Table 1.
2014 changes to the 2005 recommendations
| Organ Measures | 2005 Recommendation | 2014 Recommendation |
|---|---|---|
| Skin | Skin response is measured using the body surface area of erythematous rash, moveable sclerosis and non-moveable sclerosis | Skin response is measured using the updated NIH Skin Score Detailed collection of type of BSA involvement no longer collected except for non-moveable sclerosis Skin and/or joint tightening is an exploratory measure |
| Size of skin ulcers is documented | Presence or absence, not size, of skin ulcer is documented | |
| Eye | Eye response is measured by change in Schirmer’s test | Eye response is measured by change in NIH Eye Score |
| Mouth | Mouth response is measured by change in the Modified Oral Mucosa Score. Scores range from 0–15 | Remove mucoceles from the Modified Oral Mucosa Score. Scores range from 0–12 |
| Oral chronic GVHD is described as “hyperkeratosis” changes | The term “hyperkeratosis” is replaced by “lichen-like” changes | |
| Patients’ symptoms of mouth dryness and mouth pain are captured on 0–10 scales | No longer recommended. Mouth sensitivity is still captured on a 0–10 scale. | |
| GI | Change from a 0 to 1 in the NIH GI and esophagus response measures are considered progression | Change from a 0 to 1 in these measures is no longer considered progression |
| Liver | Liver response is measured by change in ALT, bilirubin and alkaline phosphatase | Simplification of the definitions of improvement and progression |
| Lung | Lung response is measured by change in %FEV1 and DLCO after calculation of the Lung Function Score | Lung response is measured by change in %FEV1 |
| Joints and Fascia | Joints and Fascia are not included in response assessment | The NIH Joint and Fascia Score and the P-ROM are used to assess joint response |
| Hematology | Platelet count and absolute eosinophil count are collected to measure hematologic response | Platelet count and absolute eosinophil count are collected only at baseline to provide prognostic information |
| Other | All abnormalities are documented and attributed to chronic GVHD | All abnormalities are documented but the organ is not evaluable if there is another well documented non-chronic GVHD cause |
| Ancillary Measures | ||
| Quality of life | Pediatric surveys CHRI and ASK are recommended | No longer recommended |
| SF36, FACT-BMT and HAP are recommended | SF36 OR FACT-BMT plus HAP are strongly encouraged | |
| Functional status | Two minute walk distance is recommended | Two minute walk distance provides prognostic information, consider assessing only at baseline |
| Grip strength is recommended | No longer recommended | |
| Karnofsky or Lansky performance status is recommended | Karnofsky or Lansky performance status is strongly encouraged only at baseline | |
| Response Assignments | ||
| Response category | Mixed response category is not recognized | Mixed response category is recognized and considered progression |
| Other | No comment on whether responses can be assessed in the setting of additional organ-directed treatments | If topical or organ-directed treatments are added, any CR or PR in those organs should be reported as occurring in the setting of additional local therapy. |
| No comment on whether responses can be assessed in the setting of additional systemic immunosuppressive treatments | Addition of systemic immunosuppressive treatment is considered treatment failure, unless otherwise specified in the protocol |