Q76-120: Pre-HCT Therapy

Complete a “Line of Therapy” section for each line of therapy administered prior to the start of the preparative regimen. If multiple lines of therapy are administered, copy and complete questions 77-120 for each line of therapy.

Question 76: Was therapy given (including chemotherapy used to mobilize stem cells)?

Indicate if the recipient received treatment for WM or LPL after diagnosis and before the start of the preparative regimen. If “yes,” continue with question 77. If “no,” continue with question 121.

Question 77: Systemic therapy

Systemic therapy refers to a delivery mechanism where a therapeutic agent is delivered orally or intravenously, enters the bloodstream, and is distributed throughout the body.

Indicate “yes” if the patient received systemic therapy and continue with question 78. If the patient did not receive systemic therapy, indicate “no” and continue with question 109.

Questions 78-79: Date therapy started

Indicate “known” if the therapy start date is documented and specify the start date in question 79. If the date is unknown, indicate this and continue with question 80.

Questions 80-81: Date therapy stopped

Indicate “known” if the therapy completion date is documented, and specify the date therapy stopped in question 81. If the patient received systemic therapy in cycles, specify the first day of the last cycle of systemic therapy. If the patient received a single line or single administration, indicate the last day systemic therapy was administered.

If the date is unknown, indicate this and continue with question 82.

Question 82: Number of cycles

Indicate if the number of cycles is “known” or “unknown.” If the number of cycles is known, continue with question 83 and specify the number of cycles of chemotherapy administered. If the patient received a single administration or one line of chemotherapy, indicate a single cycle. If the patient received a long-term maintenance therapy consisting of a single agent, indicate “known” for question 82; leave question 83 blank and override the error as “not applicable.”

If the number of cycles is unknown, continue with question 84.

Questions 84-107: Specify systemic therapy agents

Systemic therapy agents and treatment regimens vary based on disease, prognosis, and protocol. Drugs may be administered in an inpatient or outpatient setting, and treatment may consist of one or multiple drugs. Additionally, drugs may be administered on a single day, over consecutive days, or continuously.

Indicate “yes” or “no” for each therapeutic agent listed. Do not leave any response blank. If the recipient received an agent that is not listed, check “yes” for “other systemic therapy” and specify the treatment in question 107.

Question 108: Was this line of therapy given for stem cell mobilization (priming)?

Systemic therapy may be given for stem cell priming. For example, mobilization occurs during the recovery phase after cyclophosphamide administration. As such, it may be administered with cytokines to overcome the suppressive effect of previous therapeutic agents. Indicate if this line of therapy was given for stem cell mobilization.

Question 109: Radiation therapy

Radiation therapy uses high-energy, ionizing radiation to kill malignant cells. Much like non-targeted systemic therapy, radiation therapy does not specifically target malignant cells and does have significant side effects. For that reason, high-dose radiation often targets a limited field.

Indicate if the recipient received radiation treatment for WM or LPL after the time of diagnosis and before the start of the preparative regimen. If “yes,” continue with question 110. If “no,” continue with question 117.

Questions 110-111: Date therapy started

Indicate “known” if the radiation therapy start date is documented, and specify the first date of radiation administration in question 111. If the date is unknown, indicate this and continue with question 112.

Questions 112-113: Date therapy stopped

Indicate “known” if the radiation therapy completion date is documented, and specify the last date of radiation administration in question 113. If the date is unknown, indicate this and continue with question 114.

Questions 114-116: Specify site(s) of radiation therapy

Specify radiation site(s). If question 109 is answered “yes,” at least one site of radiation therapy must be specified in questions 114-116.

Question 117: Best response to line of therapy

Indicate the patient’s best response to this line of therapy.

See WM Response Criteria for disease status definitions.

Question 118: Date assessed

Enter the date the best response to the line of therapy was established. Report the date of the pathological (e.g., bone marrow biopsy) or radiological (e.g., CT scan) evaluation; if neither was reported, report the date of blood/serum assessment (e.g., CBC, peripheral blood smear). Enter the date the sample was collected for pathological and/or laboratory evaluation. If the recipient was treated for extramedullary disease and a radiological assessment (e.g., X-ray, CT scan, MRI scan, PET scan) was performed to assess disease response, enter the date the imaging took place for radiologic assessment. If no pathological, radiographic, or laboratory assessment was performed to establish the best response to the line of therapy, report the office visit in which the physician clinically assessed the recipient’s response.

If the exact date is not known, use the process for reporting partial or unknown dates as described in General Instructions, Guidelines for Completing Forms.

Question 119: Did disease relapse/progress following this line of therapy?

Relapse is the recurrence of disease after CR. WM or LPL relapse is demonstrated by reappearance of disease characteristics including IgM paraprotein, lymphadenopathy and/or organomegaly, and bone marrow histologic involvement.

See WM Response Criteria for disease status definitions. Indicate if relapse or progression occurred following the line of therapy being reported. If question 117 is answered “progressive disease,” question 119 must be “yes.”

Question 120: Date of relapse/progression

Enter the date of the assessment that identified relapse or progression following the line of therapy. Enter the date the sample was collected for pathological and laboratory evaluation or enter the date the imaging took place. If the physician determined evidence of relapse in a clinical assessment during an office visit, report the date of assessment.