Division of Hematology and Medical Oncology, Mayo Clinic, Phoenix, AZ, USA.
Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA.
Eur Urol Oncol. 2020 Dec;3(6):717-724. doi: 10.1016/j.euo.2020.07.001. Epub 2020 Aug 15.
ECOG3805 is a randomized trial of testosterone suppression with or without docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC). Deeper prostate-specific antigen (PSA) suppression is prognostic for outcome. However, the concordance of PSA rise and radiographic progression has not been examined previously in mHSPC, whereas this has been reported in metastatic castration-resistant prostate cancer.
To determine the patterns of progression by PSA and radiographic parameters in patients in ECOG3805.
DESIGN, SETTING, AND PARTICIPANTS: We conducted a retrospective analysis of all patients in ECOG3805. Patients were classified according to the PSA level at progression (whether PSA level was below 2.0 ng/mL or not) and the type of progression event in the study (either PSA progression as defined by the study with or without clinical progression, or clinical progression alone). Baseline demographics, clinical outcomes, and patterns of progression were compared between the groups.
One in eight patients had clinical progression below a PSA level of 2 ng/mL, and approximately 25% developed clinical progression in the absence of confirmed PSA progression. Overall survival from randomization was shorter in patients with clinical progression without confirmed PSA progression than in patients with PSA progression alone as the first progression. Patient demographics at study entry were not predictive of the pattern of progression. Study limitations include its retrospective and post hoc nature.
Clinical progression prior to PSA rise or at low PSA levels is a relatively frequent phenomenon in mHSPC and is associated with poorer overall survival. Further biological and clinical studies of these patients are warranted.
Reliance on prostate-specific antigen (PSA) alone is an inadequate strategy to monitor patients undergoing treatment for metastatic hormone-sensitive prostate cancer. Prostate cancer can get worse on scans even with low PSA and/or no or small changes in PSA. Imaging should be added to PSA testing to monitor patients with metastatic prostate cancer.
ECOG3805 是一项针对转移性激素敏感前列腺癌（mHSPC）的睾酮抑制与多西他赛联合或不联合治疗的随机试验。前列腺特异性抗原（PSA）的更深抑制与预后相关。然而，mHSPC 中之前尚未检查 PSA 升高与影像学进展的一致性，而转移性去势抵抗性前列腺癌中已有报道。
确定 ECOG3805 中患者的 PSA 和影像学参数进展模式。
设计、设置和参与者：我们对 ECOG3805 中的所有患者进行了回顾性分析。根据进展时的 PSA 水平（PSA 水平是否低于 2.0ng/mL）和研究中的进展事件类型（是否为研究定义的 PSA 进展伴有或不伴有临床进展，或仅临床进展）对患者进行分类。比较了各组的基线人口统计学特征、临床结局和进展模式。
八分之一的患者在 PSA 水平低于 2ng/mL 时发生临床进展，约 25%的患者在无确认 PSA 进展的情况下发生临床进展。与仅 PSA 进展作为首次进展的患者相比，无确认 PSA 进展的临床进展患者的随机分组后总生存期更短。研究入组时的患者人口统计学特征不能预测进展模式。研究的局限性包括其回顾性和事后性质。
在 PSA 升高之前或 PSA 水平较低时发生的临床进展是 mHSPC 中相对常见的现象，与总生存期较差相关。需要对这些患者进行进一步的生物学和临床研究。
仅依赖前列腺特异性抗原（PSA）是监测接受转移性激素敏感前列腺癌治疗的患者的一种不充分策略。即使 PSA 较低且/或 PSA 无变化或变化较小，扫描也可能显示前列腺癌恶化。应将影像学检查添加到 PSA 检测中，以监测转移性前列腺癌患者。
