title: The association of financial difficulties with clinical outcomes in cancer patients: secondary analysis of 16 academic prospective clinical trials conducted in Italy.
abstract: 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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  Even in a public health system, financial difficulties are associated with relevant cancer patients outcomes like QOL and survival.
  
  
  
  Any registered clinical trial number should be indicated after the abstract.
authors: Research Department, Clinical Trial Unit, National Cancer Institute, G.Pascale Foundation - IRCCS, Naples f.perrone@istitutotumori.na.it.
authors: F
authors: F
authors: Perrone
authors: Drug Science Department, University of Piemonte Orientale, Novara, and CERGAS (Centre for Research on Health and Social Care Management), Bocconi University, Milan.
authors: C
authors: C
authors: Jommi
authors: Research Department, Clinical Trial Unit, National Cancer Institute, G.Pascale Foundation - IRCCS, Naples.
authors: M
authors: M
authors: Di Maio
authors: Research Department, Clinical Trial Unit, National Cancer Institute, G.Pascale Foundation - IRCCS, Naples.
authors: A
authors: A
authors: Gimigliano
authors: Department of Oncology/Hematology, Division of Medical Oncology, 'S.G. Moscati' Hospital, Avellino.
authors: C
authors: C
authors: Gridelli
authors: Urogynecologic Department, Medical Oncology, National Cancer Institute, G.Pascale Foundation - IRCCS, Naples.
authors: S
authors: S
authors: Pignata
authors: Department of Internal and Experimental Medicine 'F. Magrassi ed A. Lanzara', Division of Medical Oncology, Second University of Naples, Naples.
authors: F
authors: F
authors: Ciardiello
authors: Senology Department, Medical Oncology, National Cancer Institute, G.Pascale Foundation - IRCCS, Naples.
authors: F
authors: F
authors: Nuzzo
authors: Senology Department, Medical Oncology, National Cancer Institute, G.Pascale Foundation - IRCCS, Naples.
authors: A
authors: A
authors: de Matteis
authors: Department of Medicine, Development of Innovative Treatment Unit, IST National Institute for Cancer Research - IRCCS SanMartino, Genoa.
authors: L
authors: L
authors: Del Mastro
authors: Research Department, Clinical Trial Unit, National Cancer Institute, G.Pascale Foundation - IRCCS, Naples.
authors: J
authors: J
authors: Bryce
authors: Research Department, Clinical Trial Unit, National Cancer Institute, G.Pascale Foundation - IRCCS, Naples.
authors: G
authors: G
authors: Daniele
authors: Departments of Thoracic Medical Oncology.
authors: A
authors: A
authors: Morabito
authors: Research Department, Clinical Trial Unit, National Cancer Institute, G.Pascale Foundation - IRCCS, Naples.
authors: M C
authors: MC
authors: Piccirillo
authors: Thoracic Surgical and Medical Oncology, Division of Thoracic Surgery, National Cancer Institute, G.Pascale Foundation - IRCCS, Naples, Italy.
authors: G
authors: G
authors: Rocco
authors: European Medicines Agency, London, UK.|Department of Mental Health and Preventive Medicine, Medical Statistics, Second University of Naples, Naples, Italy.
authors: L
authors: L
authors: Guizzaro
authors: Department of Mental Health and Preventive Medicine, Medical Statistics, Second University of Naples, Naples, Italy.
authors: C
authors: C
authors: Gallo
mesh_terms: D000368:Aged; D001943:Breast Neoplasms / Q000191:economics* / Q000453:epidemiology; D002986:Clinical Trials as Topic / Q000191:economics*; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D016015:Logistic Models; D008175:Lung Neoplasms / Q000191:economics* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000191:economics* / Q000453:epidemiology; D016016:Proportional Hazards Models; D011788:Quality of Life; D011795:Surveys and Questionnaires
keywords: financial toxicity; overall survival; public health system; quality of life