Prospective Evaluation of the NIH Staging Criteria in Chronic GVHD and Correlation to Quality of Life - Results of a German Multicenter Validation Trial.

The NIH staging and response criteria offer for the first time the chance for uniform documentation and evaluation of physical functioning and quality of life aspects of chronic graft-versus-host disease (cGVHD) as well as its response to immunosuppressive treatment. Here we present the interim analysis of a prospective Germany multicenter study on the NIH staging criteria in cGVHD.

Methods: Seventy-six patients (median age 46 years, range 19–64) after allogeneic hematopoetic stem cell transplantation (HSCT) for hematologic malignancies were evaluated according to the NIH criteria based cGVHD activity assessment, the Lee Chronic GVHD Symptom-Scale, FACT-BMT, human activity profile (HAP), SF 36, Berliner Social Support Scale (BSSS), 24 item Adjective Measure (24 - AM), Hospital Anxiety and Depression Scale (HADS) and the NCCN-Distress-Thermometer. Enrolment occurred between day 100 and 1 year after HSCT or in the presence of active cGVHD also at later time points. Follow-up surveys were conducted at 1, 2, 3, 5, 8, 12 and 18 months after baseline survey. At all time points disease status, comorbidities and medication were documented. Additionally the NIH-Symptom-Scale was applied for clinician rating of cGVHD symptoms.

Results: Fifty-one patients had cGVHD (mild n=15, moderate n=32, severe n=4) while 25 patients did not have cGVHD. The cGVHD NIH consensus grading as well as the 10 point scale correlated with impairment of physical functioning (p<0.01, r=.48), the FACT-G total score (p=0.02, r=.33) and mental health (p<0.01, r=.41). The HAP maximum activity score correlated inversely with severity of cGVHD (p=0.028, r=.44), with the physical functioning (p<0.01, r=.53) and with role limitation due to physical problems (p<0.01, r=.43) evaluated by the SF36. In addition an impaired physical functioning correlated with role limitations due to emotional problems (p<0.01, r=.52) and with impaired mental health (p<0,01, r=.63). Moreover the HAP maximum activity score correlated with emotional well being as evaluated by the FACT (p<0.01, r=.39). Depression as measured by the HADS depression score correlated with pain (p<0,01, r=.35) and impaired physical functioning (p=0.03, r=.26) while the HADS anxiety score did not. The results demonstrate, that severity of cGVHD as assessed by the NIH consensus grading and the 10 point scale correlate with impairment of physical functioning as well as daily activities and quality of life. Moreover reduction of daily activities lead to impairment of emotional well being.