A single line of therapy refers to any agents administered during the same time period with the same intent. If a recipient’s response changes resulting in a change of treatment, a new line of therapy should be reported. Additionally, if therapy is changed because a favorable response was not achieved, a new line of therapy should be reported.
Question 59: Was therapy given? (at any time prior to the start of the preparative regimen / infusion)
Indicate if the recipient received therapy (see question 64 for a list of common therapies) at any time between diagnosis and the start of the preparative regimen / infusion. If the recipient received therapy, report Yes. If the recipient did not receive therapy or if no information is available to determine if the recipient received therapy, select No and go to question 71.
If this is a report of a subsequent transplant for aplastic anemia and this baseline disease insert has previously been completed for a prior transplant, indicate if the recipient received treatment for aplastic anemia between Day 0 of the previous transplant and the start of the preparative regimen for the subsequent transplant.
Questions 60 – 61 Date therapy started
Indicate whether the therapy start date is Known or Unknown. If the therapy start date is Known, report the date the recipient began this line of therapy. If the start date is partially known (i.e., the recipient started treatment in mid – July 2010), use the process described for reporting partial or unknown dates in General Instructions, Guidelines for Completing Forms.
If the therapy start date is not known or the start date cannot be estimated due to limited documentation, report Unknown.
Questions 62 – 63: Date therapy stopped
Indicate if the stop date is Known or Unknown. If the therapy is being given in cycles, report the date the recipient started the last cycle for this line of therapy. Otherwise, report the final administration date for the therapy being reported. If the stop date is partially known, use the process for reporting partial or unknown dates as described in the General Instructions, Guidelines for Completing Forms.
If the therapy stop date is not known or the end date cannot be estimated due to limited documentation, select Unknown.
Report Not applicable if the recipient is still receiving therapy at the start of the preparative regimen / infusion.
Questions 64 – 66: Specify therapy given (check all drugs given as part of this line of therapy)
Select the therapy administered as part of the line of therapy being reported. If the recipient received a therapy which is not listed, select Other treatment and specify the treatment in question 66. Report the generic name of the agent, not the brand name.
- Androgens: Male hormones can cause the bone marrow to create more red blood cells. Examples include danazol, fluoxymesterone, oxymethalone, stanazole, and testosterone.
- ATG: Anti-thymocyte globulin (ATG) is an immunosuppressive therapy that attack lymphocytes (T-cells).
If ATG was administered as part of the line of therapy being reported, specify the type as Horse or Rabbit in question 65. Select all that apply.
- Cyclosporine (CSA, Neoral, Sandimmune): An immunosuppressive treatment that prevents T-cells from becoming active.
- Nplate (romiplostim): A bone marrow stimulant given for thrombocytopenia.
- Prednisone (given without ATG): A steroid administered to increase the WBC and platelet counts.
Do not report this drug given if given with ATG (administered to offset the side effects of ATG).
- Promacta (eltrombopag): A bone marrow stimulant, administered to treat thrombocytopenia by working with the body to create more platelets.
- Tacrolimus (FK 506): Inhibits the production of interleukin-2 by T-cells. Also known as Prograf.
- Other treatment: Includes those treatments not already listed above. If the recipient received treatments not listed, such as chemotherapy (not given as the preparative regimen for transplant), select this option and specify which other treatment(s) were administered in question 66.
Question 67: Best response to line of therapy
Indicate the best response to the line of therapy using the criteria provided below. The best response is determined by a disease assessment, such as hematologic testing, pathology study, and / or physician assessment.
Complete
Requires all of the following:
- Transfusion independent
- Hemoglobin normal for age
- ANC > 1,500 / mm3
- Platelets > 150,000 / mm3
Partial
Requires all of the following:
- No longer meeting the criteria for aplastic anemia (ANC < 500 / mm3, hemoglobin < 10 g / dL, platelets 20,000 / mm3, and ARC < 20,000 / mm3)
- Transfusion independent
None / recurrence of transfusion dependence
Requires:
- Transfusion dependence; and / or
- Marrow cellularity < 25%; and
At least two of the following:
- Hemoglobin < 10 g / dL
- ANC < 500 / mm3
- Platelets < 20,000 / mm3
- Manual ARC < 20,000 / mm3
Question 68: Date assessed
Report the date of the best response to the line of therapy established. This should be the first date where the response reported above was achieved and is documented within the progress notes.
If the best response was achieved prior to starting the line of therapy being reported, indicate the first assessment which was performed after initiating the current line of therapy and confirms the sustained response.
If the exact date is not known, use the process described for reporting partial or unknown dates in General Instructions, Guidelines for Completing Forms.
Question 69: Was there recurrent disease following this line of therapy?
Indicate if there was recurrent disease following this line of therapy, using the criteria listed below.
Recurrent disease requires the following:
- Transfusion dependence; and / or
- Marrow cellularity < 25%; and
At least two of the following:
- Hemoglobin < 10 g / dL
- ANC < 500 / mm3
- Platelets < 20,000 / mm3
- Manual ARC < 20,000 / mm3
Report Yes if the recipient met the criteria for recurrent disease after starting this line of therapy and prior to starting a subsequent line of therapy.
Report No if the recipient did not have recurrent disease following this line of therapy and continue with question 71. Also, report No if the recipient had recurrent disease after this line of therapy but after beginning a subsequent line of therapy. This episode of recurrent disease will be captured in the instance (i.e., copy) of questions 60 – 70 completed for the subsequent line of therapy. This question is meant to capture only recurrent disease occurring after this line of therapy and prior to starting a new one.
If this is the last line of therapy administered prior to infusion, only report Yes if recurrent disease occurred prior to infusion. Recurrent disease occurring after the infusion date will be reported on the Aplastic Anemia Post-HCT Date (2128) Form.
Question 70: Date of recurrence
Enter the assessment date recurrent disease was established following initiation of this line of therapy. Report the date of pathological evaluation (i.e., bone marrow biopsy) or blood / serum assessment (i.e., CBC, peripheral blood smear). Enter the date the sample was collected for pathologic and laboratory evaluations. If the physician determines evidence of recurrent disease following a clinical assessment during an office visit, report the date of assessment.
If the exact date is not known, use the process described for reporting partial or unknown dates in General Instructions, Guidelines for Completing Forms.
Section Updates:
| Question Number | Date of Change | Add/Remove/Modify | Description | Reasoning (If applicable) |
|---|---|---|---|---|
| . | . | . | . | . |
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