F Perrone1, C Jommi2, M Di Maio3, A Gimigliano3, C Gridelli4, S Pignata5, F Ciardiello6, F Nuzzo7, A de Matteis7, L Del Mastro8, J Bryce3, G Daniele3, A Morabito9, M C Piccirillo3, G Rocco10, L Guizzaro11,12, C Gallo12. 1. Research Department, Clinical Trial Unit, National Cancer Institute, G.Pascale Foundation - IRCCS, Naples f.perrone@istitutotumori.na.it. 2. Drug Science Department, University of Piemonte Orientale, Novara, and CERGAS (Centre for Research on Health and Social Care Management), Bocconi University, Milan. 3. Research Department, Clinical Trial Unit, National Cancer Institute, G.Pascale Foundation - IRCCS, Naples. 4. Department of Oncology/Hematology, Division of Medical Oncology, 'S.G. Moscati' Hospital, Avellino. 5. Urogynecologic Department, Medical Oncology, National Cancer Institute, G.Pascale Foundation - IRCCS, Naples. 6. Department of Internal and Experimental Medicine 'F. Magrassi ed A. Lanzara', Division of Medical Oncology, Second University of Naples, Naples. 7. Senology Department, Medical Oncology, National Cancer Institute, G.Pascale Foundation - IRCCS, Naples. 8. Department of Medicine, Development of Innovative Treatment Unit, IST National Institute for Cancer Research - IRCCS SanMartino, Genoa. 9. Departments of Thoracic Medical Oncology. 10. Thoracic Surgical and Medical Oncology, Division of Thoracic Surgery, National Cancer Institute, G.Pascale Foundation - IRCCS, Naples, Italy. 11. European Medicines Agency, London, UK. 12. Department of Mental Health and Preventive Medicine, Medical Statistics, Second University of Naples, Naples, Italy.
Abstract
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.
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 cancerpatients 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 cancerpatients outcomes like QOL and survival. CLINICAL TRIALS NUMBER: Any registered clinical trial number should be indicated after the abstract.
Authors: Alexander Fabian; Justus Domschikowski; Wolfgang Greiner; Gunnar Bockelmann; Elias Karsten; Alexander Rühle; Nils H Nicolay; Anca L Grosu; Jürgen Dunst; David Krug Journal: Strahlenther Onkol Date: 2022-04-25 Impact factor: 3.621
Authors: Ryan W Huey; Goldy C George; Penny Phillips; Revenda White; Siqing Fu; Filip Janku; Daniel D Karp; Aung Naing; Sarina Piha-Paul; Vivek Subbiah; Apostolia M Tsimberidou; Shubham Pant; Timothy A Yap; Jordi Rodon; Funda Meric-Bernstam; Ya-Chen Tina Shih; David S Hong Journal: Oncologist Date: 2021-04-21
Authors: Mina S Sedrak; Rachel A Freedman; Harvey J Cohen; Hyman B Muss; Aminah Jatoi; Heidi D Klepin; Tanya M Wildes; Jennifer G Le-Rademacher; Gretchen G Kimmick; William P Tew; Kevin George; Simran Padam; Jennifer Liu; Andrew R Wong; Andrea Lynch; Benjamin Djulbegovic; Supriya G Mohile; William Dale Journal: CA Cancer J Clin Date: 2020-10-01 Impact factor: 508.702