Q1 – 11: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder

*Reporting Multiple New Malignancies
A single Subsequent Neoplasms (3500) form will come due whenever a new malignancy / disorder is reported on the Post-TED (2450), Post-HCT Follow-Up (2100) or Cellular Therapy Essential Data Follow-Up Form (4100) form. However, if there is a diagnosis of more than one malignancy in the reporting period, excluding non-melanoma skin cancers (see Recurrent Non-Melanoma Skin Cancers note box below), a separate Subsequent Neoplasms (3500) form must be submitted to report each new malignancy.

*Recurrent Non-Melanoma Skin Cancers
For basal cell and / or squamous cell skin cancer, report the number of skin cancer lesions diagnosed in the current reporting period. If basal cell or squamous cell skin cancer was diagnosed again in a future reporting period, report Yes, a new malignancy occurred on the appropriate post-infusion follow-up form and specify the number of skin cancer lesions identified in the reporting period. For example, a recipient was diagnosed with basal cell skin cancer on the neck in the one-year reporting period and two months later, within the same reporting period, there was a diagnosis of basal cell skin cancer located on the nose. In the two-year reporting period, another basal cell skin cancer was diagnosed, located on the arm. For the one-year reporting period, report Yes, there was a new malignancy on the one-year post-infusion follow-up form and a single Subsequent Neoplasms (3500) form will come due to report both basal cell malignancies detected (report two in Number of non-melanoma skin cancer lesions). For the two-year reporting period, report Yes, there was a new malignancy on the two-year post-infusion follow-up form and a single Subsequent Neoplasms (3500) form will come due to report third basal cell malignancies detected (report one in Number of non-melanoma skin cancer lesions).

*Post-Transplant Lymphoproliferative Disorder (PTLD)
PTLD should be reported as a new malignancy if it was confirmed via a biopsy (treatment not required) or PTLD was suspected and treated.

*New Malignancy Documentation
The submission of pathology reports and other supportive documentation for each reported new malignancy is strongly recommended.
For instructions on how to attach documents in FormsNet3^SM, refer to the FormsNet3 Training Guide.

Question 1: Specify the new malignancy

Specify which new malignancy / disorder was diagnosed during the reporting period and any applicable questions.

If the new malignancy / disorder is not found in the list, select Other new malignancy and specify. An example of an Other new malignancy includes histiocytic sarcoma.

Report myeloid sarcoma as Acute myeloid leukemia (AML).

Do not report CNS relapse of lymphoma as a new malignancy for recipients whose primary disease for infusion is lymphoma. This should be reported as a relapse. However, in cases where a recipient received an infusion for a disease other than lymphoma and later develops CNS lymphoma, lymphoma should be reported as a new malignancy.

Question 2: Specify type of PTLD

Specify the type of PTLD as Monomorphic or Polymorphic using the guidelines listed below. The PTLD type should be documented within the pathology report, if available. If the documentation is unclear, seek clinician clarification.

• Monomorphic: Fulfills the criteria for one of the B-cell or NK/T-cell lymphomas.
• Polymorphic: Characterized by the overproduction of both B-cells and T-cells but fail to meet the criteria for lymphoma.

If the PTLD type is not known, select Unknown.

Question 3: Specify type of leukemia / lymphoma

Specify if the type of leukemia or lymphoma is B-cell or T-cell. If this information is unknown, seek clinician clarification.

Question 4: Specify oropharyngeal cancer

If the new malignancy is Oropharyngeal cancer, specify the type. If the type is not listed, select Other oropharyngeal cancer, and specify. Examples of ‘other’ include nasopharynx and hypopharynx.

Question 5: Specify gastrointestinal malignancy

If the new malignancy is Gastrointestinal malignancy, specify the type. If the type is not listed, select Other gastrointestinal malignancy, and specify.

*Number of Non-Melanoma Skin Cancer Lesions
For the skin cancer (basal cell or squamous cell) for which the Subsequent Neoplasm (3500) is being completed for, report the number of skin cancer lesions diagnosed in the current reporting period. For example, a recipient was diagnosed with basal cell skin cancer on the neck in the one-year reporting period and two months later, within the same reporting period, there was a diagnosis of basal cell skin cancer located on the nose. For the one-year reporting period, report Yes, there was a new malignancy on the one-year post-infusion follow-up form and a single Subsequent Neoplasms (3500) form will come due to report both basal cell malignancies detected (report two in Number of non-melanoma skin cancer lesions).

Question 6: Number of non-melanoma skin cancer lesions

Report the number of non-melanoma skin cancer lesions diagnosed in the current reporting period.

Question 7: Specify genitourinary malignancy

If the new malignancy is Genitourinary malignancy, specify the type. If the type is not listed, select Other genitourinary malignancy, and specify. Examples include penis and fallopian tube.

Question 8: Specify CNS malignancy

If the new malignancy is CNS malignancy, specify the type. If the type is not listed, select Other CNS malignancy, and specify.

*Adenocarcinoma
Adenocarcinoma is a general term used to describe a type of cancer that develops in glandular tissue and can occur in many parts of the body. If the new malignancy is an ‘adenocarcinoma,’ do not report ‘adenocarcinoma’ in the Specify other new malignancy data field. Report this malignancy by further defining the location from one of the options listed above. If the location is not listed an option on the form, report the location in the Specify other new malignancy data field.

Question 9: Specify other new malignancy

If the new malignancy is Other new malignancy, Other oropharyngeal cancer, Other gastrointestinal malignancy*¸ *Other genitourinary malignancy, or Other CNS malignancy, specify the type.

Question 10: Date of diagnosis

Report the diagnosis date of the new malignancy / disorder, using the pathologic diagnosis date. If the original assessment confirming diagnosis is not available, report the date of diagnosis indicated in the progress notes.

If there are multiple non-melanoma skin cancer lesions detected in the current reporting period, report the diagnosis date as the date when the first lesion was identified.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Cell Origin Evaluation Documentation
The submission of cell origin evaluation (i.e., VNTR, cytogenetics, FISH) reports and other supportive documentation for each reported new malignancy is strongly recommended. For instructions on how to attach documents in FormsNet3^SM, refer to the FormsNet3 Training Guide.

Question 11: Was the new malignancy donor / cell product derived?

Indicate whether the new malignancy originated from the donor / cell product. If testing to determine the cell origin of the new malignancy was not completed, select Not done.

Section Updates:

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