研究动态
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低 PSA 水平的多西紫杉醇治疗的高级别前列腺癌的死亡风险:荟萃分析。

Mortality Risk for Docetaxel-Treated, High-Grade Prostate Cancer With Low PSA Levels: A Meta-Analysis.

发表日期:2023 Nov 01
作者: Brandon A Mahal, Lucia Kwak, Wanling Xie, James A Eastham, Nicholas D James, Howard M Sandler, Felix Y Feng, Meryem Brihoum, Karim Fizazi, Christopher Sweeney, Praful Ravi, Anthony V D'Amico
来源: JAMA Network Open

摘要:

前列腺特异性抗原水平较低 (PSA;<4 ng/mL) 的高级别前列腺癌患者死亡风险很高,需要改进治疗模式。为了评估这些患者是否将多西紫杉醇添加到标准治疗中( SOC)治疗与降低前列腺癌特异性死亡率(PCSM)和全因死亡率(ACM)相关。2000年至2022年的PubMed搜索。在美国、法国和英国进行的五项前瞻性随机临床试验(RCT)评估 SOC 治疗采用放疗和雄激素剥夺疗法 (ADT) 或根治性前列腺切除术与 SOC 加多西他赛的比较。个体数据包括来自非转移性前列腺癌患者、PSA 水平低于 4 ng/mL、格里森评分为 8 至 8 分的患者。 10.患者在2006年2月21日至2015年12月31日之间开始治疗(中位随访时间,7.1[IQR,5.4-9.9]年)。数据于2022年12月16日进行分析。根据体能状态(1 vs 0或健康状况良好)、格里森评分(9或10 vs 8)、肿瘤类别( T3-T4 与 T1-T2 或 TX),以及 ADT 持续时间(2 年与 4-6 个月)。在 2184 名患者的队列中,4 项随机对照试验中有 145 名患者 (6.6%) 符合资格(中位年龄为 63 [IQR] ,46-67]年)。 31 名患者死亡,其中 22 人死于前列腺癌。 139 名患者 (95.9%) 的体能状态为 0,6 名患者 (4.1%) 的体能状态为 1。与 SOC 相比,随机接受 SOC 加多西紫杉醇治疗的患者 ACM(HR,0.51 [95% CI,0.24-1.09])和 PCSM(sHR,0.42 [95% CI,0.17-1.02])风险降低,但不显着。 ACM 风险降低(HR,0.46 [95% CI,0.21-1.02])在体力状态为 0 的患者中更为明显,并且对于 PCSM 而言也很显着(sHR,0.30 [95% CI,0.11-0.86])。对于健康状况良好、PSA 水平低于 4 ng/mL、格里森评分为 8 至 10 分的患者,在 SOC 治疗中添加多西紫杉醇与 PCSM 显着降低相关,因此有可能改善预后。
Patients with high-grade prostate cancer with low levels of prostate-specific antigen (PSA; <4 ng/mL) are at high risk of mortality, necessitating an improved treatment paradigm.To assess for these patients whether adding docetaxel to standard of care (SOC) treatment is associated with decreased prostate cancer-specific mortality (PCSM) and all-cause mortality (ACM).PubMed search from 2000 to 2022.Five prospective randomized clinical trials (RCTs) performed in the US, France, and the United Kingdom evaluating SOC treatment with radiotherapy and androgen deprivation therapy (ADT) or with radical prostatectomy vs SOC plus docetaxel.Individual data were included from patients with nonmetastatic prostate cancer, a PSA level of less than 4 ng/mL, and a Gleason score of 8 to 10. Patients initiated treatment between February 21, 2006, and December 31, 2015 (median follow-up, 7.1 [IQR, 5.4-9.9] years). Data were analyzed on December 16, 2022.Hazard ratio (HR) of ACM and subdistribution HR (sHR) of PCSM adjusted for performance status (1 vs 0 or good health), Gleason score (9 or 10 vs 8), tumor category (T3-T4 vs T1-T2 or TX), and duration of ADT (2 years vs 4-6 months).From a cohort of 2184 patients, 145 patients (6.6%) in 4 RCTs were eligible (median age, 63 [IQR, 46-67] years). Thirty-one patients died, and of these deaths, 22 were due to prostate cancer. Performance status was 0 for 139 patients (95.9%) and 1 for 6 patients (4.1%). A reduced but nonsignificant risk of ACM (HR, 0.51 [95% CI, 0.24-1.09]) and PCSM (sHR, 0.42 [95% CI, 0.17-1.02]) was associated with patients randomized to SOC plus docetaxel compared with SOC. The risk reduction in ACM (HR, 0.46 [95% CI, 0.21-1.02]) was more pronounced among patients with a performance status of 0 and was significant for PCSM (sHR, 0.30 [95% CI, 0.11-0.86]).Adding docetaxel to SOC treatment for patients who are in otherwise good health with a PSA level of less than 4 ng/mL and a Gleason score of 8 to 10 was associated with a significant reduction in PCSM and therefore has the potential to improve prognosis.