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立体定向体部放疗治疗局限性前列腺癌:多机构前瞻性 II 期试验联盟的汇总分析。

Stereotactic body radiotherapy for localized prostate cancer: pooled analysis from a multi-institutional consortium of prospective phase II trials.

机构信息

Department of Radiation Oncology, UCLA, Los Angeles, CA.

出版信息

Radiother Oncol. 2013 Nov;109(2):217-21. doi: 10.1016/j.radonc.2013.08.030. Epub 2013 Sep 20.

Abstract

PURPOSE

The effectiveness of stereotactic body radiotherapy (SBRT) for localized prostate cancer is tested.

METHODS AND MATERIALS

A total of 1100 patients with clinically localized prostate cancer were enrolled in separate prospective phase 2 clinical trials of SBRT from 8 institutions during 2003-11 and pooled for analysis. SBRT using the CyberKnife delivered a median dose of 36.25Gy in 4-5 fractions. Patients were low-risk (58%), intermediate-risk (30%) and high-risk (11%). A short-course of androgen deprivation therapy (ADT) was given to 14%. PSA relapse defined as a rise >2ng/ml above nadir was analyzed with the Kaplan Meier method.

RESULTS

With a median follow-up of 36months there were 49 patients with PSA failure (4.5%), 9 of whom were subsequently determined to be benign PSA bounces. The 5-year biochemical relapse free survival (bRFS) rate was 93% for all patients; 95%, 83% and 78% for GS ⩽6, 7 and ⩾8, respectively (p=0.001), and 95%, 84% and 81% for low-, intermediate- and high-risk patients, respectively (p<0.001). No differences were observed with ADT (p=0.71) or as a function of total dose (p=0.17). A PSA bounce of >0.2ng/ml was noted among 16% of patients. For 135 patients possessing a minimum of 5years follow-up, the 5-year bRFS rate for low- and intermediate-risk patients was 99% and 93%, respectively.

CONCLUSION

PSA relapse-free survival rates after SBRT compare favorably with other definitive treatments for low and intermediate risk patients. The current evidence supports consideration of SBRT among the therapeutic options for these patients.

摘要

目的

测试立体定向体放射治疗(SBRT)治疗局限性前列腺癌的疗效。

方法和材料

2003 年至 2011 年期间,8 家机构分别开展了 SBRT 的前瞻性 2 期临床试验,共纳入 1100 例临床局限性前列腺癌患者,对这些数据进行汇总分析。SBRT 使用 CyberKnife 提供 36.25Gy 的中位剂量,分为 4-5 个分数。患者的风险程度为低危(58%)、中危(30%)和高危(11%)。14%的患者接受了短期雄激素剥夺治疗(ADT)。采用 Kaplan-Meier 法分析 PSA 复发(定义为 PSA 水平高于最低点上升>2ng/ml)。

结果

中位随访 36 个月后,有 49 例患者出现 PSA 失败(4.5%),其中 9 例随后被确定为良性 PSA 反弹。所有患者的 5 年生化无复发生存率(bRFS)为 93%;GS ⩽6、7 和 ⩾8 的患者分别为 95%、83%和 78%(p=0.001),低危、中危和高危患者的 bRFS 分别为 95%、84%和 81%(p<0.001)。ADT(p=0.71)或总剂量(p=0.17)对结果没有影响。16%的患者出现 PSA 反弹>0.2ng/ml。对于 135 例至少随访 5 年的患者,低危和中危患者的 5 年 bRFS 率分别为 99%和 93%。

结论

SBRT 后 PSA 无复发生存率与低危和中危患者的其他确定性治疗方法相比具有优势。目前的证据支持将 SBRT 作为这些患者的治疗选择之一。

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