Faculty of Medicine, University of Helsinki, Helsinki, Finland.
Department of Urology, Helsinki University Hospital, Helsinki, Finland.
Eur Urol. 2019 Nov;76(5):586-595. doi: 10.1016/j.eururo.2019.07.001. Epub 2019 Jul 30.
It remains unclear whether patients with positive surgical margins or extracapsular extension benefit from adjuvant radiotherapy following radical prostatectomy.
To compare the effectiveness and tolerability of adjuvant radiotherapy following radical prostatectomy.
DESIGN, SETTING, AND PARTICIPANTS: This was a randomised, open-label, parallel-group trial. A total of 250 patients were enrolled between April 2004 and October 2012 in eight Finnish hospitals, with pT2 with positive margins or pT3a, pN0, M0 cancer without seminal vesicle invasion.
A total of 126 patients received adjuvant radiotherapy at 66.6Gy.
The primary endpoint was biochemical recurrence-free survival, which we analysed using the Kaplan-Meier method and Cox proportional hazard regression. Overall survival, cancer-specific survival, local recurrence, and adverse events were secondary endpoints.
The median follow-up time for patients who were alive when the follow-up ended was 9.3yr in the adjuvant group and 8.6yr in the observation group. The 10-yr survival for biochemical recurrence was 82% in the adjuvant group and 61% in the observation group (hazard ratio [HR] 0.26 [95% confidence interval {CI} 0.14-0.48], p<0.001), and for overall survival 92% and 87%, respectively (HR 0.69 [95% CI 0.29-1.60], p=0.4). Two and four metastatic cancers occurred, respectively. Out of the 43 patients with biochemical recurrence in the observation group, 37 patients received salvage radiotherapy. In the adjuvant group, 56% experienced grade 3 adverse events, versus 40% in the observation group (p=0.016). Only one grade 4 adverse event occurred (adjuvant group). A limitation of this study was the number of patients.
Adjuvant radiotherapy following radical prostatectomy is generally well tolerated and prolongs biochemical recurrence-free survival compared with radical prostatectomy alone in patients with positive margins or extracapsular extension.
Radiotherapy given immediately after prostate cancer surgery prolongs prostate-specific antigen progression-free survival, but causes more adverse events, when compared with surgery alone.
目前尚不清楚根治性前列腺切除术后切缘阳性或囊外扩展的患者是否受益于辅助放疗。
比较根治性前列腺切除术后辅助放疗的效果和耐受性。
设计、地点和参与者：这是一项随机、开放标签、平行组试验。2004 年 4 月至 2012 年 10 月，在芬兰的 8 家医院共纳入了 250 名 pT2 伴切缘阳性或 pT3a、pN0、M0 且无精囊侵犯的癌症患者。
共 126 例患者接受 66.6Gy 的辅助放疗。
主要终点是生化无复发生存率，我们采用 Kaplan-Meier 法和 Cox 比例风险回归进行分析。总生存、癌症特异性生存、局部复发和不良事件为次要终点。
当随访结束时存活的患者的中位随访时间在辅助组为 9.3 年，在观察组为 8.6 年。生化复发的 10 年生存率在辅助组为 82%，观察组为 61%（风险比[HR]0.26[95%置信区间{CI}0.14-0.48]，p<0.001），总生存率分别为 92%和 87%（HR 0.69[95%CI 0.29-1.60]，p=0.4）。分别有 2 例和 4 例发生转移性癌症。观察组中有 43 例生化复发的患者接受了挽救性放疗。在辅助组中，56%的患者发生 3 级不良事件，而观察组为 40%（p=0.016）。仅在辅助组中发生 1 例 4 级不良事件。该研究的一个局限性是患者数量。
与单纯根治性前列腺切除术相比，根治性前列腺切除术后辅助放疗耐受性良好，可延长切缘阳性或囊外扩展患者的生化无复发生存期。
与单纯手术相比，前列腺癌手术后立即给予放疗可延长前列腺特异性抗原无进展生存期，但会导致更多的不良事件。
