2-weekly versus 3-weekly docetaxel for metastatic castration-resistant prostate cancer: complete quality of life results from the randomised, phase-III PROSTY trial

Treatment with 2-weekly docetaxel 50 mg/m² was shown to improve overall survival and was better tolerated than the standard 75 mg/m² 3-weekly regimen in men with metastatic castration-resistant prostate cancer (mCRPC) in the original randomised PROSTY trial. The aim of this study was to investigate, whether quality of life (QoL) effects would differ between the 2-weekly docetaxel 50 mg/m² regimen from the standard 3-weekly 75 mg/m² treatment. QoL data were collected with the Functional Assessment of Cancer Therapy – Prostate (FACT-P) and Functional Assessment of Cancer Therapy Advanced Prostate Symptom Index − 8 Item version (FAPSI-8). Pain was measured using the Visual Analogue Scale (VAS). A total of 743 forms from 163 patients were analysed in Arm A (2-weekly docetaxel), and 704 forms from 173 patients were analysed in Arm B (3-weekly docetaxel). The data were analysed using both the Wilcoxon signed rank test (with Holm–Bonferroni adjustment) and Mann–Whitney U models. No major differences were found in total QoL. Total QoL was higher at month 8 in Arm B (<i>p</i> = .020), but this was reversed in the following month (<i>p</i> = .043), and no statistically significant differences were found during other months. Compared to Arm A, participants in Arm B had longer-lasting deterioration in FAPSI-8 scores and emotional well-being subdomain at the beginning of treatment (<i>p</i> &lt; .05). Various one-month differences were found in FACT-P subdomains (except for functional well-being), and these favoured participants in Arm A, except for the prostate-cancer subdomain. There were no differences in pain. Based on our results, 2-weekly docetaxel was not inferior to 3-weekly docetaxel in terms of total health-related QoL and seemed to be superior at least in terms of the FAPSI-8 and emotional well-being subdomain in the first three to four months of treatment. More research on the topic is suggested to confirm the results.

在初始随机对照PROSTY试验中，针对转移性去势抵抗性前列腺癌（metastatic castration-resistant prostate cancer, mCRPC）男性患者，2周一次给予多西他赛50mg/m²的治疗方案可改善总生存期，且相较于标准的3周一次75mg/m²方案耐受性更佳。本研究旨在探究2周一次50mg/m²多西他赛方案与标准3周一次75mg/m²多西他赛治疗方案的生活质量（quality of life, QoL）影响是否存在差异。本研究采用癌症治疗功能评价量表-前列腺癌版（Functional Assessment of Cancer Therapy – Prostate, FACT-P）与癌症治疗功能评价量表-晚期前列腺症状指数8项版（Functional Assessment of Cancer Therapy Advanced Prostate Symptom Index − 8 Item version, FAPSI-8）收集生活质量数据，采用视觉模拟评分法（Visual Analogue Scale, VAS）评估疼痛程度。A组（2周一次多西他赛组）共纳入163例患者，有效分析问卷743份；B组（3周一次多西他赛组）共纳入173例患者，有效分析问卷704份。数据分析采用Wilcoxon符号秩检验（辅以Holm-Bonferroni校正）与Mann-Whitney U模型。整体生活质量未观察到显著组间差异：B组在治疗第8个月时的整体生活质量更高（p=0.020），但该优势在次月出现逆转（p=0.043），其余时间点均无统计学差异。相较于A组，B组受试者在治疗初期的FAPSI-8评分与情绪健康维度恶化持续时间更长（p<0.05）。FACT-P量表各维度（功能健康维度除外）均存在1个月周期的组间差异，除前列腺癌相关维度外，其余维度均更有利于A组受试者。疼痛评分未观察到组间差异。基于本研究结果，2周一次多西他赛方案在整体健康相关生活质量方面不劣于3周一次方案，且在治疗前3~4个月内，至少在FAPSI-8评分与情绪健康维度上表现更优。建议开展更多相关研究以验证本研究结论。