Ramos C G, Carvalhal G F, Smith D S, Mager D E, Catalona W J
Department of Surgery, Washington University School of Medicine, St. Louis, Missouri, USA.
J Urol. 1999 Apr;161(4):1212-5.
Favorable results with 125iodine (I) brachytherapy have been reported in select patients with localized prostate cancer. We evaluate the results of radical prostatectomy in patients matched for similar pretreatment clinicopathological characteristics.
From May 1983 to April 1998, 1 surgeon (W. J. C.) performed radical retropubic prostatectomy in 1,952 men (mean age plus or minus standard deviation 63+/-7 years), of whom 1,364 had Gleason score 6 or less on preoperative needle biopsy, a preoperative serum prostate specific antigen (PSA) value available and clinical stage T1 or T2 disease. We categorized all patients by preoperative Gleason score, preoperative PSA and clinical stage. For each Gleason score-by-PSA stratum we randomly selected by computer the number of men necessary to achieve the same overall distribution of clinical characteristics as in a series of patients treated with brachytherapy. All men were followed with semiannual PSA measurements and annual digital rectal examinations. Serum PSA greater than 0.3 ng/ml was considered evidence of cancer recurrence. Simple univariate statistics were used to compare clinical characteristics between series, and 7-year recurrence-free survival was estimated using Kaplan-Meier product limit estimates. To avoid a possible chance extreme result from 1 random sample we estimated 7-year recurrence-free survival in 5 computer selected random samples of our population.
Mean 7-year recurrence-free survival was 84% (95% confidence intervals 78 to 89) for the radical prostatectomy series compared to 79% (confidence intervals not provided) for the 125I brachytherapy series.
Radical prostatectomy yielded a proportionately but not statistically significant higher 7-year probability of nonprogression than 125I brachytherapy in patients with favorable clinicopathological characteristics. Comparisons are confounded by residual differences in clinicopathological features of tumors between groups and different treatment end points to determine outcomes. Further prospective, randomized clinical trials are required for valid comparisons.
有报道称，125碘（I）近距离放射治疗对部分局限性前列腺癌患者取得了良好效果。我们评估了具有相似治疗前临床病理特征的患者行根治性前列腺切除术的结果。
1983年5月至1998年4月，1名外科医生（W.J.C.）对1952名男性患者（平均年龄±标准差63±7岁）实施了耻骨后根治性前列腺切除术，其中1364例患者术前穿刺活检Gleason评分≤6分，有术前血清前列腺特异性抗原（PSA）值且临床分期为T1或T2期疾病。我们根据术前Gleason评分、术前PSA和临床分期对所有患者进行分类。对于每个Gleason评分-PSA分层，我们通过计算机随机选择必要数量的男性，以使其临床特征的总体分布与一系列接受近距离放射治疗的患者相同。所有男性均接受半年一次的PSA检测和每年一次的直肠指检。血清PSA大于0.3 ng/ml被视为癌症复发的证据。采用简单单变量统计方法比较各系列之间的临床特征，并使用Kaplan-Meier乘积限估计法估计7年无复发生存率。为避免1个随机样本可能出现的极端结果，我们在计算机选择的5个随机样本中估计了总体人群的7年无复发生存率。
根治性前列腺切除术系列的平均7年无复发生存率为84%（95%置信区间78至89），而125I近距离放射治疗系列为79%（未提供置信区间）。
在具有良好临床病理特征的患者中，根治性前列腺切除术的7年无进展概率比125I近距离放射治疗略高，但无统计学意义。由于两组肿瘤临床病理特征的残留差异以及用于确定结局的不同治疗终点，比较结果受到混淆。需要进一步开展前瞻性随机临床试验以进行有效比较。
