他拉唑帕利联合恩杂鲁胺对比奥拉帕利联合醋酸阿比特龙及尼拉帕利联合醋酸阿比特龙用于转移性去势抵抗性前列腺癌：一项匹配调整间接比较
Talazoparib plus enzalutamide versus olaparib plus abiraterone acetate and niraparib plus abiraterone acetate for metastatic castration-resistant prostate cancer: a matching-adjusted indirect comparison.
作者信息
Castro Elena, Wang Di, Walsh Sarah, Craigie Samantha, Haltner Anja, Nazari Jonathan, Niyazov Alexander, Samjoo Imtiaz A
机构信息
Hospital Universitario 12 de Octubre, Madrid, Spain.
EVERSANA™, Burlington, ON, Canada.
出版信息
Prostate Cancer Prostatic Dis. 2024 Dec 7. doi: 10.1038/s41391-024-00924-x.
BACKGROUND
Without head-to-head trials between talazoparib+enzalutamide (TALA + ENZA), olaparib+abiraterone acetate (OLAP + AAP), and niraparib plus AAP (NIRA + AAP) the ability to evaluate their relative efficacy as first-line (1 L) treatment in metastatic castration-resistant prostate cancer (mCRPC) is limited. The objective of this study was to assess the relative efficacy between TALA + ENZA (TALAPRO-2) versus OLAP + AAP (PROpel) and NIRA + AAP (MAGNITUDE) in 1 L mCRPC via a matching-adjusted indirect treatment comparison (MAIC).
METHODS
Patient-level data from TALAPRO-2 and published data from PROpel and MAGNITUDE were used. TALAPRO-2 data were reweighted to satisfy the eligibility criteria for PROpel and MAGNITUDE. Talazoparib (0.5 mg/day) plus enzalutamide (160 mg/day) was compared to olaparib (300 mg twice daily) plus abiraterone acetate (1000 mg/day) and niraparib (200 mg/day) plus abiraterone acetate (1000 mg/day). Hazard ratios (HRs) were calculated for radiographic progression-free survival (rPFS) and overall survival (OS), and odds ratios (ORs) for prostate-specific antigen (PSA) response and objective response rate (ORR). Additional efficacy outcomes were assessed.
RESULTS
In all-comers, TALA + ENZA was statistically superior to OLAP + AAP for rPFS (HR: 0.727; 95% confidence interval [CI]: 0.565, 0.935) and PSA response (OR: 1.663; 1.101, 2.510), and numerically favored for OS (HR: 0.847; 0.667, 1.076) and ORR (OR: 1.109; 0.646, 1.903). In patients with homologous recombination repair mutations (HRRm), relative to NIRA + AAP, TALA + ENZA was statistically superior for rPFS (HR: 0.460; 0.280, 0.754), and numerically favored for OS (HR: 0.601; 0.347, 1.041) and ORR (OR: 1.524; 0.579, 4.016).
CONCLUSIONS
Results suggest that TALA + ENZA may provide improvements in clinical outcomes relative to OLAP + AAP and NIRA + AAP in 1 L mCRPC; however, inherent limitations associated with the complexity of the analyses must be considered.
背景
由于缺乏他拉唑帕利+恩杂鲁胺（TALA + ENZA）、奥拉帕利+醋酸阿比特龙（OLAP + AAP）和尼拉帕利+醋酸阿比特龙（NIRA + AAP）之间的头对头试验，评估它们作为转移性去势抵抗性前列腺癌（mCRPC）一线（1L）治疗的相对疗效的能力有限。本研究的目的是通过匹配调整间接治疗比较（MAIC）评估TALA + ENZA（TALAPRO-2）与OLAP + AAP（PROpel）和NIRA + AAP（MAGNITUDE）在1L mCRPC中的相对疗效。
方法
使用来自TALAPRO-2的患者水平数据以及来自PROpel和MAGNITUDE的已发表数据。对TALAPRO-2数据进行重新加权，以满足PROpel和MAGNITUDE的纳入标准。将他拉唑帕利（0.5mg/天）+恩杂鲁胺（160mg/天）与奥拉帕利（300mg，每日两次）+醋酸阿比特龙（1000mg/天）以及尼拉帕利（200mg/天）+醋酸阿比特龙（1000mg/天）进行比较。计算影像学无进展生存期（rPFS）和总生存期（OS）的风险比（HR），以及前列腺特异性抗原（PSA）反应和客观缓解率（ORR）的比值比（OR）。评估其他疗效结果。
结果
在所有受试者中，TALA + ENZA在rPFS（HR：0.727；95%置信区间[CI]：0.565，0.935）和PSA反应（OR：1.663；1.101，2.510）方面在统计学上优于OLAP + AAP，在OS（HR：0.847；0.667，1.076）和ORR（OR：1.109；0.646，1.903）方面数值上更有利。在同源重组修复突变（HRRm）患者中，相对于NIRA + AAP，TALA + ENZA在rPFS方面在统计学上更优（HR：0.460；0.280，0.754），在OS（HR：0.601；0.347，1.041）和ORR（OR：1.
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