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Abstract：
UNASSIGNED: The objective of the study is to evaluate whether low nadir testosterone during treatment with triptorelin pamoate, a luteinising hormone-releasing hormone (LHRH) agonist, is associated with improved clinical outcomes in patients with advanced prostate cancer using a retrospective analysis of clinical trial data.
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.
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.
摘要：
■本研究的目的是评估帕莫酸曲普瑞林治疗期间睾酮最低点是否低，促黄体激素释放激素（LHRH）激动剂，通过对临床试验数据的回顾性分析,与晚期前列腺癌患者的临床结局改善相关.
■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。
■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。
