Abstract
Oral chronic GVHD (cGVHD) is a serious complication of alloSCT. Scales and instruments to measure oral cGVHD activity and severity have not been prospectively validated. The objective of this study was to describe the characteristics of oral cGVHD and determine the measures most sensitive to change. Patients enrolled in the cGVHD Consortium with oral involvement were included. Clinicians scored oral changes according to the National Institutes of Health (NIH) criteria, and patients completed symptom and quality-of-life measures at each visit. Both rated change on an eight-point scale. Of the 458 participants, 72% (n=331) had objective oral involvement at enrollment. Lichenoid change was the most common feature (n=293; 89%). At visits where oral change could be assessed, 50% of clinicians and 56% of patients reported improvement, with worsening reported in 4–5% for both the groups (weighted kappa=0.41). Multivariable regression modeling suggested that the measurement changes most predictive of perceived change by clinicians and patients were erythema and lichenoid, NIH severity and symptom scores. Oral cGVHD is common and associated with a range of signs and symptoms. Measurement of erythema and lichenoid changes and symptoms may adequately capture the activity of oral cGVHD in clinical trials but require prospective validation.
This is a preview of subscription content, access via your institution
Access options
Subscribe to this journal
Receive 12 print issues and online access
$259.00 per year
only $21.58 per issue
Buy this article
- Purchase on Springer Link
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
Similar content being viewed by others
References
Lee SJ, Vogelsang G, Flowers ME . Chronic graft-versus-host disease. Biol Blood Marrow Transplant 2003; 9: 215–233.
Arai S, Jagasia M, Storer B, Chai X, Pidala J, Cutler C et al. Global and organ-specific chronic graft-versus-host disease severity according to the 2005 NIH Consensus Criteria. Blood 2011; 118: 4242–4249.
Flowers ME, Parker PM, Johnston LJ, Matos AV, Storer B, Bensinger WI et al. Comparison of chronic graft-versus-host disease after transplantation of peripheral blood stem cells versus bone marrow in allogeneic recipients: long-term follow-up of a randomized trial. Blood 2002; 100: 415–419.
Imanguli MM, Alevizos I, Brown R, Pavletic SZ, Atkinson JC . Oral graft-versus-host disease. Oral Dis 2008; 14: 396–412.
Schubert MM, Correa ME . Oral graft-versus-host disease. Dent Clin North Am 2008; 52: 79–109 viii-ix.
Couriel D, Carpenter PA, Cutler C, Bolanos-Meade J, Treister NS, Gea-Banacloche J et al. Ancillary therapy and supportive care of chronic graft-versus-host disease: national institutes of health consensus development project on criteria for clinical trials in chronic Graft-versus-host disease: V. Ancillary Therapy and Supportive Care Working Group Report. Biol Blood Marrow Transplant 2006; 12: 375–396.
Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ et al. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant 2005; 11: 945–956.
Martin PJ, Weisdorf D, Przepiorka D, Hirschfeld S, Farrell A, Rizzo JD et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. Design of Clinical Trials Working Group report. Biol Blood Marrow Transplant 2006; 12: 491–505.
Pavletic SZ, Martin P, Lee SJ, Mitchell S, Jacobsohn D, Cowen EW et al. Measuring therapeutic response in chronic graft-versus-host disease: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. Response Criteria Working Group report. Biol Blood Marrow Transplant 2006; 12: 252–266.
Rationale and design of the chronic GVHD cohort study: improving outcomes assessment in chronic GVHD. Biol Blood Marrow Transplant 2011; 17: 1114–1120.
Jacobsohn DA, Chen AR, Zahurak M, Piantadosi S, Anders V, Bolanos-Meade J et al. Phase II study of pentostatin in patients with corticosteroid-refractory chronic graft-versus-host disease. J Clin Oncol 2007; 25: 4255–4261.
Lee S, Cook EF, Soiffer R, Antin JH . Development and validation of a scale to measure symptoms of chronic graft-versus-host disease. Biol Blood Marrow Transplant 2002; 8: 444–452.
Fleiss J, Cohen J . The equivalence of weighted kappa and the intraclass correlation coefficient as measures of reliability. Educ Psychol Meas 1973; 33: 613–619.
Gardiner JC, Luo Z, Roman LA . Fixed effects, random effects and GEE: what are the differences? Stat Med 2009; 28: 221–239.
Fitzmaurice GMLN, Ware JH . Applied longitudinal analysis 2nd edn Wiley: Hoboken, 2011.
Laird NM . Missing data in longitudinal studies. Stat Med 1988; 7: 305–315.
Pavletic SZ, Lee SJ, Socie G, Vogelsang G . Chronic graft-versus-host disease: implications of the National Institutes of Health consensus development project on criteria for clinical trials. Bone Marrow Transplant 2006; 38: 645–651.
Palmer JM, Lee SJ, Chai X, Storer BE, Flowers ME, Schultz KR et al. Poor agreement between clinician response ratings and calculated response measures in patients with chronic graft-versus-host disease. Biol Blood Marrow Transplant 2012; 18: 1649–1655.
Treister NS, Stevenson K, Kim H, Woo SB, Soiffer R, Cutler C . Oral chronic graft-versus-host disease scoring using the NIH consensus criteria. Biol Blood Marrow Transplant 2009; 16: 108–114.
Mitchell SA, Jacobsohn D, Thormann Powers KE, Carpenter PA, Flowers ME, Cowen EW et al. A multicenter pilot evaluation of the National Institutes of Health chronic graft-versus-host disease (cGVHD) therapeutic response measures: feasibility, interrater reliability, and minimum detectable change. Biol Blood Marrow Transplant 2011; 17: 1619–1629.
Elad S, Zeevi I, Or R, Resnick IB, Dray L, Shapira MY . Validation of the National Institutes of Health (NIH) scale for oral chronic graft-versus-host disease (cGVHD). Biol Blood Marrow Transplant 2009; 16: 62–69.
Treister NS, Cook EF, Antin J, Lee SJ, Soiffer R, Woo SB . Clinical evaluation of oral chronic graft-versus-host disease. Biol Blood Marrow Transplant 2008; 14: 110–115.
Treister NS, Stevenson K, Kim H, Woo SB, Soiffer R, Cutler C . Oral chronic graft-versus-host disease scoring using the NIH consensus criteria. Biol Blood Marrow Transplant 2010; 16: 108–114.
Castellarin P, Stevenson K, Biasotto M, Yuan A, Woo SB, Treister NS . Extensive dental caries in patients with oral chronic graft-versus-host disease. Biol Blood Marrow Transplant 2012; 18: 1573–1579.
Pidala J, Kurland B, Chai X, Majhail N, Weisdorf DJ, Pavletic S et al. Patient-reported quality of life is associated with severity of chronic graft-versus-host disease as measured by NIH criteria: report on baseline data from the Chronic GVHD Consortium. Blood 2011; 117: 4651–4657.
Pidala J, Kurland BF, Chai X, Vogelsang G, Weisdorf DJ, Pavletic S et al. Sensitivity of changes in chronic graft-versus-host disease activity to changes in patient-reported quality of life: results from the Chronic Graft-versus-Host Disease Consortium. Haematologica 2011; 96: 1528–1535.
Inamoto Y, Martin PJ, Chai X, Jagasia M, Palmer J, Pidala J et al. Clinical benefit of response in chronic graft-versus-host disease. Biol Blood Marrow Transplant 2012; 18: 1517–1524.
Acknowledgements
This work was supported by Grants CA118953 and CA163438.
Author contributions: SP, DW, JP, JP, PM, YI, MA, MF, DJ, MJ, SA, SJL and CC contributed clinical data; XC and BFK performed statistical analysis and drafted the manuscript; NT, CC and SJL designed research and drafted the manuscript; and all authors contributed to analysis and interpretation of data and critical review of the manuscript.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Competing interests
The authors declare no conflict of interest.
Additional information
Supplementary Information accompanies the paper on Bone Marrow Transplantation website
Supplementary information
Rights and permissions
About this article
Cite this article
Treister, N., Chai, X., Kurland, B. et al. Measurement of oral chronic GVHD: results from the Chronic GVHD Consortium. Bone Marrow Transplant 48, 1123–1128 (2013). https://doi.org/10.1038/bmt.2012.285
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1038/bmt.2012.285
Keywords
This article is cited by
-
Effect of ruxolitinib on the oral mucosa of patients with steroid-refractory chronic Graft-versus-Host disease and oral involvement
Clinical Oral Investigations (2022)
-
Nilotinib in steroid-refractory cGVHD: prospective parallel evaluation of response, according to NIH criteria and exploratory response criteria (GITMO criteria)
Bone Marrow Transplantation (2020)
-
Graft Versus Host Disease Clinical Trials: Is it Time for Patients Centered Outcomes to Be the Primary Objective?
Current Hematologic Malignancy Reports (2019)
-
Confounding factors affecting the National Institutes of Health (NIH) chronic Graft-Versus-Host Disease Organ-Specific Score and global severity
Bone Marrow Transplantation (2016)