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结肠癌开始治愈性治疗的时间与生存的关系:一项基于国家登记的观察性非劣效性研究。

Survival in relation to time to start of curative treatment of colon cancer: A national register-based observational noninferiority study.

机构信息

Department of Surgery, SSORG-Scandinavian Surgical Outcomes Research Group, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

Region Västra Götaland, Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.

出版信息

Colorectal Dis. 2023 Aug;25(8):1613-1621. doi: 10.1111/codi.16638. Epub 2023 Jun 14.

DOI:10.1111/codi.16638
PMID:37317006
Abstract

AIM

There are ample discussions regarding the timing of treatment, especially in the era after Covid that caused delay to treatment. The aim of this study was to determine whether a delayed start to curative treatment, within 29-56 days after a diagnosis of colon cancer, was noninferior to starting treatment within 28 days, with regard to all-cause mortality.

METHOD

This is a national register-based observational noninferiority study, with a noninferiority margin of hazard ratio (HR) 1.1, including all patients treated with curative intent for colon cancer in Sweden between 2008 and 2016. The primary outcome was all-cause mortality. Secondary outcomes were length of hospital stay, readmissions and reoperations within 1 year after surgery. Exclusion criteria were emergency surgery, disseminated disease at diagnosis, missing diagnosis date and treatment for another cancer 5 years before colon cancer diagnosis.

RESULTS

A total of 20 836 individuals were included. A period of 29-56 days from diagnosis to start of curative treatment was noninferior versus starting treatment within 28 days for the primary outcome of all-cause mortality (HR 0.95, 95% CI 0.89-1.00). Starting treatment within 29-56 days was associated with a shorter length of stay (average 9.2 vs. 10 days) but a higher risk of reoperation compared to within 28 days. Post hoc analyses demonstrated that surgical modality was driving survival rather than time to treatment. Overall survival was greater after laparoscopic surgery (HR 0.78, 95% CI 0.69-0.88).

CONCLUSION

For patients with colon cancer, a period of up to 56 days from diagnosis to the start of curative treatment did not lead to worse overall survival.

摘要

目的

关于治疗时机的讨论已经很多,尤其是在新冠疫情导致治疗延迟之后。本研究旨在确定在结肠癌诊断后 29-56 天开始根治性治疗是否不劣于在 28 天内开始治疗,从而降低全因死亡率。

方法

这是一项全国范围内基于登记的观察性非劣效性研究,非劣效性边界为风险比(HR)1.1,纳入了 2008 年至 2016 年期间在瑞典接受根治性治疗的所有结肠癌患者。主要结局为全因死亡率。次要结局为术后 1 年内的住院时间、再入院和再手术。排除标准为急诊手术、诊断时已扩散的疾病、缺失诊断日期和在结肠癌诊断前 5 年内治疗其他癌症。

结果

共纳入 20836 例患者。与诊断后 28 天内开始根治性治疗相比,诊断后 29-56 天开始治疗在全因死亡率的主要结局上不劣效(HR 0.95,95%CI 0.89-1.00)。在 29-56 天内开始治疗的患者住院时间更短(平均 9.2 天 vs. 10 天),但与 28 天内开始治疗相比,再手术的风险更高。事后分析表明,手术方式是影响生存率的因素,而不是治疗时间。与开腹手术相比,腹腔镜手术的总生存率更高(HR 0.78,95%CI 0.69-0.88)。

结论

对于结肠癌患者,诊断后至开始根治性治疗的时间不超过 56 天不会导致总体生存率降低。

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