Garvan Institute of Medical Research & The Kinghorn Cancer Centre, 370 Victoria Street, Sydney, NSW, 2010, Australia.
St Vincent's Prostate Cancer Centre, Sydney, NSW, Australia.
World J Urol. 2018 Sep;36(9):1383-1389. doi: 10.1007/s00345-018-2281-z. Epub 2018 Mar 28.
The design, conduct and completion of randomized trials for curative prostate cancer (PCa) treatments are challenging. To evaluate the effect of robot-assisted radical prostatectomy (RARP) versus focal irreversible electroporation (IRE) on patient-reported quality of life (QoL) and early oncological control using propensity-scored matching.
Patients with T1c-cT2b significant PCa (high-volume ISUP 1 or any 2/3) who received unifocal IRE were pair-matched to patients who received nerve-sparing RARP. Patient-reported outcomes were prospectively assessed using the Expanded Prostate Cancer Index Composite (EPIC), AUA symptom score and Short Form of Health Survey (SF-12) physical and mental components. Oncological failure was defined as biochemical recurrence (RARP) or positive follow-up biopsies (IRE). Generalized mixed-effect models were used to compare IRE and RARP.
50 IRE patients were matched to 50 RARP patients by propensity score. IRE was significantly superior to RARP in preserving pad-free continence (UC) and erections sufficient for intercourse (ESI). The absolute differences were 44, 21, 13, 14% for UC and 32, 46, 27, 22% for ESI at 1.5, 3, 6, and 12 months, respectively. The EPIC summary scores showed no statistically significant differences. Urinary symptoms were reduced for IRE and RARP patients at 12 months, although IRE patient initially had more complaints. IRE patients experienced more early oncological failure than RARP patients.
These data demonstrated the superior preservation of UC and ESI with IRE compared to RARP up to 12 months after treatment. Long-term oncological data are warranted to provide ultimate proof for or against focal therapy.
治愈性前列腺癌(PCa)治疗的随机试验的设计、实施和完成具有挑战性。使用倾向评分匹配评估机器人辅助根治性前列腺切除术(RARP)与局灶性不可逆电穿孔(IRE)对患者报告的生活质量(QoL)和早期肿瘤控制的影响。
接受单灶 IRE 治疗的 T1c-cT2b 局限性高容量 ISUP1 或任何 2/3 前列腺癌(PCa)患者与接受神经保留 RARP 治疗的患者进行配对。使用扩展前列腺癌指数复合量表(EPIC)、AUA 症状评分和健康调查简表(SF-12)的身体和精神成分,前瞻性评估患者报告的结果。肿瘤学失败定义为生化复发(RARP)或阳性随访活检(IRE)。使用广义混合效应模型比较 IRE 和 RARP。
通过倾向评分对 50 例 IRE 患者和 50 例 RARP 患者进行了匹配。IRE 在保持无垫控尿(UC)和性交足够勃起(ESI)方面明显优于 RARP。在 1.5、3、6 和 12 个月时,UC 的绝对差异分别为 44、21、13、14%,ESI 的绝对差异分别为 32、46、27、22%。EPIC 综合评分无统计学差异。IRE 和 RARP 患者的尿症状在 12 个月时均有所改善,尽管 IRE 患者最初的抱怨更多。IRE 患者的早期肿瘤学失败率高于 RARP 患者。
这些数据表明,与 RARP 相比,IRE 在治疗后 12 个月内 UC 和 ESI 的保存更具优势。需要长期的肿瘤学数据来提供对局部治疗的最终证明或反对。