Elsevier

Annals of Oncology

Volume 27, Issue 12, December 2016, Pages 2224-2229
Annals of Oncology

Original article
Miscellaneous tumors
The association of financial difficulties with clinical outcomes in cancer patients: secondary analysis of 16 academic prospective clinical trials conducted in Italy

https://doi.org/10.1093/annonc/mdw433Get rights and content
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ABSTRACT

Financial difficulties, measured by the EORTC C30 questionnaire, were associated with worse quality of life and shorter overall survival of cancer patients enrolled in 16 academic clinical trials performed within the Italian public health system. The pooled database included 3670 patients with lung, breast or ovarian cancer. This finding support further studies on financial toxicity in Europe.

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.

Clinical Trials number

Any registered clinical trial number should be indicated after the abstract.

Key words

financial toxicity
public health system
quality of life
overall survival

Cited by (0)

The views expressed in this article are the personal views of the author and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.

Present address: Oncology Department, University of Turin, Orbassano, Italy.