Department of Urology and Andrology, CHU Reims, France.
BJU Int. 2011 Jun;107(12):1899-905. doi: 10.1111/j.1464-410X.2010.09710.x. Epub 2010 Nov 17.
• To determine oncological outcomes after high-intensity focused ultrasonography (HIFU) treatment in patients with localized prostate cancer using a new, more accurate, definition ('Stuttgart' definition) of biochemical failure.
• We performed a retrospective review of all patients in our centre who received first-line treatment with a second-generation Ablatherm™ device (EDAP-TMS, Lyon, France). • Oncological failure was given either by biochemical failure (prostate-specific antigen, PSA, nadir plus 1.2 g/mL) (Stuttgart definition) or the start of salvage therapy because of a persistently positive biopsy after the HIFU procedure. • The 5-year biochemical-free survival rate and 5-year disease-free survival rate were calculated.
• In total, 53 patients were included (mean age, 72.5 ± 4.5 years, range 60-79 years; 28 low risk and 25 intermediate risk). None had undergone previous hormonal therapy. Mean ±sd follow-up was 45.4 ± 15.5 months (range 16-71 years). Mean (range) pre-treatment PSA was 8.5 ± 4 (0.29-18) ng/mL. The median (range) PSA nadir value was 1 (0.01-14) ng/mL and occurred after a mean (range) of 5.09 (3-24) months. • Overall, 36 patients (67.9%) experienced oncological failure. • These included 33 cases (62.2%) of biochemical failure. A PSA nadir of ≤0.2, 0.21-1.0 and >1 ng/mL was reached in 20.8%, 30.2% and 49% of patients, respectively, and was associated with biochemical failure in 9.1%, 30.3% and 60.6%, respectively. • The 5-year biochemical-free survival rate and disease-free survival rate were 21.7% and 13.5%, respectively. In multivariate analysis, a PSA nadir of >1 ng/mL was significantly associated with a risk of biochemical and oncological failure (P= 0.002 and P < 0.001). • Oncological failure was not associated with any risk group. • No patient died from prostate cancer.
• In our experience, Ablatherm™ treatment for clinically localized prostate cancer was associated with a high rate of biochemical failure as determined by the 'Stuttgart' definition, and did not achieve effective cancer control. • The PSA nadir value after HIFU treatment was a significant predictor of treatment failure.
使用新的、更准确的生化失败定义（“斯图加特”定义）来确定局部前列腺癌患者高强度聚焦超声（HIFU）治疗后的肿瘤学结果。
我们对在我们中心接受第二代 Ablatherm 设备（EDAP-TMS，法国里昂）一线治疗的所有患者进行了回顾性分析。肿瘤学失败的定义为生化失败（前列腺特异性抗原，PSA，最低点加 1.2 g/mL）（斯图加特定义）或由于 HIFU 手术后活检持续阳性而开始挽救性治疗。计算了 5 年无生化生存率和 5 年无病生存率。
共纳入 53 例患者（平均年龄 72.5±4.5 岁，范围 60-79 岁；低危 28 例，中危 25 例）。无患者接受过激素治疗。平均随访时间为 45.4±15.5 个月（范围 16-71 年）。治疗前 PSA 的平均值±标准差为 8.5±4（0.29-18）ng/mL。中位（范围）PSA 最低点值为 1（0.01-14）ng/mL，平均发生时间为 5.09（3-24）个月。总体而言，36 例患者（67.9%）发生了肿瘤学失败。这些包括 33 例（62.2%）生化失败。20.8%、30.2%和 49%的患者 PSA 最低点分别为≤0.2、0.21-1.0 和>1ng/mL，分别有 9.1%、30.3%和 60.6%的患者出现生化失败。5 年无生化生存率和无病生存率分别为 21.7%和 13.5%。多变量分析显示，PSA 最低点>1ng/mL 与生化和肿瘤学失败的风险显著相关（P=0.002 和 P<0.001）。肿瘤学失败与任何风险组无关。无患者死于前列腺癌。
在我们的经验中，Ablatherm 治疗临床局限性前列腺癌与“斯图加特”定义所确定的高生化失败率相关，并未实现有效的癌症控制。HIFU 治疗后 PSA 最低点是治疗失败的重要预测因素。
