UNASSIGNED: Data were pooled from three prospective, 9-12-month Phase III studies of triptorelin monotherapy in patients with advanced prostate cancer (including NCT00751790). The serum testosterone concentration suppression targets evaluated were <0.35 nmol/L (<10 ng/dl), <0.7 nmol/L (<20 ng/dl), <1.7 nmol/L (<50 ng/dl) and ≥1.7 nmol/L. Overall survival (OS) and disease-specific survival (DSS) by testosterone suppression group were assessed by Kaplan-Meier analysis, with log-rank test. The time frame for the primary analysis was Days 1-518 (median OS follow-up 254 days [range, 29-518 days]) and for the sensitivity analyses was Days 1-262. Supplementary analyses combined the ≥0.7- to <1.7-nmol/L and ≥1.7-nmol/L groups.
UNASSIGNED: The sample size comprised 592 patients (most received triptorelin monotherapy; four reported concomitant androgen receptor-axis-targeted therapy). Nadir testosterones of <0.35, ≥0.35 to <0.7, ≥0.7 to <1.7 and ≥1.7 nmol/L were achieved by 96%, 3.2%, 0.34% and 0.17% of patients, respectively. Better OS with decreasing level of nadir testosterone was observed (p < 0.001) and this persisted after sensitivity/supplemental analyses (all p < 0.001). Differences in DSS with decreasing levels of nadir testosterone were not statistically significant in the primary analysis. Sensitivity/supplemental analysis showed better DSS with decreasing level of nadir testosterone (Days 1-262, p = 0.01; combined groups Days 1-518, p = 0.03; combined groups Days 1-262, p = 0.005).
UNASSIGNED: Low nadir testosterone achieved during treatment with the LHRH agonist triptorelin was associated with improved OS and DSS in patients with advanced prostate cancer.
■数据来自三个前瞻性,曲普瑞林单药治疗晚期前列腺癌患者(包括NCT00751790)的9-12个月III期研究。评估的血清睾酮浓度抑制目标<0.35nmol/L(<10ng/dl),<0.7nmol/L(<20ng/dl),<1.7nmol/L(<50ng/dl)和≥1.7nmol/L通过Kaplan-Meier分析评估睾酮抑制组的总生存期(OS)和疾病特异性生存期(DSS),用对数秩检验。主要分析的时间范围为第1-518天(中位OS随访254天[范围,29-518天]),敏感性分析为第1-262天。补充分析结合≥0.7-至<1.7-nmol/L和≥1.7-nmol/L组。
■样本量包括592名患者(大多数接受曲普瑞林单药治疗;4例报告伴随雄激素受体轴靶向治疗)。<0.35,≥0.35至<0.7,≥0.7至<1.7和≥1.7nmol/L的最低点睾丸激素达到96%,3.2%,0.34%和0.17%的患者,分别。随着最低点睾酮水平的降低,观察到更好的OS(p<0.001),并且在敏感性/补充分析后仍然存在(所有p<0.001)。在主要分析中,DSS与最低点睾丸激素水平降低的差异无统计学意义。敏感性/补充分析显示,随着最低点睾酮水平的降低,DSS更好(第1-262天,p=0.01;组合组第1-518天,p=0.03;组合组第1-262天,p=0.005)。
■在晚期前列腺癌患者中,LHRH激动剂曲普瑞林治疗期间所达到的最低点睾酮与OS和DSS改善相关。