Babkoor Abdulrahman A, Aljabri Yazeed, Alzubaidi Ahmad, Alhazmi Rayan, Alsaedi Zeyad, Alghamdi Faris, Tamim Tariq, Aldagani Ahmad, Seddiqi Irfan, Tashkandi Emad
Medicine, Umm Al-Qura University, Makkah, SAU.
Pharmacy, King Abdullah Medical City, Makkah, SAU.
Cureus. 2022 Jan 24;14(1):e21560. doi: 10.7759/cureus.21560. eCollection 2022 Jan.
Novel oral anti-androgens (NOAAs) represent a new class of drugs that are being approved for prostate cancer. However, fatigue and anemia are among the most common treatment-related symptoms. Hence, we conducted a meta-analysis of randomized controlled trials (RCTs) to investigate the relative risks (RRs) of fatigue and anemia associated with NOAAs. PubMed, Cochrane, EMBASE, and abstracts presented at the annual meeting of the American Society of Clinical Oncology and European Society of Clinical Oncology were searched for phase III and V RCTs of NOAAs from January 2000 to March 2020. Safety profile from each selected study was evaluated for all-grade and high-grade fatigue and anemia adverse events. The RRs with 95% confidence intervals (95% CIs) were calculated using random-effects for all-grade and high-grade events. Our analysis involved 15 RCTs, including 16,795 patients. Overall, 9,177 patients were treated with NOAAs in the experimental arm, whereas 7,095 received a standard of care in the control arm. The RR of all-grade and high-grade fatigue was 1.26 (95% CI 1.15-1.38) and 1.24 (95% CI 0.83-1.84), and that of all-grade and high-grade anemia was 0.81 (95% CI 0.77-1.19) and 0.81 (95% CI 0.61-1.06), respectively. Our findings suggest that NOAAs are associated with an increased risk of fatigue but decreased risk of anemia. Patients should be frequently monitored to identify adverse events to improve oncological outcomes and optimize the overall treatment efficacy and safety. Not all the RCTs addressed fatigue and anemia simultaneously as side effects of NOAA treatment.
新型口服抗雄激素药物(NOAAs)是一类正在被批准用于前列腺癌治疗的新型药物。然而,疲劳和贫血是最常见的与治疗相关的症状。因此,我们进行了一项随机对照试验(RCT)的荟萃分析,以研究与NOAAs相关的疲劳和贫血的相对风险(RRs)。检索了PubMed、Cochrane、EMBASE以及在美国临床肿瘤学会和欧洲临床肿瘤学会年会上发表的摘要,以查找2000年1月至2020年3月期间NOAAs的III期和V期RCT。对每项入选研究的安全性概况进行评估,以了解所有级别和高级别疲劳及贫血不良事件。使用随机效应模型计算所有级别和高级别事件的RR及95%置信区间(95% CIs)。我们的分析纳入了15项RCT,共16,795例患者。总体而言,试验组有9,177例患者接受了NOAAs治疗,而对照组有7,095例患者接受了标准治疗。所有级别和高级别疲劳的RR分别为1.26(95% CI 1.15 - 1.38)和1.24(95% CI 0.83 - 1.84),所有级别和高级别贫血的RR分别为0.81(95% CI 0.77 - 1.19)和0.81(95% CI 0.61 - 1.06)。我们的研究结果表明,NOAAs与疲劳风险增加但贫血风险降低有关。应经常对患者进行监测,以识别不良事件,从而改善肿瘤治疗效果并优化整体治疗的疗效和安全性。并非所有RCT都同时将疲劳和贫血作为NOAA治疗的副作用进行研究。