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多西他赛联合雄激素剥夺疗法一线治疗少数族裔去势敏感性转移性前列腺癌的疗效

Efficacy of Upfront Docetaxel With Androgen Deprivation Therapy for Castration-Sensitive Metastatic Prostate Cancer Among Minority Patients.

作者信息

Pathak Surabhi, Thekkekara Romy, Yadav Udit, Ahmed Ahmed Tarig, Yim Barbara, Lad Thomas E, Mullane Michael, Batra Kumar Kunnal, Aronow Wilbert S, Psutka Sarah P

机构信息

Division of Hematology-Oncology, Department of Medicine, John H. Stroger, Jr. Hospital of Cook County, Chicago, IL.

Division of Cardiology, Department of Medicine, New York Medical College at Westchester Medical Center, Valhalla, NY.

出版信息

Am J Ther. 2020 May 5;28(4):e380-e387. doi: 10.1097/MJT.0000000000001085.

Abstract

BACKGROUND

Upfront docetaxel (UD) with androgen deprivation therapy (ADT) has been demonstrated to improve survival outcomes in metastatic castration-sensitive prostate cancer (mCSPC). However, existing studies have included predominantly Caucasian patients.

STUDY QUESTION

To compare the efficacy of addition of UD to ADT in mCSPC to ADT alone among minority patients.

STUDY DESIGN

Retrospective study of mCSPC patients.

MEASURES AND OUTCOMES

Patients treated with UD and ADT between January 2014 and December 2017 (UD + ADT, n = 44) were compared with those treated with ADT alone between January 2008 and January 2017 (ADT, n = 38); patients of Caucasian ethnicity were excluded. The outcome of interest was progression-free survival (PFS), which was estimated using Kaplan-Meier analysis and Cox proportional hazard analysis.

RESULTS

Overall, 63 (76.8%) patients were African American and 16 (19.5%) were Hispanic. Fifty-five (67%) patients had high-volume mCSPC. The median follow-up was 14 months [95% confidence interval (CI): 10.4-16.5] for UD + ADT and 42 months (95% CI: 17-66.9) for ADT. Median PFS did not differ between groups: UD + ADT: 16 versus ADT: 18 months [hazard ratio (HR) for UD + ADT = 0.88, 95% CI: 0.48-1.62; P = 0.70]. In patients with high-volume disease, median PFS remained similar (UD + ADT: 16 vs. ADT: 14 months (HR for UD + ADT = 0.64, 95% CI: 0.33-1.25; P = 0.19). On multivariable analysis, prolonged time to nadir PSA, HR = 0.83 (95% CI: 0.76-0.90), was independently associated with PFS. The most common toxicities in UD + ADT were anemia and fatigue. Major limitations include small sample size and potential for selection bias due to the retrospective study design.

CONCLUSIONS

In this retrospective review of a minority mCSPC cohort, UD + ADT was not associated with improved PFS compared with ADT alone. Although further study with larger sample size is needed, these results underscore the importance of ensuring accrual of minorities in clinical trials, reflective of the real-world setting.

摘要

背景

多西他赛一线治疗(UD)联合雄激素剥夺治疗(ADT)已被证明可改善转移性去势敏感性前列腺癌(mCSPC)患者的生存结局。然而,现有研究主要纳入的是白种人患者。

研究问题

比较在少数族裔患者中,UD联合ADT治疗mCSPC与单纯ADT治疗的疗效。

研究设计

对mCSPC患者进行回顾性研究。

测量指标与结局

将2014年1月至2017年12月期间接受UD联合ADT治疗的患者(UD + ADT组,n = 44)与2008年1月至2017年1月期间单纯接受ADT治疗的患者(ADT组,n = 38)进行比较;排除白种人患者。感兴趣的结局指标是无进展生存期(PFS),采用Kaplan-Meier分析和Cox比例风险分析进行评估。

结果

总体而言,63例(76.8%)患者为非裔美国人,16例(19.5%)为西班牙裔。55例(67%)患者患有高负荷mCSPC。UD + ADT组的中位随访时间为14个月[95%置信区间(CI):10.4 - 16.5],ADT组为42个月(95% CI:17 - 66.9)。两组的中位PFS无差异:UD + ADT组为16个月,ADT组为18个月[UD + ADT组的风险比(HR)= 0.88,95% CI:0.48 - 1.62;P = 0.70]。在高负荷疾病患者中,中位PFS仍然相似(UD + ADT组:16个月 vs. ADT组:14个月(UD + ADT组的HR = 0.64,95% CI:0.33 - 1.25;P = 0.19)。多变量分析显示,最低PSA水平出现时间延长,HR = 0.83(95% CI:0.76 - 0.90),与PFS独立相关。UD + ADT组最常见的毒性反应是贫血和疲劳。主要局限性包括样本量小以及由于回顾性研究设计存在选择偏倚的可能性。

结论

在这项对少数族裔mCSPC队列的回顾性研究中,与单纯ADT相比,UD联合ADT并未改善PFS。尽管需要更大样本量的进一步研究,但这些结果强调了在临床试验中确保少数族裔患者入组的重要性,这反映了现实世界的情况。

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