George Washington University School of Medicine, 2300 I St NW, Washington, DC 20052.
George Washington University School of Medicine, 2300 I St NW, Washington, DC 20052.
Clin Genitourin Cancer. 2024 Jun;22(3):102092. doi: 10.1016/j.clgc.2024.102092. Epub 2024 Apr 9.
Concern for overtreatment in very low-, low-, and favorable intermediate-risk prostate cancer has promoted a more conservative approach through active surveillance (AS) with comparable survival outcomes. We analyzed the National Cancer Database (NCDB) to determine if delaying radical prostatectomy greater than 6 months is associated with an increase in the rate of adverse pathology or secondary treatment (adjuvant or salvage) at radical prostatectomy.
Utilizing the NCDB from 2004 to 2019, 40 to 75-year-old men with very low-, low-, and favorable-intermediate-risk prostate cancer, as defined by the National Comprehensive Cancer Network, were identified for this study. These individuals received radical prostatectomy either before or after 6 months following diagnosis. Clinical, demographic, and pathologic characteristics were obtained. Adverse pathologic outcomes were defined as pT3-4N0-1 and/or positive surgical margins. Multiple logistic regression models were used to predict delays in treatment, adverse pathologic outcomes, and receipt of secondary therapy. Survival analysis was performed using the Cox Proportional Hazards Model and the Kaplan-Meier Method.
Of the 195,397 patients who met inclusion criteria, only 13,393 patients received surgery 6 months after diagnosis. The median time of delay was 7.5 months compared to 2.3 months in the immediate treatment group. Overall, delaying surgery had no statistically significant impact on adverse pathologic outcomes, regardless of risk category. However, when accounting for the interaction between race and delayed treatment, non-Hispanic black patients who received a delay in treatment were more likely to experience adverse features (OR 1.12, 95%CI 1.00-1.26, P = .041). Conversely, patients who had delayed surgery were less likely to receive additional therapy (either adjuvant or salvage) (OR 0.60, 95%CI 0.52-0.68, P < .001). Survival analysis showed that both groups fared well, with a 5-year survival of 97% for both groups. The treatment group was not predictive of survival.
Overall, delaying surgery more than 6 months following diagnosis did not have a significant impact on adverse pathologic features or overall survival. However, when specifically looking at non-Hispanic black patients with a treatment delay, these patients were at increased risk for adverse features, suggesting that the negative impact of treatment delay depends on the patient's race. As race is a social construct, this finding likely points to the complex socioeconomic factors that contribute to overall health outcomes rather than any inherent disease characteristics. Lastly, delayed treatment patients were actually less likely to require secondary therapy, regardless of race, possibly reflecting high clinician acumen in selecting patients appropriate for treatment delay. The results suggest that patients who ultimately "fail" AS and require subsequent surgery have overall comparable survival outcomes. However, pathologic outcomes are dependent on the patient's underlying race, with non-Hispanic black patients experiencing an increased risk of adverse outcomes if treatment is delayed.
由于对极低危、低危和中危前列腺癌过度治疗的担忧,通过主动监测(AS)采用更保守的方法已取得与生存结局相当的效果。本研究旨在通过国家癌症数据库(NCDB)分析,明确诊断后延迟根治性前列腺切除术超过 6 个月是否与不良病理结果或辅助或挽救性治疗(adjuvant 或 salvage)的发生率增加有关。
本研究利用 NCDB 2004 年至 2019 年的数据,纳入符合美国国家综合癌症网络(National Comprehensive Cancer Network)定义的极、低危和中危前列腺癌患者,年龄 40 至 75 岁。这些患者在诊断后 6 个月内或 6 个月后接受根治性前列腺切除术。获取患者的临床、人口统计学和病理学特征。不良病理学结果定义为 pT3-4N0-1 和/或阳性切缘。采用多因素逻辑回归模型预测治疗延迟、不良病理结果和接受辅助或挽救性治疗。采用 Cox 比例风险模型和 Kaplan-Meier 方法进行生存分析。
在符合纳入标准的 195397 例患者中,仅有 13393 例患者在诊断后 6 个月内接受手术治疗。中位延迟时间为 7.5 个月,而即刻治疗组的中位延迟时间为 2.3 个月。总体而言,无论风险类别如何,延迟手术治疗与不良病理结果无统计学显著相关性。然而,当考虑种族和延迟治疗之间的交互作用时,接受延迟治疗的非西班牙裔黑人患者更可能出现不良特征(OR 1.12,95%CI 1.00-1.26,P =.041)。相反,接受延迟手术的患者接受辅助或挽救性治疗的可能性较低(OR 0.60,95%CI 0.52-0.68,P <.001)。生存分析显示两组患者预后良好,两组患者的 5 年生存率均为 97%。治疗组对生存无预测价值。
总体而言,诊断后延迟手术治疗超过 6 个月对不良病理特征或总体生存率无显著影响。然而,具体观察接受治疗延迟的非西班牙裔黑人患者时,这些患者出现不良特征的风险增加,表明治疗延迟的负面影响取决于患者的种族。由于种族是一种社会建构,这一发现可能指向导致整体健康结果的复杂社会经济因素,而不是任何固有疾病特征。最后,延迟治疗的患者实际上不太可能需要辅助治疗,无论种族如何,这可能反映了临床医生在选择适合延迟治疗的患者方面的高超能力。研究结果表明,最终“失败”AS 并需要后续手术的患者具有相当的总生存结局。然而,病理结局取决于患者的基础种族,非西班牙裔黑人患者如果治疗延迟则出现不良结局的风险增加。