Is time to castration resistant prostate cancer a potential intermediate end-point for time to metastasis among men initiating androgen deprivation therapy for non-metastatic prostate cancer with rapid PSA doubling time (<9 months)?
Is time to castration resistant prostate cancer a potential intermediate end-point for time to metastasis among men initiating androgen deprivation therapy for non-metastatic prostate cancer with rapid PSA doubling time (<9 months)?
复制标题
对于针对 PSA 快速倍增时间（<9 个月）的非转移性前列腺癌开始雄激素剥夺治疗的男性，去势抵抗性前列腺癌的时间是否是转移时间的潜在中间终点？
DOI：
10.1038/s41391-022-00585-8
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发表时间：
2023
影响因子：
4.8
通讯作者：
Freedland,StephenJ
中科院分区：
文献类型：
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作者：
Klaassen,Zachary;Howard,Lauren;Wallis,ChristopherJD;Janes,JessicaL;DeHoedt,Amanda;Aronson,WilliamJ;Polascik,ThomasJ;Amling,ChristopherJ;Kane,ChristopherJ;Cooperberg,MatthewR;Terris,MarthaK;Wu,Yuan;Freedland,StephenJ
目的无转移生存期（MFS）是非转移性去势抵抗性前列腺癌（CRPC）男性总生存期（OS）的替代指标，但在患有非转移性去势敏感性疾病的男性中，这一终点可能需要数年时间才能实现。本研究的目的是检查是否进展到CRPC是一个潜在的中间终点发展转移性疾病的患者与生化复发（BCR）后根治性前列腺切除术（RP）的Materials and MethodsMen与BCR后RP谁PSA倍增时间（PSADT）< 9个月，并没有转移的时候，开始雄激素剥夺治疗（ADT）（n= 210）包括在内。主要目的是评估无CRPC生存期（CRPC-FS）和MFS之间的相关性，次要目的是评估转移时间和CRPC时间之间的相关性。Kendall’s Tau被用来检验主要和次要outcome.ResultsThe中位MFS为104个月（95%CI：83-114）和中位CRPC-FS为100个月（95%CI：80-114）的相关性。根据Kaplan-Meier曲线，至MFS和CRPC-FS的时间的最大差异约为70%的无生存期，MFS为61.2个月，CRPC-FS为49.6个月。CRPC-FS与MFS之间以及CRPC时间与转移时间之间的Kendall’s Tau为0.867（95% CI：0.765-0.968）和0.764（95%置信区间：0.644-0.884）。结论鉴于CRPC-FS与MFS之间的高度相关性，经过验证，CRPC-FS可作为局部治疗后开始ADT的BCR男性试验的潜在中间终点。
PurposeMetastasis-free survival (MFS) is a surrogate for overall survival (OS) in men with non-metastatic castration-resistant prostate cancer (CRPC), but this endpoint may take years to develop in men with non-metastatic castrate-sensitive disease. The study objective was to examine whether progression to CRPC is a potential intermediate endpoint for developing metastatic disease in patients with biochemical recurrence (BCR) after radical prostatectomy (RP).Materials and methodsMen with BCR following RP who had PSA doubling times (PSADT) < 9 months and no metastasis at the time of initiating androgen deprivation therapy (ADT) (n= 210) were included. The primary objective was to assess the correlation between CRPC-free survival (CRPC-FS) and MFS, and the secondary objective was to assess the correlation between time to metastasis and time to CRPC. Kendall’s Tau was used to test the correlation for the primary and secondary outcomes.ResultsThe median MFS was 104 months (95% CI: 83–114) and median CRPC-FS was 100 months (95% CI: 80–114). Based on the Kaplan–Meier curve, the greatest difference in time to MFS and CRPC-FS was around 70% free survival, which was reached at 61.2 months for MFS and 49.6 months for CRPC-FS. Kendall’s Tau for the correlation between CRPC-FS and MFS and between time to CRPC and time to metastasis was 0.867 (95% CI: 0.765–0.968) and 0.764 (95% CI: 0.644–0.884), respectively.ConclusionsGiven the high correlation between CRPC-FS and MFS, after validation, CRPC-FS may serve as a potential intermediate endpoint in trials for men with BCR initiating ADT following local therapy.