KSHV-associated MCD response criteria
| Response category . | Response and criteria . |
|---|---|
| Clinical response | CR |
| Full resolution of all signs and symptoms attributable to MCD, lasting 1 cycle (3-4 wk depending on regimen); requires normalization of involved nodal areas on physical examination | |
| SFD | |
| Full resolution of all symptoms attributable to MCD | |
| PR | |
| Improvement in at least 50% of signs and symptoms by at least 1 grade (NCI-CTCAE, Version 3), with no increased MCD-related increases, lasting 1 cycle (3-4 wk depending on regimen) | |
| SD | |
| No change in signs and symptoms of MCD meeting criteria for CR, PR, or PD | |
| PD | |
| Worsening of 2 or more symptoms by at least 1 grade | |
| Biochemical response* | CR |
| Normalization of abnormalities attributed to MCD in the following laboratory values: hemoglobin, platelets, albumin, sodium, and CRP, lasting 1 cycle (3-4 wk depending on regimen) | |
| PR | |
| At least 50% improvement in all laboratory value abnormalities attributable to MCD, lasting 1 cycle (3-4 wk depending on regimen) | |
| SD | |
| No change in biochemical parameters that meet criteria for CR, PR, or PD | |
| PD | |
| ≥ 25% and 1 grade worsening of at least 2 biochemical parameters attributable to MCD OR clear deterioration in one parameter with negative impact on physiologic or health status | |
| Radiographic response | CR |
| Normalization of all lymph nodes to < 1.5 cm in greatest transverse dimension, with decrease to < 1 cm of lymph nodes that measure 1.1-1.5 cm at baseline, or 75% decrease in SPD of measured lymph nodes; spleen < 12 cm greatest dimension, no pleural effusions | |
| Cru | |
| Residual lymph node mass > 1.5 cm or spleen > 12 cm that has decrease by ≥ 75% and does not change over 1 y | |
| PR | |
| For lymph nodes, ≥ 50% decrease in SPD of 6 dominant nodes; for spleen, ≥ 50% decrease in longest transverse dimension | |
| SD | |
| Not meeting criteria for CR, CRu, PR, or PD | |
| PD | |
| For lymph nodes, ≥ 25% increase in the SPD; for spleen, increase ≥ 25% in longest dimension | |
| Overall response | CR |
| CR in all categories | |
| PR | |
| PR or better in all categories | |
| SD | |
| SD or better in all categories | |
| PD | |
| Progression in any 1 category |
| Response category . | Response and criteria . |
|---|---|
| Clinical response | CR |
| Full resolution of all signs and symptoms attributable to MCD, lasting 1 cycle (3-4 wk depending on regimen); requires normalization of involved nodal areas on physical examination | |
| SFD | |
| Full resolution of all symptoms attributable to MCD | |
| PR | |
| Improvement in at least 50% of signs and symptoms by at least 1 grade (NCI-CTCAE, Version 3), with no increased MCD-related increases, lasting 1 cycle (3-4 wk depending on regimen) | |
| SD | |
| No change in signs and symptoms of MCD meeting criteria for CR, PR, or PD | |
| PD | |
| Worsening of 2 or more symptoms by at least 1 grade | |
| Biochemical response* | CR |
| Normalization of abnormalities attributed to MCD in the following laboratory values: hemoglobin, platelets, albumin, sodium, and CRP, lasting 1 cycle (3-4 wk depending on regimen) | |
| PR | |
| At least 50% improvement in all laboratory value abnormalities attributable to MCD, lasting 1 cycle (3-4 wk depending on regimen) | |
| SD | |
| No change in biochemical parameters that meet criteria for CR, PR, or PD | |
| PD | |
| ≥ 25% and 1 grade worsening of at least 2 biochemical parameters attributable to MCD OR clear deterioration in one parameter with negative impact on physiologic or health status | |
| Radiographic response | CR |
| Normalization of all lymph nodes to < 1.5 cm in greatest transverse dimension, with decrease to < 1 cm of lymph nodes that measure 1.1-1.5 cm at baseline, or 75% decrease in SPD of measured lymph nodes; spleen < 12 cm greatest dimension, no pleural effusions | |
| Cru | |
| Residual lymph node mass > 1.5 cm or spleen > 12 cm that has decrease by ≥ 75% and does not change over 1 y | |
| PR | |
| For lymph nodes, ≥ 50% decrease in SPD of 6 dominant nodes; for spleen, ≥ 50% decrease in longest transverse dimension | |
| SD | |
| Not meeting criteria for CR, CRu, PR, or PD | |
| PD | |
| For lymph nodes, ≥ 25% increase in the SPD; for spleen, increase ≥ 25% in longest dimension | |
| Overall response | CR |
| CR in all categories | |
| PR | |
| PR or better in all categories | |
| SD | |
| SD or better in all categories | |
| PD | |
| Progression in any 1 category |
Data are based on signs and symptoms probably or definitely attributed to KSHV-MCD.
CR indicates complete response; SFD, symptom-free disease; PR, partial response; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; SD, stable disease; PD, progressive disease; SPD, sum products of the diameters; and Cru, complete response, unconfirmed.
Determination of partial or complete biochemical responses was not based on improvements in hemoglobin or platelet counts that occurred within 3 weeks (one cycle) of transfusions or growth factor support.