阿比特龙在体能状态差的转移性去势抵抗性前列腺癌患者中的疗效。
Outcomes with abiraterone acetate in metastatic castration-resistant prostate cancer patients who have poor performance status.
机构信息
Department of Medical Oncology, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.
Division of Medical Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
出版信息
Eur Urol. 2015 Mar;67(3):441-7. doi: 10.1016/j.eururo.2014.01.030. Epub 2014 Jan 31.
BACKGROUND
Although abiraterone acetate (abiraterone) has proven efficacy in two randomised phase 3 trials in metastatic castration-resistant prostate cancer (mCRPC), patients who had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥2 were either excluded or under-represented in these trials.
OBJECTIVE
To compare outcomes in ECOG PS 0-1 and ≥2 in mCRPC patients treated with abiraterone.
DESIGN, SETTING, AND PARTICIPANTS: Cancer registries from three Canadian centres were used to retrospectively identify mCRPC patients (postdocetaxel and docetaxel-naïve) treated with abiraterone. ECOG PS, clinicopathologic characteristics, prostate-specific antigen (PSA) response, and survival data were collected.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Survival outcomes were estimated using the Kaplan-Meier method and compared using the log-rank test. Cox proportional hazards modelling was used to examine the effect of clinicopathologic characteristics on overall survival (OS) and time to PSA progression.
RESULTS AND LIMITATIONS
A total of 519 patients were identified; 61% (n=318) and 39% (n=201) were ECOG PS 0-1 and ≥2, respectively. ECOG PS 0-1 patients were significantly more likely than PS ≥2 patients to achieve a PSA decline ≥50% from baseline (45% vs 32%; p=0.003, Fisher exact test) and had significantly longer median time to PSA progression (5.2 mo vs 4.1 mo; p=0.023), median treatment duration (7.4 mo vs 4.5 mo; p<0.001), and median OS (20.0 mo vs 9.1 mo; p<0.001). On multivariate analysis, ECOG PS was a significant factor for OS (p<0.001), time to PSA progression (p=0.043), and PSA decline (p=0.002). Potential limitations include the retrospective study design and subjective nature of ECOG PS classification.
CONCLUSIONS
ECOG PS ≥2 mCRPC patients treated with abiraterone have inferior outcomes compared with ECOG 0-1 patients, especially in regard to OS. These data indicate that early initiation of abiraterone prior to a decline in PS may be warranted.
PATIENT SUMMARY
We found that advanced prostate cancer patients who have worse performance status (PS) derive less benefit from abiraterone, indicating that earlier treatment before PS declines could improve outcomes.
背景
尽管醋酸阿比特龙（阿比特龙）在两项转移性去势抵抗性前列腺癌（mCRPC）的随机 3 期试验中已被证明具有疗效，但这些试验排除或代表性不足患有东部合作肿瘤学组（ECOG）表现状态（PS）≥2 的患者。
目的
比较 ECOG PS 0-1 和≥2 的 mCRPC 患者接受醋酸阿比特龙治疗的结果。
设计、地点和参与者：使用来自加拿大三个中心的癌症登记处，回顾性地确定接受阿比特龙治疗的 mCRPC 患者（多西他赛和紫杉醇治疗后）。收集 ECOG PS、临床病理特征、前列腺特异性抗原（PSA）反应和生存数据。
测量和统计分析
使用 Kaplan-Meier 方法估计生存结果，并使用对数秩检验进行比较。使用 Cox 比例风险模型检查临床病理特征对总生存（OS）和 PSA 进展时间的影响。
结果和局限性
共确定了 519 名患者；ECOG PS 0-1 和≥2 分别占 61%（n=318）和 39%（n=201）。ECOG PS 0-1 患者与 PS≥2 患者相比，更有可能从基线下降 PSA 下降≥50%（45%比 32%；p=0.003，Fisher 确切检验），且 PSA 进展的中位时间更长（5.2 个月比 4.1 个月；p=0.023），中位治疗持续时间（7.4 个月比 4.5 个月；p<0.001），中位 OS（20.0 个月比 9.1 个月；p<0.001）。多变量分析显示，ECOG PS 是 OS（p<0.001）、PSA 进展时间（p=0.043）和 PSA 下降（p=0.002）的重要因素。潜在的局限性包括回顾性研究设计和 ECOG PS 分类的主观性。
结论
与 ECOG 0-1 患者相比，接受醋酸阿比特龙治疗的 ECOG PS≥2 的 mCRPC 患者预后较差，尤其是 OS。这些数据表明，在 PS 下降之前尽早开始阿比特龙治疗可能是合理的。
患者总结
我们发现，表现状态（PS）较差的晚期前列腺癌患者从阿比特龙中获益较少，这表明在 PS 下降之前进行更早的治疗可能会改善预后。
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