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多西他赛在新诊断的转移性前列腺癌中的真实世界应用、安全性及疗效

Real-world uptake, safety profile and outcomes of docetaxel in newly diagnosed metastatic prostate cancer.

作者信息

Rulach Robert J, McKay Stephen, Neilson Sam, White Lillian, Wallace Jan, Carruthers Ross, Lamb Carolynn, Cascales Almudena, Marashi Husam, Glen Hilary, Venugopal Balaji, Sadoyze Azmat, Sidek Norma, Russell J Martin, Alhasso Abdulla, Dodds David, Laskey Jennifer, Jones Robert J, MacLeod Nicholas

机构信息

The Beatson West of Scotland Cancer Centre, Glasgow, UK.

University Hospital Ayr, Ayr, UK.

出版信息

BJU Int. 2018 Feb;121(2):268-274. doi: 10.1111/bju.14025. Epub 2017 Oct 15.

Abstract

OBJECTIVES

To investigate the uptake, safety and efficacy of docetaxel chemotherapy in hormone-naïve metastatic prostate cancer (mPC) in the first year of use outside of a clinical trial.

PATIENTS AND METHODS

Patients in the West of Scotland Cancer Network with newly diagnosed mPC were identified from the regional multidisciplinary team meetings and their treatment details were collected from electronic patient records. The rate of febrile neutropenia, hospitalisations, time to progression, and overall survival were compared between those patients who received docetaxel and androgen-deprivation therapy (ADT), or ADT alone using survival analysis.

RESULTS

Of the 270 eligible patients, 103 received docetaxel (38.1%). 35 patients (34%) were hospitalised and there were 17 episodes of febrile neutropenia (16.5%). Two patients (1.9%) died within 30 days of chemotherapy. Patients who received ADT alone had an increased risk of progression (hazard ratio [HR] 2.03, 95% confidence interval [CI] 1.27-3.25; log-rank test, P = 0.002) and had an increased risk of death (HR 5.88, 95% CI: 2.52-13.72; log-rank test, P = 0.001) compared to the docetaxel group. The risk of febrile neutropenia was nine-times greater if chemotherapy was started within 3 weeks of ADT initiation (95% CI: 1.22-77.72; P = 0.032).

CONCLUSION

Docetaxel chemotherapy in hormone-naïve mPC has significant toxicities, but has a similar effect on time to progression and overall survival as seen in randomised trials. Chemotherapy should be started at ≥3 weeks after ADT.

摘要

目的

在临床试验之外的第一年,研究多西他赛化疗在激素初治转移性前列腺癌(mPC)中的摄取、安全性和疗效。

患者与方法

从苏格兰西部癌症网络中,通过区域多学科团队会议识别出新诊断为mPC的患者,并从电子病历中收集他们的治疗细节。使用生存分析比较接受多西他赛和雄激素剥夺疗法(ADT)或仅接受ADT的患者的发热性中性粒细胞减少率、住院率、疾病进展时间和总生存期。

结果

在270名符合条件的患者中,103名接受了多西他赛治疗(38.1%)。35名患者(34%)住院,有17例发热性中性粒细胞减少事件(16.5%)。两名患者(1.9%)在化疗后30天内死亡。与多西他赛组相比,仅接受ADT的患者疾病进展风险增加(风险比[HR]2.03,95%置信区间[CI]1.27 - 3.25;对数秩检验,P = 0.002),死亡风险增加(HR 5.88,95% CI:2.52 - 13.72;对数秩检验,P = 0.001)。如果在ADT开始后3周内开始化疗,发热性中性粒细胞减少的风险会增加9倍(95% CI:1.22 - 77.72;P = 0.032)。

结论

激素初治mPC中的多西他赛化疗具有显著毒性,但在疾病进展时间和总生存期方面与随机试验中的效果相似。化疗应在ADT开始后≥3周开始。

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