Kim Isaac Yi, Mitrofanova Antonina, Panja Sukanya, Sterling Joshua, Srivastava Arnav, Kim Juliana, Kim Sinae, Singer Eric A, Jang Thomas L, Ghodoussipour Saum, Saraiya Biren, Mayer Tina, Sabaawy Hatem E, Yuh Bertram, Byun Seok Soo, Kim Wun-Jae, Horie Shigeo
Section of Urologic Oncology, Rutgers Cancer Institute of New Jersey and Division of Urology, Rutgers Robert Wood Johnson Medical School, Rutgers, the State University of New Jersey, New Brunswick, NJ, USA.
Department of Health Informatics, School of Health Related Professions, Rutgers Biomedical and Health Sciences, Rutgers University, Newark, NJ, USA.
Prostate Int. 2022 Jun;10(2):75-79. doi: 10.1016/j.prnil.2022.03.001. Epub 2022 Mar 9.
Approximately 7% of patients with newly diagnosed prostate cancer (PCa) in the US will have have metastatic disease. The dogma that there is no role for surgery in this population has been questioned recently. Here we report long-term outcomes of a phase 1 clinical trial on cytoreductive radical prostatectomy.
This is a multicenter phase 1 trial. The major inclusion criterion was biopsy proven N1M0 or NxM1a/b PCa. Primary end point was the Clavien-Dindo-based major complication rate. Secondary outcomes were biochemical progression and overall survival. RNA-seq correlative study was conducted in nine select cases as a pilot study.
Final accrual was 32 patients of which 25 and 7 were cNxM1 and cN1M0, respectively. With the median follow-up of 46 months (interquartile range 31.7 - 52.7 months), 25 out of the 32 patients (75%) were alive at the time of last contact. There were three disparate groups based on the oncologic outcome: favorable, intermediate, and poor. In seven men with favorable response, androgen deprivation therapy was switched to intermittent approach and five remain free of any evidence of disease after more than two years off all systemic therapy with the normalization of serum testosterone. Of these five patients, three had M1 disease. Long-term use of one pad or less per day was 80%. RNA-seq analysis revealed an enriched downregulation of tumor necrosis factor (TNF)-α signature in the favorable group.
Overall long-term oncologic outcome of cytoreductive radical prostatectomy was significantly higher than historical results. Importantly, the combination of surgery with systemic therapy may result in a long durable response in a minority of men who present with metastatic PCa.
在美国，约7%新诊断的前列腺癌（PCa）患者会出现转移性疾病。手术在此类患者中无作用的传统观念最近受到了质疑。在此，我们报告一项关于减瘤性根治性前列腺切除术的1期临床试验的长期结果。
这是一项多中心1期试验。主要纳入标准为经活检证实为N1M0或NxM1a/b期PCa。主要终点是基于Clavien-Dindo分级的主要并发症发生率。次要结局为生化进展和总生存期。对9例选定病例进行了RNA测序相关性研究作为一项探索性研究。
最终入组32例患者，其中cNxM1和cN1M0分别为25例和7例。中位随访46个月（四分位间距31.7 - 52.7个月），32例患者中有25例（75%）在最后一次随访时存活。根据肿瘤学结局有三个不同的组：良好、中等和不良。在7例反应良好的男性中，雄激素剥夺治疗改为间歇性治疗，5例在停用所有全身治疗且血清睾酮恢复正常两年多后仍无任何疾病证据。在这5例患者中，3例有M1期疾病。长期每天使用一个或更少尿垫的比例为80%。RNA测序分析显示，良好组中肿瘤坏死因子（TNF）-α特征的下调更为明显。
减瘤性根治性前列腺切除术的总体长期肿瘤学结局显著高于既往结果。重要的是，手术与全身治疗相结合可能会使少数转移性PCa患者产生长期持久反应。
