Mohammadpour Reza Ali, Yazdani-Charati Jamshid, Faghani SZahra, Alizadeh Ahad, Barzegartahamtan Mohammadreza
Department of Biostatistics, Faculty of Health, Mazandaran University of Medical Sciences, Sari, Iran.
Department of Epidemiology and Reproductive Health, Reproductive Epidemiology Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
PeerJ. 2019 Jul 1;7:e7172. doi: 10.7717/peerj.7172. eCollection 2019.
One of the characteristics of Prostate-Specific Antigen (PSA) is PSA slope. It is the rate of diminishing PSA marker over time after radiotherapy (RT) in prostate cancer (PC) patients. The purpose of this study was to evaluate the relationship between increasing RT doses and PSA slope as a potential surrogate for PC recurrence.
This retrospective study was conducted on PC patients who were treated by radiotherapy in the Cancer Institute of Iran during 2007-2012. By reviewing the records of these patients, the baseline PSA measurement before treatment (iPSA), Gleason score (GS), clinical T stage (T. stage), and periodic PSA measurements after RT and the total radiation dose received were extracted for each patient separately. We used a Bayesian dose-response model, analysis of variance, Kruskal-Wallis test, Kaplan-Meier product-limit method for analysis. Probability values less 0.05 were considered statistically significant.
Based on the D'Amico risk assessment system, 13.34% of patients were classified as "Low Risk", 51.79% were "Intermediate Risk", and 34.87% were "High Risk". In terms of radiation doses, 12.31% of the patients received fewer than 50 Gy, 15.38% received 50 to 69 Gy, 61.03% received 70 Gy, and 11.28% received more than 70 Gy. The PSA values decreased after RT for all dose levels. The slope of PSA changes was negative for 176 of 195 patients. By increasing the dosage of radiation, the PSA decreased but these changes were not statistically significant ( = 0.701) and PSA slope as a surrogate end point cannot met the Prentice's criteria for PC recurrence.
Significant changes in the dose-response relationship were not observed when the PSA slope was considered as the response criterion. Therefore, although the absolute value of the PSA decreased with increasing doses of RT, the relationship between PSA slope changes and increasing doses was not clear and cannot be used as a reliable response surrogate endpoint.
前列腺特异性抗原(PSA)斜率是PSA的特征之一。它是前列腺癌(PC)患者放疗(RT)后PSA标志物随时间下降的速率。本研究的目的是评估增加放疗剂量与PSA斜率之间的关系,将其作为PC复发的潜在替代指标。
本回顾性研究针对2007年至2012年期间在伊朗癌症研究所接受放疗的PC患者进行。通过查阅这些患者的记录,分别提取每位患者治疗前的基线PSA测量值(iPSA)、 Gleason评分(GS)、临床T分期(T分期)、放疗后的定期PSA测量值以及所接受的总辐射剂量。我们使用贝叶斯剂量反应模型、方差分析、Kruskal-Wallis检验、Kaplan-Meier乘积限界法进行分析。概率值小于0.05被认为具有统计学意义。
根据达米科风险评估系统,13.34%的患者被归类为“低风险”,51.79%为“中风险”,34.87%为“高风险”。在辐射剂量方面,12.31%的患者接受的剂量少于50 Gy,15.38%接受50至69 Gy,61.03%接受70 Gy,11.28%接受超过70 Gy。所有剂量水平放疗后PSA值均下降。195例患者中有176例PSA变化斜率为负。随着辐射剂量的增加,PSA下降,但这些变化无统计学意义(P = 0.701),且PSA斜率作为替代终点不符合PC复发的普伦蒂斯标准。
将PSA斜率作为反应标准时,未观察到剂量反应关系的显著变化。因此,尽管PSA的绝对值随放疗剂量增加而下降,但PSA斜率变化与剂量增加之间的关系不明确,不能用作可靠的反应替代终点。