1020O_PR - The effect of financial difficulties on clinical outcomes in Italian cancer patients: A pooled analysis of 16 academic prospective clinical trials

Date 10 October 2016
Event ESMO 2016 Congress
Session Public health and health economics
Topics Bioethics, Legal, and Economic Issues
Presenter Francesco Perrone
Citation Annals of Oncology (2016) 27 (6): 1-36. 10.1093/annonc/mdw435
Authors F. Perrone1, C. Jommi2, M. Di Maio3, A. Gimigliano1, C. Gridelli4, S. Pignata5, F. Ciardiello6, F. Nuzzo7, A. de Matteis7, L. Del Mastro8, J. Bryce1, G. Daniele1, A. Morabito9, M.C. Piccirillo1, G. Rocco9, L. Guizzaro10, C. Gallo10
  • 1Clinical Trial Unit, Istituto Nazionale Tumori – I.R.C.C.S - Fondazione Pascale, 80131 - Napoli/IT
  • 2Dipartimento Di Scienze Del Farmaco, Università del Piemonte Orientale, Novara/IT
  • 3Oncologia, Università degli Studi di Torino, Torino/IT
  • 4Medical Oncology, Azienda Ospedaliera S. Giuseppe Moscati, 83100 - Avellino/IT
  • 5Urogynecology, Istituto Nazionale Tumori – I.R.C.C.S - Fondazione Pascale, 80131 - Napoli/IT
  • 6Oncology, Second University of Naples, 80131 - Napoli/IT
  • 7Senology, Istituto Nazionale Tumori – I.R.C.C.S - Fondazione Pascale, 80131 - Napoli/IT
  • 8Medical Oncology, IRCCS AOU San Martino - IST-Istituto Nazionale per la Ricerca sul Cancro, Genova/IT
  • 9Thoracic Oncology, Istituto Nazionale Tumori – I.R.C.C.S - Fondazione Pascale, 80131 - Napoli/IT
  • 10Statistica Medica, AOU Seconda Università degli Studi di Napoli (AOU-SUN), Napoli/IT

Abstract

Background

Cancer may cause financial difficulties, particularly when co-payment is required for antineoplastic treatment. The impact of financial difficulties in countries with public health systems is unknown. We investigated the prognostic value of financial difficulties on clinical outcomes of cancer patients enrolled in academic clinical trials performed within the Italian public health system.

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 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 prognostic role of FB on clinical outcomes (survival, global QOL response [questions 29/30] and the occurrence of severe toxicity), and (ii) the effect of FT on survival using a landmark time of 4.5 months. Multivariable analyses were performed using logistic regression models or the Cox model adjusting for trial, gender, age, region, period of enrolment, baseline global QOL and, where appropriate, FB and global QOL response. Results are reported as odds ratios (OR) or hazard ratios (HR) with 95% confidence intervals (CI).

Results

At baseline, 26% of 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 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.

Conclusions

Even in a public health system, financial difficulties are associated with relevant cancer patients outcomes like QOL and survival.

Clinical trial identification

Legal entity responsible for the study

Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G.Pascale, IRCCS, Naples

Funding

Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G.Pascale, IRCCS, Naples

Disclosure

All authors have declared no conflicts of interest.