Neoadjuvant Cabazitaxel plus Abiraterone/Leuprolide Acetate in Patients with High-Risk Prostate Cancer: ACDC-RP Phase II Trial

被引：6

作者：

Fleshner, Neil E. ^{[1
]}

Sayyid, Rashid K. ^{[1
,10
]}

Hansen, Aaron R. ^{[2
]}

Chin, Joseph L. K. ^{[3
]}

Fernandes, Ricardo ^{[4
]}

Winquist, Eric ^{[4
]}

van der Kwast, Theodorus ^{[5
]}

Sweet, Joan ^{[5
]}

Lajkosz, Katherine ^{[6
]}

Kenk, Miran ^{[1
]}

Hersey, Karen ^{[1
]}

Veloso, Rosette ^{[1
]}

Berlin, Doron ^{[1
]}

Herrera-Caceres, Jaime O. ^{[1
]}

Sridhar, Srikala ^{[2
]}

Moussa, Madeleine ^{[7
]}

Finelli, Antonio ^{[1
]}

Hamilton, Robert J. ^{[1
]}

Kulkarni, Girish S. ^{[1
]}

Zlotta, Alexandre R. ^{[8
]}

Joshua, Anthony M. ^{[9
]}

机构：

[1] Univ Hlth Network, Princess Margaret Canc Ctr, Div Urol Oncol, Toronto, ON, Canada

[2] Princess Margaret Canc Ctr, Div Med Oncol & Hematol, Toronto, ON, Canada

[3] Western Univ, Dept Surg, Div Urol, London, ON, Canada

[4] Western Univ, London Hlth Sci Ctr, Schulich Sch Med & Dent, Div Med Oncol,Dept Oncol, London, ON, Canada

[5] Univ Toronto, Dept Lab Med & Pathobiol, Toronto, ON, Canada

[6] Univ Toronto, Dept Biostat, Toronto, ON, Canada

[7] Western Univ, Dept Pathol & Lab Med, London, ON, Canada

[8] Sinai Hlth Syst, Dept Surg, Urol, Toronto, ON, Canada

[9] St Vincents Hosp, Garvan Inst Med Res, Kinghorn Canc Ctr, Sydney, Australia

[10] Univ Toronto, Princess Margaret Canc Ctr, 700 Univ Ave, Toronto, ON M5G 1Z5, Canada

来源：

CLINICAL CANCER RESEARCH | 2023年 / 29卷 / 19期

关键词：

RADICAL PROSTATECTOMY; BONE-MARROW; SUPPRESSION; THERAPY; CELLS;

D O I：

10.1158/1078-0432.CCR-23-0731

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：3867 / 3874

页数：8

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