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选择经诊断患有前列腺癌的男性进行主动监测使用风险计算器:一项前瞻性影响研究。

Selecting men diagnosed with prostate cancer for active surveillance using a risk calculator: a prospective impact study.

机构信息

Department of Urology Public Health, Erasmus Medical Center, Rotterdam, Netherlands.

出版信息

BJU Int. 2012 Jul;110(2):180-7. doi: 10.1111/j.1464-410X.2011.10679.x. Epub 2011 Nov 23.

DOI:10.1111/j.1464-410X.2011.10679.x
PMID:22112199
Abstract

UNLABELLED

Study Type - Prognosis (cohort series). Level of Evidence 2a. What's known on the subject? and What does the study add? The present study is one of the first to investigate urologists' and patients' compliance with recommendations based on a risk calculator that calculates the probability of indolent prostate cancer. A threshold was set for a recommendation of active surveillance vs active treatment. Active surveillance recommendations based on a prostate cancer risk calculator were followed by most patients, but 30% with active treatment recommendations chose active surveillance instead. This indicates that the threshold may be too high for urologists and patients.

OBJECTIVES

• To assess urologists' and patients' compliance with treatment recommendations based on a prostate cancer risk calculator (RC) and the reasons for non-compliance. • To assess the difference between patients who were compliant and non-compliant with recommendations based on this RC.

PATIENTS AND METHODS

• Eight urologists from five Dutch hospitals included 240 patients with prostate cancer (PCa), aged 55-75 years, from December 2008 to February 2011. • The urologists used the European Randomized Study of Screening for Prostate Cancer RC which predicts the probability of potentially indolent PCa (P[indolent]), using serum prostate-specific antigen (PSA), prostate volume and pathological findings on biopsy. • Inclusion criteria were PSA <20 ng/mL, clinical stage T1 or T2a-c disease, <50% positive sextant biopsy cores, ≤ 20 mm cancer tissue, ≥ 40 mm benign tissue and Gleason ≤ 3 + 3. If the P(indolent) was >70%, active surveillance (AS) was recommended, and active treatment (AT) otherwise. • After the treatment decision, patients completed a questionnaire about their treatment choice, related (dis)advantages, and validated measurements of other factors, e.g. anxiety.

RESULTS

• Most patients (45/55, 82%) were compliant with an AS recommendation. Another 54 chose AS despite an AT recommendation (54/185, 29%). • The most common reason for non-compliance with AT recommendations by urologists was the patient's preference for AS (n= 30). These patients most often reported the delay of physical side effects of AT as the main advantage (n= 19). • Those who complied with AT recommendations had higher mean PSA levels (8 vs 7 ng/mL, P= 0.02), higher mean amount of cancer tissue (7 vs 3 mm, P < 0.001), lower mean P(indolent) (36% vs 55%, P < 0.001), and higher mean generic anxiety scores (42 vs 38, P= 0.03) than those who did not comply.

CONCLUSIONS

• AS recommendations were followed by most patients, while 29% with AT recommendations chose AS instead. • Although further research is needed to validate the RC threshold, the current version is already useful in treatment decision-making in men with localized PCa.

摘要

目的

评估泌尿科医生和患者对基于前列腺癌风险计算器(RC)的治疗建议的遵从性,以及不遵从的原因。评估基于此 RC 建议符合和不符合的患者之间的差异。

患者和方法

2008 年 12 月至 2011 年 2 月,来自荷兰五家医院的 8 位泌尿科医生纳入了 240 名年龄在 55-75 岁的前列腺癌(PCa)患者。泌尿科医生使用欧洲随机筛查前列腺癌研究 RC,该 RC 使用血清前列腺特异性抗原(PSA)、前列腺体积和前列腺活检的病理发现预测潜在惰性 PCa 的概率(P[indolent])。纳入标准为 PSA<20ng/mL、临床分期 T1 或 T2a-c 期、<50%阳性六分活检核心、≤20mm 癌组织、≥40mm 良性组织和 Gleason≤3+3。如果 P(indolent)>70%,则建议进行主动监测(AS),否则建议进行主动治疗(AT)。治疗决策后,患者完成了一份关于他们的治疗选择、相关(不利)因素以及其他因素(如焦虑)的验证性测量的问卷。

结果

大多数患者(45/55,82%)符合 AS 建议。另有 54 名患者尽管建议 AT,但仍选择 AS(54/185,29%)。泌尿科医生不建议 AT 建议的最常见原因是患者对 AS 的偏好(n=30)。这些患者最常报告的 AT 带来的主要优势是延迟出现身体副作用(n=19)。那些遵从 AT 建议的患者的平均 PSA 水平更高(8 与 7ng/mL,P=0.02)、平均癌组织量更大(7 与 3mm,P<0.001)、平均 P(indolent)更低(36%与 55%,P<0.001)和平均一般焦虑评分更高(42 与 38,P=0.03)。

结论

AS 建议被大多数患者遵循,而 29%的 AT 建议患者选择了 AS。虽然需要进一步研究来验证 RC 阈值,但目前的版本已经在局部 PCa 患者的治疗决策中有用。

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