卡巴他赛治疗转移性去势抵抗性前列腺癌男性患者的生活质量与疼痛缓解：非干预性“QoLiTime”研究

Quality of life and pain relief in men with metastatic castration-resistant prostate cancer on cabazitaxel: the non-interventional 'QoLiTime' study.

作者信息

Hofheinz Ralf-Dieter, Lange Carsten, Ecke Thorsten, Kloss Susanne, Linsse Burkhard, Windemuth-Kieselbach Christine, Hammerer Peter, Al-Batran Salah-Eddin

机构信息

University Hospital Mannheim, Mannheim, Germany.

Private Practice, Bernburg, Germany.

出版信息

BJU Int. 2017 May;119(5):731-740. doi: 10.1111/bju.13658. Epub 2016 Sep 30.

DOI:10.1111/bju.13658

PMID:27618249

Abstract

OBJECTIVE

To examine health-related quality of life (QoL) in men with metastatic castration-resistant prostate cancer (mCRPC) on cabazitaxel.

PATIENTS AND METHODS

Men with mCRPC receiving cabazitaxel (25 mg/m², every 3 weeks) and 10 mg/day oral prednis(ol)one were enrolled (2011-2014) in the non-interventional prospective 'QoLiTime' study. Primary outcome was change in QoL (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item) with respect to prostate-specific antigen (PSA) response after four cycles of cabazitaxel. Secondary outcomes included occurrence of adverse events (AEs).

RESULTS

Of 527 men, 348 received four cycles of cabazitaxel and 266 had the necessary PSA level measurements. After four cycles, 92 (34.6%) men had a PSA level decrease ≥50% (responders). QoL remained stable throughout the study (P = 0.62). Change in QoL did not differ between responders and non-responders (P = 0.69). Change in PSA level and global health status between baseline and four cycles showed an inversely proportional relationship (correlation coefficient -0.14; 95% confidence interval -0.26 to -0.01; P = 0.03), with increasing PSA level corresponding to lower health status. Responders showed no change in physical functioning vs baseline (-1.75, P = 0.12); non-responders showed a reduction vs baseline (-7.00, P < 0.001) and responders (P = 0.05). Responders showed an improvement in pain vs baseline (-7.61, P = 0.05) and vs non-responders (P = 0.01). AEs occurred in 292 patients (55.4%), most commonly anaemia (16.5%), fatigue (12.3%) and diarrhoea (11.8%). Neutropenia and febrile neutropenia were reported in 3.8% and 3.6% of patients, respectively.

CONCLUSION

Prostate-specific antigen level response was associated with stable physical functioning and improvement in pain. Symptom increases were seen in areas typical of chemotoxicity, but QoL was maintained.

摘要

目的

研究接受卡巴他赛治疗的转移性去势抵抗性前列腺癌（mCRPC）男性患者的健康相关生活质量（QoL）。

患者与方法

2011年至2014年，将接受卡巴他赛（25mg/m²，每3周一次）和每日10mg口服泼尼松（龙）的mCRPC男性患者纳入非干预性前瞻性“QoLiTime”研究。主要结局是卡巴他赛四个周期后，QoL（欧洲癌症研究与治疗组织生活质量问卷30项）相对于前列腺特异性抗原（PSA）反应的变化。次要结局包括不良事件（AE）的发生情况。

结果

527名男性患者中，348名接受了四个周期的卡巴他赛治疗，266名进行了必要的PSA水平测量。四个周期后，92名（34.6%）男性患者的PSA水平下降≥50%（反应者）。在整个研究过程中，QoL保持稳定（P = 0.62）。反应者与非反应者之间的QoL变化无差异（P = 0.69）。基线与四个周期之间的PSA水平变化与总体健康状况呈反比关系（相关系数-0.14；95%置信区间-0.26至-0.01；P = 0.03），PSA水平升高对应健康状况下降。反应者的身体功能与基线相比无变化（-1.75，P = 0.12）；非反应者与基线相比有所下降（-7.00，P < 0.001），且与反应者相比有差异（P = 0.05）。反应者的疼痛与基线相比有所改善（-7.61，P = 0.05），且与非反应者相比有差异（P = 0.01）。292例患者（55.4%）发生AE，最常见的是贫血（16.5%）、疲劳（12.3%）和腹泻（11.8%）。分别有3.8%和3.6%的患者报告出现中性粒细胞减少和发热性中性粒细胞减少。