Lymphoma Response Criteria

*Reporting Lymphoma Disease Status on TED Forms
When reporting the disease status on the TED forms (Disease Classification (2402) and Post-TED (2450) forms), report the disease status using the metabolic (PET) criteria. If it is not possible to use the metabolic criteria, then the radiographic criteria may be used to determine the disease status. As a reminder, normal morphology of the bone marrow is not required to report complete remission when using the metabolic (PET) criteria.

*Relapse Post-Infusion
There may be scenarios where a recipient ‘relapses’ post-infusion with a less severe type of lymphoma (i.e., received an infusion for DLBCL, with or without a history of follicular lymphoma, and post-infusion, relapsed with follicular lymphoma). In this case, the relapse of the ‘less severe lymphoma’ should be reported as a relapse on the Post-TED (2450) and Lymphoma Post-Infusion (2118) Forms.

Metabolic Criteria

*Deauville Scores
A Deauville score does not need to be documented on the PET scan in order to report a specific disease status.

Complete Remission (CR)

Complete metabolic remission requires all of the following:

• A score of 1, 2, or 3 with or without a residual mass on a PET 5 point scale; and
• Disappearance of any previously non-measured lesions; and
• No new lesions; and
• No evidence of FDG-avid disease in the marrow.
  

Partial Remission

Partial metabolic remission requires all of the following:

• Score 4 or 5 on a PET 5 point scale with reduced uptake compared with baseline; and
• No new lesions.
  

Stable Disease

Does not meet metabolic criteria for complete remission, partial remission, or progressive disease.

Progressive Disease (after Partial Remission, Stable Disease), Relapsed Disease (after Complete Remission)

Metabolic progression or relapse requires at least one of the following:

• Score 4 or 5 on a PET 5 point scale with increased uptake compared with baseline; or
• Any new FDG-avid foci consistent with lymphoma; or
• New or recurrent FDG avid foci in the bone marrow.
  

*CNS Lymphoma and MRIs
For recipient’s with CNS lymphoma, an MRI may be used in place of the CT for the radiographic response criteria.

Radiographic Response Criteria

The following acronyms are used in the radiographic response criteria provided below:

LDi: longest transverse diameter of a lesion
SDi: shortest axis perpendicular to the LDi
SPD: sum of the product of the perpendicular diameters for multiple lesions
PPD: cross product of the LDi and perpendicular diameter

Complete Remission (CR)

Complete radiographic remission requires all of the following:

• All target nodes / nodal masses must have regressed as measured by CT to ≤ 1.5 cm in longest diameter; and
• Disappearance of any previously non-measured lesions; and
• No extralymphatic sites of disease; and
• No organomegally.
  

Normal morphology of bone marrow is also required for a complete radiological remission if the marrow was an involved site. Immunohistochemical stains must be negative if morphology is indeterminate.

Partial Remission

Partial radiographic remission requires all of the following:

• ≥ 50% decrease in the SPD of up to 6 target measurable nodes and extranodal sites¹; and
• No increase in the size of previously non-measurable lesions; and
• No new lesions.
  

If splenomegaly is present, a > 50% decrease in spleen length is also required to report a partial radiological remission

Stable Disease

Does not meet radiographic criteria for complete remission, partial remission, or progressive disease.

Progressive Disease (after Partial Remission, Stable Disease), Relapsed Disease (after Complete Remission)

Radiographic progression or relapse requires at least one of the following:

• An individual node must be abnormal with:
  • LDi >1.5 cm; and
  • ≥ 50% increase from nadir in the PPD; or
• An increase in LDi or SDi from nadir
  • ≥ 0.5 cm increase in LDi or SDi from nadir for any lesion ≤ 2cm; or
  • ≥ 1.0 cm increase in LDi or SDi from nadir for any lesion > 2 cm; or
• A 50% increase in spleen length compared to its prior increase beyond baseline; or
• New or recurrent splenomegally; or
• Clear progression of pre-existing non-measured lesions; or
• Regrowth of any previously resolved lesions; or
• A new node > 1.5 cm in any axis; or
• A new extranodal site > 1.0 cm in any axis or if < 1.0 cm in any axis, its presence must be unequivocally attributable to lymphoma; or
• Assessable disease of any size unequivocally attributable to lymphoma; or
• New or recurrent involvement of the bone marrow.
  

¹ For lesions too small to measure on CT, assign 5mm x 5mm as the default value and then 0 mm x 0 mm when the lesion is no longer visible. For a node >5 mm x 5 mm, but smaller than normal, use the actual measurement of the node for calculations.

Adapted from: Cheson, B. D., Fisher, R. I., Barrington, S. F., Cavalli, F., Schwartz, L. H., Zucca, E., & Lister, T. A. (2014). Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification. Journal of Clinical Oncology, 32(27), 3059-3067. doi:10.1200/jco.2013.54.8800

Manual Updates:
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.

If you need to reference the historical Manual Change History for this form, please click here or reference the retired manual section on the Retired Forms Manuals webpage.

Date	Manual Section	Add/Remove/Modify	Description
10/17/2022	LYM Response Criteria	Add	Blue instruction box added to clarify an MRI may be used in place of a CT for the radiographic response criteria for recipients with CNS lymphoma.
5/18/2022	LYM Response Criteria	Add	Blue instruction box added for instructions on how to report the scenario where a recipient relapses with a less severe type of lymphoma post-infusion.
5/18/2022	LYM Response Criteria	Add	Blue instruction box added for clarification that Deauville scores not required to report a disease status for the metabolic criteria.
11/19/2021	LYM Response Criteria	Add	Blue instructional box on how to report the disease status on the TED forms added.
11/20/2018	LYM Response Criteria	Modify	Modified the response criteria to show the metabolic response criteria first and then the radiographic response criteria for ease of use.
05/10/2018	LYM Response Criteria	Add	Added “Relapsed Disease” to “Progressive Disease” criteria and included clarification on when to report these disease status.
1/30/18	LYM Response Criteria	Add	Version 2 of the Lymphoma Response Criteria section of the Forms Instructions Manual released. Version 2 corresponds to revision 4 of the LYM Pre- and Post-Infusion Forms (Forms 2018 / 2118).

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