Division of Medical Oncology, Department of Onco-Hematology, IRCCS-CROB, Referral Cancer Center of Basilicata, Via Padre Pio 1, 85028, Rionero in Vulture, PZ, Italy.
Department of Medical, Surgery and Health Sciences, University of Trieste, Piazza Ospitale 1, 34129, Trieste, Italy.
Med Oncol. 2018 Jan 31;35(3):29. doi: 10.1007/s12032-018-1081-z.
New hormonal therapies have enriched the therapeutic armamentarium for patients with castration-resistant prostate cancer (CRPC). Fatigue is one of the most common adverse events registered in phase III trials of these new drugs. The aim of this article is to perform a meta-analysis based on all available literature data focused on the risk rate (RR) of fatigue from new hormonal agent-based therapy in patients with CRPC. A total of 11,751 cases were included from 11 randomized trials. The analysis revealed that the second generation of hormonal therapies increased the RR of any-grade fatigue (RR = 1.27) and grade 3-4 fatigue (RR = 1.25). This last adverse event was always higher in a pre-chemotherapy setting. In conclusion, given the limitations of a literature-based study, rather than a meta-analysis based on individual patients' data, our study confirmed the increase in the RR for any-grade and grade 3-4 fatigue during the second generation of hormonal therapies, with particular attention being paid to grade 3-4 in the pre-chemotherapy setting of the disease.
新的激素治疗方法丰富了去势抵抗性前列腺癌（CRPC）患者的治疗手段。疲劳是这些新药 III 期临床试验中登记的最常见不良事件之一。本文旨在基于所有可用的文献数据，对基于新型激素药物治疗 CRPC 患者的疲劳风险率（RR）进行荟萃分析。共有 11 项随机试验纳入了 11751 例病例。分析表明，第二代激素治疗增加了任何级别疲劳（RR=1.27）和 3-4 级疲劳（RR=1.25）的 RR。后一种不良事件在化疗前环境中总是更高。总之，鉴于基于文献的研究的局限性，而不是基于个体患者数据的荟萃分析，我们的研究证实了第二代激素治疗中任何级别和 3-4 级疲劳的 RR 增加，特别是在疾病的化疗前环境中注意 3-4 级。
