Nieto-Gómez P, Ubago-Pérez R, Cabeza-Barrera J
Unidad de Gestión Clínica de Farmacia Hospitalaria, Hospital Universitario San Cecilio, Granada, España.
Unidad de Gestión Clínica de Farmacia Hospitalaria, Hospital Universitario San Cecilio, Granada, España.
Actas Urol Esp (Engl Ed). 2019 Sep;43(7):355-363. doi: 10.1016/j.acuro.2019.03.007. Epub 2019 May 24.
To perform an adjusted indirect comparison of the efficacy of enzalutamide and apalutamide in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) with a high risk of progression to metastatic disease.
After carrying out a literature search, we performed an adjusted indirect comparison (Bucher et al.) of the relative efficacy of enzalutamide and apalutamide in patients with nmCRPC with a high risk of progression to metastatic disease. The outcomes included were metastasis-free survival (MFS) and PSA response rate (PSARR).
There were no statistically significant differences between enzalutamide and apalutamide regarding the analysed outcomes. For the comparison enzalutamide+ADT vs. apalutamide+ADT: MFS a HR (95% CI)=1,036 (0.781-1.373) was obtained. For PSARR, a RR (95% CI)=0.81 (0.339-1.938) was obtained.
The adjusted indirect comparison performed in this study shows that there are no statistically significant differences in terms of efficacy regarding MFS and PSARR between enzalutamide+ADT and apalutamide+ADT in patients with nmCRPC with a high risk of progression to metastatic disease. However, in order to confirm these results, an independent trial with direct comparison between both drugs would be required.
对恩杂鲁胺和阿帕鲁胺在有进展为转移性疾病高风险的非转移性去势抵抗性前列腺癌（nmCRPC）患者中的疗效进行校正间接比较。
在进行文献检索后，我们对恩杂鲁胺和阿帕鲁胺在有进展为转移性疾病高风险的nmCRPC患者中的相对疗效进行了校正间接比较（Bucher等人的方法）。纳入的结局包括无转移生存期（MFS）和前列腺特异性抗原反应率（PSARR）。
就分析的结局而言，恩杂鲁胺和阿帕鲁胺之间无统计学显著差异。对于恩杂鲁胺+雄激素剥夺治疗（ADT）与阿帕鲁胺+ADT的比较：MFS的风险比（HR，95%置信区间）=1.036（0.781 - 1.373）。对于PSARR，相对危险度（RR，95%置信区间）=0.81（0.339 - 1.938）。
本研究中进行的校正间接比较表明，在有进展为转移性疾病高风险的nmCRPC患者中，恩杂鲁胺+ADT与阿帕鲁胺+ADT在MFS和PSARR疗效方面无统计学显著差异。然而，为了证实这些结果，需要进行一项对两种药物进行直接比较的独立试验。
