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Response criteria in mycosis fungoides and Sézary syndrome

Response criteria in mycosis fungoides and Sézary syndrome
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.
CR: complete response; PR: partial response; SD: stable disease; PD: progressive disease; SPD: sum of the maximum linear dimension (major axis) X longest perpendicular dimension (minor axis); NI: noninvolved.
* Based on modified Severity Weighted Assessment Tool score.
¶ A biopsy of normal appearing skin is unnecessary to assign a complete response. However, a skin biopsy should be performed of a representative area of the skin if there is any question of residual disease (persistent erythema or pigmentary change) where otherwise a complete response would exist. If histologic features are suspicious or suggestive of mycosis fungoides/Sézary syndrome (see histologic criteria for early mycosis fungoides[2]), the response should be considered a partial response only.
Δ Whichever criterion occurs first.
Peripheral and central lymph nodes.
§ As determined by absolute numbers of neoplastic cells/microL.
¥ If a bone marrow biopsy was performed at baseline and determined to unequivocally be indicative of lymphomatous involvement, then to confirm a global CR where blood assessment now meets criteria for B0, a repeat bone marrow biopsy must show no residual disease or the response should be considered a PR only.
‡ There is no PR in those with B1 disease at baseline as the difference within the range of neoplastic cells that define B1 is not considered significant and should not affect determination of global objective response.
† It is recommended that not only the proportion of patients who achieve a response or an unfavorable outcome be calculated but a life table account for the length of the interval during which each patient is under observation also be generated.
References:
  1. Cheson BD, Bennett JM, Grever M, et al. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: Revised guidelines for diagnosis and treatment. Blood 1996; 87:4990.
  2. Sacks H, Chalmers TC, Smith H Jr. Randomized versus historical controls for clinical trials. Am J Med 1982; 72:233.
From: Olsen EA, Whittaker S, Kim YH, et al. Clinical end points and response criteria in mycosis fungoides and Sézary syndrome: a consensus statement of the International Society for Cutaneous Lymphomas, the United States Cutaneous Lymphoma Consortium, and the Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer. J Clin Oncol 2011; 29:2598-607. Reprinted with permission. Copyright © 2011 American Society of Clinical Oncology. All rights reserved.
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