Q224 – 233: Disease Assessment at the Failure of the 1st Line of Therapy (DLBCL Only)

*Disease Assessments at the Failure of the 1st Line of Therapy (DLBCL only)
The Disease Assessment at the Failure of the 1st Line of Therapy (DLBCL only) section will only be completed if the primary disease for infusion is de novo diffuse large b-cell lymphoma (DLBCL) or untreated lymphoma which transformed DLBCL. This includes but is not limited to the following subtypes: cell of origin unknown, germinal center B-cell type, and activated B-cell type (non-GCB). If this is a report of a subsequent infusion and:
1. The prior infusion was an autologous HCT that was not reported, complete the Disease Assessment at the Failure of the 1st Line of Therapy; or
2. A prior Lymphoma Pre-Infusion (2018) form was not completed, complete the Disease Assessment at the Failure of the 1st Line of Therapy; or
3. A prior Lymphoma Pre-Infusion (2018) form was completed, skip to Disease Assessment at the Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Question 224: Did recipient achieve a CR after 1st line of therapy?

Refer to the international working group criteria provided in LYM Response Criteria section of the Forms Instruction Manual to review the CR criteria. Specify if the recipient achieved a CR (radiographic or metabolic) in response to their first line of therapy. CR must be achieved prior to the initiation of the second line of therapy (or infusion) to report Yes.

If the recipient did not receive therapy between diagnosis of DLBCL and the start of the preparative regimen / lymphodepleting therapy (or infusion if preparative regimen / lymphodepleting therapy was not given), leave this question blank, override the validation error using the code “unable to answer,” and specify in the comments the recipient did not receive therapy for DLBCL prior to the start of the preparative regimen / lymphodepleting therapy (or infusion).

*Disease Assessments
Complete the disease assessment questions based on testing / evaluations performed between the end of the first line of therapy and the start of the second line of therapy. If a second line of therapy was not given prior to infusion, complete these questions based on testing performed between the end of the first line of therapy and the start of the preparative regimen / lymphodepleting therapy (or infusion if no preparative regimen was given). If multiple tests were performed during this time frame, report the most recent testing.

Questions 225 – 227: LDH

Indicate whether the recipient’s LDH value was known during the time frame specified above. If Known, report the test result, units of measurement and the upper limit of normal for the lab.

Question 228: Stage of organ involvement

Using Table 1. Lymphoma Staging below, report the organ involvement during the time frame specified above.

If staging at this time is not available or not known, select Unknown.

Table 1. Lymphoma Staging

Stage	Description
Stage I	Involvement of a single lymph node region or of a single extralymphatic organ or site
Stage II	Involvement of two or more lymph node regions on same side of diaphragm, or localized involvement of an extralymphatic organ or site, and one or more lymph node regions on same side of diaphragm
Stage III	Involvement of lymph node regions on both sides of diaphragm, which may also be accompanied by localized involvement of extralymphatic organ or site, the spleen, or both
Stage IV	Diffuse or disseminated involvement of one or more extralymphatic organs in tissues with or without associated lymph node enlargement/involvement

Graphic 2. Lymphoma Staging²

² “Staging Lymphomas.” Patients Against Lymphoma. 05 May 2013. Accessed on 9/22/2013 at http://www.lymphomation.org/stage.htm.

Graphic 3. Staging Classification³

³ “Ann Arbor” Staging Classification,” “Lymphoma: Clinical- Hodgkin’s Lymphoma.” Pathology Tool. University of Virginia Medical School. 02 May 2012. Accessed 9/22/2013 at http://www.med-ed.virginia.edu/courses/path/innes/wcd/hodgclinic.cfm.

Questions 229 – 230: ECOG score

Recipient performance status is a critical data field that has been determined to be essential for all outcome-based studies. If a performance score is not documented in the source documentation (e.g., inpatient progress note, physician’s clinic notes), data management professionals should not assign a performance score based on analysis of available documents. Rather, a physician should provide documentation of the performance score. Documentation from an RN who has been trained and authorized to determine performance scores may also be used.

If the performance score has been documented using Karnofsky or Lansky scales, refer to Appendix L: Karnofsky / Lansky Performance Status for assistance converting the score to the ECOG scale.

Report whether the recipient’s ECOG score during the time frame specified above and if Known, report the score.

Question 231: Did the recipient have known extranodal involvement?

Extranodal refers to the presentation of lymphoma outside of the lymph nodes. Common areas of extranodal involvement may include bone, gastrointestinal tract, and skin.

Splenic involvement in lymphoma is also common. It is usually evidenced by enlargement of the spleen (splenomegaly). Splenic or other extranodal involvement is most often detected by imaging techniques or pathological findings.

Specify if extranodal involvement was identified during the time frame specified above.

Questions 232 – 233: Specify site(s) of involvement (check all that apply)

Specify all sites with known lymphomatous involvement during the time frame specified above. Clarifications on some of the available option values are found below:

• Adrenal: The adrenals gland are small glands that sit on the top of each kidney and product hormones including sex hormones and cortisol. Select this option if there was lymphomatous involvement of or derived from the adrenal glands or their secretions.
• Cerebrospinal fluid (CSF): A clear, colorless body fluid found in the brain and spinal cord that is produced by specialized ependymal cells.
• Epidural space: The epidural space is an anatomic space that is the outermost part of the spinal canal. The epidural space contains lymphatics, spinal nerve roots, loose fatty tissue, small arteries, and a network of internal vertebral venous plexuses.
• Gastrointestinal (GI) tract: Any of the organs that food and liquids travel through when they are swallowed, digested, absorbed, and leave the body as feces. These organs include the mouth, pharynx, esophagus, stomach, small intestine, large intestine, rectum, and anus.
• Pericardium: Of or pertaining to the membrane enclosing the heart that consists of an outer fibrous later and an inner double layer of serous membrane.
• Pleura: The delicate serous membrane that lines each half of the thorax of mammals and is folded back over the surface of the lung of the same side. The function of the pleura is to allow optimal expansion and contraction of the lungs during breathing.
• Skin: Of or pertaining to the outer or surrounding layer of the skin (epidermis).
• Spleen: Of or pertaining to the abdominal organ involved in the product and removal of blood cells.
  

If an involved site was documented but is not listed as an option, check Other site and report all other sites of lymphomatous involvement.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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