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老年转移性去势抵抗性前列腺癌患者的一线治疗:一项前瞻性国际注册研究。

First-line treatment in senior adults with metastatic castration-resistant prostate cancer: A prospective international registry.

作者信息

Droz Jean-Pierre, Efstathiou Eleni, Yildirim Asif, Cabrera Paula, Soo Kim Choung, Horchani Ali, Heidenreich Axel, Rinck-Junior José Augusto, Hitier Simon, Ӧzen Haluk

机构信息

Department of Cancer Environment Research Unit, Léon-Bérard Cancer Center, Claude-Bernard-Lyon1 University, Lyon, France.

Department Medical Oncology, University of Athens, Athens, Greece.

出版信息

Urol Oncol. 2016 May;34(5):234.e21-9. doi: 10.1016/j.urolonc.2015.12.005. Epub 2016 Jan 14.

Abstract

AIMS

To compare the efficacy and tolerability of taxane and nontaxane therapy in senior adults with chemonaïve metastatic castration-resistant prostate cancer (mCRPC), and examine the effect of patient health status on outcomes.

PATIENTS AND METHODS

Between 2009 and 2011, 333 patients aged≥70 years with mCRPC were enrolled in a prospective international registry. Patients were categorized as having received taxane-based or nontaxane therapy, and classified as fit, vulnerable, frail, or terminal, according to investigator judgement or International Society of Geriatric Oncology guidelines. Efficacy measures included overall survival (OS) and progression-free survival. Grade 3/4 toxicities were recorded. Predictors of OS were identified using multivariate Cox regression.

RESULTS

The proportions of fit/vulnerable/frail patients were 65%/14%/17% (International Society of Geriatric Oncology), and 39%/43%/17% (investigator). In single-factor analyses, taxane therapy improved OS (hazard ratio [95%CI] = 0.53 [0.30-0.93]; P = 0.027) and progression-free survival (hazard ratio [95% CI] = 0.55 [0.40-0.76]; P<0.001) vs. nontaxane therapy. Patients with frailty also benefited from taxane therapy (adapted regimen in 52%). In multivariate analysis, taxanes improved OS even with poor prognostic factors present (P = 0.017); age was unrelated to prognosis. Taxane therapy was well tolerated; most common grade 3/4 toxicities (taxane vs. nontaxane) were fatigue (17% vs. 4%), nausea/vomiting (14% vs. 5%) and neutropenia (10% vs. 1%).

CONCLUSIONS

The results of this nonrandomized, observational study suggest that first-line taxane therapy may benefit senior adults with mCRPC more than alternative therapies. Treatment decisions should not be based on chronological age.

摘要

目的

比较紫杉烷类与非紫杉烷类疗法对初治转移性去势抵抗性前列腺癌(mCRPC)老年患者的疗效和耐受性,并研究患者健康状况对治疗结果的影响。

患者与方法

2009年至2011年期间,333例年龄≥70岁的mCRPC患者被纳入一项前瞻性国际登记研究。根据研究者判断或老年肿瘤学会国际指南,患者被分类为接受了基于紫杉烷类的治疗或非紫杉烷类治疗,并分为健康、脆弱、虚弱或终末期。疗效指标包括总生存期(OS)和无进展生存期。记录3/4级毒性反应。使用多因素Cox回归确定OS的预测因素。

结果

根据老年肿瘤学会国际指南,健康/脆弱/虚弱患者的比例分别为65%/14%/17%;根据研究者判断,该比例分别为39%/43%/17%。单因素分析中,与非紫杉烷类疗法相比,紫杉烷类疗法改善了OS(风险比[95%置信区间]=0.53[0.30 - 0.93];P = 0.027)和无进展生存期(风险比[95%置信区间]=0.55[0.40 - 0.76];P<0.001)。虚弱患者也从紫杉烷类疗法中获益(52%采用调整方案)。多因素分析中,即使存在不良预后因素,紫杉烷类仍可改善OS(P = 0.017);年龄与预后无关。紫杉烷类疗法耐受性良好;最常见的3/4级毒性反应(紫杉烷类与非紫杉烷类)为疲劳(17%对4%)、恶心/呕吐(14%对5%)和中性粒细胞减少(10%对1%)。

结论

这项非随机观察性研究结果表明,一线紫杉烷类疗法对mCRPC老年患者可能比其他疗法更有益。治疗决策不应基于实际年龄。

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