Questions 62 – 69: Laboratory values at diagnosis
For each value below, indicate if the result was known at diagnosis. If Known, specify the value and the units of measurement, taking care to convert them to a unit available on the form, if necessary.
- WBC: The white blood cell count is a value that represents all the white blood cells in the blood. If the count is too high or too low, the ability to fight infection may be impaired.
- Hemoglobin (untransfused): Hemoglobin is a molecule in red blood cells that delivers oxygen to tissues throughout the body. A low hemoglobin count is considered “anemia” and blood transfusions, or growth factors may be required to increase the hemoglobin level. Report a hemoglobin value from diagnosis without supported blood transfusions. If there is no hemoglobin value available without transfusions report Not known.
- Platelets (untransfused) : Platelets are formed elements within the blood that help with coagulation. A low platelet count, called thrombocytopenia, may lead to easy bleeding or bruising. Thrombocytopenia may require platelet transfusions. Report a platelet count from diagnosis without supported transfusions. If there is no platelet count available without transfusions report Not known.
- Hematocrit: The hematocrit is the percentage (sometimes displayed as a proportion) of red blood cells relative to the total blood volume. Low hematocrit may require red blood cell transfusions or growth factors.
Questions 70 – 83: Specify the following tumor marker analyses performed at diagnosis
Tumor markers, also known as biomarkers, are substances produced by cancer tissue or by the body in response to cancer at higher-than-normal levels. In certain situations, these substances can be used to detect and monitor disease due to their elevated presence in blood, urine, and/or tissue. The labs listed below have been identified as potential tumor markers for neuroblastoma.
For each tumor marker, indicate if it was analyzed at diagnosis. If analyzed, select Known, specify the value, unit of measurement and upper limit for the lab, if applicable. If the analysis was performed and the value is not known or it is unknown if performed, select Not known.
- Homovanillic acid (HVA): Catecholamines (e.g. epinephrine/adrenaline) are secreted as hormones from the adrenal medulla. Neuroblastomas typically produce excessive levels of these catecholamines. After catecholamines are secreted they are broken down into metabolites including Homovanillic acid (HVA) and Vanillylmandelic acid (VMA). Both HVA and VMA are excreted in the urine. As a result, elevated levels of HVA and VMA detected by urinary analysis can be indicative of neuroblastoma.
- Neuron specific enolase (NSE): A glycolytic enzyme (enolase) specific to neuronal-type tissues. NSE may be excessively expressed by neuroblastomas and indicative of disease.
- Serum ferritin: Ferritin is a blood protein that contains iron. A ferritin level indicates how much iron a person’s body is storing. If the ferritin level is lower than normal, it indicates the body’s iron stores are low (iron deficiency). If the ferritin level is higher than normal it could indicate hemochromatosis, a condition that causes the body to store too much iron. Other causes of an elevated ferritin level include liver disease, acute and chronic inflammatory conditions, malignancy (neuroblastoma) to name a few.
- Vanillylmandelic acid (VMA): Both HVA and VMA are excreted in the urine. As a result, elevated levels of HVA and VMA detected by urinary analysis can be indicative of neuroblastoma.
- LDH: Lactate dehydrogenase is an enzyme found in the cytoplasm of almost all tissues, which converts L-lactate into pyruvate, or pyruvate into L-lactate depending on the oxygen level. For some diseases, high levels indicate active disease (e.g., lymphoma, multiple myeloma and neuroblastoma).
- Other tumor marker analysis: If testing for a tumor marker was performed at diagnosis and is not listed above, select Known, and specify the other tumor marker, value and units of measurements. Examples of other testing can include Chromogranin A (CgA) or Neuropeptide Y (NpY)
Question 84: Was a DNA analysis performed at diagnosis?
DNA analysis is useful in further characterizing neuroblastoma and can provide prognostic and therapeutic value. Types of DNA analysis include ploidy testing to measure total cell DNA, detecting the presence of proto-oncogenes, and quantifying amplification.
Indicate if DNA analysis was performed at diagnosis.
Questions 85 – 88: Specify the tissue(s) analyzed
For each tissue, specify if DNA analysis was performed on the bone marrow, the first-degree tumor (primary tumor) at diagnosis. If DNA analysis was performed at diagnosis on a tissue type other than bone marrow or first-degree tumor, select Yes for Other tissue and specify.
Questions 89 – 92: Specify ploidy
Ploidy refers to the number of chromosome sets in a cell. Examples of ploidy includes the modal number and the DNA index. Karyotyping is a technique often used to determine a cell’s ploidy and proliferative activity while flow cytometry may measure the DNA index.
The modal number is the number of chromosomes present. A normal diploid cell has two sets of chromosomes or 46 total chromosomes. The “46” is the modal number.
The DNA index is a ratio between the DNA content of a normal cell (1) and a tumor cell (occasionally differing from 1) dictated via flow cytometry. See Figure 1 below for an example of a DNA index within a flow cytometry report.
Specify if the modal number and DNA index were known at diagnosis and specify the value.
Figure 1. DNA index in a flow cytometry report.
Questions 93 – 99: Specify any methods used to determine the presence of proto-oncogenes
Proto-oncogenes are normal genes that typically encode proteins with regulatory roles in cell growth and cell death. When proto-oncogenes are altered, they can contribute to cancer. N-myc and trk A are proto-oncogenes associated with neuroblastoma. This is often assessed by FISH. Specify any methods used to assess the presence of proto-oncogenes a diagnosis.
- N-myc amplification: An oncogene that encodes for the n-myc protein. This proto-oncogene amplification is often associated with poor prognosis / outcomes for neuroblastoma. If N-myc amplification was Known, indicate if proto-oncogenes were detected and specify the copy number. If N-myc amplification was not assessed or unknown at diagnosis, select Not known.
- trk A expression: A protein that is encoded is encoded by the NTRK1 gene. Expression of this protein in tumors is often associated with a favorable prognosis / outcome. If trk A expression was Known, specify the expression of proto-oncogenes as documented in the report. Use the following guidelines:
- High: Expression detected in high levels
- Low: Expression detected in low levels
- Absent: Expression absent
If trk A expression was not assessed or unknown at diagnosis, select Not known.
- Other molecular abnormalities: Specify if other molecular abnormalities were present at diagnosis. If Yes, specify the molecular abnormality(ies). If other molecular abnormalities were assessed and not detected, select No. If it is not known if testing for other molecular markers were performed at diagnosis or if testing was performed but the results are not known, select Unknown.
Question 100: Was a cytogenetic analysis performed at diagnosis?
Cytogenetics is the study of chromosomes. Cytogenetic assessment involves testing blood or bone marrow for the presence of known chromosomal abnormalities that reflect the recipient’s disease.
Testing methods you may see include conventional chromosome analysis (karyotyping). For more information about cytogenetic testing and terminology, see Appendix C: Cytogenetics.
Indicate whether a karyotype analysis was obtained at diagnosis using the guidelines provided below. Do not report any testing performed after the treatment for neuroblastoma has started.
- Yes: Karyotype was obtained at diagnosis and metaphases were evaluable.
- Yes, but no evaluable metaphases: Karyotype was performed at diagnosis, but metaphases were not evaluable.
- No: Karyotype was not performed at diagnosis.
- Unknown: It is unknown if karyotype was performed at diagnosis.
Questions 101 – 104: Specify the tissue(s) analyzed
For each tissue, indicate if it karyotyping was performed at the time of diagnosis.
If a tissue type was analyzed and not listed as an option, select Yes for Other tissue and specify.
If karyotyping was not performed or it is not known if performed on the tissue, select No.
Questions 105 – 106: Number of metaphases
Metaphase is a cell life cycle stage indicative of mitotic activity (cell division). A normal metaphase includes 46 chromosomes (46, XX or 46, XY).
Specify if the number of metaphases was known at the time of diagnosis. If Known, report the number of metaphases.
Question 107: Was the karyotype abnormal?
Indicate if the karyotype was abnormal at diagnosis. If abnormalities were not identified or it is unknown if abnormalities were present at diagnosis, report No or Unknown, respectively.
Questions 108 – 113: Specify the karyotype abnormalities
For each of the karyotype abnormalities, indicate if the abnormality was identified at diagnosis. If the abnormality was not detected at diagnosis, select No. If it is not known if the abnormality was identified at diagnosis, report Unknown. This option should be used sparingly and only when there is no information available about the results of the cytogenetics performed at diagnosis.
If an abnormality was identified but is not listed, report Yes for Other abnormality and specify the abnormality.
Question 114: Specify the International Neuroblastoma Staging System (INSS) disease stage at diagnosis
The International Neuroblastoma Staging System (INSS) is a standardized way to classify the extent of the cancer and considers surgical excision of the tumor. Specify the recipient’s INSS stage at diagnosis. The stage may be documented in progress notes or can be confirmed with a clinician using Table 1 below.
If the INSS stage at diagnosis was not known or if only the Pediatric Oncology Group (POG) stage or the Evans Group stage is known, select Unknown.
Table 1. International Neuroblastoma Staging System
| Stage | Definition |
|---|---|
| Stage 1 | Localized tumor with complete gross excision, with or without microscopic residual disease; representative ipsilateral lymph nodes negative for tumor microscopically (nodes attached to and removed with the primary tumor may be positive) |
| Stage 2A | Localized tumor with incomplete gross excision; representative ipsilateral nonadherent lymph nodes negative for tumor microscopically. |
| Stage 2B | Localized tumor with or without complete gross excision, with ipsilateral nonadherent lymph nodes positive for tumor; enlarged contralateral lymph nodes must be negative microscopically. |
| Stage 3 | Unresectable unilateral tumor infiltrating across the midline (defined as the vertebral column; tumors originating on one side and crossing the midline must infiltrate to or beyond the opposite side of the vertebral column), with or without regional lymph node involvement; or localized unilateral tumor with contralateral regional lymph node involvement; or midline tumor with bilateral extension by infiltration (unresectable) or by lymph node involvement. |
| Stage 4 | Any primary tumor with dissemination to distant lymph nodes, bone, bone marrow, liver, skin and/or other organs (except as defined for stage 4S). |
| Stage 4S | Localized primary tumor (as defined for Stages 1, 2A, or 2B), with dissemination limited to skin, liver, and/or bone marrow (marrow involvement in Stage 4S should be minimal i.e., <10% of total nucleated cells identified as malignant on bone marrow biopsy or on marrow aspirate; more extensive marrow involvement would be considered to be Stage 4; the MIBG scan (if performed) should be negative in the marrow). Stage 4S is limited to infants < 1 year of age. |
Question 115: Specify the POG Stage
Using Table 2 below, specify if the recipient’s POG stage at diagnosis is known, and report the stage.
Table 2. Pediatric Oncology Group
| Stage | Definition |
|---|---|
| A | Complete gross excision of primary tumor, margins histologically negative or positive. Intracavitary lymph nodes not intimately adhered to and removed with resected tumor must be histologically free of tumor. If primary is in abdomen or pelvis, liver must be histologically free of tumor. |
| B | Incomplete gross resection of primary. Lymph nodes and liver must be histologically free of tumor. |
| C | Complete or incomplete gross resection of primary. Intracavitary nodes (cavity of primary) histologically positive for tumor. Liver histologically free of tumor. |
| D | Disseminated disease beyond intracavitary nodes in bone marrow, bone, liver, skin, or lymph nodes beyond cavity containing primary tumor. |
Question 116: Specify the Evans Stage
Using Table 3 below, specify if the recipient’s Evans stage at diagnosis is known, and report the stage
Table 3. Evans Stage
| Stage | Definition |
|---|---|
| I | Tumor confined to the organ structure of origin |
| II | Tumors extending in continuity beyond the organ or structure of origin but not crossing the midline. Regional lymph nodes on the ipsilateral side may be involved |
| III | Tumors extending in continuity beyond the organ or structure or origin but not crossing the midline. Regional lymph nodes on the homolateral side may be involved |
| IV | Remote disease involving skeleton, soft tissues, distant lymph node groups, etc. |
| IV-S | Patients with local stage I or II disease but who have remote disease confined to one or more the following: liver, skin, bone marrow, (with no evidence of bone metastases on complete skeletal survey). |
Question 117: Are other family members known to have neuroblastoma or ganglioneuroma?
Gene mutations that increase the risk of developing neuroblastoma can be inherited. Indicate whether immediate family members or other relatives have been diagnosed with neuroblastoma or ganglioneuroma.
Questions 118 – 125: Specify the family member(s) diagnosed with neuroblastoma or ganglioneuroma
For each family members listed, indicate if they were diagnosed with neuroblastoma or ganglioneuroma.
If a sibling is diagnosed with neuroblastoma or ganglioneuroma, specify the number of sisters and / or brothers affected. If the number of siblings affected is not known, select Number of affected sisters unknown and / or Number of affected brothers unknown.
If a relative not listed was diagnosed with a neuroblastoma or ganglioneuroma, indicate Yes for Other relative and specify the relationship.
If it is not known if a family member is diagnosed with a neuroblastoma or ganglioneuroma, select Unknown. This option should be used sparingly and only when the health history is not known for the family member.
Question 126: Does the recipient have a family history of other genetic diseases in first-degree blood relatives?
Indicate if the recipient has a family history of other genetic diseases in first-degree blood relatives. First degree relatives include parents, siblings and offspring.
Questions 127 – 132: Specify the diagnoses present in the immediate family
Specify the immediate family member’s genetic disease(s). If it is not known if any immediate family members were diagnosed with the genetic, select Unknown.
- Beckwith-Wiedemann (EMG) syndrome: A common overgrowth / cancer predisposing disorder caused by changes on chromosome 11. EMG syndrome is characterized by a wide arrange of physical symptoms including; increased growth and birth weight, enlargement of internal organs and abdominal wall defects.
- Nesidioblastosis: A rare disorder of the beta cells of the pancreas, causing persistent hyperinsulinemic hypoglycemia.
- Neurofibromatosis: A genetic disorder in which causes tumors to form within the nervous system (brain, spinal cord, nerves, etc.)
- Trisomy 18: A chromosomal disorder associated with physical abnormalities such as decreased growth and birth weight, heart defect and abnormally shaped head and small facial features.
- Other disease: If an immediate family member was diagnosed with a genetic disease not listed above, select Yes and specify the disease. Examples of other genetic diseases include PHOX2B mutation, neurocristopathy, and ALK germline mutation.
Question 133: Did spontaneous regression of the recipient’s tumor occur?
In certain cases of neuroblastoma, generally those with early disease onset (<1 year of age), spontaneous regression of the disease is possible.
Indicate whether spontaneous regression of the recipient’s tumor occurred prior to infusion.
Question 134: Did the recipient undergo surgery as part of the initial disease treatment plan?
Treatment for neuroblastoma is determined based on the recipient’s risk group:
- Low-risk neuroblastoma is typically treated with surgery, chemotherapy, or a combination of the two. In certain instances, observation may be the course of action.
- Intermediate-risk neuroblastoma is typically treated with surgery, chemotherapy, a combination of surgery and chemotherapy, or less commonly, radiotherapy.
- High-risk neuroblastoma therapy can include a regimen of surgery, chemotherapy, radiotherapy, hematopoietic cell transplant, cis-retinoic acid and immunotherapy.
Indicate if surgery was performed as part of initial treatment (either at diagnosis or after induction therapy).
If it is not known if surgery was completed as part of the initial treatment plan, select No.
Question 135: Specify surgery timepoint
Indicate the timepoint when the surgery was performed.
Question 136: Specify the histological diagnosis of resected tissue
Neuroblastic tumors can be classified as anglioneuroblastomas, ganglioneuromas, or neuroblastomas. These neuroblastic tumors differ histologically in degree of cellular and extracellular maturation.
- Ganglioneuroblastoma: Consists of mature gangliocytes and immature neuroblasts resulting in intermediate aggressive behavior.
- Ganglioneuroma: The most benign tumor of the three and exhibits greater degrees of maturation.
- Neuroblastoma: The most malignant and immature of the three tumors.
Specify the histological diagnosis of the resected tissue.
Questions 137 – 152: Specify the site(s) of surgery
For each site, specify whether each of the anatomical locations listed was a site of surgery for disease. If surgery was performed at a listed site, indicate Yes, specify the extent using Table 4 below, and date of surgery. If surgery was performed at a site not listed, select Yes for Other site, specify the extent, date of surgery, and surgery site.
Table 4. Extent of Surgery
| Gross | ≥95% resection, no radiographic residual tumor |
|---|---|
| Near | 90-95% resection, minimal radiographic residual tumor |
| Subtotal | 51-89% resection, moderate radiographic residual tumor |
| Partial | 10-50% resection, significant radiographic residual tumor |
| Biopsy | <10 % resection, no radiographic change from pre-op |
Question 153: Did the recipient undergo radiotherapy as part of the initial disease treatment plan?
Radiation therapy utilizes high-energy radiation to kill cancer cells. Indicate whether radiotherapy was used as part of the initial disease treatment plan. If radiotherapy was not used or if no information is available to determine if radiotherapy was given as part of the initial disease treatment plan, report No or Unknown.
Questions 154 – 160: Specify the site(s) of radiotherapy
For each site, indicate if radiation therapy was given. For each site radiotherapy was given to specify the total number of fractions given to this site and the dose per fraction in centigrays (cGy / rads).
If the site of radiotherapy is not listed, select Yes for Other site and specify.
Question 161: Did the recipient undergo chemotherapy as part of the initial disease treatment plan?
Indicate if the recipient received chemotherapy as part of the initial disease treatment plan.
If chemotherapy was not given or if no information is available to determine if chemotherapy was given as part of the initial disease treatment plan, report No or Unknown.
Question 162: Specify the date the first chemotherapy cycle began
Chemotherapy is usually administered in cycles with rest periods between the cycles. This enables cancer cells to be attacked at vulnerable times and provides healthy cells adequate time to recover from the damage. A cycle can last one or more days and may repeat weekly, bi-weekly, monthly, etc. A chemotherapy course may consist of multiple cycles.
Report the date the first chemotherapy cycle began.
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 and cannot be estimated, select the Date the first chemotherapy cycle began unknown.
Question 163: Specify the date the last chemotherapy cycle began
Report the date when the last chemotherapy cycle given as part of the initial treatment plan began.
If the start date of the last cycle 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 end date is not known and cannot be estimated, select Date the last chemotherapy cycle began unknown.
Question 164: Specify the total number of chemotherapy cycles given
A chemotherapy course may consist of multiple cycles. Report the total number of chemotherapy cycles as part of the initial treatment plan the recipient received.
If the therapy is not given in cycles or the number of cycles is not known, check the Number of chemotherapy cycles given unknown.
Questions 165 – 176: Specify the treatment(s) given
Treatments vary based on protocol. A treatment may consist of a single drug or a combination of drugs. Additionally, the drugs may be administered on one day, over consecutive days, or continuously.
For each drug listed, indicate if the recipient received the therapy as part of the initial treatment plan. If the recipient received an agent that is not listed, select Yes for Other treatment and specify the treatment. Report the generic name and not the brand name.
Question 177: Specify the best response to chemotherapy
Based on the International Neuroblastoma Response Criteria, specify the best response to the initial treatment plan. The best response is determined by a disease assessment, such as radiology or pathology and may occur during the therapy or after, but prior to starting the next treatment / infusion.
If the disease status was not reassessed prior to starting the next treatment or infusion, select Unknown.
Questions 178 – 179: Did neuroblastoma recur?
Indicate if neuroblastoma recurred (after achieving a CR) after the initial disease treatment plan and prior to starting any subsequent therapy (or infusion). If disease recurred, specify the first date of recurrence following the initial treatment and prior to starting additional therapy or infusion.
If CR was not achieved in response to the initial treatment plan, select No, the neuroblastoma did not recur.
If the exact date is not known, use the process for reporting estimated dates as described in the General Instructions, Guidelines for Completing Forms.
Question 180: Specify the date of the best response to chemotherapy was determined
Enter the date the best response to chemotherapy was established. This should be the earliest date all international working group criteria were met for the response reported above. Report the collection date of the first pathological evaluation, radiographic, or lab assessment (e.g., bone marrow biopsy, CT scan, urine studies, etc.). 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 estimated dates as described in the General Instructions, Guidelines for Completing Forms.
If the date of best response was not known, select the Date best response to chemotherapy was determined unknown. This option should be used sparingly and only when an estimated date cannot be reported.
Question 181: Did the recipient undergo surgery, chemotherapy or other cytotoxic treatment for persistent or recurrent disease after the initial treatment but prior to the preparative regimen?
Indicate whether the recipient underwent surgery, chemotherapy or other cytotoxic treatment after the initial disease treatment but before the start of the preparative regimen / infusion.
Question 182: Date therapy started
Enter the date the recipient first began this line of therapy.
If the exact date is not known (e.g. the recipient started in mid – July 2010), use the process for reporting estimated dates as described in the General Instructions, Guidelines for Completing Forms.
Question 183: Date therapy stopped
Enter the date of the final administration for the therapy reported. If the therapy is administered in cycles, report the date the last cycle started for this line of therapy.
If the exact date is not known (e.g. the recipient started in mid-July 2010), use the process for reporting estimated dates as described in the General Instructions, Guidelines for Completing Forms.
Question 184: Systemic therapy
Systemic therapy refers to a delivery mechanism where a therapeutic agent is delivered orally or intravenously to the whole body. These drugs enter the bloodstream and are distributed throughout the body.
Specify if the recipient received systemic therapy after the initial treatment plan as part of the reported line of therapy.
If it is not known if systemic therapy was given as part of the line of therapy being reported, select No.
h4.Question 185: Number of cycles
Chemotherapy is usually administered in cycles with rest periods between the cycles. This enables cancer cells to be attacked at vulnerable times and provides healthy cells adequate time to recover from the damage. A cycle can last one or more days and may repeat weekly, bi-weekly, monthly, etc. A chemotherapy course may consist of multiple cycles.
Enter the number cycles the recipient received during this line of therapy being reported. If the therapy is not given in cycles or the number of cycles is not known, then check Number of cycles unknown / not applicable.
Questions 186 – 197: Treatment
For each drug, indicate if it was given as part of the line of therapy being reported. Do not leave any response blank.
If the recipient received an agent that is not listed, check Yes for the Other therapy and specify the treatment. Report the generic name and not the brand name.
Question 198: 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 therapy after the initial treatment as part of the line of therapy being reported.
If it is not known if radiation therapy was given as part of the line of therapy being reported, select No.
Questions 199 – 205: Specify the site(s) of radiation therapy
For each site, indicate if radiation therapy was given. If radiation was given specify the number of fractions administered to the site and the dose per fraction in centigrays (cGy / rads).
If radiation was given to a site not listed, select Yes for Other site, and specify.
Questions 206 – 207: Surgical biopsy / resection
Indicate if surgery was used to biopsy or resect all or a portion of the tumor tissue as part of the reported line of therapy.
If not known if surgery or a resection was not performed as part of the line of therapy, being reported, select No.
Question 208: Type of surgery
Specify the type of surgery performed (biopsy, partial, gross total, etc.).
- Gross total: > 95% resection, no radiographic residual tumor
- Near total: 90 – 95% resection, minimal radiographic residual tumor.
- Subtotal: 51 – 89% resection, moderate radiographic residual tumor.
- Partial: 10 – 50% resection, significant radiographic residual tumor. This method of approach is often used when there is a risk of neurological damage
- Biopsy: < 10 % resection, no radiographic change from pre-op. Usually preformed to be examined and confirm diagnosis.
Question 209: Histologic diagnosis
Neuroblastic tumors can be classified as ganglioneuroblastomas, ganglioneuromas, or neuroblastomas. These neuroblastic tumors differ histologically in degree of cellular and extracellular maturation. Ganglioneuroblastomas consist of mature gangliocytes and immature neuroblasts resulting in intermediate aggressive behavior. Ganglioneuroma is the most benign tumor of the three and exhibits greater degrees of maturation. Neuroblastoma is the most malignant and immature of the three tumors.
Indicate if the biopsied / resected tissue has the histological diagnosis of Ganglioneuroblastoma, Ganglioneuroma, or Neuroblastoma.
Question 210: Best response to line of therapy
Based on the International Neuroblastoma Response Criteria, specify the best response to the reported line of therapy. The best response is determined by a disease assessment, such as radiology or pathology and may occur during the therapy or after, but prior to starting the next treatment / infusion.
If the disease status was not reassessed prior to starting the next treatment or infusion, select Unknown.
Question 211: Date response evaluated
Enter the date the best response to chemotherapy was established. This should be the earliest date all international working group criteria were met for the response reported above. Report the collection date of the first pathological evaluation, radiographic, or lab assessment (e.g., bone marrow biopsy, CT scan, urine studies, etc.). If no pathological, radiographic, or lab 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 date of best response is not known, use the process for reporting estimated dates as described in the General Instructions, Guidelines for Completing Forms.
Question 212: Did the patient relapse / progress following this line of therapy?
Indicate if relapse / progression occurred during the reported line of therapy or after, but prior to starting a new line of therapy / infusion. Refer to the Neuroblastoma Response Criteria section of the Forms Instructions Manual.
Question 213: Date of relapse / progression
Report the date of the first assessment that identified relapse or progression. The date the sample was collected for pathological / laboratory evaluation or the date the imaging took place should be reported. If the physician determined evidence of relapse in a clinical assessment during an office visit, report the date of clinic visit.
If the exact date is not known but can be estimated, then use the process for reporting estimated dates as described in the General Instructions, Guidelines for Completing Forms.
Questions 214 – 228: Specify any sites of tumor involvement at any time after
diagnosis but prior to the preparative regimen
For each site, indicate if there was tumor involvement at any time after diagnosis but prior to the start of the preparative regimen / infusion. Do not leave any response blank.
If there was tumor involvement at a site not listed, indicate Yes, for Other site and specify the site.
Section Updates
| Question Number | Date of Change | Add/Remove/Modify | Description | Reasoning (if applicable) |
|---|---|---|---|---|
| . | . | . | . | . |
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