BACKGROUND LATITUDE, a randomized, double-blind trial, compared abiraterone acetate and prednisone (AAP) + androgen deprivation therapy (ADT) versus placebo (PBO) + ADT in high-risk metastatic castration-sensitive prostate cancer (mCSPC). OBJECTIVE To assess the correlation of prostate-specific antigen (PSA) kinetics with overall survival (OS) and radiological progression-free survival (rPFS). DESIGN, SETTING, AND PARTICIPANTS A post hoc analysis of data from 597 men receiving AAP + ADT and 602 receiving PBO + ADT. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The associations of PSA-related outcomes (rates of confirmed 50% [PSA50] and 90% [PSA90] decline from baseline PSA [Prostate Cancer Working Group 2 criteria], rates of PSA < 0.2 ng/ml, median nadir PSA, time to PSA nadir [TPN], and time to PSA progression [TPP] with long-term outcomes [OS and rPFS]) were evaluated. Hazard ratios (HRs) were estimated using Cox proportional hazard model. Correlations of TPP with coprimary endpoints rPFS and OS were evaluated using Kendall's tau (KT). RESULTS AND LIMITATIONS AAP + ADT significantly delayed median TPP versus PBO + ADT (33.2 vs 7.4 mo; HR: 0.3, p <  0.001). TPP correlated with rPFS (KT = 0.921) and OS (KT = 0.666). In the AAP + ADT group, 91% had PSA50 and 79% had PSA90 responses (relative risk [RR]: 1.36 and 2.30, respectively; p <  0.001 for both comparisons vs PBO + ADT). Compared with nonresponders, PSA50 and PSA90 responders had reduced risk of death (RR: 0.44 and 0.12, respectively). At 6 mo, 40% receiving AAP + ADT and 6.5% receiving PBO + ADT achieved PSA ≤0.1 ng/ml, which was significantly associated with longer rPFS and OS. Median nadir PSA was 0.09 ng/ml with AAP + ADT versus 2.36 ng/ml with PBO + ADT. Median TPN (AAP + ADT, 6.4 mo; PBO + ADT, 3.8 mo) positively correlated with rPFS and OS. CONCLUSIONS Superior PSA response dynamics with AAP + ADT versus ADT + PBO strongly correlated with long-term outcomes of rPFS and OS in high-risk mCSPC. PATIENT SUMMARY We found that low prostate-specific antigen levels (≤0.1 ng/ml) after 6 mo may indicate a good long-term response to treatment. Our results need confirmation.

中文翻译：

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醋酸阿比特龙+泼尼松或安慰剂治疗雄激素剥夺治疗的转移性去势敏感性前列腺癌中前列腺特异性抗原动力学与总生存和无放射进展生存的相关性：LATITUDE 3期研究的事后分析。

背景LATITUDE是一项随机，双盲试验，比较了高危转移性去势敏感性前列腺癌（mCSPC）中的醋酸阿比特龙和泼尼松（AAP）+雄激素剥夺疗法（ADT）与安慰剂（PBO）+ ADT的比较。目的评估前列腺特异性抗原（PSA）动力学与总生存期（OS）和放射学无进展生存期（rPFS）的相关性。设计，地点和参与者对597名接受AAP + ADT的男性和602名接受PBO + ADT的男性的数据进行事后分析。结果测量和统计分析PSA相关结局的相关性（确诊的50％[PSA50]和90％[PSA90]的比率从基线PSA [前列腺癌第2组标准]下降，PSA的比率<0.2 ng / ml，中位数最低点PSA，达到最低点[TPN]的时间，评估PSA进展的时间[TPP]和长期结果[OS和rPFS]）。危险比（HRs）使用Cox比例危险模型估算。使用Kendall's tau（KT）评估了TPP与共主要终点rPFS和OS的相关性。结果与局限性AAP + ADT显着延迟了TPP的中位值相对于PBO + ADT（33.2 vs 7.4 mo； HR：0.3，p <0.001）。TPP与rPFS（KT = 0.921）和OS（KT = 0.666）相关。在AAP + ADT组中，有91％的患者具有PSA50反应，而79％的患者具有PSA90反应（相对危险度[RR]：分别为1.36和2.30；与PBO + ADT相比，两者的p <0.001）。与无反应者相比，PSA50和PSA90反应者的死亡风险降低了（RR：分别为0.44和0.12）。在6 mo时，接受AAP + ADT的40％和接受PBO + ADT的6.5％的PSA≤0.1ng / ml，这与更长的rPFS和OS显着相关。AAP + ADT的最低中位PSA为0.09 ng / ml，而PBO + ADT的平均中位PSA为2.36 ng / ml。TPN中值（AAP + ADT，6.4 mo； PBO + ADT，3.8 mo）与rPFS和OS正相关。结论在高风险mCSPC中，AAP + ADT与ADT + PBO相比，出色的PSA反应动力学与rPFS和OS的长期预后密切相关。病人总结我们发现6个月后前列腺特异性抗原水平低（≤0.1ng / ml）可能表明对治疗有良好的长期反应。我们的结果需要确认。结论在高风险mCSPC中，AAP + ADT与ADT + PBO相比，优越的PSA反应动力学与rPFS和OS的长期预后密切相关。病人总结我们发现6个月后前列腺特异性抗原水平低（≤0.1ng / ml）可能表明对治疗有良好的长期反应。我们的结果需要确认。结论在高风险mCSPC中，AAP + ADT与ADT + PBO相比，出色的PSA反应动力学与rPFS和OS的长期预后密切相关。病人总结我们发现6个月后前列腺特异性抗原水平低（≤0.1ng / ml）可能表明对治疗有良好的长期反应。我们的结果需要确认。