Division of Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.
Division of Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.
Eur Urol. 2019 Oct;76(4):443-449. doi: 10.1016/j.eururo.2019.02.004. Epub 2019 Feb 22.
The optimal duration of hormonal therapy (HT) when associated with postprostatectomy radiation therapy (RT) remains controversial.
To test the impact of HT duration among patients treated with postprostatectomy RT, stratified by clinical and pathologic characteristics.
DESIGN, SETTING, AND PARTICIPANTS: The study included 1264 patients who received salvage RT (SRT) to the prostatic and seminal vesicle bed at eight referral centers after radical prostatectomy (RP). Patients received SRT for either rising prostate-specific antigen (PSA) or PSA persistence after RP, defined as PSA ≥0.1ng/ml at 1mo after surgery. Administration of concomitant HT was at the discretion of the treating physician.
The outcome of interest was clinical recurrence (CR) after SRT, as identified by imaging. Multivariable Cox regression analysis was used to test the association between CR and HT duration. We applied an interaction test between HT duration and baseline risk factors to assess the hypothesis that CR-free survival differed by HT duration according to patient profile. Three risk factors were prespecified for evaluation: pT stage ≥pT3b, pathologic Gleason ≥8, and PSA level at SRT >0.5 ng/ml. The relationship between HT duration and CR-free survival rate at 8yr was graphically explored according to the number of risk factors (0 vs 1 vs ≥2).
Overall, 1125 men (89%) received SRT for rising PSA and 139 (11%) were treated for PSA persistence. Concomitant HT was administered to 363 patients (29%), with a median HT duration of 9mo. At median follow-up of 93mo after surgery, 182 patients developed CR. The 8-yr CR-free survival was 92%. On multivariable analysis, HT duration was inversely associated with the risk of CR (hazard ratio 0.95; p=0.022). A total of 531 (42%) patients had none of the prespecified risk factors, while 507 (40%) had one and 226 (18%) had two or more risk factors. The association between HT duration and CR was significantly different by risk factors (0 vs 1, p=0.001; 0 vs ≥2, p<0.0001). We observed a significant effect of HT duration for patients with two or more risk factors, for whom HT administration was beneficial when given for up to 36mo. This effect was attenuated among patients with one risk factor, with concomitant HT slightly beneficial when administered for a shorter time (<12mo). Conversely, for patients with no risk factors, the risk of CR remained low and constant regardless of HT duration.
The oncologic benefit of HT duration among men receiving SRT for increasing PSA after RP depends on their clinical and pathologic characteristics. Our data suggested a significant effect of long-term HT for patients with two or more adverse features. Conversely, short-term HT was sufficient for patients with a single risk factor, whereas patients without any risk factors did not show a significant benefit from concomitant HT.
We tested the impact of hormonal therapy (HT) duration during radiation therapy after radical prostatectomy. We identified three risk factors and observed a different impact of HT duration by clinical and pathologic characteristics. Patients with more adverse features benefit from long-term concomitant HT. On the contrary, for patients with a single risk factor, short-term HT may be reasonable. Patients without any risk factors did not show a significant benefit from concomitant HT.
在与前列腺癌根治术后放疗（RT）联合应用时，激素治疗（HT）的最佳持续时间仍存在争议。
在接受前列腺癌根治术后 RT 的患者中，根据临床和病理特征，检验 HT 持续时间的影响。
设计、地点和参与者：这项研究包括 1264 名在 8 个转诊中心接受挽救性 RT（SRT）治疗前列腺和精囊床的患者，这些患者在前列腺根治术后（RP）因 PSA 升高或 PSA 持续存在而接受 SRT，定义为手术后 1 个月 PSA≥0.1ng/ml。同时 HT 的应用由治疗医生决定。
我们感兴趣的结局是 SRT 后通过影像学确定的临床复发（CR）。采用多变量 Cox 回归分析检验 CR 与 HT 持续时间之间的关联。我们应用 HT 持续时间与基线风险因素之间的交互检验，以评估根据患者特征，CR 无复发生存率是否因 HT 持续时间而异的假设。为评估预设了三个风险因素：pT 期≥pT3b、病理 Gleason≥8 和 SRT 时 PSA 水平>0.5ng/ml。根据风险因素的数量（0 个、1 个和≥2 个），以图形方式探索 HT 持续时间与 8 年 CR 无生存率之间的关系。
总的来说，1125 名男性（89%）因 PSA 升高接受 SRT，139 名（11%）因 PSA 持续接受治疗。363 名患者（29%）接受了同时 HT，中位 HT 持续时间为 9 个月。在手术后中位随访 93 个月时，182 名患者出现 CR。8 年 CR 无生存率为 92%。多变量分析显示，HT 持续时间与 CR 风险呈负相关（风险比 0.95；p=0.022）。共有 531 名（42%）患者没有预设的风险因素，507 名（40%）患者有 1 个风险因素，226 名（18%）患者有 2 个或更多风险因素。HT 持续时间与 CR 的关联在风险因素之间有显著差异（0 与 1，p=0.001；0 与≥2，p<0.0001）。我们观察到，对于有两个或更多风险因素的患者，HT 持续时间有显著的影响，对于这些患者，HT 的应用在 36 个月内是有益的。对于有一个风险因素的患者，这种影响减弱，HT 短时间（<12 个月）应用略有获益。相反，对于没有风险因素的患者，无论 HT 持续时间如何，CR 的风险仍然较低且保持不变。
接受 RP 后因 PSA 升高而接受 SRT 的男性接受 HT 持续时间的肿瘤学获益取决于他们的临床和病理特征。我们的数据表明，对于有两个或更多不良特征的患者，长期 HT 有显著效果。相反，对于有一个风险因素的患者，短期 HT 是足够的，而没有任何风险因素的患者则没有从同时 HT 中获得显著获益。
我们测试了在前列腺癌根治术后放疗期间 HT 持续时间的影响。我们确定了三个风险因素，并根据临床和病理特征观察到 HT 持续时间的不同影响。具有更多不良特征的患者从长期同时 HT 中获益。相反，对于有单个风险因素的患者，短期 HT 可能是合理的。没有任何风险因素的患者从同时 HT 中没有明显获益。
