Negative Delta-Prostate-Specific Antigen Time Ratio as Potential New Marker of Progression-Free Survival in Castration-Resistant Prostate Cancer Patients Treated With First-Line Enzalutamide or Docetaxel

Tae Hwan Kim, S. Choo, K. Shim, Sun Il Kim
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Abstract

Purpose: We propose a new potential marker of progression-free survival (PFS) called negative delta-prostate-specific antigen (PSA) time ratio (NDPSATR) and compare it with conventional PSA response, defined as PSA decline ≥50% at 12 weeks from pretreatment baseline (PSAR50) in metastatic castration-resistant prostate cancer (mCRPC) patients treated with first-line enzalutamide (ENZ) or docetaxel (DTX).Materials and Methods: All patients diagnosed as mCRPC at Ajou University Hospital from 2016 were included. Delta-PSA days is PSA change between 2 consecutive measurements during a regimen multiplied by interval days. A negative delta-PSA days value represents a positive PSA response. NDPSATR is calculated by dividing the sum of days on negative delta-PSA days by total days on the regimen. Student t-test was used to compare mean values and Kaplan-Meier survival curves for PFS were obtained.Results: Of 57 patients identified, 22 and 35 were treated with ENZ and DTX, respectively. Rates of PSAR50 for ENZ and DTX were 72.7% and 20.6%, respectively. Mean NDPSATR for ENZ and DTX were 0.40 and 0.46, respectively and the difference was not statistically significant. For ENZ, median PFS (mPFS) of PSAR50 and non-PSAR50 were 14.3 and 4.8 months, respectively and there was significant difference in PFS (p=0.002). For DTX, mPFS of PSAR50 and non-PSAR50 were 15.0 and 6.5 months, respectively but there was no significant difference in PFS (p=0.055). At cutoff value of 0.4, rate of NDPSATR ≥0.4 for ENZ and DTX were 36.4% and 62.9%, respectively. For ENZ, mPFS of NDPSATR ≥0.4 and NDPSATR <0.4 were not achieved and 14.1 months, respectively and there was no significant difference in PFS (p=0.895). For DTX, mPFS of NDPSATR ≥0.4 and NDPSATR <0.4 were 9.7 and 6.3 months, respectively and there was a significant difference in PFS (p=0.045).Conclusions: NDPSATR ≥0.4 may be a good marker of PFS in CRPC patients treated with DTX and may replace PSAR50.
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δ-前列腺特异性抗原时间比阴性作为阉割耐药前列腺癌患者接受一线恩杂鲁胺或多西他赛治疗后无进展生存期的潜在新标记物
目的:在接受一线恩杂鲁胺(ENZ)或多西他赛(DTX)治疗的转移性耐药阉割前列腺癌(mCRPC)患者中,我们提出了一种新的无进展生存期(PFS)潜在标志物--负δ-前列腺特异性抗原(PSA)时间比(NDPSATR),并将其与传统的PSA反应(定义为12周时PSA较治疗前基线下降≥50%(PSAR50))进行了比较:纳入2016年以来在阿州大学医院确诊为mCRPC的所有患者。Delta-PSA天数是指疗程中两次连续测量之间的PSA变化乘以间隔天数。Delta-PSA天数为负值代表PSA反应为阳性。NDPSATR 的计算方法是将负 delta-PSA 天数的总和除以疗程总天数。采用学生 t 检验比较平均值,并得出 PFS 的 Kaplan-Meier 生存曲线:在确定的57名患者中,分别有22人和35人接受了ENZ和DTX治疗。ENZ和DTX的PSAR50率分别为72.7%和20.6%。ENZ和DTX的平均NDPSATR分别为0.40和0.46,差异无统计学意义。ENZ的PSAR50和非PSAR50的中位PFS(mPFS)分别为14.3个月和4.8个月,PFS差异显著(P=0.002)。对于 DTX,PSAR50 和非 PSAR50 的 mPFS 分别为 15.0 个月和 6.5 个月,但 PFS 无显著差异(p=0.055)。截断值为0.4时,ENZ和DTX的NDPSATR≥0.4的比例分别为36.4%和62.9%。对于ENZ,NDPSATR≥0.4和NDPSATR<0.4的mPFS分别为14.1个月和14.1个月,PFS无显著差异(P=0.895)。对于DTX,NDPSATR≥0.4和NDPSATR<0.4的mPFS分别为9.7个月和6.3个月,PFS有显著差异(P=0.045):结论:NDPSATR≥0.4可能是DTX治疗的CRPC患者PFS的良好标志,并可能取代PSAR50。
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