UC Davis Comprehensive Cancer Center, Sacramento, CA, USA.
SWOG Statistics and Data Management Center, Seattle, WA, USA.
Eur Urol Oncol. 2024 Oct;7(5):1097-1104. doi: 10.1016/j.euo.2024.03.001. Epub 2024 Mar 23.
A robust decrease in prostate-specific antigen (PSA) in response to androgen deprivation therapy (ADT) has been evaluated as a prognostic factor in patients with metastatic hormone-sensitive prostate cancer (mHSPC) since 2006, but the treatment of mHSPC has since evolved to include intensified therapy.
We assessed the association of PSA levels at 3 (PSA-3mo) and 7 (PSA-7mo) mo with overall survival (OS) in patients with mHSPC treated with ADT combined with either bicalutamide or orteronel in the S1216 phase 3 clinical trial.
DESIGN, SETTING, AND PARTICIPANTS: PSA responses to treatment of patients in the S1216 trial were categorized as: complete response (CR) if PSA was ≤0.2 ng/ml, partial response if PSA was >0.2 and ≤4 ng/ml, and no response (NR) if PSA was >4 ng/ml.
A Cox analysis (adjusted for treatment arm and three stratification factors: performance status, severity of disease, and early vs late induction) was used for OS association. While PSA-7mo association was a prespecified objective, PSA-3mo association was also evaluated.
A total of 1251 and 1231 patients from the S1216 study were evaluable for PSA-3mo and PSA-7mo, respectively. A PSA-7mo CR was associated with improved OS compared with NR (HR: 0.20; p < 0.0001). A PSA-3mo CR showed a similar association to NR (HR: 0.34; p < 0.0001). The association of a PSA response with survival did not differ by treatment arm at either time point.
The PSA-3mo and PSA-7mo responses were strongly associated with OS; taken with other emerging prognostic biomarkers, these markers may allow for early identification of patients at the highest risk of death, aid with counseling in clinical practice, and permit design of future clinical trials targeting these patients.
A low prostate-specific antigen level at 3 or 7 mo after starting treatment for metastatic hormone-sensitive prostate cancer predicts longer survival regardless of the first treatment given with androgen deprivation therapy.
自 2006 年以来，前列腺特异性抗原（PSA）在接受雄激素剥夺治疗（ADT）后的显著下降已被评估为转移性激素敏感前列腺癌（mHSPC）患者的预后因素，但 mHSPC 的治疗此后已发展为包括强化治疗。
我们评估了在 S1216 三期临床试验中接受 ADT 联合比卡鲁胺或阿特龙治疗的 mHSPC 患者 PSA 在 3 个月（PSA-3mo）和 7 个月（PSA-7mo）时的水平与总生存期（OS）的相关性。
设计、设置和参与者：S1216 试验中患者的 PSA 治疗反应分为完全缓解（CR），即 PSA≤0.2ng/ml；部分缓解（PR），即 PSA＞0.2ng/ml 且≤4ng/ml；无反应（NR），即 PSA＞4ng/ml。
使用 Cox 分析（调整治疗组和三个分层因素：表现状态、疾病严重程度以及早期与晚期诱导）评估 OS 相关性。PSA-7mo 相关性是预先设定的目标，同时也评估了 PSA-3mo 相关性。
来自 S1216 研究的 1251 例和 1231 例患者分别可评估 PSA-3mo 和 PSA-7mo。与 NR 相比，PSA-7mo CR 与改善的 OS 相关（HR：0.20；p<0.0001）。PSA-3mo CR 与 NR 也有类似的相关性（HR：0.34；p<0.0001）。在这两个时间点，PSA 反应与生存的相关性不因治疗组而异。
PSA-3mo 和 PSA-7mo 反应与 OS 密切相关；与其他新兴的预后生物标志物结合使用，这些标志物可能有助于早期识别死亡风险最高的患者，为临床实践中的咨询提供帮助，并为针对这些患者的未来临床试验设计提供依据。
转移性激素敏感前列腺癌患者开始治疗后 3 或 7 个月时前列腺特异性抗原水平较低，预测生存时间较长，无论最初使用何种雄激素剥夺疗法。
