Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Apr 27;13(4):e069090.
doi: 10.1136/bmjopen-2022-069090.

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

Petra C Vinke #  1 , Marc Combalia #  2   3 , Geertruida H de Bock  4 , Clémence Leyrat  5 , Anne Mea Spanjaart  6   7   8 , Stephane Dalle  9   10   11 , Maria Gomes da Silva  12 , Aurore Fouda Essongue  11 , Aurélie Rabier  11 , Myriam Pannard  13 , Mohammad S Jalali  14 , Amal Elgammal  15   16 , Mike Papazoglou  15   17   18 , Mohand-Said Hacid  19 , Catherine Rioufol  20 , Marie-José Kersten  6   7   8 , Martijn Gh van Oijen  21 , Erick Suazo-Zepeda  4 , Ananya Malhotra  22 , Emmanuel Coquery  19 , Amélie Anota  23   24 , Marie Preau  13 , Mathieu Fauvernier  10   25   26 , Elsa Coz  10   25   26 , Susana Puig  27   3   28 , Delphine Maucort-Boulch  10   25   26
Affiliations

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

Petra C Vinke et al. BMJ Open. .

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.

Trial registration number: NCT05626764.

Keywords: Adverse events; Epidemiology; ONCOLOGY.

PubMed Disclaimer

Conflict of interest statement

Competing interests: M-JK: honoraria from Kite, a Gilead Company, Novartis and Miltenyi Biotec, Roche, and Bristol Myers Squibb/Celgene; consultancy or advisory role for Kite, a Gilead Company, Roche, Novartis, Bristol Myers Squibb/Celgene and Miltenyi Biotec; research funding from Kite, a Gilead Company, Roche, Takeda and Celgene; and travel support from Kite, a Gilead Company, Roche, Novartis and Miltenyi Biotec. All other authors declare that they have no competing interests.

Figures

Figure 1
Figure 1
Structure of the ‘monitoring multidimensional aspects of QUAlity of Life after cancer ImmunoTherapy, an Open smart digital Platform for personalised prevention and patient management’ (QUALITOP) project.
Figure 2
Figure 2
Timeline of patient monitoring in the historic and prospective cohorts of the ‘monitoring multidimensional aspects of QUAlity of Life after cancer ImmunoTherapy, an Open smart digital Platform for personalised prevention and patient management’ (QUALITOP) project.
Figure 3
Figure 3
Framework for the medical and psychosocial determinants of quality of life.
Figure 4
Figure 4
Simplified representation of the architecture of the smart data platform and its underlying medical data lake.
See this image and copyright information in PMC

References

    1. Dobosz P, Dzieciątkowski T. The intriguing history of cancer immunotherapy. Front Immunol 2019;10:2965. 10.3389/fimmu.2019.02965 - DOI - PMC - PubMed
    1. Herbst RS, Baas P, Kim D-W, et al. . Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet 2016;387:1540–50. 10.1016/S0140-6736(15)01281-7 - DOI - PubMed
    1. Hodi FS, O’Day SJ, McDermott DF, et al. . Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010;363:711–23. 10.1056/NEJMoa1003466 - DOI - PMC - PubMed
    1. Rizvi NA, Mazières J, Planchard D, et al. . Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Lancet Oncol 2015;16:257–65. 10.1016/S1470-2045(15)70054-9 - DOI - PMC - PubMed
    1. Larkin J, Chiarion-Sileni V, Gonzalez R, et al. . Five-year survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med 2019;381:1535–46. 10.1056/NEJMoa1910836 - DOI - PubMed

Publication types

Associated data