STRIVE 和 TERRAIN 试验中转移性去势抵抗性前列腺癌患者临床进展的需要治疗人数分析。
Number-needed-to-treat analysis of clinical progression in patients with metastatic castration-resistant prostate cancer in the STRIVE and TERRAIN trials.
机构信息
Astellas Pharma, Inc., 1 Astellas Way, Northbrook, IL, 60062, USA.
Carolina Urologic Research Center, Myrtle Beach, SC, USA.
出版信息
BMC Urol. 2018 Sep 6;18(1):77. doi: 10.1186/s12894-018-0387-7.
BACKGROUND
This analysis estimated the number needed to treat with enzalutamide versus bicalutamide to achieve one additional patient with chemotherapy-naïve metastatic castration-resistant prostate cancer who would obtain clinical benefit regarding progression-free survival, radiographic progression-free survival, or no prostate-specific antigen progression at 1 and 2 years following treatment initiation.
METHODS
Clinical event rates were obtained from the STRIVE (NCT01664923) and TERRAIN (NCT01288911) trials, and the number needed to treat was the inverse of the absolute rate difference between the event rates of enzalutamide and bicalutamide. The 95% Confidence Interval of the number needed to treat was derived from the 95% Confidence Interval of the event rate difference.
RESULTS
Using STRIVE data (patients with metastatic disease: n = 128 enzalutamide; n = 129 bicalutamide) comparing enzalutamide with bicalutamide at 1 and 2 years, the numbers needed to treat to achieve one additional patient with chemotherapy-naïve metastatic castration-resistant prostate cancer with progression-free survival were 2.0 and 2.8, respectively; with radiographic progression-free survival, 2.6 and 3.0, respectively; and without prostate-specific antigen progression, 1.8 and 2.4, respectively. Using TERRAIN data (n = 184 enzalutamide; n = 191 bicalutamide) comparing enzalutamide with bicalutamide at 1 and 2 years, the numbers needed to treat to achieve one additional patient with progression-free survival were 4.3 and 3.7, respectively; with radiographic progression-free survival, 10.0 and 2.8, respectively; and without prostate-specific antigen progression, 2.1 and 3.2, respectively.
CONCLUSIONS
The combined data from TERRAIN and STRIVE demonstrated that treating chemotherapy-naïve metastatic castration-resistant prostate cancer with enzalutamide leads to more patients without clinical progression at 1 and 2 years than with bicalutamide.
TRIAL REGISTRATION
STRIVE (NCT01664923; registration date: August 10, 2012) and TERRAIN (NCT01288911; registration date: February 1, 2011).
背景
本分析估计了与比卡鲁胺相比，使用恩扎卢胺治疗需要多少患者，才能使一名新诊断为化疗初治转移性去势抵抗性前列腺癌患者在治疗开始后 1 年和 2 年时，在无化疗的转移性去势抵抗性前列腺癌患者中获得进展无进展生存期、影像学无进展生存期或前列腺特异性抗原进展方面的临床获益。
方法
临床事件发生率来自 STRIVE（NCT01664923）和 TERRAIN（NCT01288911）试验，治疗需要的人数为恩扎卢胺和比卡鲁胺之间事件发生率绝对差异的倒数。治疗需要的人数的 95%置信区间来自事件发生率差异的 95%置信区间。
结果
使用 STRIVE 数据（转移性疾病患者：恩扎卢胺 n=128；比卡鲁胺 n=129）比较恩扎卢胺与比卡鲁胺在 1 年和 2 年时，使一名新诊断为化疗初治转移性去势抵抗性前列腺癌患者获得无化疗的转移性去势抵抗性前列腺癌患者的进展无进展生存期的治疗需要人数分别为 2.0 和 2.8；影像学无进展生存期分别为 2.6 和 3.0；无前列腺特异性抗原进展分别为 1.8 和 2.4。使用 TERRAIN 数据（恩扎卢胺 n=184；比卡鲁胺 n=191）比较恩扎卢胺与比卡鲁胺在 1 年和 2 年时，使一名新诊断为化疗初治转移性去势抵抗性前列腺癌患者获得无化疗的转移性去势抵抗性前列腺癌患者的进展无进展生存期的治疗需要人数分别为 4.3 和 3.7；影像学无进展生存期分别为 10.0 和 2.8；无前列腺特异性抗原进展分别为 2.1 和 3.2。
结论
TERRAIN 和 STRIVE 的联合数据表明，与比卡鲁胺相比，用恩扎卢胺治疗新诊断为化疗初治转移性去势抵抗性前列腺癌可使更多患者在 1 年和 2 年时无临床进展。
试验注册
STRIVE（NCT01664923；注册日期：2012 年 8 月 10 日）和 TERRAIN（NCT01288911；注册日期：2011 年 2 月 1 日）。
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