Context

Salvage radiotherapy (SRT) is a standard of care for men who recur postprostatectomy, and recent randomized trials have assessed the benefit and toxicity of adding hormone therapy (HT) to SRT with differing results.

Objective

To perform a systematic review of randomized phase III trials of the use of SRT ± HT and generate a framework for the use of HT with SRT.

Evidence acquisition

Systematic literature searches were conducted on February 15, 2017 in three databases (MEDLINE [via PubMed], EMBASE, and ClinicalTrials.gov) for human-only randomized clinical trials from January 30, 1990, through January 30, 2017. Only two randomized trials met all inclusion criteria.

Evidence synthesis

Overall survival benefits from HT were found in one trial, which was limited to when follow-up extended to ≥10 yr, pre-SRT prostate-specific antigen (PSA) ≥0.7 ng/ml, or when higher Gleason grade or positive margins were present. Both trials demonstrated a benefit from HT in men with higher pre-SRT PSAs. Three prognostic factors appeared to discriminate improvements in meaningful clinical endpoints (eg, distant metastasis or survival): pre-SRT PSA, Gleason score, and margin status. Two years of bicalutamide monotherapy resulted in higher rates of gynecomastia with a trend for worse survival when given in favorable risk patients, and 6 mo of luteinizing hormone–releasing hormone agonist therapy resulted in higher rates of hot flashes and long-term hypertension.

Conclusions

Similar to the selective use of HT with radiotherapy in localized prostate cancer, not all patients appear to derive a meaningful benefit from HT with SRT. Patient, tumor, and treatment factors must be considered when recommending the use of HT with SRT. Knowledge gaps exist in the level 1 data regarding the optimal duration and type of HT, as well as the ability to use predictive biomarkers to personalize the use of HT with SRT. Important clinical trials (RADICALS and NRG GU-006) are aimed to answer these questions.

Patient summary

In this report, we performed a systematic review of the literature to determine the benefit and harm of adding hormone therapy to salvage radiotherapy (SRT) for recurrent prostate cancer. We found that the benefit of hormone therapy varied by important prognostic factors, including pre-SRT prostate-specific antigen, Gleason grade, and surgical margin status. Our group then developed a framework on how best to utilize hormone therapy with SRT.

中文翻译：

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激素疗法与挽救性放射疗法治疗复发性前列腺癌的系统评价和框架

语境

挽救性放疗（SRT）是前列腺切除术后复发男性的标准治疗方法，最近的随机试验评估了在SRT上加激素治疗（HT）的益处和毒性，但结果不同。

客观的

对使用SRT±HT的随机III期临床试验进行系统评价，并建立将HT与SRT结合使用的框架。

取证

系统文献检索于2017年2月15日在三个数据库（MEDLINE [via PubMed]，EMBASE和ClinicalTrials.gov）中进行，用于1990年1月30日至2017年1月30日的仅人类随机临床试验。只有两个随机试验符合所有纳入标准。

证据综合

在一项试验中发现了HT的总体生存获益，仅限于随访延长至≥10年，SRT前前列腺特异性抗原（PSA）≥0.7ng / ml或更高的Gleason评分或阳性切缘时展示。两项试验均表明，SRT前PSA较高的男性可从HT中获益。三种预后因素似乎可以区分有意义的临床终点（例如，远处转移或生存）的改善：SRT前PSA，格里森评分和边缘状态。比卡鲁胺单药治疗两年后，在风险较高的患者中使用时，男子乳腺乳腺炎的发生率较高，且生存趋势较差；而黄体化激素释放激素激动剂治疗6个月后，潮热和长期高血压的发生率较高。

结论

与在局部前列腺癌中选择性使用HT放疗相似，并非所有患者似乎都能从SRT HT中获得有意义的益处。建议在SRT中使用HT时，必须考虑患者，肿瘤和治疗因素。在1级数据中，关于HT的最佳持续时间和类型以及使用预测性生物标志物个性化HT与SRT的使用能力存在知识差距。重要的临床试验（RADICALS和NRG GU-006）旨在回答这些问题。

病人总结

在本报告中，我们对文献进行了系统的综述，以确定在复发性前列腺癌的挽救性放疗（SRT）中增加激素治疗的利弊。我们发现激素治疗的益处因重要的预后因素而异，包括SRT前前列腺特异性抗原，Gleason分级和手术切缘状态。然后，我们的小组就如何最好地利用SRT进行激素疗法建立了一个框架。