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Use of Concomitant Androgen Deprivation Therapy in Patients Treated with Early Salvage Radiotherapy for Biochemical Recurrence After Radical Prostatectomy: Long-term Results from a Large, Multi-institutional Series
European Urology ( IF 23.4 ) Pub Date : 2017-12-08 , DOI: 10.1016/j.eururo.2017.11.020
Giorgio Gandaglia , Nicola Fossati , R. Jeffrey Karnes , Stephen A. Boorjian , Michele Colicchia , Alberto Bossi , Thomas Seisen , Cesare Cozzarini , Nadia Di Muzio , Barbara Noris Chiorda , Emanuele Zaffuto , Thomas Wiegel , Shahrokh F. Shariat , Gregor Goldner , Steven Joniau , Antonino Battaglia , Karin Haustermans , Gert De Meerleer , Valérie Fonteyne , Piet Ost , Hendrick Van Poppel , Francesco Montorsi , Alberto Briganti

Background

Hormonal manipulation concomitant to salvage radiotherapy (SRT) given for biochemical recurrence (BCR) after radical prostatectomy (RP) improved outcomes in two randomized trials. However, neither of these studies focused on men treated at low prostate-specific antigen (PSA) levels.

Objective

To test if the impact of androgen deprivation therapy (ADT) on metastasis in patients undergoing early SRT varies according to prostate cancer (PCa) features.

Design, setting, and participants

A total of 525 patients received SRT at PSA levels ≤2 ng/ml.

Outcome measurements and statistical analyses

Multivariable Cox regression analyses assessed factors associated with metastasis. We tested the hypothesis that the impact of ADT varied according to the risk of metastasis. An interaction with groups (concomitant ADT vs no ADT) and the probability of distant metastasis according to a newly developed model was tested. A nonparametric curve explored the relationship between the risk of metastasis and 10-yr metastasis rates according to ADT.

Results and limitations

Median PSA and radiotherapy dose were 0.42 ng/ml and 66 Gy, respectively. Overall, 178 (34%) patients received ADT. At a median follow-up of 104 mo, 71 patients experienced metastasis. Grade group ≥4 (hazard ratio [HR]: 1.66; 95% confidence interval [CI]: 1.01–3.30), pT3b/4 (HR: 2.61; 95% CI: 1.51–4.52), and dose (HR: 0.82; 95% CI: 0.76–0.89) were associated with metastasis. The impact of ADT differed according to the risk of metastasis calculated using a multivariable model (p = 0.01). This was confirmed when considering patients treated with early SRT (p = 0.046), where ADT was associated with a reduction in the rate of metastasis only in eSRT; patients with more aggressive characteristics (ie, pT3b/4 and grade group ≥4, or pT3b/4 and PSA at eSRT ≥0.4 ng/ml).

Conclusions

The beneficial effect of ADT concomitant to eSRT varied significantly according to disease characteristics, such that only men with more aggressive PCa features benefit from ADT in the eSRT setting for BCR after RP.

Patient summary

The oncological benefits of concomitant androgen deprivation therapy (ADT) in patients undergoing salvage radiotherapy (SRT) vary according to pathological characteristics. Only patients with more aggressive disease characteristics seemed to benefit from the use of hormonal manipulation at the time of early SRT. Conversely, the potential side effects of ADT could be spared in patients with low prostate-specific antigen levels and favorable pathological features.



中文翻译:

早期前列腺癌根治术后生化复发的早期抢救放疗对伴随雄激素剥夺疗法的使用:来自大型,多机构研究的长期结果

背景

在两项随机试验中,进行根治性前列腺切除术(RP)后进行生化复发(BCR)的挽救性放疗(SRT)伴随的激素操作改善了结局。但是,这些研究都没有针对以低前列腺特异性抗原(PSA)水平治疗的男性。

客观的

要测试雄激素剥夺疗法(ADT)对接受早期SRT的患者转移的影响是否根据前列腺癌(PCa)的特征而有所不同。

设计,设置和参与者

共有525例患者接受PSA≤2 ng / ml的SRT。

成果测量和统计分析

多变量Cox回归分析评估了与转移相关的因素。我们检验了ADT的影响根据转移风险而变化的假设。根据新开发的模型,测试了各组之间的相互作用(伴随的ADT与无ADT)和远处转移的可能性。根据ADT,非参数曲线探讨了转移风险与10年转移率之间的关系。

结果与局限性

PSA中位数和放射治疗剂量分别为0.42 ng / ml和66 Gy。总体上,有178名(34%)患者接受了ADT。在104个月的中位随访中,有71例患者发生了转移。≥4级组(危险比[HR]:1.66; 95%置信区间[CI]:1.01-3.30),pT3b / 4(HR:2.61; 95%CI:1.51-4.52)和剂量(HR:0.82; 95%CI:0.76-0.89)与转移相关。根据使用多变量模型计算的转移风险,ADT的影响有所不同(p  = 0.01)。当考虑接受早期SRT治疗的患者时,这一点得到了证实(p  = 0.046),其中ADT仅与eSRT中的转移率降低相关。具有较侵略性特征的患者(即pT3b / 4和等级组≥4,或pS3b / 4和PSA在eSRT≥0.4ng / ml时)。

结论

根据疾病的特点,伴随eSRT的ADT的有益作用差异很大,因此只有在RP后BCR的eSRT设置中,只有具有更具侵略性PCa特征的男性才能从eDT中受益于ADT。

病人总结

进行抢救性放疗(SRT)的患者中伴随雄激素剥夺治疗(ADT)的肿瘤学益处因病理特征而异。在早期SRT时,只有具有更具侵略性的疾病特征的患者似乎可以从激素操纵中受益。相反,在前列腺特异性抗原水平低且病理特征良好的患者中,可以避免ADT的潜在副作用。

更新日期:2017-12-08
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