Optimal Duration of Androgen Deprivation Therapy With Definitive Radiotherapy for Localized Prostate Cancer: A Meta-Analysis.

Background

To determine the ideal duration of ADT for patients with prostate cancer treated with radiotherapy.

确定接受放射治疗的前列腺癌患者理想雄激素剥夺疗法（ADT）的持续时间。

data_sources

This individual patient data meta-analysisof 13 randomized phase 3 clinical trials evaluated the use of radiotherapy alone or with ADT.

这项对13项随机III期临床试验的个体患者数据荟萃分析评估了仅使用放疗或与雄激素剥夺治疗（ADT）联合使用的疗效。

It included patients with a median follow-up of 11.3 (IQR, 9.5-14.5) years and ADT duration of 0 to 36 months.

研究纳入了中位随访时间为11.3年（四分位数间距，9.5-14.5年）以及ADT持续时间为0至36个月的患者。

Most patients (7392 [72%]) included had National Comprehensive Cancer Network high-risk or very high-risk disease.

大多数纳入的患者（7392 [72%]）患有美国国家综合癌症网络定义的高风险或极高风险疾病。

study_selection

For this meta-analysis, a systematic literature search from 1980 to 2020 was performed in trial registries (Cochrane Central Register of Controlled Trials and ClinicalTrials.gov), MEDLINE (1966-2020), Embase (1982-2020), Web of Science, and Scopus to identify trials.

为了这项荟萃分析，从1980年到2020年，在试验注册处（Cochrane对照试验注册中心和ClinicalTrials.gov）、MEDLINE（1966-2020）、Embase（1982-2020）、Web of Science和Scopus中进行了系统的文献搜索，以确定试验。

data_extraction_and_synthesis

Intention-to-treatand as-treated analyses were performed.

进行了意向治疗和按治疗分析。

The number needed to treat to prevent 1 distant metastasis at 10 years was calculated based on prognostic risk group.

基于预后风险组，计算了在10年内预防1例远处转移所需的治疗人数。

The analyses were conducted from January 5 to August 15, 2023.

分析工作从2023年1月5日进行至8月15日。

main_outcomes_and_measures

The primary end point for this study was overall survival, defined as time to death or last follow-up from randomization.

本研究的主要终点是总生存，定义为从随机分组到死亡或最后随访的时间。

Secondary end points included biochemical recurrence, distant metastasis (DM), prostate cancer-specific mortality, and other-cause mortality.

次要终点包括生化复发、远处转移（DM）、前列腺癌特异性死亡和其他原因死亡。

Results

The median (IQR) age among the 10 266 male patients was 70 (65-74) years.

10266名男性患者中，年龄的中位数（四分位数间距）为70（65-74）岁。

Longer durations of ADT were associated with nonlinear improvement in relative benefits of DM, prostate cancer-specific mortality, and overall survival, with reduced estimated benefits beyond 9 to 12 months of ADT based on the end point.

更长的雄激素剥夺治疗（ADT）时间与去势治疗（DM）的相对益处、前列腺癌特异性死亡率和总生存（OS）的非线性改善相关，超过9至12个月的ADT治疗后，基于终点的估计益处减少。

There was a near-linear increase in other-cause mortality associated with long-term ADT use (hazard ratio, 1.28; 95% CI, 1.09-1.50; P = .002 for 28 vs 0 months of ADT).

长期使用雄激素剥夺治疗（ADT）与他因死亡率的近似线性增加相关（风险比，1.28；95%置信区间，1.09-1.50；P = .002，比较28个月与0个月的ADT）。

The optimal ADT duration based on 10-year DM was 0, 6, 12 months, and undefined for patients with 1 intermediate-risk factor, 2 or more intermediate-risk factors, and National Comprehensive Cancer Network high-risk and very high-risk disease, respectively.

基于10年无病生存率的ADT最佳治疗时长为：具有1个中危因素的患者为0个月，具有2个或更多中危因素的患者为6个月，以及美国国家综合癌症网络高危和极高危疾病的患者为12个月，具体时长尚不明确。

conclusions_and_relevance

The results of this meta-analysissuggest that, for men with localized prostate cancer treated with definitive radiotherapy and ADT, there are relative and absolute benefits from increasing durations of ADT that help provide individualized risk estimates.

这项荟萃分析的结果表明，对于接受根治性放疗和ADT治疗的局限性前列腺癌男性患者，延长ADT治疗时长可以带来相对和绝对的益处，有助于提供个性化的风险评估。