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纳入临床试验的晚期非小细胞肺癌患者受教育程度的预后影响。

Prognostic impact of education level of patients with advanced non-small cell lung cancer enrolled in clinical trials.

机构信息

Clinical Trials Unit, National Cancer Institute, Napoli, Italy.

出版信息

Lung Cancer. 2012 Jun;76(3):457-64. doi: 10.1016/j.lungcan.2012.01.002. Epub 2012 Jan 31.

DOI:10.1016/j.lungcan.2012.01.002
PMID:22297086
Abstract

BACKGROUND

Socioeconomic status can potentially affect prognosis of cancer patients. Our aim was to describe potential differences in demographic and clinical characteristics, treatment, and survival by education level in patients with advanced non-small cell lung cancer (NSCLC) enrolled in clinical trials of first-line treatment.

METHODS

Individual data of Italian patients with advanced NSCLC (stage IV, or IIIB with supraclavicular nodes or malignant pleural effusion), ECOG performance status (PS) 0-2, enrolled in four phase III randomized trials conducted between 1996 and 2005 were pooled. Information about education was available for 1680 of 1709 patients (98.3%). Patients were divided in two groups according to education level: high (patients with at least high school diploma) or low (those with less than high school diploma). Survival analyses were stratified by treatment arm within trial.

RESULTS

There were 312 (19%) and 1368 (81%) patients with high and low education, respectively. Education level was significantly different among birth cohorts, with a time-trend toward higher education level. Patients with high education were significantly younger (median age 65 vs. 70), were less frequently unfit at diagnosis (ECOG PS2 5% vs. 16%), and their tumor type was more frequently adenocarcinoma (47% vs. 37%). Number of treatment cycles received was not significantly different between education groups. Median survival was 9.4 and 7.6 months in high and low education, respectively (p=0.012). At multivariable analysis, female sex, better PS and high education level (Hazard Ratio 0.85, 95%CI 0.73-0.99, p=0.03) were independently associated with longer survival.

CONCLUSIONS

In Italian patients enrolled in four randomized trials of first-line chemotherapy for advanced NSCLC, high education was significantly more frequent among younger patients, and was associated with lower proportion of PS2 patients. Education level did not significantly affect number of chemotherapy cycles received. Overall survival was longer in patients with high education, after adjustment for PS and other prognostic factors. The exact underlying mechanisms of the independent prognostic role of education level are substantially unknown, but lead-time bias (anticipation in diagnosis and time to inclusion in the trial), differences in adherence to care outside the trial procedures, differences in comorbidities and life-style factors may all contribute.

摘要

背景

社会经济地位可能会影响癌症患者的预后。我们的目的是描述在接受一线治疗的临床试验中入组的晚期非小细胞肺癌(NSCLC)患者中,根据教育水平在人口统计学和临床特征、治疗和生存方面的潜在差异。

方法

汇总了 1996 年至 2005 年间进行的四项 III 期随机试验中入组的晚期 NSCLC(IV 期或 IIIB 期伴锁骨上淋巴结或恶性胸腔积液)、ECOG 体能状态(PS)0-2 的意大利患者的个体数据。共有 1709 例患者中的 1680 例(98.3%)可获得教育信息。根据教育水平将患者分为两组:高(至少高中文凭)或低(低于高中文凭)。在试验内的治疗组内进行生存分析。

结果

分别有 312 例(19%)和 1368 例(81%)患者的教育水平较高和较低。教育水平在出生队列中差异显著,存在受教育程度升高的趋势。高教育水平的患者明显更年轻(中位年龄 65 岁 vs. 70 岁),诊断时体能状态不佳(ECOG PS2 为 5% vs. 16%)的比例较低,肿瘤类型更常为腺癌(47% vs. 37%)。两组之间接受的治疗周期数无显著差异。高教育组和低教育组的中位生存期分别为 9.4 个月和 7.6 个月(p=0.012)。多变量分析显示,女性、更好的 PS 和高教育水平(风险比 0.85,95%CI 0.73-0.99,p=0.03)与更长的生存期独立相关。

结论

在入组四项晚期 NSCLC 一线化疗的随机试验的意大利患者中,高教育水平在年轻患者中更为常见,且与 PS2 患者的比例较低相关。教育水平对接受的化疗周期数无显著影响。在校正 PS 和其他预后因素后,高教育水平的患者总生存时间更长。教育水平独立预后作用的确切潜在机制尚不清楚,但可能与诊断前导时间(诊断和纳入试验的时间)、试验外护理依从性差异、合并症和生活方式因素差异有关。

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