Publication on: “Monitoring multidimensional aspects of quality of life after cancer immunotherapy: protocol for the international multicentre, observational QUALITOP cohort study”

Abstract

Introduction: 

Immunotherapies, such as immune checkpoint inhibitors and chimeric antigen receptor T-cell therapy, have significantly improved the clinical outcomes of various malignancies. However, they also cause immune-related adverse events (irAEs) that can be challenging to predict, prevent and treat. Although they likely interact with health-related quality of life (HRQoL), most existing evidence on this topic has come from clinical trials with eligibility criteria that may not accurately reflect real-world settings. The QUALITOP project will study HRQoL in relation to irAEs and its determinants in a real-world study of patients treated with immunotherapy.

Methods and analysis: 

This international, observational, multicentre study takes place in France, the Netherlands, Portugal and Spain. We aim to include about 1800 adult patients with cancer treated with immunotherapy in a specifically recruited prospective cohort, and to additionally obtain data from historical real-world databases (ie, databiobanks) and medical administrative registries (ie, national cancer registries) in which relevant data regarding other adult patients with cancer treated with immunotherapy has already been stored. In the prospective cohort, clinical health status, HRQoL and psychosocial well-being will be monitored until 18 months after treatment initiation through questionnaires (at baseline and 3, 6, 12 and 18 months thereafter), and by data extraction from electronic patient files. Using advanced statistical methods, including causal inference methods, artificial intelligence algorithms and simulation modelling, we will use data from the QUALITOP cohort to improve the understanding of the complex relationships among treatment regimens, patient characteristics, irAEs and HRQoL.

Ethics and dissemination: 

All aspects of the QUALITOP project will be conducted in accordance with the Declaration of Helsinki and with ethical approval from a suitable local ethics committee, and all patients will provide signed informed consent. In addition to standard dissemination efforts in the scientific literature, the data and outcomes will contribute to a smart digital platform and medical data lake. These will (1) help increase knowledge about the impact of immunotherapy, (2) facilitate improved interactions between patients, clinicians and the general population and (3) contribute to personalised medicine.

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Publication on: “Quality of life after treatment with immune checkpoint inhibitors for lung cancer; the impact of age”

Abstract

Introduction: 

Immune checkpoint inhibitors (ICIs) have revolutionized lung cancer treatment. However, it remains unclear as to whether changes in Health-Related Quality-of-Life (HRQoL) are associated with the age of lung cancer patients treated using ICIs. This study aimed to evaluate this possible association and to compare ICI-treated patients’ HRQoL scores with normative data of an age-matched non-cancer general population.

Methods: 

Lung cancer patients from the OncoLifeS data-biobank were included if they were treated with ICIs, irrespective of other treatments, at the University Medical Center Groningen between 2015 and 2021 and had completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30), both at the start of ICI treatment and after six months. Association of age as a continuous variable (per 10 years) and changes in HRQoL scores between baseline and 6 months was assessed using multivariable regression analyses. Clinical relevance of differences in HRQoL scores between OncoLifeS and the general population was classified into trivial, small, medium, and large, for three age groups (<60, 60-69 and ≥ 70 years).

Results: 

151 patients were included with a mean age of 65.8 years. An increase in age per 10 years was associated with a larger decrease in the summary HRQoL score(β = -3.28,CI95%-6.42;-0.14), physical(β = -4.8, CI95% -8.71;-0.88), cognitive(β = -4.51,CI95%-8.24;-0.78), role functioning(β = -5.41,CI95%-10.78;-0.05), symptom burden(β = -3.66,CI95%-6.6;-0.73), and smaller negative changes in financial difficulties(β = 6.5 95 % CI 3.16; 9.85). OncoLifeS HRQoL scores were lower than those of the general population and differences were most often classified as large and medium.

Conclusion: 

Older lung cancer patients experience larger deteriorations in most HRQoL domains after 6 months of ICI treatment. Also, these patients showed significantly lower HRQoL scores compared to the general population.

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PUBLICATION ON “Associations between treatments, comorbidities and multidimensional aspects of quality of life among patients with advanced cancer in the Netherlands—a 2017–2020 multicentre cross‑sectional study”

Abstract

Objective

To investigate associations between quality of life (QoL) and 1) immunotherapy and other cancer treatments

received three months before QoL measurements, and 2) the comorbidities at the time of completion or in the year prior to

QoL measurements, among patients with advanced cancer.

Methods A cross-sectional study is conducted on patients with advanced cancer in the Netherlands. The data come from the

baseline wave of the 2017–2020 eQuiPe study. Participants were surveyed via questionnaires (including EORTC QLQ-C30).

Using multivariable linear and logistic regression models, we explored statistical associations between QoL components

and immunotherapy and other cancer treatments as well as pre-existing comorbidities while adjusting for age, sex, socioeconomic

status.

Results

Of 1088 participants with median age 67 years, 51% were men. Immunotherapy was not associated with global

QoL but was associated with reduced appetite loss (odds ratio (OR) = 0.6, 95%CI = [0.3,0.9]). Reduced global QoL was

associated with chemotherapy (adjusted mean difference (β) = − 4.7, 95% CI [− 8.5,− 0.8]), back pain (β = − 7.4, 95% CI

[− 11.0,− 3.8]), depression (β = − 13.8, 95% CI [− 21.5,− 6.2]), thyroid diseases (β = − 8.9, 95% CI [− 14.0,− 3.8]) and

diabetes (β = − 4.5, 95% CI [− 8.9,− 0.5]). Chemotherapy was associated with lower physical (OR = 2.4, 95% CI [1.5,3.9])

and role (OR = 1.8, 95% CI [1.2,2.7]) functioning, and higher pain (OR = 1.9, 95% CI [1.3,2.9]) and fatigue (OR = 1.6, 95%

CI [1.1,2.4]).

Conclusion

Our study identified associations between specific cancer treatments, lower QoL and more symptoms. Monitoring

symptoms may improve QoL of patients with advanced cancer. Producing more evidence from real life data would help

physicians in better identifying patients who require additional supportive care.

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