新辅助卡巴他赛加阿比特龙/亮丙瑞林在高危前列腺癌患者中的应用：ACDC-RP Ⅱ期试验。
Neoadjuvant Cabazitaxel plus Abiraterone/Leuprolide Acetate in Patients with High-Risk Prostate Cancer: ACDC-RP Phase II Trial.
机构信息
Division of Urologic Oncology, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
出版信息
Clin Cancer Res. 2023 Oct 2;29(19):3867-3874. doi: 10.1158/1078-0432.CCR-23-0731.
PURPOSE
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.
PATIENTS AND METHODS
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.
RESULTS
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).
CONCLUSIONS
Neoadjuvant cabazitaxel addition to abiraterone acetate/leuprolide acetate prior to radical prostatectomy did not improve pCR/MRD in clinically localized, high-risk prostate cancer.
目的
新辅助治疗的早期强化治疗可能会改善接受根治性前列腺切除术治疗的高危局限性前列腺癌患者的结局。我们的目的是比较局部高危前列腺癌患者接受新辅助阿比特龙醋酸酯联合亮丙瑞林醋酸酯联合或不联合卡巴他赛治疗前的病理、肿瘤学和安全性结局。
患者和方法
这是一项开放标签、多中心、二期试验，将临床局限性、D'Amico 高危前列腺癌患者随机分配至新辅助阿比特龙醋酸酯（1000mg/天）和亮丙瑞林醋酸酯（每 3 个月 22.5mg）联合或不联合卡巴他赛（25mg/m2）治疗，然后行根治性前列腺切除术。主要结局是病理完全缓解（pCR）或微小残留疾病（MRD）。次要结局包括手术切缘、淋巴结受累、病理分期、12 个月生化无复发生存率（BRFS）和安全性特征。
结果
按方案人群包括 70 例患者[卡巴他赛组（Arm A）：37 例，无卡巴他赛组（Arm B）：33 例]。中位患者年龄和前列腺特异性抗原水平分别为 63.5 岁[四分位间距（IQR），58.0-68.0]和 21.9ng/mL（IQR，14.6-42.8）。pCR/MRD 分别发生在 Arm A 和 B 的 16 例（43.2%）和 15 例（45.5%）患者（P=0.85）。pCR 分别发生在 Arm A 和 B 的 2 例（5.4%）和 3 例（9.1%）患者（P=0.66）。活检标本中阳性核心比例≤25%的患者发生 pCR/MRD 的可能性增加（P=0.04）。发生 pCR/MRD 的患者 12 个月 BRFS 率更高（96.0% vs. 62.0%，P=0.03）。Arm A 和 B 的 3+级不良事件发生率分别为 42.5%和 23.7%（P=0.078）。
结论
在临床局限性、高危前列腺癌患者中，新辅助卡巴他赛联合阿比特龙醋酸酯/亮丙瑞林醋酸酯治疗并不能提高 pCR/MRD。
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