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前瞻性剂量递增 II 期试验的长期结果:间质脉冲剂量率近距离放疗作为中高危前列腺癌的增敏剂。

Long term results of a prospective dose escalation phase-II trial: interstitial pulsed-dose-rate brachytherapy as boost for intermediate- and high-risk prostate cancer.

机构信息

University Hospital Erlangen, Germany.

出版信息

Radiother Oncol. 2012 Aug;104(2):181-6. doi: 10.1016/j.radonc.2012.07.003. Epub 2012 Jul 30.

Abstract

PURPOSE

We reviewed our seven year single institution experience with pulsed dose rate brachytherapy dose escalation study in patients with intermediate and high risk prostate cancer.

MATERIALS AND METHODS

We treated a total of 130 patients for intermediate and high risk prostate cancer at our institution between 2000 and 2007 using PDR-brachytherapy as a boost after conformal external beam radiation therapy to 50.4 Gy. The majority of patients had T2 disease (T1c 6%, T2 75%, T3 19%). Seventy three patients had intermediate-risk and 53 patients had high-risk disease according to the D'Amico classification. The dose of the brachytherapy boost was escalated from 25 to 35 Gy - 33 pts. received 25 Gy (total dose 75 Gy), 63 pts. 30 Gy (total dose 80 Gy) and 34 pts. 35 Gy, (total dose 85 Gy) given in one session (dose per pulse was 0.60 Gy or 0.70 Gy/h, 24h per day, night and day, with a time interval of 1h between two pulses). PSA-recurrence-free survival according to Kaplan-Meier using the Phoenix definition of biochemical failure was calculated and also late toxicities according to Common Toxicity Criteria scale were assessed.

RESULTS

At the time of analysis with a median follow-up of 60 months biochemical control was achieved by 88% of patients - only 16/130 patients (12.3%) developed a biochemical relapse. Biochemical relapse free survival calculated according to Kaplan-Meier for all patients at 5 years was 85.6% (83.9% for intermediate-risk patients and 84.2% for high-risk patients) and at 9 years' follow up it was 79.0%. Analysing biochemical relapse free survival separately for different boost dose levels, at 5 years it was 97% for the 35 Gy boost dose and 82% for the 25 and 30 Gy dose levels. The side effects of therapy were negligible: There were 18 cases (15%) of grade 1/2 rectal proctitis, one case (0.8%) of grade 3 proctitis, 18 cases (15%) of grade 1/2 cystitis, and no cases (0%) with dysuria grade 3. No patient had a bulbourethral stricture requiring dilation or new onset incontinence.

CONCLUSIONS

Image-guided conformal PDR-brachytherapy using up to 35 Gy as boost dose after 50 Gy of external beam radiation therapy (total dose up to 85 Gy) is a very effective treatment option with very low morbidity in patients with intermediate or high risk prostate cancer. Further dose escalation seems possible.

摘要

目的

我们回顾了我们机构在过去 7 年中对中高危前列腺癌患者进行脉冲剂量率近距离放疗剂量递增研究的经验。

材料和方法

我们于 2000 年至 2007 年间,在我们的机构中使用 PDR 近距离放疗对 130 例中高危前列腺癌患者进行治疗,作为外照射 50.4Gy 后的强化治疗。大多数患者患有 T2 疾病(T1c 占 6%,T2 占 75%,T3 占 19%)。根据 D'Amico 分类,73 例患者为中危,53 例患者为高危。近距离放疗强化剂量从 25 至 35Gy 递增 - 33 例患者接受 25Gy(总剂量 75Gy),63 例患者接受 30Gy(总剂量 80Gy),34 例患者接受 35Gy(总剂量 85Gy),单次治疗(脉冲剂量为 0.60Gy 或 0.70Gy/h,每天 24 小时,日夜治疗,两次脉冲之间间隔 1 小时)。根据 Phoenix 生化失败定义,使用 Kaplan-Meier 计算 PSA 无复发生存率,根据常见毒性标准评估晚期毒性。

结果

在中位随访 60 个月时进行分析,88%的患者达到生化控制 - 仅 16/130 例患者(12.3%)出现生化复发。根据 Kaplan-Meier 计算的所有患者的生化无复发生存率在 5 年时为 85.6%(中危患者为 83.9%,高危患者为 84.2%),9 年随访时为 79.0%。分别分析不同强化剂量水平的生化无复发生存率,5 年时 35Gy 强化剂量为 97%,25Gy 和 30Gy 剂量水平为 82%。治疗的副作用可以忽略不计:18 例(15%)出现 1/2 级直肠炎,1 例(0.8%)出现 3 级直肠炎,18 例(15%)出现 1/2 级膀胱炎,无 3 级排尿困难病例(0%)。无患者出现尿道球部狭窄需要扩张或新发尿失禁。

结论

在 50Gy 外照射治疗后,使用高达 35Gy 的图像引导的适形 PDR 近距离放疗作为强化治疗(总剂量高达 85Gy)是一种非常有效的治疗选择,对中高危前列腺癌患者的发病率非常低。进一步提高剂量似乎是可行的。

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