Response in specific tissues | |||||
Location | Response | Definition | |||
Skin* | CR | 100 percent clearance of skin lesions.¶ | |||
PR | 50 to 99 percent clearance of skin disease from baseline without new tumors (T3) in patients with T1, T2, or T4 only skin disease. | ||||
SD | <25 percent increase to <50 percent clearance in skin disease from baseline without new tumors (T3) in patients with T1, T2, or T4 only skin disease. | ||||
PDΔ | ≥25 percent increase in skin disease from baseline; OR New tumors (T3) in patients with T1, T2, or T4 only skin disease; OR Loss of response: in those with complete or partial response, increase of skin score of greater than the sum of nadir plus 50 percent baseline score. | ||||
Relapse | Any disease recurrence in those with complete response. | ||||
Lymph nodes◊ | CR | All lymph nodes are now ≤1.5 cm in greatest transverse (long axis) diameter by method used to assess lymph nodes at baseline or biopsy negative for lymphoma; in addition, lymph nodes that were N3 classification and ≤1.5 cm in their long axis and >1 cm in their short axis at baseline, must now be ≤1 cm in their short axis or biopsy negative for lymphoma. | |||
PR | Cumulative reduction ≥50 percent of the SPD of each abnormal lymph node at baseline and no new lymph node >1.5 cm in the diameter of the long axis or >1 cm in the diameter of the short axis if the long axis is 1 to 1.5 cm diameter. | ||||
SD | Fails to attain the criteria for CR, PR, and PD. | ||||
PDΔ | ≥50 percent increase in SPD from baseline of lymph nodes; OR Any new node >1.5 cm in the long axis or >1 cm in the short axis if 1 to 1.5 cm in the long axis that is proven to be N3 histologically; OR Loss of response: >50 percent increase from nadir in SPD of lymph nodes in those with PR. | ||||
Relapse | Any new lymph node >1.5 cm in the long axis in those with CR proven to be N3 histologically. | ||||
Viscera | CR | Liver or spleen or any organ considered involved at baseline should not be enlarged on physical exam and should be considered normal by imaging; no nodules should be present on imaging of liver or spleen; any post treatment mass must be determined by biopsy to be negative for lymphoma. | |||
PR | ≥50 percent regression in any splenic or liver nodules, or in measureable disease (SPD) in any organs abnormal at baseline; no increase in size of liver or spleen and no new sites of involvement. | ||||
SD | Fails to attain the criteria for CR, PR, or PD. | ||||
PDΔ | >50 percent increase in size (SPD) of any organs involved at baseline; OR New organ involvement; OR Loss of response: >50 percent increase from nadir in the size (SPD) of any previous organ involvement in those with PR. | ||||
Relapse | New organ involvement in those with CR. | ||||
Blood§ | CR¥ | B0 | |||
PR‡ | >50 percent decrease in quantitative measurements of blood tumor burden from baseline in those with high tumor burden at baseline (B2). | ||||
SD | Fails to attain criteria for CR, PR, or PD. | ||||
PDΔ | B0 to B2; OR >50 percent increase from baseline and at least 5000 neoplastic cells/microL[1]; OR Loss of response: in those with PR who were originally B2 at baseline, >50 percent increase from nadir and at least 5000 neoplastic cells/microL. | ||||
Relapse | Increase of neoplastic blood lymphocytes to ≥B1 in those with CR. | ||||
Global response score | |||||
Global score† | Definition | Skin | Nodes | Blood | Viscera |
CR | Complete disappearance of all clinical evidence of disease | CR | All categories have CR/NI. | ||
PR | Regression of measurable disease | CR | All categories do not have a CR/NI and no category has a PD. | ||
PR | No category has a PD and if any category involved at baseline, at least one has a CR or PR. | ||||
SD | Failure to attain CR, PR, or PD representative of all disease | PR | No category has a PD and if any category involved at baseline, no CR or PR in any. | ||
SD | CR/NI, PR, SD in any category and no category has a PD. | ||||
PD | Progressive disease | PD in any category. | |||
Relapse | Recurrence disease in prior CR | Relapse in any category. |
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