治疗后 4 周的前列腺特异性抗原早期水平与晚期前列腺癌的阿比特龙和恩杂鲁胺治疗：一项国际协作分析。
Early Post-treatment Prostate-specific Antigen at 4 Weeks and Abiraterone and Enzalutamide Treatment for Advanced Prostate Cancer: An International Collaborative Analysis.
机构信息
The Institute of Cancer Research, Sutton, UK; The Royal Marsden NHS Foundation Trust, Sutton, UK; University of Naples Federico II, Naples, Italy.
Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.
出版信息
Eur Urol Oncol. 2020 Apr;3(2):176-182. doi: 10.1016/j.euo.2019.06.008. Epub 2019 Jul 13.
BACKGROUND
Declines in prostate-specific antigen (PSA) levels at 12wk are used to evaluate treatment response in metastatic castration-resistant prostate cancer (mCRPC). PSA fall by ≥30% at 4wk (PSA4w30) has been reported to be associated with better outcome in a single-centre cohort study.
OBJECTIVE
To evaluate clinical relevance of early PSA decline in mCRPC patients treated with next-generation hormonal treatments (NGHTs) such as abiraterone and enzalutamide.
DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective multicentre analysis. Eligible patients received NGHT for mCRPC between 6 January 2006 and 31 December 2017 in 13 cancer centres worldwide, and had PSA levels assessed at baseline and at 4 and/or 12wk after treatment. PSA response was defined as a ≥30% decline (progression as a ≥25% increase) from baseline.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Association with overall survival (OS) was analysed using landmark multivariable Cox regression adjusting for previous chemotherapy, including cancer centre as a shared frailty term.
RESULTS AND LIMITATIONS
We identified 1358 mCRPC patients treated with first-line NGHT (1133 had PSA available at 4wk, and 948 at both 4 and 12wk). Overall, 583 (52%) had a PSA4w30; it was associated with longer OS (median: 23; 95% confidence interval [CI]: 21-25) compared with no change (median: 17; 95% CI: 15-18) and progression (median: 13; 95% CI: 10-15). A PSA12w30 was associated with lower mortality (median OS 22 vs 14; hazard ratio=0.57; 95% CI=0.48-0.67; p<0.001). PSA4w30 strongly correlated with PSA12w30 (ρ=0.91; 95% CI=0.90-0.92; p<0.001). In total, 432/494 (87%) with a PSA4w30 achieved a PSA12w30. Overall, 11/152 (7%) patients progressing at 4wk had a PSA12w30 (1% of the overall population).
CONCLUSIONS
PSA changes in the first 4wk of NGHT therapies are strongly associated with clinical outcome from mCRPC and can help guide early treatment switch decisions.
PATIENT SUMMARY
Prostate-specific antigen changes at 4wk after abiraterone/enzalutamide treatment are important to determine patients' outcome and should be taken into consideration in clinical practice.
背景
在转移性去势抵抗性前列腺癌（mCRPC）中，12 周时前列腺特异性抗原（PSA）水平的下降用于评估治疗反应。据报道，4 周时 PSA 下降≥30%（PSA4w30）与单中心队列研究中的更好结局相关。
目的
评估下一代激素治疗（NGHT）如阿比特龙和恩扎卢胺治疗 mCRPC 患者早期 PSA 下降的临床相关性。
设计、地点和参与者：这是一项回顾性多中心分析。符合条件的患者在全球 13 个癌症中心于 2006 年 1 月 6 日至 2017 年 12 月 31 日期间接受 NGHT 治疗 mCRPC，并且在基线以及治疗后 4 和/或 12 周时评估了 PSA 水平。PSA 反应定义为与基线相比下降≥30%（进展定义为≥25%增加）。
测量和统计分析结果
使用 landmark 多变量 Cox 回归分析与总生存（OS）的相关性，调整了先前的化疗，包括将癌症中心作为共同脆弱性项。
结果和局限性
我们确定了 1358 名接受一线 NGHT 治疗的 mCRPC 患者（1133 名患者在 4 周时具有 PSA 数据，948 名患者在 4 和 12 周时均具有 PSA 数据）。总体而言，583 名患者（52%）出现 PSA4w30；与无变化（中位：23；95%置信区间 [CI]：21-25）和进展（中位：13；95%CI：10-15）相比，它与更长的 OS 相关。PSA12w30 与较低的死亡率相关（中位 OS 22 与 14；风险比=0.57；95%CI=0.48-0.67；p<0.001）。PSA4w30 与 PSA12w30 强烈相关（ρ=0.91；95%CI=0.90-0.92；p<0.001）。总共，432/494（87%）出现 PSA4w30 的患者实现了 PSA12w30。总体而言，4 周时进展的 152 名患者中有 11 名（总体人群的 7%）出现 PSA12w30。
结论
NGHT 治疗后前 4 周的 PSA 变化与 mCRPC 的临床结局密切相关，有助于指导早期治疗转换决策。
患者总结
阿比特龙/恩扎卢胺治疗后 4 周时的前列腺特异性抗原变化对于确定患者的预后很重要，应在临床实践中加以考虑。
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