The association of financial difficulties with clinical outcomes in cancer patients: Secondary analysis of 16 academic prospective clinical trials conducted in Italy

F. Perrone, G. C. Jommi, Cesare Gridelli, S. Pignata, F. Ciardiello, F. Nuzzo, A. De Matteis, J. Bryce, G. Daniele, A. Morabito, M. C. Piccirillo, G. Rocco, L. Guizzaro

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)2224-2229
Number of pages6
JournalAnnals of Oncology
Volume27
Issue number12
DOIs
Publication statusPublished - Dec 1 2016

Fingerprint

Italy
Quality of Life
Clinical Trials
Confidence Intervals
Neoplasms
Public Health
Odds Ratio
Survival
Logistic Models
Proportional Hazards Models
Ovarian Neoplasms
Multicenter Studies
Lung Neoplasms
Breast Neoplasms
Surveys and Questionnaires
Therapeutics

Keywords

  • Financial toxicity
  • Overall survival
  • Public health system
  • Quality of life

ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

The association of financial difficulties with clinical outcomes in cancer patients : Secondary analysis of 16 academic prospective clinical trials conducted in Italy. / Perrone, F.; Jommi, G. C.; Gridelli, Cesare; Pignata, S.; Ciardiello, F.; Nuzzo, F.; De Matteis, A.; Bryce, J.; Daniele, G.; Morabito, A.; Piccirillo, M. C.; Rocco, G.; Guizzaro, L.

In: Annals of Oncology, Vol. 27, No. 12, 01.12.2016, p. 2224-2229.

Research output: Contribution to journalArticle

@article{29f9d22b4a364ee1a9844a5def5326a9,
title = "The association of financial difficulties with clinical outcomes in cancer patients: Secondary analysis of 16 academic prospective clinical trials conducted in 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.",
keywords = "Financial toxicity, Overall survival, Public health system, Quality of life",
author = "F. Perrone and Jommi, {G. C.} and Cesare Gridelli and S. Pignata and F. Ciardiello and F. Nuzzo and {De Matteis}, A. and J. Bryce and G. Daniele and A. Morabito and Piccirillo, {M. C.} and G. Rocco and L. Guizzaro",
year = "2016",
month = "12",
day = "1",
doi = "10.1093/annonc/mdw433",
language = "English",
volume = "27",
pages = "2224--2229",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "NLM (Medline)",
number = "12",

}

TY - JOUR

T1 - The association of financial difficulties with clinical outcomes in cancer patients

T2 - Secondary analysis of 16 academic prospective clinical trials conducted in Italy

AU - Perrone, F.

AU - Jommi, G. C.

AU - Gridelli, Cesare

AU - Pignata, S.

AU - Ciardiello, F.

AU - Nuzzo, F.

AU - De Matteis, A.

AU - Bryce, J.

AU - Daniele, G.

AU - Morabito, A.

AU - Piccirillo, M. C.

AU - Rocco, G.

AU - Guizzaro, L.

PY - 2016/12/1

Y1 - 2016/12/1

N2 - 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.

AB - 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.

KW - Financial toxicity

KW - Overall survival

KW - Public health system

KW - Quality of life

UR - http://www.scopus.com/inward/record.url?scp=85009882020&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85009882020&partnerID=8YFLogxK

U2 - 10.1093/annonc/mdw433

DO - 10.1093/annonc/mdw433

M3 - Article

AN - SCOPUS:85009882020

VL - 27

SP - 2224

EP - 2229

JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

IS - 12

ER -