Long-term Outcomes of Stereotactic Body Radiotherapy for Low-Risk and Intermediate-Risk Prostate Cancer
Long-term Outcomes of Stereotactic Body Radiotherapy for Low-Risk and Intermediate-Risk Prostate Cancer
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DOI：
10.1001/jamanetworkopen.2018.8006
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发表时间：
2019-02-01
影响因子：
13.8
通讯作者：
King, Christopher R.
中科院分区：
文献类型：
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作者：
Kishan, Amar U.;Dang, Audrey;King, Christopher R.
重要性立体定向体部放射治疗利用技术的改进，允许在4至5个疗程的跨度内完成前列腺癌的外部射束放射治疗。虽然越来越多的短期数据支持这种方法，但长期结果却鲜有报道。目的评估立体定向体部放射治疗低危和中危前列腺癌的长期结果。这项队列研究分析了2142名男性患者的个体数据，这些患者参加了10项单机构II期试验和2项多机构II期试验。2000年1月1日至2012年12月31日期间，立体定向体部放疗治疗低风险和中风险前列腺癌的机构II期试验。根据2013年1月1日至2018年5月1日的随访结果进行统计学分析。主要结局和指标使用竞争风险框架估计生化复发的累积发生率。医生评分的泌尿生殖系统和胃肠道毒性事件结局根据每项单独研究定义，通常通过放射治疗肿瘤学组或不良事件通用术语标准评分系统进行定义。在中心审查后，使用Kaplan-Meier方法估计晚期3级或更高毒性事件的累积发生率。（平均[SD]年龄，67.9 [9.5]岁）有资格进行分析，其中1185人692例（32.3%）为有利的中危疾病，265例（12.4%）为不利的中危疾病。中位随访期为6.9年（四分位距，4.9 - 8.1年）。7年累积生化复发率为4.5%（95% CI，3.2%-5.8%）低风险疾病，8.6%（95% CI，6.2%-11.0%）对于有利的中危疾病，14.9%对于不利的中危疾病，为10.2%（95%CI，9.5%-20.2%），对于所有中危疾病，为10.2%（95%CI，8.0%-12.5%）。急性3级或以上泌尿生殖系统毒性事件的粗发生率为0.60%（n = 13），胃肠道毒性事件的粗发生率为0.09%（n = 2），晚期3级或以上泌尿生殖系统毒性事件的7年累积发生率为2.4%（95% CI，1.8%-3.2%），晚期3级或以上胃肠道毒性事件发生率为0.4%（95%CI，0.2%-0.8%）。结论和相关性在这项研究中，低危和中危疾病的立体定向体部放疗与严重毒性事件的低发生率和生化控制的高发生率相关。这些数据表明，立体定向体部放射治疗是一个适当的低风险和中等风险的前列腺癌的最终治疗方式。
IMPORTANCE Stereotactic body radiotherapy harnesses improvements in technology to allow the completion of a course of external beam radiotherapy treatment for prostate cancer in the span of 4 to 5 treatment sessions. Although mounting short-term data support this approach, long-term outcomes have been sparsely reported.OBJECTIVE To assess long-term outcomes after stereotactic body radiotherapy for low-risk and intermediate-risk prostate cancer.DESIGN, SETTING, AND PARTICIPANTS This cohort study analyzed individual patient data from 2142 men enrolled in 10 single-institution phase 2 trials and 2 multi-institutional phase 2 trials of stereotactic body radiotherapy for low-risk and intermediate-risk prostate cancer between January 1, 2000, and December 31, 2012. Statistical analysis was performed based on follow-up from January 1, 2013, to May 1, 2018.MAIN OUTCOMES AND MEASURES The cumulative incidence of biochemical recurrence was estimated using a competing risk framework. Physician-scored genitourinary and gastrointestinal toxic event outcomes were defined per each individual study, generally by Radiation Therapy Oncology Group or Common Terminology Criteria for Adverse Events scoring systems. After central review, cumulative incidences of late grade 3 or higher toxic events were estimated using a Kaplan-Meier method.RESULTS A total of 2142 men (mean [SD] age, 67.9 [9.5] years) were eligible for analysis, of whom 1185 (55.3%) had low-risk disease, 692 (32.3%) had favorable intermediate-risk disease, and 265 (12.4%) had unfavorable intermediate-risk disease. The median follow-up period was 6.9 years (interquartile range, 4.9-8.1 years). Seven-year cumulative rates of biochemical recurrence were 4.5%(95% CI, 3.2%-5.8%) for low-risk disease, 8.6%(95% CI, 6.2%-11.0%) for favorable intermediate-risk disease, 14.9% (95% CI, 9.5%-20.2%) for unfavorable intermediate-risk disease, and 10.2%(95% CI, 8.0%-12.5%) for all intermediate-risk disease. The crude incidence of acute grade 3 or higher genitourinary toxic events was 0.60% (n = 13) and of gastrointestinal toxic events was 0.09% (n = 2), and the 7-year cumulative incidence of late grade 3 or higher genitourinary toxic events was 2.4%(95% CI, 1.8%-3.2%) and of late grade 3 or higher gastrointestinal toxic events was 0.4%(95% CI, 0.2%-0.8%).CONCLUSIONS AND RELEVANCE In this study, stereotactic body radiotherapy for low-risk and intermediate-risk disease was associated with low rates of severe toxic events and high rates of biochemical control. These data suggest that stereotactic body radiotherapy is an appropriate definitive treatment modality for low-risk and intermediate-risk prostate cancer.