冷冻消融术治疗≥75岁非转移性前列腺癌患者的疗效分析

Effect of prostate cryoablation in the treatment of elderly patients(≥age of 75 years)with non-metastatic prostate cancer

目的探讨前列腺冷冻消融术单独或联合雄激素剥夺治疗(ADT),对≥75岁非转移性前列腺癌(PCa)患者的有效性及安全性。方法回顾性分析2014年6月—2019年12月在中山大学肿瘤防治中心接受前列腺冷冻消融术的49例≥75岁非转移性(cT_(1)~T_(4)N_(0)M_(0))PCa患者的临床资料。患者中位年龄79(77,82)岁,中位初诊前列腺特异性抗原(PSA)为14.0(8.9,31.4)ng/mL,根据CUA风险分层进行分组,中危组14例(28.6%),高危组35例(71.4%)。18例患者行新辅助ADT,19例患者行辅助ADT,其中有10例既接受新辅助ADT,又接受辅助ADT。统计分析术后并发症、术后4~8周PSA、术后最低PSA、5年无生化复发生存率、5年总体生存率、5年PCa特异性生存率。采用log-rank检验评估生存曲线间的差异。结果所有患者手术均顺利。中位随访48(29,69)个月。术后17例(34.7%)出现阴囊水肿,15例(30.6%)出现尿潴留。1例(2.0%)出现尿失禁,所有患者术后均有勃起功能障碍,无尿道直肠瘘发生。32例(65.3%)出现Clavien-DindoⅠ级并发症,4例(8.2%)出现Ⅲ级并发症。术后4~8周中位PSA为0.082 ng/mL。未接受ADT的22例(44.9%)患者术后中位最低PSA为0.130 ng/mL。5例(10.2%)出现生化复发,5年无生化复发生存率为86.6%。中危组与高危组5年无生化复发生存率比较差异无统计学意义(88.9%vs 85.5%,P=0.662)。5例(10.2%)死亡,5年总体生存率为88.7%,5年PCa特异性生存率为100%。结论前列腺冷冻消融术单独或联合ADT治疗≥75岁非转移性PCa患者的近期肿瘤控制好,严重并发症少,安全性较高,可作为≥75岁非转移性PCa患者的治疗方式之一。在广泛开展此项治疗前,还需要大规模随机对照临床试验的验证。

Objective To explore the effectiveness and safety of prostate cryoablation alone or combined with androgen deprivation therapy(ADT)in the treatment of elderly patients(age≥75 years)with non-metastatic prostate cancer(PCa).Methods The clinical data of 49 elderly patients(age≥75 years)with non-metastatic(cT_(1)-T_(4)N_(0)M_(0))PCa who received prostate cryoablation in the Sun Yat-Sen University Cancer Center from June 2014 to December 2019 were retrospectively analyzed.The median age was 79(77,82)years old,and the median PSA at diagnosis was 14.0(8.9,31.4)ng/mL.Fourteen cases(28.6%)were in the intermediate-risk group and 35(71.4%)cases were in the high-risk group according to the CUA risk classification.Eighteen cases received neoadjuvant ADT,19 cases received adjuvant ADT,and 10 cases received both.Side effects,PSA of 4 to 8 weeks and nadir PSA after cryoablation,as well as 5-year biochemical progression-free survival,5-year overall survival and 5-year cancer specific survival were analyzed.The log-rank test was used to compare survival rates between groups.Results Operations were performed successfully.The median follow-up period was 48(29,69)months.Seventeen cases(34.7%)experienced scrotal edema,and 15 cases(30.6%)experienced urinary retention.Permanent incontinence occurred in 1 case(2.0%).All cases had erectile dysfunction.No urethrorectal fistula occurred in our study.In total,32 cases(65.3%)experienced Clavien-Dindo gradeⅠcomplications,4 cases(8.2%)experienced gradeⅢcomplications.The median PSA of 4 to 8 weeks after cryoablation was 0.082 ng/mL.The median nadir postoperative PSA of 22 cases(44.9%)who received no neoadjuvant or adjuvant ADT was 0.130 ng/mL.Five cases(10.2%)experienced biochemical recurrence.Overall,5-years biochemical progression-free survival was 86.6%.Between intermediate-risk group and high-risk group,the difference of 5-year biochemical progression-free survival was not significant(88.9%vs 85.5%,P=0.662).Five cases(10.2%)died.The 5-year overall survival was 88.7%,and 5-year cancer-specific survival was 100%.Conclusion The short-term effect of cancer control of prostate cryoablation alone or combined with ADT for elderly(age≥75 years)patients with non-metastatic PCa is satisfied,so it could be an alternative for these patients for its low incidence of complications and high safety.However,large prospective randomized controlled trials are needed before it becomes widely applied.