Work

Chronic GVHD Severity and Sensitivity to Change in Patient-Reported Quality of Life: Results From the Chronic GVHD Consortium

Year: 2011

Type: article

Abstract: Chronic graft-versus-host disease (GVHD) threatens patient-reported quality of life (QOL) after allogeneic hematopoietic cell transplantation. However, the sensitivity of serially assessed chronic GVHD severity to change in QOL has not been determined. We examined the sensitivity of changes in chronic GVHD severity (determined separately by NIH consensus severity criteria, physician-assessed severity, and patient-reported chronic GVHD severity) to changes in QOL as measured with the SF-36 and FACT instruments in a prospectively assembled multi-center cohort of chronic GVHD affected HCT recipients. A total of 341 individual adult (median age 52, range 19 – 79) patients (182 incident, 159 prevalent) from 6 transplant centers contributed data to an analysis encompassing 917 total visits. Chronic GVHD involvement most commonly included skin (56%), oral (53%), ocular (55%), and hepatic (39%) manifestations. On follow up, the majority had unchanged chronic GVHD severity. However, follow up visits demonstrated improvement (NIH 16%, physician 20%, patient 22%), or rather worsening (NIH 17%, physician 14%, patient 16%) in others. Subjects with complete or with missing data had similar clinical characteristics, excepting that those without missing data were more likely to have a college or post-graduate degree (p = 0.007). Univariable analysis accounting for repeated observations was performed to examine the relationship between change in chronic GVHD severity and change in QOL. Multivariable analysis was performed considering patient socio-demographic, disease, and transplantation covariates. Conclusions discerned in univariable analysis persisted: Change in NIH severity was not sensitive to change in QOL. Change in physician-assessed severity was sensitive to changes in SF-36 MCS (mental component summary), and FACT-TOI (trial outcome index), FACT-Total, and FACT-BMT (BMT subscale). Change in patient-reported severity was sensitive to changes in all QOL outcomes (p < 0.001 for each). These data demonstrate that NIH and physician determined chronic GVHD severity assessment do not capture the full symptom burden experienced by chronic GVHD affected patients. The data support the incorporation of patient-reported chronic GVHD severity in the evaluation of severity change and therapeutic response in the conduct of clinical trials as well as routine clinical practice for those affected by chronic GVHD.

Source: Transplantation and Cellular Therapy

DOI: 10.1016/j.bbmt.2010.12.257