TOOKAD® Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of localized prostate cancer.
TOOKAD® Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of localized prostate cancer.
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Takad®可溶性局灶性治疗：三项II期研究的合并分析，评估了局部前列腺癌的最低侵入性消融。
DOI：
10.1007/s00345-015-1505-8
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发表时间：
2015-07
影响因子：
3.4
通讯作者：
Emberton, M.
中科院分区：
文献类型：
--
作者：
Azzouzi, A. R.;Barret, E.;Bennet, J.;Moore, C.;Taneja, S.;Muir, G.;Villers, A.;Coleman, J.;Allen, C.;Scherz, A.;Emberton, M.
关键词：
评价TOOKAD® Soluble在局限性前列腺癌（LPCa）患者中进行局灶性血管靶向光动力治疗（VTP）时推荐药物和光剂量的6个月效果。我们对来自3项研究的117名患有LPCa、PSA <10 ng/mL且Gleason评分≤7（3 + 4）的男性进行了汇总分析，这些男性接受了10分钟单次静脉输注4 mg/kg TOOKAD® Soluble，在经直肠超声引导下，通过经会阴纤维在前列腺中以200 J/cm的753 nm光激活。主要终点是经治疗肺叶6个月的阴性活检。在第1、3和6个月测量PSA。在第7天、第3个月和第6个月进行磁共振成像。在第7天、第1、3和6个月报告国际前列腺症状评分（IPSS）、国际勃起功能指数（IIEF-5）和不良事件。总体可评价人群（N = 114）的第6个月阴性活检率为68.4%，接受半消融治疗且光密度指数（LDI）≥ 1的患者（N = 67）为80.6%。第-1周的平均前列腺坏死率分别为76.5%和86.3%。在两组中，第6个月的PSA水平均降低了2.0 ng/mL。IPSS和IIEF-5较基线的微小变化表明，尿功能略有改善，性功能略有恶化。使用4 mg/kg和200 J/cm的TOOKAD® Soluble进行局灶性VTP治疗后，整个人群的6个月活检阴性率为68.4%，而接受半消融治疗且LDI ≥ 1的患者的6个月活检阴性率为80.6%。治疗耐受性良好。两项III期研究将于2015年初完成。
To evaluate the 6-month effects of the recommended drug and light dosage in focal vascular-targeted photodynamic therapy (VTP) using TOOKAD® Soluble in patients with localized prostate cancer (LPCa). We performed a pooled analysis of 117 men with LPCa, PSA <10 ng/mL, and Gleason score ≤7 (3 + 4), from 3 studies who received a 10-min intravenous infusion of a single dose of 4 mg/kg TOOKAD® Soluble, activated by a 753-nm light at 200 J/cm delivered in the prostate by transperineal fibres under transrectal ultrasound guidance. Primary endpoint was 6-month negative biopsies in the treated lobe(s). PSA was measured at month 1, 3, and 6. Magnetic resonance imaging was performed at day 7, month 3, and 6. International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF-5) and adverse events were reported at day 7, month 1, 3, and 6. Month 6 negative biopsy rate was 68.4 % in the overall evaluable population (N = 114) and 80.6 % for patients treated by hemiablation with light density index (LDI) ≥ 1 (N = 67). Mean prostate necroses at week-1 were 76.5 and 86.3 %, respectively. In both groups, PSA levels at month 6 decreased by 2.0 ng/mL. Small changes from baseline for IPSS and IIEF-5 indicated a slight improvement in urinary function and a slight deterioration in sexual function. Focal VTP treatment with TOOKAD® Soluble at 4 mg/kg and 200 J/cm resulted in a negative 6-month biopsy rate of 68.4 % for the whole population and 80.6 % for patients treated by hemiablation with LDI ≥ 1. The treatment was well tolerated. Two phase III studies will reach completion in early 2015.
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DOI：
10.1056/nejmoa1209978
发表时间：
2013-01-31
期刊：
The New England journal of medicine
影响因子：
--
作者：
Resnick MJ;Koyama T;Fan KH;Albertsen PC;Goodman M;Hamilton AS;Hoffman RM;Potosky AL;Stanford JL;Stroup AM;Van Horn RL;Penson DF
通讯作者：
Penson DF
DOI：
10.1056/nejmoa1113162
发表时间：
2012-07-19
期刊：
The New England journal of medicine
影响因子：
--
作者：
Wilt TJ;Brawer MK;Jones KM;Barry MJ;Aronson WJ;Fox S;Gingrich JR;Wei JT;Gilhooly P;Grob BM;Nsouli I;Iyer P;Cartagena R;Snider G;Roehrborn C;Sharifi R;Blank W;Pandya P;Andriole GL;Culkin D;Wheeler T;Prostate Cancer Intervention versus Observation Trial (PIVOT) Study Group
通讯作者：
Prostate Cancer Intervention versus Observation Trial (PIVOT) Study Group
影响因子：
4.5
作者：
Azzouzi, Abdel-Rahmene;Barret, Eric;Emberton, Mark
通讯作者：
Emberton, Mark
影响因子：
3.3
作者：
Mazor, O;Brandis, A;Scherz, A
通讯作者：
Scherz, A
影响因子：
2.6
作者：
Klotz, Laurence
通讯作者：
Klotz, Laurence