卡巴齐塔塞尔
医学
前列腺癌
醋酸阿比特龙酯
新辅助治疗
泌尿科
四分位间距
前列腺切除术
内科学
紫杉烷
肿瘤科
癌症
外科
雄激素剥夺疗法
乳腺癌
作者
Neil Fleshner,Rashid K. Sayyid,Aaron R. Hansen,Joseph L. Chin,Ricardo Fernandes,Eric Winquist,Theodorus H. van der Kwast,Joan Sweet,Katherine Lajkosz,Miran Kenk,Karen Hersey,Rosette Veloso,Doron Berlin,Jaime O. Herrera-Cáceres,Srikala S. Sridhar,Madeleine Moussa,Antonio Finelli,Robert J. Hamilton,Girish S. Kulkarni,Alexandre R. Zlotta,Anthony M. Joshua
标识
DOI:10.1158/1078-0432.ccr-23-0731
摘要
Early treatment intensification with neoadjuvant therapy may improve outcomes in patients with high-risk, localized prostate cancer treated with radical prostatectomy. Our objective was to compare pathologic, oncologic, and safety outcomes of neoadjuvant abiraterone acetate plus leuprolide acetate with or without cabazitaxel prior to radical prostatectomy in patients with localized, high-risk prostate cancer.This open-label, multicenter, phase II trial randomized men with clinically localized, D'Amico high-risk prostate cancer to neoadjuvant abiraterone acetate (1,000 mg/day) and leuprolide acetate (22.5 mg every 3 months) with or without cabazitaxel (25 mg/m2) prior to radical prostatectomy. The primary outcome was pathologic complete response (pCR) or minimal residual disease (MRD). Secondary outcomes included surgical margins, lymph node involvement, pathologic stage, 12-month biochemical relapse-free survival (BRFS) rates, and safety profile.The per-protocol population consisted of 70 patients [cabazitaxel arm (Arm A): 37, no cabazitaxel arm (Arm B): 33]. Median patient age and prostate-specific antigen levels were 63.5 years [interquartile range (IQR), 58.0-68.0] and 21.9 ng/mL (IQR, 14.6-42.8), respectively. pCR/MRD occurred in 16 (43.2%) versus 15 patients (45.5%) in arms A and B, respectively (P = 0.85). pCR occurred in two (5.4%) versus three patients (9.1%) in arms A and B, respectively (P = 0.66). Patients with ≤ 25% total biopsy cores positive had increased odds of pCR/MRD (P = 0.04). Patients with pCR/MRD had superior 12-month BRFS rates (96.0% vs. 62.0%, P = 0.03). Grade 3+ adverse events occurred in 42.5% and 23.7% of patients in arms A and B, respectively (P = 0.078).Neoadjuvant cabazitaxel addition to abiraterone acetate/leuprolide acetate prior to radical prostatectomy did not improve pCR/MRD in clinically localized, high-risk prostate cancer.