Baciarello Giulia, Özgüroğlu Mustafa, Mundle Suneel, Leitz Gerhard, Richarz Ute, Hu Peter, Feyerabend Susan, Matsubara Nobuaki, Chi Kim N, Fizazi Karim
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.
Eur J Cancer. 2022 Feb;162:56-64. doi: 10.1016/j.ejca.2021.11.026. Epub 2021 Dec 23.
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).
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.
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).
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.
ClinicalTrials.gov, number NCT01715285.
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。
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。
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）。
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。
ClinicalTrials.gov，编号NCT01715285。
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