醋酸阿比特龙联合泼尼松对去势敏感性前列腺癌合并内脏转移患者四年随访的影响：LATITUDE研究的事后探索性分析
Impact of abiraterone acetate plus prednisone in patients with castration-sensitive prostate cancer and visceral metastases over four years of follow-up: A post-hoc exploratory analysis of the LATITUDE study.
作者信息
Baciarello Giulia, Özgüroğlu Mustafa, Mundle Suneel, Leitz Gerhard, Richarz Ute, Hu Peter, Feyerabend Susan, Matsubara Nobuaki, Chi Kim N, Fizazi Karim
机构信息
Gustave Roussy, University of Paris-Saclay, Villejuif, France; Medical Oncology Department, Fondazione IRCCS Istituto Dei Tumori, Milan, Italy.
Cerrahpaşa Medical Faculty, Istanbul University Cerrahpaşa, Istanbul, Turkey.
出版信息
Eur J Cancer. 2022 Feb;162:56-64. doi: 10.1016/j.ejca.2021.11.026. Epub 2021 Dec 23.
BACKGROUND
A post-hoc analysis of the phase-3 LATITUDE study assessed the impact of abiraterone acetate plus prednisone (AA+P) on overall survival (OS) and radiographic progression-free survival (rPFS) in men with metastatic castration-sensitive prostate cancer (mCSPC) and visceral metastases (VM).
METHODS
Newly diagnosed mCSPC patients were randomized (1:1) to AA+P and androgen deprivation therapy (ADT) or placebo+ADT. Patients with VM in liver or lungs with or without other soft tissue and bone metastases (based on CT/MRI) at baseline were analyzed, after 51.8 months' median follow-up. Co-primary endpoints, OS and rPFS, were analyzed.
RESULTS
Among 1199 patients enrolled, 228 (19%) had VM at baseline (114 each in AA+P and placebo groups), of which 53 (23.2%; AA+P = 29, Placebo = 24) had liver metastases and 117 (51.3%; AA+P = 60, Placebo = 57) had lung metastases. In patients with VM, treatment with AA+P versus placebo showed an improvement in OS (median 55.4 vs 33.0 months; HR = 0.582; 95%CI = 0.406-0.835;P = 0.0029) and rPFS (median 30.7 vs 18.3 months; HR = 0.527; 95%CI = 0.366-0.759;P = 0.0005), comparable to that of patients without VM. AA+P versus placebo in lung metastases patients was associated with greater improvement in OS (HR = 0.60; 95%CI = 0.35-1.04;P = 0.0678) than in liver metastases patients (HR = 0.82; 95%CI = 0.41-1.66;P = 0.5814). AA+P versus placebo showed improvement in rPFS in lung metastases patients (HR = 0.50; 95%CI = 0.29-0.89;P = 0.0157), but not in liver metastases patients (HR = 1.05; 95%CI = 0.53-2.09; P = 0.8970).
CONCLUSION
AA+P treatment improved both rPFS and OS in men with mCSPC and visceral disease, especially those with lung metastases. Men with liver metastases had a poorer prognosis and their optimal treatment remains to be defined.
REGISTRATION
ClinicalTrials.gov, number NCT01715285.
背景
一项针对3期LATITUDE研究的事后分析评估了醋酸阿比特龙联合泼尼松（AA+P）对转移性去势敏感性前列腺癌（mCSPC）合并内脏转移（VM）男性患者总生存期（OS）和影像学无进展生存期（rPFS）的影响。
方法
将新诊断的mCSPC患者随机（1:1）分为AA+P联合雄激素剥夺治疗（ADT）组或安慰剂+ADT组。在中位随访51.8个月后，对基线时存在肝脏或肺部VM且伴有或不伴有其他软组织和骨转移（基于CT/MRI）的患者进行分析。对共同主要终点OS和rPFS进行分析。
结果
在1199例入组患者中，228例（19%）在基线时存在VM（AA+P组和安慰剂组各114例），其中53例（23.2%；AA+P组=29例，安慰剂组=24例）有肝转移，117例（51.3%；AA+P组=60例，安慰剂组=57例）有肺转移。在有VM的患者中，与安慰剂相比，AA+P治疗使OS（中位生存期55.4 vs 33.0个月；HR=0.582；95%CI=0.406-0.835；P=0.0029）和rPFS（中位生存期30.7 vs 18.3个月；HR=0.527；95%CI=0.366-0.759；P=0.0005）均有改善，与无VM的患者相当。与安慰剂相比，AA+P在肺转移患者中的OS改善程度（HR=0.60；95%CI=0.35-1.04；P=0.0678）大于肝转移患者（HR=0.82；95%CI=0.41-1.66；P=0.5814）。与安慰剂相比，AA+P在肺转移患者的rPFS方面有改善（HR=0.50；95%CI=0.29-0.89；P=0.0157），但在肝转移患者中无改善（HR=1.05；95%CI=0.53-2.09；P=0.8970）。
结论
AA+P治疗改善了mCSPC合并内脏疾病男性患者的rPFS和OS，尤其是肺转移患者。肝转移男性患者预后较差，其最佳治疗方案仍有待确定。
注册信息
ClinicalTrials.gov，编号NCT01715285。
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