Validation of the National Institutes of Health (NIH) Consensus Criteria for Chronic GVHD (cGVHD) Staging Correlated With Established Indicators of Disease Severity and Prognosis

Biology of Blood and Marrow Transplantation2011Vol. 17(2), pp. S160–S161

Abstract

In 2005, the NIH Consensus Project proposed the cGVHD severity score to standardize clinician evaluation and staging of cGVHD. This analysis was conducted to validate NIH scoring variables as adequate determinants of disease severity. 189 adults were enrolled on the prospective NCI cross-sectional cGVHD natural history study between 2004-2010. Median age was 46 yrs (18–70), median time from transplant was 35 mos (3.5–255) and median prior therapies was 4 (0–9). 88% were classified as classic and 12% as overlap. Median follow-up of surviving pts was 30.3 mos (1-70). NIH scores for key organs and global severity were compared to sub-specialist evaluations (SSE) and 10 continuous outcome measures [Lee Symptom Scale; SF-36 (physical/mental); FACT-BMT; HAP score (MAS/AAS), 2 min walk test, grip strength, and joint ROM]. NIH scores were compared to categorical outcomes: intensity of immunosuppression scale (IIS), therapeutic intent at enrollment (TI) and clinician 7-point global assessment of change (CGA).Table 1NIH ScoresNIH Global ScoreN (%)1 = mild2 (1)2 = moderate62 (33)3 = severe125 (66)NIH Organ ScoreN (%)NIH Organ ScoreN (%)SkinLiver0 = none42 (22)0 = none91 (48)1 = mild30 (16)1 = mild64 (34)2 = moderate46 (24)2 = moderate34 (18)3 = severe71 (38)3 = severe0MouthLungs0 = none59 (31)0 = none45 (24)1 = mild104 (55)1 = mild79 (42)2 = moderate23 (12)2 = moderate42 (22)3 = severe3 (1.5)3 = severe23 (12)EyesJoints and Fascia0 = none33 (17)0 = none75 (40)1 = mild66 (35)1 = mild40 (21)2 = moderate69 (36)2 = moderate55 (29)3 = severe21 (11)3 = severe19 (10)GI TractGenital (female only n= 90)0 = none107 (57)0 = none46 (51)1 = mild62 (33)1 = mild13 (14)2 = moderate14 (7)2 = moderate13 (14)3 = severe6 (3)3 = severe18 (9)NIH - National Institutes of Health, N - number, GI - gastrointestinal. Open table in a new tab NIH - National Institutes of Health, N - number, GI - gastrointestinal. 125/189 had a severe NIH global score; mean number of involved organs was 4.8 (1-8) with a mean average NIH score of 1.09 (0.14-2.14). NIH scores for skin, mouth, eyes and female genital corresponded to SSE scores and standard measures: skin % BSA, oral Schubert score, and Schirmer's test, each with two-sided P values of 80 vs. <80 (HR = 0.43; p = 0.025) and NIH lung score of 3 vs. 0-2 (HR = 8.9; p < 0.0001). High association of NIH scores with SSE suggests they are appropriate for clinical and research assessment, perhaps substituting for complex sub-specialist evaluations. In moderate to severely affected pts high NIH lung score is the most powerful independent predictor of poor survival. These results indicate the NIH severity score is reliable for assessing cGVHD.

Abstract

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