Nyberg Martin, Akre Olof, Bock David, Carlsson Sigrid V, Carlsson Stefan, Hugosson Jonas, Lantz Anna, Steineck Gunnar, Stranne Johan, Tyritzis Stavros, Wiklund Peter, Haglind Eva, Bjartell Anders
Department of Urology, Skåne University Hospital, Malmö, Sweden.
Department of Translational Medicine, Division of Urological Cancers, Faculty of Medicine, Lund University, Lund, Sweden.
Eur Urol Open Sci. 2020 Aug 19;20:54-61. doi: 10.1016/j.euros.2020.06.005. eCollection 2020 Jul.
Conclusive evidence of superiority in oncological outcome for robot-assisted laparoscopic prostatectomy (RALP) over retropubic radical prostatectomy (RRP) is lacking.
To compare RALP and RRP regarding recurrent disease and to report the mortality rate 6 yr after surgery.
A total of 4003 men with localized prostate cancer were enrolled between 2008 and 2011 in Laparoscopic Prostatectomy Robot Open (LAPPRO)- a prospective, controlled, nonrandomized trial performed at 14 Swedish centers.
Data were collected at visits and by patient questionnaires at 3, 12, and 24 mo, and through a structured telephone interview at 6 yr. Cause of death was retrieved from the National Cause of Death Register in Sweden. The modified Poisson regression approach was used for analyses.
After adjustment for patient-, tumor-, and surgeon-related confounders, no statistically significant difference was observed between RALP and RRP in biochemical recurrence rate (14 vs 16%, relative risk [RR] 0.77, 95% confidence interval [CI] 0.56-1.06) or in not cured endpoint (22% vs 23%, RR 0.82, 95% CI 0.6-1.11). Stratified by D'Amico risk group, a significant benefit for RALP existed for recurrent disease in high-risk patients (RR 0.47, 95% CI 0.26-0.86, = 0.02). All-cause mortality was 3% ( = 96). Prostate cancer-specific mortality was 0.6% ( = 21) overall, 0.3% ( = 8) after RALP, and 1.5% ( = 13) after RRP. The nonrandomized design is a limitation.
No significant difference was observed for cancer recurrence rate between RALP and RRP 6 yr after surgery. However, in a subgroup analysis, we found a significant benefit for RALP regarding recurrence rate in the high-risk group. Larger studies with longer follow-up are needed to make a firm conclusion and to evaluate a possible survival benefit.
In general, the oncological outcome is comparable between robotic and open radical prostatectomy 6 yr after surgery. For high-risk patients, our findings indicate that there is an advantage for robotics, but further studies with longer follow-up time is needed to make a firm conclusion.
缺乏确凿证据表明机器人辅助腹腔镜前列腺切除术（RALP）在肿瘤学结局方面优于耻骨后根治性前列腺切除术（RRP）。
比较RALP和RRP的疾病复发情况，并报告术后6年的死亡率。
设计、地点和参与者：2008年至2011年间，共有4003例局限性前列腺癌男性患者纳入了腹腔镜前列腺切除术机器人开放手术（LAPPRO）——一项在14个瑞典中心进行的前瞻性、对照、非随机试验。
在术后3个月、12个月和24个月的随访及患者问卷调查中收集数据，并在6年时通过结构化电话访谈收集数据。死亡原因从瑞典国家死亡原因登记处获取。采用改良泊松回归方法进行分析。
在对患者、肿瘤和外科医生相关的混杂因素进行调整后，RALP和RRP在生化复发率（14%对16%，相对风险[RR]0.77，95%置信区间[CI]0.56 - 1.06）或未治愈终点（22%对23%，RR 0.82，95%CI 0.6 - 1.11）方面未观察到统计学上的显著差异。按达米科风险组分层，RALP在高危患者的疾病复发方面存在显著益处（RR 0.47，95%CI 0.26 - 0.86，P = 0.02）。全因死亡率为3%（n = 96）。前列腺癌特异性死亡率总体为0.6%（n = 21），RALP术后为0.3%（n = 8），RRP术后为1.5%（n = 13）。非随机设计是一个局限性。
术后6年，RALP和RRP在癌症复发率方面未观察到显著差异。然而，在亚组分析中，我们发现RALP在高危组的复发率方面有显著益处。需要进行更大规模、更长随访时间的研究才能得出确凿结论并评估可能的生存益处。
总体而言，机器人辅助根治性前列腺切除术和开放性根治性前列腺切除术术后6年的肿瘤学结局相当。对于高危患者，我们的研究结果表明机器人手术有优势，但需要更长随访时间的进一步研究才能得出确凿结论。
