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一项针对接受抗癌治疗的不可治愈癌症门诊患者的预后工具的临床验证:PRONOPALL 研究。

Clinical validation of a prognostic tool in a population of outpatients treated for incurable cancer undergoing anticancer therapy: PRONOPALL study.

机构信息

Medical Oncology Department, Centre Jean Bernard/Clinique Victor Hugo, Le Mans.

Observatory of Cancer Bretagne Pays de la Loire, Siège Médical Institut de Cancérologie de l'Ouest, Site Paul Papin, Angers.

出版信息

Ann Oncol. 2017 Jul 1;28(7):1612-1617. doi: 10.1093/annonc/mdx172.

Abstract

BACKGROUND

In 2008, a study of the characteristics of hospitalised patients led to the development of a prognostic tool that distinguished three populations with significantly different 2-month survival rates. The goal of our study aimed at validating prospectively this prognostic tool in outpatients treated for cancer in terminal stage, based on four factors: performance status (ECOG) (PS), number of metastatic sites, serum albumin and lactate dehydrogenase.

PATIENTS AND METHODS

PRONOPALL is a multicentre study of current care. About 302 adult patients who met one or more of the following criteria: life expectancy under 6 months, performance status ≥ 2 and disease progression during the previous chemotherapy regimen were included across 16 institutions between October 2009 and October 2010. Afterwards, in order to validate the prognostic tool, the score was ciphered and correlated to patient survival.

RESULTS

Totally 262 patients (87%) were evaluable (27 patients excluded and 13 unknown score). Median age was 66 years [37-88], and women accounted for 59%. ECOG PS 0-1 (46%), PS 2 (37%) and PS 3-4 (17%). The primary tumours were: breast (29%), colorectal (28%), lung (13%), pancreas (12%), ovary (11%) and other (8%). About 32% of patients presented one metastatic site, 35% had two and 31% had more than two. The median lactate dehydrogenase level was 398 IU/l [118-4314]; median serum albumin was 35 g/l [13-54]. According to the PRONOPALL prognostic tool, the 2-month survival rate was 92% and the median survival rate was 301 days [209-348] for the 130 patients in population C, 66% and 79 days [71-114] for the 111 patients in population B, and 24% and 35 days for [14-56] the 21 patients in population A. These three populations survival were statistically different (P <0.0001).

CONCLUSION

PRONOPALL study confirms the three prognostic profiles defined by the combination of four factors. This PRONOPALL score is a useful decision-making tool in daily practice.

摘要

背景

2008 年,一项对住院患者特征的研究导致了一种预后工具的开发,该工具区分了具有显著不同 2 个月生存率的三个人群。我们的研究旨在前瞻性验证该预后工具在晚期癌症门诊患者中的应用,基于四个因素:体能状态(ECOG)(PS)、转移部位数量、血清白蛋白和乳酸脱氢酶。

患者和方法

PRONOPALL 是一项当前护理的多中心研究。大约 302 名符合以下一个或多个标准的成年患者被纳入研究:预期寿命不足 6 个月、PS≥2 且在前一化疗方案期间疾病进展,这些患者分布在 16 家机构中,研究时间为 2009 年 10 月至 2010 年 10 月。之后,为了验证预后工具,对评分进行了加密,并与患者生存相关联。

结果

共有 262 名患者(87%)可评估(27 名患者被排除,13 名患者评分未知)。中位年龄为 66 岁[37-88],女性占 59%。ECOG PS 0-1(46%)、PS 2(37%)和 PS 3-4(17%)。主要肿瘤为:乳腺癌(29%)、结直肠癌(28%)、肺癌(13%)、胰腺癌(12%)、卵巢癌(11%)和其他(8%)。约 32%的患者有一个转移部位,35%的患者有两个转移部位,31%的患者有三个或更多转移部位。中位乳酸脱氢酶水平为 398IU/L[118-4314];中位血清白蛋白为 35g/L[13-54]。根据 PRONOPALL 预后工具,130 名 C 组患者的 2 个月生存率为 92%,中位生存率为 301 天[209-348];111 名 B 组患者的 2 个月生存率为 66%,中位生存率为 79 天[71-114];21 名 A 组患者的 2 个月生存率为 24%,中位生存率为 35 天[14-56]。这三组患者的生存情况有统计学差异(P<0.0001)。

结论

PRONOPALL 研究证实了由四个因素组合定义的三种预后特征。这种 PRONOPALL 评分是日常实践中一种有用的决策工具。

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