The association of financial difficulties with clinical outcomes in cancer patients: secondary analysis of 16 academic prospective clinical trials conducted in Italy
The association of financial difficulties with clinical outcomes in cancer patients: secondary analysis of 16 academic prospective clinical trials conducted in Italy
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DOI：
10.1093/annonc/mdw433
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发表时间：
2016-12-01
影响因子：
50.5
通讯作者：
Gallo, C.
中科院分区：
文献类型：
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作者：
Perrone, F.;Jommi, C.;Gallo, C.
背景：癌症可能会造成经济困难，但其对拥有公共卫生系统的国家的影响尚不清楚。我们评估了参加意大利公共卫生系统内进行的学术临床试验的癌症患者的财务困难与临床结果之间的关联。患者和方法：使用 EORTC 生活质量 (QOL) C30 问卷，汇总了 16 项肺癌、乳腺癌或卵巢癌前瞻性多中心试验的数据。问题 28 将与疾病或治疗相关的经济困难分为“完全不”到“非常严重”四类。我们将财务负担（FB）定义为基线调查问卷中报告的任何财务困难，将财务毒性（FT）定义为后续调查问卷中的分数恶化。我们研究了 (i) FB 与临床结果（生存、总体 QOL 反应 [问题 29/30] 和严重毒性）的关联，以及 (ii) FT 与生存的关联。使用逻辑回归模型或 Cox 模型进行多变量分析，调整试验、性别、年龄、地区和入组时间、基线整体生活质量以及（如果适用）FB 和整体生活质量反应。结果以优势比 (OR) 或风险比 (HR) 的形式报告，置信区间 (CI) 为 95%。结果：在基线时，3670 名研究患者中有 26% 报告有 FB，与较差的基线整体生活质量显着相关。 FB 与死亡风险（HR 0.94，95% CI 0.85-1.04，P = 0.23）和严重毒性（OR 0.90，95% CI 0.76-1.06，P = 0.19）无关，但预测整体 QOL 反应较差的可能性较高（OR 1.35，95% CI 1.08-1.70，P = 0.009）。在治疗期间，2735 名患者（74.5%）填写了后续问卷，其中 616 名患者（22.5%）发生了 FT，且与死亡风险增加显着相关（HR 1.20，95% CI 1.05-1.37，P = 0.007）。多项敏感性分析证实了这些发现。结论：即使在公共卫生系统中，财务困难也与癌症患者的相关结果（如生活质量和生存率）相关。
Background: Cancer may cause financial difficulties, but its impact in countries with public health systems is unknown. We evaluated the association of financial difficulties with clinical outcomes of cancer patients enrolled in academic clinical trials performed within the Italian public health system.Patients and methods: Data were pooled from 16 prospective multicentre trials in lung, breast or ovarian cancer, using the EORTC quality of life (QOL) C30 questionnaire. Question 28 scores financial difficulties related to disease or treatment in four categories from 'not at all' to 'very much'. We defined financial burden (FB) as any financial difficulty reported at baseline questionnaire, and financial toxicity (FT) as score worsening in a subsequent questionnaire. We investigated (i) the association of FB with clinical outcomes (survival, global QOL response [questions 29/30] and severe toxicity), and (ii) the association of FT with survival. Multivariable analyses were performed using logistic regression models or the Cox model adjusting for trial, gender, age, region and period of enrolment, baseline global QOL and, where appropriate, FB and global QOL response. Results are reported as odds ratio (OR) or hazard ratio (HR) with 95% confidence intervals (CI).Results: At baseline 26% of the 3670 study patients reported FB, significantly correlated with worse baseline global QOL. FB was not associated with risks of death (HR 0.94, 95% CI 0.85-1.04, P = 0.23) and severe toxicity (OR 0.90, 95% CI 0.76-1.06, P = 0.19) but was predictive of a higher chance of worse global QOL response (OR 1.35, 95% CI 1.08-1.70, P = 0.009). During treatment, 2735 (74.5%) patients filled in subsequent questionnaires and 616 (22.5%) developed FT that was significantly associated with an increased risk of death (HR 1.20, 95% CI 1.05-1.37, P = 0.007). Several sensitivity analyses confirmed these findings.Conclusion: Even in a public health system, financial difficulties are associated with relevant cancer patients outcomes like QOL and survival.