Patient-reported symptom burden of chronic graft versus host disease: a systematic literature review

ABSTRACT

Introduction

Chronic graft-versus-host disease (GVHD) is a life-threating complication of allogeneic hematopoietic stem cell transplantation (HSCT) leading to high morbidity and quality of life issues. We conducted a systematic literature review on the patient reported symptom burden of chronic GVHD.

Areas covered

English-language articles published between 2005 and November 2018 were searched using CENTRAL, EMBASE and MEDLINE. Studies that used the 2005 or 2015 National Institute of Health consensus criteria for the diagnosis and staging of chronic GVHD were included.

Expert opinion

Patient reported symptom burden was widely assessed in the literature (n = 38). The Lee Chronic GVHD Symptom Scale was the most frequently used instrument (n = 28), followed by the NIH Patient-reported Symptom scores (n = 11). Association of symptom burden with clinical outcome assessment endpoints (e.g. mortality) and with quality of life measures was investigated by fairly low number of studies with limited generalizability. By systematically investigating the influencing factors of symptom burden this review helps to better understand patients’ perceptions and may help improving the management and care of chronic GVHD. However, data on influencing factors was quite diverse, which indicates that specific questions identified as research gaps need to be incorporated in randomized clinical trials in a more systematic way.

KEYWORDS:

• Chronic graft-versus-host disease
• symptom burden
• patient reported outcome
• systematic literature review
• Symptom Scales

Acknowledgement

The authors would like to acknowledge the valuable support from Malalatiana Be Harvel employee of Janssen Europe, Middle East & Africa in the preparation of this manuscript.

Article highlights box

• The patient-reported symptom burden among patients diagnosed with chronic GVHD was frequently reported in the literature and the Lee Chronic GVHD Symptom Scale was the most frequently used instrument.

• By systematically investigating the influencing factors of the symptom burden this review helps to improve the management and care of chronic GVHD patients.

• Some studies indicated an association between the symptom burden and major clinical endpoints (i.e. overall mortality or non-relapse mortality), which supports that PROs need to be considered in prospective randomized controlled studies and even in clinical practice.

Declaration of interest

M Csanadi and T Agh are employees of Syreon Research Institute. Syreon Research Institute received grant from Janssen Global Services, LLC to conduct the study. S Farkas-Raduly is employee of Syreon Research Romania. Syreon Research Romania received no grant from Janssen Global Services, LLC. B Gros is an employee of Janssen-Cilag S.A., Spain. C Tapprich is an employee of Janssen-Cilag GmbH, Germany. JJ Trudeau is an employee of Janssen Global Services, LLC. JH Lipton has nothing to disclose. J Mattsson received lecture honorarium from Mallinckrodt Pharmaceuticals. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

This research was financially supported by Janssen Global Services, LLC.