Q56: New Malignancy, Lymphoproliferative or Myeloproliferative Disorder

*Combined Follow-Up
In scenarios where a cellular therapy was given after an HCT and this form is now being completed based on the subsequent cellular therapy date, these questions do not apply and are disabled.

Question 56. Did a new malignancy, myeloproliferative, or lymphoproliferative disease / disorder occur that is different from the disease / disorder for which the HCT or cellular therapy was performed? (include clonal cytogenetic abnormalities, and post-transplant lymphoproliferative disorders)

Indicate whether a new or secondary malignancy, lymphoproliferative disorder, or myeloproliferative disorder has developed. Do not report recurrence, progression, or transformation of the recipient’s primary disease (disease for which the transplant was performed), or relapse of a prior malignancy.

New malignancies, lymphoproliferative disorders, or myeloproliferative disorders include but are not limited to:

• Skin cancers (basal, squamous, melanoma)
• New leukemia
• New myelodysplasia
• Solid tumors
• PTLD (post-transplant lymphoproliferative disorder) (report as NHL)
  

The following should not be reported as new malignancy:

• Recurrence of primary disease (report as relapse or disease progression)
• Relapse of malignancy from recipient’s pre-HCT medical history
• Breast cancer found in other (i.e., opposite) breast (report as relapse)
• Post-HCT cytogenetic abnormalities associated with the pre-HCT diagnosis (report as relapse)
• Transformation of MDS to AML post-HCT (report as disease progression)
  

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

*Recurrent Skin Cancers
For most malignancies, do not report recurrence, progression or transformation of the recipient’s primary disease (disease for which the transplant was performed) or relapse of a prior malignancy in the “New Malignancy” section.
For example, a recipient had a basal cell skin cancer diagnosed on the neck four months post-HCT and six months later had another basal cell located on the nose. The lesion on the nose is not considered a metastasis from the neck, but a new discrete lesion. These discrete episodes should be reported as Basal cell skin malignancy on the Post-TED forms.

If a new malignancy, lymphoproliferative disorder, or myeloproliferative disorder was diagnosed during the reporting period, report Yes and complete the Subsequent Neoplasms (3500) Form, which will come due.

The Previously reported option should only be used if the same malignancy has already been reported on a Subsequent Neoplasms (3500) form that was made do on demand. See examples below. If it is unclear whether or not to use of this option, contact CIBMTR Center Support if there are questions.

Example 1. A recipient developed a new malignancy at Day +68 and is reported at the time the Day 100 Post-Infusion Follow-up (2450) form is completed. In this scenario, report Yes, the recipient developed a new malignancy, and a Subsequent Neoplasms (3500) form will be completed to report the new malignancy information. For all future reporting periods, select No.

Example 2. A recipient developed a new malignancy during the seven-year reporting period and the transplant center decided to create the Subsequent Neoplasms (3500) form as an unscheduled form in FormsNet3SM to report the new malignancy information immediately since a Post-Infusion Follow-Up for seven-year reporting period will not come due. When the eight-year Post-Infusion Follow-Up (2450) form is completed, Previously reported, will be reported since a prior Subsequent Neoplasms (3500) form has already been submitted for the new malignancy.

Example 3. 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 located on the nose. The lesion on the nose is not considered a metastasis from the neck, but a new discreet lesion. Report Yes, there was a new malignancy on the Post-HCT Follow-Up (2450), and a single Subsequent Neoplasms (3500) form will come due to report one of the basal cell malignancies. Create a second Subsequent Neoplasms (3500) form to report the other basal cell malignancy as these are discreet episodes.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
Q56	2/14/2023	Modify	Clarification added on when to use the Previously reported option: The Previously reported option should only be used if the same malignancy has already been reported on a Subsequent Neoplasms (3500) form that was made do on demand. See examples below. If it is unclear whether or not to use of this option, contact CIBMTR Center Support if there are questions. Example 1. A recipient developed a new malignancy at Day +68 and is reported at the time the Day 100 Post-Infusion Follow-up (2450) form is completed. In this scenario, report Yes, the recipient developed a new malignancy, and a Subsequent Neoplasms (3500) form will be completed to report the new malignancy information. For all future reporting periods, select No. Example 2. A recipient developed a new malignancy during the seven-year reporting period and the transplant center decided to create the Subsequent Neoplasms (3500) form as an unscheduled form in FormsNet3SM to report the new malignancy information immediately since a Post-Infusion Follow-Up for seven-year reporting period will not come due. When the eight-year Post-Infusion Follow-Up (2450) form is completed, Previously reported, will be reported since a prior Subsequent Neoplasms (3500) form has already been submitted for the new malignancy. Example 3. 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 located on the nose. The lesion on the nose is not considered a metastasis from the neck, but a new discreet lesion. Report Yes, there was a new malignancy on the Post-HCT Follow-Up (2450), and a single Subsequent Neoplasms (3500) form will come due to report one of the basal cell malignancies. Create a second Subsequent Neoplasms (3500) form to report the other basal cell malignancy as these are discreet episodes. If the new malignancy, lymphoproliferative disorder, or myeloproliferative disorder was reported in a prior reporting period, select Previously reported.	Modified to be consistent with the 2100
Q56	7/19/2023	Modify	Clarified which option to select for PTLD: Indicate whether a new or secondary malignancy, lymphoproliferative disorder, or myeloproliferative disorder has developed. Do not report recurrence, progression, or transformation of the recipient’s primary disease (disease for which the transplant was performed), or relapse of a prior malignancy. New malignancies, lymphoproliferative disorders, or myeloproliferative disorders include but are not limited to: Skin cancers (basal, squamous, melanoma) New leukemia New myelodysplasia Solid tumors PTLD (post-transplant lymphoproliferative disorder) (report as lymphoma or lymphoproliferative disease NHL )	Added for clarification
Q56	7/19/2023	Add	Blue PTLD info box added: Post-Transplant Lymphoproliferative Disorder (PTLD): PTLD should be reported as a new malignancy if it was confirmed via a biopsy (treatment not required) or suspected to be PTLD and treated.	Added for clarification

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