University of California San Diego, La Jolla, California.
Dana-Farber Cancer Institute, Boston, Massachusetts.
J Urol. 2021 Jun;205(6):1689-1697. doi: 10.1097/JU.0000000000001632. Epub 2021 Jan 27.
We report on the post-radical prostatectomy outcomes of patients enrolled in 3 randomized, multicenter, clinical trials of intense neoadjuvant androgen deprivation therapy prior radical prostatectomy.
All patients included were enrolled in trials evaluating intense androgen deprivation therapy followed by radical prostatectomy. The primary end point was time to biochemical recurrence, defined as the time from radical prostatectomy to prostate specific antigen >0.1 ng/ml or start of first post-radical prostatectomy therapy, stratified by pathological response at radical prostatectomy (presence or absence of exceptional pathological response defined as residual tumor at radical prostatectomy measuring 0-5 mm). Secondary end points included metastasis-free survival, overall survival, and time to testosterone recovery.
Overall, 117 patients were included in the analysis, of whom 78.6% (92) had high risk disease. Following neoadjuvant therapy, 21.4% (25) had 0-5 mm of residual tumor, including 9.4% (11) with a pathological complete response. Overall, 49 patients (41.9%) experienced biochemical recurrence and the 3-year biochemical recurrence-free rate was 59.1% (95% CI 49.0-67.9). Of the 25 patients with an exceptional pathological response, 2 patients (8.0%) developed biochemical recurrence while 51.1% of nonresponders (47/92) developed biochemical recurrence. Testosterone recovery was observed in 93.8% of patients (106/113). PTEN loss and intraductal carcinoma were associated with shorter time to biochemical recurrence.
In this pooled analysis of prospective trials, we demonstrate that exceptional pathological response following neoadjuvant therapy is associated with a favorable impact on biochemical recurrence. PTEN loss and intraductal carcinoma were associated with biochemical recurrence. Additional followup is warranted to evaluate the impact on long-term outcomes.
我们报告了 3 项随机、多中心临床试验中接受强化新辅助雄激素剥夺治疗后行根治性前列腺切除术患者的术后结果。
所有纳入的患者均参加了评估强化雄激素剥夺治疗后行根治性前列腺切除术的临床试验。主要终点是生化复发时间，定义为从根治性前列腺切除术到前列腺特异性抗原 >0.1ng/ml 或首次根治性前列腺切除术后治疗开始的时间，按根治性前列腺切除术后病理反应（是否存在异常病理反应，定义为根治性前列腺切除术后残留肿瘤为 0-5mm）分层。次要终点包括无转移生存、总生存和睾酮恢复时间。
总体而言，117 例患者纳入分析，其中 78.6%（92 例）患有高危疾病。新辅助治疗后，21.4%（25 例）有 0-5mm 的残留肿瘤，其中 9.4%（11 例）为病理完全缓解。总体而言，49 例患者（41.9%）发生生化复发，3 年生化无复发生存率为 59.1%（95%CI 49.0-67.9）。在 25 例异常病理反应患者中，2 例（8.0%）发生生化复发，而无反应者（92 例中的 47 例）中有 51.1%发生生化复发。93.8%的患者（106/113）出现睾酮恢复。PTEN 缺失和导管内癌与生化复发时间较短相关。
在这项前瞻性试验的汇总分析中，我们表明新辅助治疗后出现异常病理反应与生化复发的改善有关。PTEN 缺失和导管内癌与生化复发相关。需要进一步随访以评估对长期结果的影响。
