Rodriguez-Rivera J A, Rodriguez-Lay R, Zegarra-Montes L, Benzaghou F, Gaillac B, Azzouzi A R, Reis L O, Palma P
Departamento de Urología, Hospital General de Occidente, S.S.J., Guadalajara, Jalisco, México.
Departamento de Urología, Complejo Metropolitano, Caja de Seguro Social, Panamá, República de Panamá.
Actas Urol Esp (Engl Ed). 2018 Dec;42(10):632-638. doi: 10.1016/j.acuro.2018.02.009. Epub 2018 Apr 23.
To explore the proportion of patients with higher risk localized prostate cancer (PCa) that would become safely biopsy negative 12 months after non-thermal focal therapy with padeliporfin vascular-targeted photodynamic therapy (VTP).
Multicenter study in a scenario of prostate-specific antigen (PSA) ≤20ng/ml and variable PCa target volumes Gleason pattern 3 or low-volume secondary Gleason pattern 4, all patients received VTP, consisting of intravenous 4mg/kg padeliporfin activated by light-diffusing fibers in the prostate. The prostate was biopsied at baseline, months 6 and 12, PSA, patient-reported functional outcomes and quality of life (QoL) questionnaires were recorded at baseline, months 3, 6, and 12 and adverse events (AE) throughout the study.
In the intention-to-treat population (n=81), the proportion of patients with negative biopsies at month 12 was 74% (60/81 patients; 95% CI: 63.1%,83.2%). In the per-protocol population, the proportion was 79% (58/73 patients; 95% CI: 68.4%,88.0%). Questionnaire results indicated a slight improvement in urinary function and limited deterioration in sexual function. No difference in QoL was observed over time. A total of 42/81 (52%) patients reported mild or moderate and 4 of 81 (4.9%) experienced serious AE, all resolved without sequelae. No phototoxicity, cardiovascular event, fistula or prolonged urinary incontinence, secondary cancer or death was reported.
Results support the efficacy, safety, and QoL associated with padeliporfin focal treatment for low/intermediate risk localized PCa.
探讨采用帕德立卟啉血管靶向光动力疗法（VTP）进行非热聚焦治疗后12个月，高危局限性前列腺癌（PCa）患者活检结果安全转阴的比例。
多中心研究，纳入前列腺特异性抗原（PSA）≤20ng/ml且前列腺癌靶体积可变、Gleason模式为3或低体积继发性Gleason模式为4的患者，所有患者均接受VTP治疗，即静脉注射4mg/kg帕德立卟啉，通过前列腺内的光扩散纤维激活。在基线、第6个月和第12个月时对前列腺进行活检，在基线、第3个月、第6个月和第12个月记录PSA、患者报告的功能结局和生活质量（QoL）问卷，并在整个研究过程中记录不良事件（AE）。
在意向性治疗人群（n=81）中，第12个月活检结果为阴性的患者比例为74%（60/81例患者；95%CI：63.1%，83.2%）。在符合方案人群中，该比例为79%（58/73例患者；95%CI：68.4%，88.0%）。问卷结果显示，排尿功能略有改善，性功能有一定程度的恶化。随时间推移，QoL无差异。共有42/81（52%）例患者报告有轻度或中度AE，81例中有4例（4.9%）发生严重AE，均无后遗症地得到解决。未报告光毒性、心血管事件、瘘管或长期尿失禁、继发性癌症或死亡。
结果支持帕德立卟啉聚焦治疗低/中危局限性PCa的疗效、安全性及QoL。
