LUGANO-COPENHAGEN – Financial difficulties can significantly impact a cancer patient’s quality of life during treatment and may even increase their risk of death, according to the results of a pooled analysis presented at the ESMO 2016 Congress in Copenhagen.
“Financial difficulties may impact the outcome for cancer patients even in countries where the national public health system covers most of the expenses, and therefore, it is our mission to understand what are the determinants of such difficulties and whether some of them may be actionable,” said principal investigator Dr. Francesco Perrone, director of the Unità Sperimentazioni Cliniche at the National Cancer Institute of Naples, Italy.
Researchers pooled data from 16 prospective multicenter trials in Italy involving a total of 3670 patients with either lung, breast or ovarian cancer, which included the EORTC quality of life C30 questionnaire. Question 28 of this questionnaire asks patients to rate financial difficulties related to their disease or treatment on a scale from ‘not at all’ to ‘very much’.
The analysis showed that financial burden – defined as any financial difficulty reported at baseline – was present in 26% of patients at baseline, and was associated with a 35% greater risk of a worse global quality-of-life response (p = 0.009).
Furthermore, financial toxicity, defined as a worsening of the financial score in subsequent questionnaire, was observed in 22.5% of the 2735 who filled out a subsequent questionnaire, and was associated with a 20% increase in the risk of death (p = 0.007).
Perrone said the researchers had expected to find an impact on quality of life from financial hardship, but were surprised to see that worsening financial problems during treatment was associated with a higher risk of death over the course of treatment.
“The size of this impact is moderate but not negligible; it is similar in size to the effect that pushed some new drugs into the market over the last twenty years,” Dr. Perrone said.
While pointing out that it was not possible to completely disentangle financial toxicity from a worsening of a patient’s clinical condition and disease progression, Perrone said the results from this analysis reflect those observed in similar analyses conducted in the US.
“Based on common sense, we oncologists should pay attention to the social status and economic possibilities of our patients and try to advise them regarding their rights in terms of public support and respect due to their condition,” Perrone said.
Commenting on the study, Dr Nathan Cherny from the Shaare Zedek Medical Center in Jerusalem, said the study demonstrates that even when patients do not have to pay – for example, when they are participating in a clinical trial – a significant number of them enter treatment with some degree of financial burden.
“These findings underscore that even in the absence of payment or co-payment of medications, being ill with cancer often has severe and progressive financial impact on patients and their families,” Dr Cherny said.
“In the absence of substantial supports and benefits, this may not only compromise quality of life but also patient outcomes.”
Notes to Editors
Abstract LBA 1020O_PR ‘The effect of financial difficulties on clinical outcomes in Italian cancer patients: a pooled analysis of 16 academic prospective clinical trials’ will be presented by Dr. Francesco Perrone during the Proffered Paper session, Public health and health economics, on Monday 10 October 2016, 16:30 to 18:00 (CEST) in Room Oslo.
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Abstract for 1020O_PR
The effect of financial difficulties on clinical outcomes in Italian cancer patients: A pooled analysis of 16 academic prospective clinical trials
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, Naples, Italy, 2Dipartimento di Scienze del Farmaco, Università del Piemonte Orientale, Novara, Italy, 3Oncology, Università degli Studi di Torino, Turin, Italy, 4Medical Oncology, Azienda Ospedaliera S. Giuseppe Moscati, Avellino, Italy, 5Urogynecology, Istituto Nazionale Tumori – I.R.C.C.S - Fondazione Pascale, Naples, Italy, 6Oncology, Second University of Naples, Naples, Italy, 7Senology, Istituto Nazionale Tumori – I.R.C.C.S - Fondazione Pascale, Naples, Italy, 8Medical Oncology, IRCCS AOU San Martino - IST-Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy, 9Thoracic Oncology, Istituto Nazionale Tumori – I.R.C.C.S - Fondazione Pascale, Naples, Italy, 10Statistica medica, AOU Seconda Università degli Studi di Napoli (AOU-SUN), Naples, Italy
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.
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.
Keywords: Overall Survival, quality of life, financial toxicity, financial burden