Thiery-Vuillemin A, Fizazi K, Sartor O, Oudard S, Bury D, Thangavelu K, Ozatilgan A, Poole E M, Eisenberger M, de Bono J
Centre Hospitalier Régional Universitaire, Besançon, France.
Cancer Medicine, Institut Gustave Roussy, University of Paris Saclay, Villejuif, France.
ESMO Open. 2021 Apr;6(2):100089. doi: 10.1016/j.esmoop.2021.100089. Epub 2021 Mar 16.
Men with metastatic castration-resistant prostate cancer (mCRPC) are living longer, therefore optimizing health-related quality of life (HRQL), as well as survival outcomes, is important for optimal patient care. The aim of this study was to assess the HRQL in patients with mCRPC receiving docetaxel or cabazitaxel.
PROSELICA (NCT01308580) assessed the non-inferiority of cabazitaxel 20 mg/m (C20) versus 25 mg/m (C25) in patients with mCRPC after docetaxel. FIRSTANA (NCT01308567) assessed the superiority of C25 or C20 versus docetaxel 75 mg/m (D75) in patients with chemotherapy-naive mCRPC. HRQL and pain were analyzed using protocol-defined, prospectively collected, Functional Assessment of Cancer Therapy-Prostate (FACT-P) and McGill-Melzack questionnaires. Analyses included definitive improvements in HRQL, maintained or improved HRQL, and HRQL over time.
In total, 2131 patients were evaluable for HRQL across the two studies. In PROSELICA, 38.8% and 40.5% of patients receiving C20 and C25, respectively, had definitive FACT-P total score (TS) improvements. In FIRSTANA, 43.4%, 49.7%, and 44.9% of patients receiving D75, C20, and C25, respectively, had definitive FACT-P TS improvements. In both trials, definitive improvements started after cycle 1 and were maintained for the majority of subsequent treatment cycles. More than two-thirds of patients maintained or improved their FACT-P TS.
In PROSELICA and FIRSTANA, >40% of the 2131 evaluable patients with mCRPC had definitive FACT-P TS improvements; improvements occurred early and were maintained. More than 75% of patients maintained or improved their FACT-P TS.
转移性去势抵抗性前列腺癌（mCRPC）男性患者的生存期正在延长，因此优化与健康相关的生活质量（HRQL）以及生存结局，对实现最佳患者护理至关重要。本研究的目的是评估接受多西他赛或卡巴他赛治疗的mCRPC患者的HRQL。
PROSELICA（NCT01308580）评估了卡巴他赛20mg/m²（C20）与25mg/m²（C25）在多西他赛后mCRPC患者中的非劣效性。FIRSTANA（NCT01308567）评估了C25或C20对比多西他赛75mg/m²（D75）在初治mCRPC患者中的优越性。使用方案定义的、前瞻性收集的癌症治疗功能评估-前列腺（FACT-P）和麦吉尔-梅尔扎克问卷对HRQL和疼痛进行分析。分析包括HRQL的明确改善、维持或改善的HRQL以及随时间变化的HRQL。
两项研究中共有2131例患者可进行HRQL评估。在PROSELICA中，分别接受C20和C25治疗的患者中，有38.8%和40.5%的患者FACT-P总分（TS）有明确改善。在FIRSTANA中，分别接受D75、C20和C25治疗的患者中，有43.4%、49.7%和44.9%的患者FACT-P TS有明确改善。在两项试验中，明确改善在第1周期后开始，并在随后的大多数治疗周期中得以维持。超过三分之二的患者维持或改善了他们的FACT-P TS。
在PROSELICA和FIRSTANA中，2131例可评估的mCRPC患者中超过40%的患者FACT-P TS有明确改善；改善出现早且得以维持。超过75%的患者维持或改善了他们的FACT-P TS。
