STEREOTACTIC BODY RADIOTHERAPY FOR LOCALIZED PROSTATE CANCER: INTERIM RESULTS OF A PROSPECTIVE PHASE II CLINICAL TRIAL
STEREOTACTIC BODY RADIOTHERAPY FOR LOCALIZED PROSTATE CANCER: INTERIM RESULTS OF A PROSPECTIVE PHASE II CLINICAL TRIAL
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DOI：
10.1016/j.ijrobp.2008.05.059
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发表时间：
2009-03-15
影响因子：
7
通讯作者：
Presti, Joseph C., Jr.
中科院分区：
文献类型：
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作者：
King, Christopher R.;Brooks, James D.;Presti, Joseph C., Jr.
目的：前列腺癌的放射生物学特性支持大分割剂量方案。我们报告一项针对局限性前列腺癌的立体定向体部放疗（SBRT）的前瞻性I期临床试验结果。
方法和材料：41例低风险前列腺癌患者，至少随访6个月，仅使用射波刀进行图像引导的SBRT，以7.25 Gy为一个分割剂量，共5个分割，总剂量为36.25 Gy。使用经验证的生活质量问卷（国际前列腺症状评分、扩展前列腺癌指数综合评分）以及放射治疗肿瘤学组（RTOG）毒性标准评估早期（6个月）的泌尿和直肠毒性。分析前列腺特异性抗原（PSA）反应模式。
结果：中位随访时间为33个月。无RTOG 4级急性或晚期直肠/泌尿并发症。有2例患者出现RTOG 3级晚期泌尿毒性，无RTOG 3级直肠并发症。与连续5天的治疗方案相比，隔日治疗方案观察到严重直肠毒性的发生率降低（0%对38%，p = 0.0035）。12例患者（29%）在治疗后18个月（中位时间）出现良性PSA反弹（中位值为0.4 ng/mL）。在最后一次随访时，无论生化失败的定义如何，没有患者出现PSA失败。在至少随访12个月的32例患者中，25例患者（78%）达到PSA最低值。
Purpose: The radiobiology of prostate cancer favors a hypofractionated dose regimen. We report results of a prospective Phase It clinical trial of stereotactic body radiotherapy (SBRT) for localized prostate cancer.Methods and Materials: Forty-one low-risk prostate cancer patients with 6 months' minimum follow-up received 36.25 Gy in five fractions of 7.25 Gy with image-guided SBRT alone using the CyberKnife. The early (6 months) urinary and rectal toxicities were assessed using validated quality of life questionnaires (international Prostate Symptom Score, Expanded Prostate Cancer Index Composite) and the Radiation Therapy Oncology Group (RTOG) toxicity criteria. Patterns of prostate-specific antigen (PSA) response are analyzed.Results: The median follow-up was 33 months. There were no RTOG Grade 4 acute or late rectal/urinary complications. There were 2 patients with RTOG Grade 3 late urinary toxicity and none with RTOG Grade 3 rectal complications. A reduced rate of severe rectal toxicities was observed with every-other-day vs. 5 consecutive days treatment regimen (0% vs. 38%, p = 0.0035). A benign PSA bounce (median, 0.4 ng/mL) was observed in 12 patients (29%) occurring at 18 months (median) after treatment. At last follow-up, no patient has had a PSA failure regardless of biochemical failure definition. Of 32 patients with 12 months minimum follow-up, 25 patients (78%) achieved a PSA nadir