Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial
Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial
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DOI：
10.1200/jco.2017.75.3657
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发表时间：
2018-04-10
影响因子：
45.3
通讯作者：
Sweeney, Christopher J.
中科院分区：
文献类型：
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作者：
Kyriakopoulos, Christos E.;Chen, Yu-Hui;Sweeney, Christopher J.
目的多西紫杉醇联合雄激素剥夺疗法(ADT)可显著延长部分转移性激素敏感型前列腺癌患者的生存期。在此，我们介绍了CHAARTED(化疗激素治疗与雄激素消融治疗前列腺癌广泛疾病的随机试验)试验的结果，该试验具有更成熟的随访和对肿瘤体积的关注。患者和方法在这项III期研究中，790名转移性激素敏感型前列腺癌患者被随机分配到ADT联合多西紫杉醇75 mg/m(2)治疗6个周期或单独接受ADT治疗。研究的主要终点是总体生存期(OS)。对前瞻性定义的低容量和高容量疾病亚组进行了额外的分析。高容量疾病定义为存在内脏转移和/或4个至少有一个在脊柱和骨盆外的骨转移。结果在53.7个月的中位随访期，化疗组的中位OS为57.6个月，而单用ADT组为47.2个月(风险比[HR]，0.72；95%CI，0.59至0.89；P=.0018)。对于高容量疾病的患者(n=513)，接受化疗激素治疗的中位OS为51.2个月，而仅使用ADT的中位OS为34.4个月(HR，0.63；95%CI，0.50至0.79；P<；.001)。对于低容量疾病患者(n=277)，没有观察到OS益处(HR，1.04；95%CI，0.70至1.55；P=.86)。结论化疗激素治疗延长高容量疾病患者OS的临床益处得到证实；而对于低容量疾病患者，OS益处不明显。
PurposeDocetaxel added to androgen-deprivation therapy (ADT) significantly increases the longevity of some patients with metastatic hormone-sensitive prostate cancer. Herein, we present the outcomes of the CHAARTED (Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer) trial with more mature follow-up and focus on tumor volume.Patients and MethodsIn this phase III study, 790 patients with metastatic hormone-sensitive prostate cancer were equally randomly assigned to receive either ADT in combination with docetaxel 75 mg/m(2) for up to six cycles or ADT alone. The primary end point of the study was overall survival (OS). Additional analyses of the prospectively defined low- and high-volume disease subgroups were performed. High-volume disease was defined as presence of visceral metastases and/or four bone metastases with at least one outside of the vertebral column and pelvis.ResultsAt a median follow-up of 53.7 months, the median OS was 57.6 months for the chemohormonal therapy arm versus 47.2 months for ADT alone (hazard ratio [HR], 0.72; 95% CI, 0.59 to 0.89; P = .0018). For patients with high-volume disease (n = 513), the median OS was 51.2 months with chemohormonal therapy versus 34.4 months with ADT alone (HR, 0.63; 95% CI, 0.50 to 0.79; P < .001). For those with low-volume disease (n = 277), no OS benefit was observed (HR, 1.04; 95% CI, 0.70 to 1.55; P = .86).ConclusionThe clinical benefit from chemohormonal therapy in prolonging OS was confirmed for patients with high-volume disease; however, for patients with low-volume disease, no OS benefit was discerned.