一项针对低危前列腺癌的前瞻性主动监测计划的中期和长期结果。
Intermediate and Longer-Term Outcomes From a Prospective Active-Surveillance Program for Favorable-Risk Prostate Cancer.
作者信息
Tosoian Jeffrey J, Mamawala Mufaddal, Epstein Jonathan I, Landis Patricia, Wolf Sacha, Trock Bruce J, Carter H Ballentine
机构信息
All authors: The Johns Hopkins University School of Medicine, The James Buchanan Brady Urological Institute, Johns Hopkins Hospital, Baltimore, MD.
出版信息
J Clin Oncol. 2015 Oct 20;33(30):3379-85. doi: 10.1200/JCO.2015.62.5764. Epub 2015 Aug 31.
PURPOSE
To assess long-term outcomes of men with favorable-risk prostate cancer in a prospective, active-surveillance program.
METHODS
Curative intervention was recommended for disease reclassification to higher cancer grade or volume on prostate biopsy. Primary outcomes were overall, cancer-specific, and metastasis-free survival. Secondary outcomes were the cumulative incidence of reclassification and curative intervention. Factors associated with grade reclassification and curative intervention were evaluated in a Cox proportional hazards model.
RESULTS
A total of 1,298 men (median age, 66 years) with a median follow-up of 5 years (range, 0.01 to 18.00 years) contributed 6,766 person-years of follow-up since 1995. Overall, cancer-specific, and metastasis-free survival rates were 93%, 99.9%, and 99.4%, respectively, at 10 years and 69%, 99.9%, and 99.4%, respectively, at 15 years. The cumulative incidence of grade reclassification was 26% at 10 years and was 31% at 15 years; cumulative incidence of curative intervention was 50% at 10 years and was 57% at 15 years. The median treatment-free survival was 8.5 years (range, 0.01 to 18 years). Factors associated with grade reclassification were older age (hazard ratio [HR], 1.03 for each additional year; 95% CI, 1.01 to 1.06), prostate-specific antigen density (HR, 1.21 per 0.1 unit increase; 95% CI, 1.12 to 1.46), and greater number of positive biopsy cores (HR, 1.47 for each additional positive core; 95% CI, 1.26 to 1.69). Factors associated with intervention were prostate-specific antigen density (HR, 1.38 per 0.1 unit increase; 95% CI, 1.22 to 1.56) and a greater number of positive biopsy cores (HR, 1.35 for one additional positive core; 95% CI, 1.19 to 1.53).
CONCLUSION
Men with favorable-risk prostate cancer should be informed of the low likelihood of harm from their diagnosis and should be encouraged to consider surveillance rather than curative intervention.
目的
在一项前瞻性主动监测项目中评估低危前列腺癌男性患者的长期预后。
方法
若前列腺活检显示疾病重新分类为更高的癌症分级或体积增大，则建议进行根治性干预。主要结局为总生存率、癌症特异性生存率和无转移生存率。次要结局为重新分类和根治性干预的累积发生率。在Cox比例风险模型中评估与分级重新分类和根治性干预相关的因素。
结果
自1995年以来，共有1298名男性（中位年龄66岁）参与研究，中位随访时间为5年（范围0.01至18.00年），累积随访人年数为6766人年。10年时的总生存率、癌症特异性生存率和无转移生存率分别为93%、99.9%和99.4%，15年时分别为69%、99.9%和99.4%。分级重新分类的累积发生率在10年时为26%，在15年时为31%；根治性干预的累积发生率在10年时为50%，在15年时为57%。中位无治疗生存期为8.5年（范围0.01至18年）。与分级重新分类相关的因素包括年龄较大（风险比[HR]，每增加一岁为1.03；95%置信区间[CI]，1.01至1.06）、前列腺特异性抗原密度（HR，每增加0.1单位为1.21；95%CI，1.12至1.46）以及活检阳性核心数量较多（HR，每增加一个阳性核心为1.47；95%CI，1.26至1.69）。与干预相关的因素包括前列腺特异性抗原密度（HR，每增加0.1单位为1.38；95%CI，1.22至1.56）和活检阳性核心数量较多（HR，每增加一个阳性核心为1.35；95%CI，1.19至1.53）。
结论
应告知低危前列腺癌男性患者，其诊断带来危害的可能性较低，并应鼓励他们考虑进行监测而非根治性干预。
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