Neoadjuvant Therapy - Clinical Response
Organization | Field Name | ID | Required |
|---|---|---|---|
KCR | Neoadjuvant Therapy – Clinical Response (NeoadjuvTherapyClinicalResponse) | 31182 | Yes |
SEER | Neoadjuvant Therapy - Clinical Response | Yes |
Code | Description |
|---|---|
0 | Neoadjuvant therapy not given |
1 | Complete clinical response (CR) (per managing/treating physician statement) |
2 | Partial clinical response (PR) (per managing/treating physician statement) |
3 | Progressive disease (PD) (per managing/treating physician statement) |
4 | Stable disease (SD) (per managing/treating physician statement) |
5 | No response (NR) (per managing/treating physician statement) Not stated as progressive disease (PD) or stable disease (SD) |
6 | Neoadjuvant therapy done, managing/treating physician interpretation not available, treatment response inferred from imaging, biomarkers, or yc stage |
7 | Complete clinical response based on biopsy results from a pathology report (per pathologist assessment) |
8 | Neoadjuvant therapy done, response not documented or unknown |
9 | Unknown if neoadjuvant therapy performed Death certificate only (DCO) |
Description
Neoadjuvant Therapy--Clinical Response, effective for cases diagnosed 01/01/2021 and later, records the clinical outcomes of neoadjuvant therapy prior to planned surgical resection.
Rationale
This data item provides information related to the quality of care and describes the clinical outcomes after neoadjuvant therapy. Prognostically relevant information is captured by quantifying the extent of therapy-induced tumor regression. This item can provide a better risk stratification for patients who received neoadjuvant therapy. In addition, this data item can contribute to assessments of cancer care quality.
This data item records the clinical outcomes of neoadjuvant therapy as determined by the managing physician (oncologic surgeon, radiation oncologist or medical oncologist).
For the purposes of this data item, neoadjuvant therapy is defined as systemic treatment (chemotherapy, endocrine/hormone therapy, targeted therapy, immunotherapy, or biological therapy) and/or radiation therapy given to shrink a tumor before surgical resection.
Coding Guidelines
Use this data item to record the clinical response (outcomes) to neoadjuvant therapy.
Neoadjuvant Therapy--Clinical Response is evaluated after primary systemic and/or radiation therapy is completed and prior to surgical resection. It is based on clinical history, physical examination, biopsies, imaging studies, and other diagnostic work up. Do not use information from the surgical pathology report to code this data item.
Code this data item based on the managing/treating physician’s interpretation/statement of the response to neoadjuvant therapy, whenever this interpretation/statement is available.
This data item is related to Neoadjuvant Therapy [NAACCR Item #1632].
Coding Instructions
1. Assign code 0
a. When neoadjuvant therapy is not administered
i. Neoadjuvant Therapy data item [NAACCR Item #1632] coded to 0 or 3
b. When therapy administered does not qualify as neoadjuvant therapy (pre-surgical treatment) because surgical resection not planned
Example: Patient with unresectable lung cancer (no surgical resection planned), chemotherapy and radiation planned. Chemotherapy and radiation do not qualify as neoadjuvant therapy because no surgical resection is planned.
c. When the patient did not have neoadjuvant therapy based on the sequence of diagnosis and treatment
Example: Patient diagnosed with breast cancer via needle core biopsy, had surgical resection followed by chemotherapy and radiation.
d. When the primary site is unknown and neoadjuvant therapy is given to treat another site
Example: Patient is diagnosed with melanoma in the lymph nodes with no primary skin site found. The physician gives immunotherapy as neoadjuvant therapy with planned and carried out surgical resection of involved lymph nodes following completion of immunotherapy.
e. For autopsy only cases
f. For the following cases for which neoadjuvant therapy is not a part of standard treatment
i. Primary site: C420, C421, C423, C424, C809
ii. One of the following schemas
1. HemeRetic 00830
2. Ill-Defined Other 99999
3. Lymphoma 00790
4. Lymphoma-CLL/SLL 00795
5. Mycosis Fungoides 00811
6. Plasma Cell Disorders 00822
7. Plasma Cell Myeloma 00821
8. Primary Cutaneous Lymphomas (excluding MF and SS) 00812
2. A managing/treating physician statement is required to assign codes 1 – 5.
3. Assign code 1
a. When the managing/treating physician documents complete (or total) response (CR) based on clinical findings
Note 1: CR is defined as the disappearance of all known tumors/lesions and lymph nodes.
Note 2: Neoadjuvant Therapy data item [NAACCR Item #1632] coded to 1 or 2.
4. Assign code 2 when
a. The managing/treating physician documents partial response (PR) based on clinical findings or
Note: PR is defined as a decrease in the size/extent of the tumor and/or presence of lymph nodes or metastatic disease.
b. Documented as not being either complete response (CR) or progressive disease (PD)
Note: Neoadjuvant Therapy data item [NAACCR Item #1632] coded to 1 or 2.
5. Assign code 3
a. When the managing/treating physician documents
i. Progressive disease (PD) based on clinical findings or
ii. “Progression” or that the size/extent of the tumor and/or the presence of lymph nodes or metastatic disease has increased or
iii. There is evidence of new metastasis
Note 1: PD is defined as an increase in the size/extent of the tumor and/or presence of lymph nodes or metastatic disease.
Note 2: Assign code 3 when the managing/treating physician documents that the patient progressed after neoadjuvant therapy was started even if the neoadjuvant therapy was not completed. Use text fields for documentation.
Note 3: Neoadjuvant Therapy data item [NAACCR Item #1632] coded to 1 or 2.
6. Assign code 4
a. When the managing/treating physician
i. Documents no clinical response based on clinical findings due to stable disease (SD) or
ii. States that there is no change in the size/extent of the tumor and/or the presence of lymph nodes or metastatic disease
Note 1: SD is defined as no changes in the size/extent of the tumor and/or presence of lymph nodes or metastatic disease.
Note 2: Neoadjuvant Therapy data item [NAACCR Item #1632] coded to 1 or 2.
7. Assign code 5
a. When clinical evaluation after neoadjuvant therapy is done and the managing/treating physician documents no response (NR); and does not indicate
i. If the tumor progressed (code 3) or
ii. If there was change in the tumor size/extent or
iii. If the tumor was stable (see code 4)
Note 1: No response (NR), NOS is documented by the managing/treating physician based on clinical findings.
Note 2: Neoadjuvant Therapy data item [NAACCR Item #1632] coded to 1 or 2.
8. Assign code 6
a. When neoadjuvant therapy was completed, there is no statement from the managing/treating physician based on clinical evaluation documented or available, and clinical response is inferred from imaging impression, changes in biomarkers or yc stage
Note: Neoadjuvant Therapy data item [NAACCR Item #1632] coded to 1.
Example: Patient completes neoadjuvant therapy and presents to radiology for follow up scan. Per the radiology report, there is significant decrease in the size of the tumor. No documentation can be found from the managing/treating physician regarding the response.
9. Assign code 7
a. When a biopsy is done of the primary site, the pathology report states complete response, and there is no statement regarding clinical response from the managing physician
Note: Neoadjuvant Therapy data item [NAACCR Item #1632] coded to 1.
Example: Patient completes neoadjuvant therapy for a rectal cancer. Imaging does not identify definitive residual tumor. On endoscopic biopsy, the biopsy of the treated rectal tumor is negative for malignancy.
10. Assign code 8
a. When neoadjuvant therapy done, and clinical response is not documented or is unknown
Note: Neoadjuvant Therapy data item [NAACCR Item #1632] coded to 1 or 2.
Example 1: Patient completes neoadjuvant therapy; however, there is no information available regarding the status of the cancer.
Example 2: Patient starts neoadjuvant chemotherapy; however, patient expires after one cycle of chemotherapy.
Example 3: Patient starts neoadjuvant chemotherapy; however, due to rapid reporting of the case, the information is not yet available. Revise the code after treatment is completed.
11. Assign code 9
a. When it is unknown whether neoadjuvant therapy was administered
i. Planned, but unknown if given
ii. Death certificate only (DCO)
Note 1: Neoadjuvant Therapy data item [NAACCR Item #1632] coded to 9.
Note 2: Code 9 (unknown) should be used rarely.
Note 3: Use code 0 when it is clear that the patient did not have neoadjuvant therapy based on the sequence of diagnosis and treatment or on standard of care for the diagnosis.