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术后并发症对结直肠癌生存及复发的影响:来自三项大型III期随机试验的个体患者汇总数据分析

Impact of postoperative complications on the colorectal cancer survival and recurrence: analyses of pooled individual patients' data from three large phase III randomized trials.

作者信息

Aoyama Toru, Oba Koji, Honda Michitaka, Sadahiro Sotaro, Hamada Chikuma, Mayanagi Shuhei, Kanda Mitsuro, Maeda Hiromichi, Kashiwabara Kosuke, Sakamoto Junichi, Saji Shigetoyo, Yoshikawa Takaki

机构信息

Department of Surgery, Yokohama City University, Yokohama, Japan.

Department of Biostatistics, The University of Tokyo, Tokyo, Japan.

出版信息

Cancer Med. 2017 Jul;6(7):1573-1580. doi: 10.1002/cam4.1126. Epub 2017 Jun 22.

Abstract

This study assessed the impact of postoperative complications on the colorectal cancer survival and recurrence after curative surgery using pooled individual patients' data from three large phase III randomized trials. In total, 5530 patients were included in this study. The patients were classified as those with postoperative complications (C group) and those without postoperative complications (NC group). The risk factors for the overall survival (OS) and the disease-free survival (DFS) were analyzed. Postoperative complications were found in 861 (15.6%) of the 5530 patients. The OS and DFS rates at 5 years after surgery were 68.9% and 74.8%, respectively, in the C group and 75.8% and 82.2%, respectively, in the NC group, values that were significantly different between the two groups (P < 0.001). The multivariate analysis demonstrated that postoperative complications were a significant independent risk factor for the OS and DFS. Postoperative complications can worsen the colorectal cancer survival and risk of recurrence. Surgical morbidity must be considered as a stratification factor in future phase III trials evaluating the effects of adjuvant chemotherapy on colorectal cancer.

摘要

本研究使用来自三项大型III期随机试验的汇总个体患者数据,评估了术后并发症对根治性手术后结直肠癌生存及复发的影响。本研究共纳入5530例患者。这些患者被分为有术后并发症的患者(C组)和无术后并发症的患者(NC组)。分析了总生存(OS)和无病生存(DFS)的危险因素。5530例患者中有861例(15.6%)出现术后并发症。C组术后5年的OS率和DFS率分别为68.9%和74.8%,NC组分别为75.8%和82.2%,两组间差异有统计学意义(P<0.001)。多因素分析表明,术后并发症是OS和DFS的显著独立危险因素。术后并发症会使结直肠癌的生存及复发风险恶化。在未来评估辅助化疗对结直肠癌疗效的III期试验中,手术并发症必须被视为一个分层因素。

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