Mager Rene, Savko Olga, Böhm Katharina, Thomas Anita, Dotzauer Robert, Borgmann Hendrik, Jäger Wolfgang, Thomas Christian, Haferkamp Axel, Höfner Thomas, Tsaur Igor
University Medical Center Mainz, Department of Urology and Pediatric Urology, Mainz, Germany.
University Medical Center Mainz, Department of Urology and Pediatric Urology, Mainz, Germany.
Urol Oncol. 2019 Dec;37(12):999-1005. doi: 10.1016/j.urolonc.2019.07.005. Epub 2019 Jul 31.
To compare toxicity and response of docetaxel chemotherapy between metastatic hormone-sensitive prostate cancer (mHSPC) and castration-resistant metastatic prostate cancer (mCRPC) patients of the same therapeutic era for assessing of upfront docetaxel against the benchmark of docetaxel in the castrate resistant stage in the setting outside of clinical trials.
A prospectively collected database of real-world prostate cancer patients receiving docetaxel was divided in mHSPC and mCRPC cases and retrospectively analyzed. Principal objectives were toxicity measured by the common criteria of adverse events terminology and response characterized by Prostate specific antigen decline and radiographic progression-free disease at restaging. The prognostic value of suspected variables for grade 3 to 5 toxicity and response was investigated by logistic regression analysis.
Of 72 patients 34 (47%) were treated for mHSPC and 38 (53%) for mCRPC. Patients with mCRPC were older and had worse performance status (P< 0.01). In mHSPC total number of grade 3 to 5 adverse events (24, median 0, interquartile range 0-1) was significantly less than in mCRPC (46, median 1, interquartile range 1-2) (P = 0.01). Multivariable analysis revealed age as independent predictive variable for grade 3 to 5 toxicity (P = 0.03) but not disease stage, Prostate specific antigen predocetaxel, volume of disease, and Eastern Cooperative Oncology Group performance status (P > 0.05). Objective response was significantly higher in mHSPC compared to mCRPC patients (P < 0.01). Multivariable analysis confirmed mHSPC stage as independent prognostic factor for radiographic progression free disease at restaging (P < 0.01).
The association of age with toxicity and of mHSPC stage with response resulted in significantly fewer grade 3 to 5 adverse events but higher response rates for upfront docetaxel in mHSPC compared with docetaxel in the later mCRPC stage.
比较同一治疗时代转移性激素敏感性前列腺癌（mHSPC）和去势抵抗性转移性前列腺癌（mCRPC）患者多西他赛化疗的毒性和反应，以在临床试验以外的环境中，根据去势抵抗阶段多西他赛的基准评估一线多西他赛。
将前瞻性收集的接受多西他赛治疗的真实世界前列腺癌患者数据库分为mHSPC和mCRPC病例并进行回顾性分析。主要目标是通过不良事件术语通用标准测量的毒性，以及以前列腺特异性抗原下降和重新分期时影像学无进展疾病为特征的反应。通过逻辑回归分析研究疑似变量对3至5级毒性和反应的预后价值。
72例患者中，34例（47%）接受mHSPC治疗，38例（53%）接受mCRPC治疗。mCRPC患者年龄更大，体能状态更差（P<0.01）。mHSPC中3至5级不良事件总数（24例，中位数0，四分位间距0-1）显著少于mCRPC（46例，中位数1，四分位间距1-2）（P = 0.01）。多变量分析显示年龄是3至5级毒性的独立预测变量（P = 0.03），但疾病分期、多西他赛治疗前前列腺特异性抗原、疾病体积和东部肿瘤协作组体能状态不是（P>0.05）。mHSPC患者的客观反应显著高于mCRPC患者（P<0.01）。多变量分析证实mHSPC分期是重新分期时影像学无进展疾病的独立预后因素（P<0.01）。
年龄与毒性以及mHSPC分期与反应之间的关联导致3至5级不良事件显著减少，但与mCRPC后期阶段的多西他赛相比，mHSPC中一线多西他赛的反应率更高。
