Radiographic Progression With and Without Prostate-Specific Antigen Rise in Patients With Advanced Prostate Cancer Treated With Enzalutamide.

Methods

We conducted a post hoc analysis in two phase III trials (N = 2,551; ARCHES [ClinicalTrials.gov identifier: NCT02677896]; PROSPER [ClinicalTrials.gov identifier: NCT02003924]) for co-occurrence of rPD ± Prostate Cancer Working Group 2/3-defined PSA progression, and rPD ± any PSA rise from baseline/nadir by treatment.

我们在两项III期试验（N = 2,551；ARCHES [ClinicalTrials.gov标识符：NCT02677896]；PROSPER [ClinicalTrials.gov标识符：NCT02003924]）中进行了事后分析，以研究放射学进展（rPD）与前列腺癌工作组2/3定义的PSA进展的共发，以及rPD与从基线/最低点起的任何PSA升高之间的关系。

Kaplan-Meier methods were used for overall survival(OS) outcomes.

使用Kaplan-Meier方法评估总生存(OS)结果。

Results

In ARCHES, 3.5% and 8.5% of 574 patients with mHSPC treated with enzalutamide plus androgen-deprivation therapy (ADT) had no PSA rise or PSA progression at rPD, respectively.

在ARCHES研究中，574名接受恩杂鲁胺联合雄激素剥夺治疗(ADT)治疗的转移性激素敏感性前列腺癌(mHSPC)患者中，分别有3.5%和8.5%的患者在rPD时没有PSA升高或PSA进展。

Of 79 patients with rPD who received enzalutamide plus ADT, 25.3% had no PSA rise and 62.0% did not meet PSA progression criteria compared with 7.4% and 38.3% of 188 patients with rPD treated with ADT alone, respectively.

在接受恩杂鲁胺加ADT治疗的79名rPD患者中，有25.3%的患者PSA未升高，62.0%的患者未达到PSA进展标准，而在仅接受ADT治疗的188名rPD患者中，这两个比例分别为7.4%和38.3%。

In PROSPER, 4.4% and 10.3% of 933 patients with nmCRPC treated with enzalutamide plus ADT had no PSA rise or PSA progression, respectively, at rPD.

在PROSPER研究中，933名接受恩杂鲁胺加ADT治疗的nmCRPC患者中，有4.4%的患者在rPD时PSA未升高，10.3%的患者未达到PSA进展标准。

However, of 187 patients with rPD who received enzalutamide plus ADT, 21.9% had no PSA rise and 51.3% did not meet PSA progression criteria compared with 3.6% and 18.8% of 224 patients treated with placebo/ADT, respectively.

然而，在接受恩杂鲁胺加ADT治疗的187名rPD患者中，有21.9%的患者PSA未升高，51.3%的患者未达到PSA进展标准，而在接受安慰剂/ADT治疗的224名患者中，这一比例分别为3.6%和18.8%。

Liver metastases were >5-fold higher in enzalutamide-treated patients with rPD events versus control, although sample size was small.

尽管样本量较小，但与对照组相比，接受恩杂鲁胺治疗的rPD事件患者的肝转移发生率是其5倍以上。

Compared with no rPD, enzalutamide-treated patients with rPD ± PSA rise or progression had worse OS.

与无rPD的患者相比，接受恩杂鲁胺治疗的rPD ± PSA升高或进展的患者总生存期更差。

Conclusions

Given the frequent discordance and poor prognosis of imaging-based progression in the absence of PSA changes during enzalutamide treatment in mHSPC and nmCRPC, periodic surveillance using imaging is recommended.

鉴于在mHSPC和nmCRPC患者接受恩杂鲁胺治疗期间，无PSA变化时基于影像学进展的频繁不一致性和预后不良，推荐定期使用影像学进行监测。