during colorectal surgery; however, follow-up is necessary for a better assessment of its efficacy.ClinicalTrial.gov Register Number: NCT01465451.