Feasibility study: Watchful waiting for localized low to intermediate grade prostate carcinoma with selective delayed intervention based on prostate specific antigen, histological and/or clinical progression
Feasibility study: Watchful waiting for localized low to intermediate grade prostate carcinoma with selective delayed intervention based on prostate specific antigen, histological and/or clinical progression
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DOI：
10.1016/s0022-5347(05)65174-9
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发表时间：
2002-04-01
影响因子：
6.6
通讯作者：
Hruby, G
中科院分区：
文献类型：
--
作者：
Choo, R;Klotz, L;Hruby, G
目的：评价临床、前列腺特异性抗原(PSA)或组织学进展作为临床局限性前列腺癌治疗指征的选择性延迟介入的观望等待方案的可行性。材料与方法：在这项前瞻性的单臂队列研究中，临床参数有利(T1b至T2b NOMO，Gleason评分7或以下，PSA 15 ng/ml或以下)的患者接受保守治疗。当患者达到疾病进展标准，由重复前列腺活检的PSA增加率、临床进展或组织学升级三个参数任意定义时，实施适当的治疗。头两年每3个月随访一次，此后每6个月随访一次。每次就诊时进行血清PSA测定和直肠指检，并在研究登记后18个月再次进行前列腺活检。结果：自1995年11月以来，本研究共获得206例患者，中位随访时间为29个月(2~66个月)。在这些男性中，137人仍在接受监测方案，没有疾病进展，69人因各种原因退出研究。临床进展16例，PSA进展15例，组织学进展5例。2年和4年继续接受监测方案的精算概率估计分别为67%和48%，2年和4年保持无进展的概率分别为81%和67%。结论：根据疾病进展的预定义标准，选择性延迟干预的警惕等待策略是可行的。这一策略提供了基于临床或生化随时间进展的风险的个体化方法的好处，因此，它可以减轻惰性疾病患者的治疗负担，同时为那些生物活性疾病患者提供明确的治疗。
Purpose: We assessed the feasibility of a watchful waiting protocol with selective delayed intervention using clinical, prostate specific antigen (PSA) or histological progression as treatment indications for clinically localized prostate cancer.Materials and Methods: In this prospective, single arm cohort study patients with favorable clinical parameters (stage T1b to T2b NOMO, Gleason score 7 or less and PSA 15 ng./ml. or less) are conservatively treated with watchful waiting. When a patient meets disease progression criteria, arbitrarily defined by the 3 parameters of the rate of PSA increase, clinical progression or histological upgrade on repeat prostate biopsy, appropriate treatment is implemented. Patients are followed every 3 months for the first 2 years and every 6 months thereafter. Serum PSA measurement and digital rectal examination are done at each visit and repeat prostate biopsy is performed 18 months after study enrollment.Results: Since November 1995, the study has accrued 206 patients with a median followup of 29 months (range 2 to 66). Of these men 137 remain on the surveillance protocol with no disease progression, while 69 were withdrawn from study for various reasons. There was clinical, PSA and histological progression in 16, 15 and 5 cases, respectively. The estimated actuarial probability of remaining on the surveillance protocol was 67% at 2 years and 48% at 4. The probability of remaining progression-free was 81% and 67% at 2 and 4 years, respectively.Conclusions: A policy of watchful waiting with selectively delayed intervention based on predefined criteria of disease progression is feasible. This strategy offers the benefit of an individualized approach based on the demonstrated risk of clinical or biochemical progression with time and, thus, it may decrease the burden of therapy in patients with indolent disease, while providing definitive therapy for those with biologically active disease.