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临床局限性高危前列腺癌的手术延迟与病理结局。

Surgical Delay and Pathological Outcomes for Clinically Localized High-Risk Prostate Cancer.

机构信息

Division of Urology, Department of Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia.

Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia.

出版信息

JAMA Netw Open. 2020 Dec 1;3(12):e2028320. doi: 10.1001/jamanetworkopen.2020.28320.

DOI:10.1001/jamanetworkopen.2020.28320
PMID:33289846
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7724561/
Abstract

IMPORTANCE

There is a lack of data evaluating the association of surgical delay time (SDT) with outcomes in patients with localized, high-risk prostate cancer.

OBJECTIVE

To investigate the association of SDT of radical prostatectomy and final pathological and survival outcomes.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study used data from the US National Cancer Database (NCDB) and identified all patients with clinically localized (cT1-2cN0cM0) high-risk prostate adenocarcinoma diagnosed between 2006 and 2016 who underwent radical prostatectomy. Data analyses were performed from April 1 to April 12, 2020.

EXPOSURES

SDT was defined as the number of days between the initial cancer diagnosis and radical prostatectomy. SDT was categorized into 5 groups: 31 to 60, 61 to 90, 91 to 120, 121 to 150, and 151 to 180 days.

MAIN OUTCOMES AND MEASURES

The primary outcomes were predetermined as adverse pathological outcomes after radical prostatectomy, including pT3-T4 disease, pN-positive disease, and positive surgical margin. The adverse pathological score (APS) was defined as an accumulated score of the 3 outcomes (0-3). An APS of 2 or higher was considered a separate outcome to capture cases with more aggressive pathological features. The secondary outcome was overall survival.

RESULTS

Of the 32 184 patients included in the study, the median (interquartile range) age was 64 (59-68) years, and 25 548 (79.4%) were non-Hispanic White. Compared with an SDT of 31 to 60 days, longer SDTs were not associated with higher risks of having any adverse pathological outcomes (odds ratio [OR], 0.95; 95% CI, 0.80-1.12; P = .53), pT3-T4 disease (OR, 0.99; 95% CI, 0.83-1.17; P = .87), pN-positive disease (OR, 0.79; 95% CI, 0.59-1.06; P = .12), positive surgical margin (OR, 0.88; 95% CI, 0.74-1.05; P = .17), or APS greater than or equal to 2 (OR, 0.90; 95% CI, 0.74-1.05; P = .17). Longer SDT was also not associated with worse overall survival (for SDT of 151-180 days, hazard ratio, 1.12; 95% CI, 0.79-1.59, P = .53). Subgroup analyses performed for patients with very high-risk disease (primary Gleason score 5) and sensitivity analyses with SDT considered as a continuous variable yielded similar results.

CONCLUSIONS AND RELEVANCE

In this cohort study of patients who underwent radical prostatectomy within 180 days of diagnosis for high-risk prostate cancer, radical prostatectomy for high-risk prostate cancer could be safely delayed up to 6 months after diagnosis.

摘要

重要性

目前缺乏评估局部高危前列腺癌患者手术延迟时间(SDT)与结局之间关系的数据。

目的

研究根治性前列腺切除术的 SDT 与最终病理和生存结局之间的关联。

设计、设置和参与者:这项队列研究使用了美国国家癌症数据库(NCDB)的数据,纳入了 2006 年至 2016 年间诊断为临床局限性(cT1-2cN0cM0)高危前列腺腺癌并接受根治性前列腺切除术的所有患者。数据分析于 2020 年 4 月 1 日至 4 月 12 日进行。

暴露因素

SDT 定义为从最初癌症诊断到根治性前列腺切除术的天数。SDT 分为 5 组:31 至 60 天、61 至 90 天、91 至 120 天、121 至 150 天和 151 至 180 天。

主要结局和测量指标

主要结局是根治性前列腺切除术后预定的不良病理结局,包括 pT3-T4 疾病、pN 阳性疾病和阳性切缘。不良病理评分(APS)定义为 3 个结局(0-3)的累积评分。APS 为 2 或更高被认为是一个单独的结局,以捕获具有更具侵袭性病理特征的病例。次要结局是总生存。

结果

在纳入的 32184 例患者中,中位(四分位距)年龄为 64(59-68)岁,25548 例(79.4%)为非西班牙裔白人。与 SDT 为 31 至 60 天相比,较长的 SDT 与更高的发生任何不良病理结局的风险无关(比值比 [OR],0.95;95%置信区间 [CI],0.80-1.12;P=0.53)、pT3-T4 疾病(OR,0.99;95%CI,0.83-1.17;P=0.87)、pN 阳性疾病(OR,0.79;95%CI,0.59-1.06;P=0.12)、阳性切缘(OR,0.88;95%CI,0.74-1.05;P=0.17)或 APS 大于或等于 2(OR,0.90;95%CI,0.74-1.05;P=0.17)。较长的 SDT 也与总生存较差无关(SDT 为 151-180 天时,风险比为 1.12;95%CI,0.79-1.59,P=0.53)。对极高危疾病(主要 Gleason 评分 5)患者进行的亚组分析和将 SDT 视为连续变量进行的敏感性分析得出了类似的结果。

结论和相关性

在这项对高危前列腺癌患者在诊断后 180 天内接受根治性前列腺切除术的队列研究中,高危前列腺癌的根治性前列腺切除术可以在诊断后安全地延迟 6 个月。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f34/7724561/d524a3d770fa/jamanetwopen-e2028320-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f34/7724561/83037ad89dc7/jamanetwopen-e2028320-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f34/7724561/0cca99d9f19e/jamanetwopen-e2028320-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f34/7724561/d524a3d770fa/jamanetwopen-e2028320-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f34/7724561/83037ad89dc7/jamanetwopen-e2028320-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f34/7724561/0cca99d9f19e/jamanetwopen-e2028320-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f34/7724561/d524a3d770fa/jamanetwopen-e2028320-g003.jpg

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