Neoadjuvant Therapy-Clinical Response
Description
This data item records the clinical outcomes of neoadjuvant therapy prior to planned surgical resection.
Rationale
This data items provides information related to the quality of care and describes the clinical outcomes after neoadjuvant therapy. This data item provides prognostically relevant information by quantifying the extent of therapy-induced tumor regression. Therefore, 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.
Additional Info
* See Neoadjuvant Therapy section for more information on coding this data item.
* See the NCCN Guidelines-Treatment by Cancer Type (https://www.nccn.org/guidelines/category_1) for more information.
Notes
**Note 1:** **Effective years**
* This SSDI is effective for diagnosis years 2021+
* For cases diagnosed 2018-2020, this SSDI must be blank
**Note 2:** **Clinical response**
* Clinical response is based on clinical history, physical examination, biopsies, imaging studies, or other diagnostic workup and is evaluated after neoadjuvant therapy is
* Completed according to treatment plan OR
* Discontinued (due to toxicity, progression, patient refusal to continue, etc.) OR
* Still ongoing, and the last clinical assessment of response is done prior to completion
* Do **NOT** use information from the **post-neoadjuvant surgical pathology** report to code this data item. (See Neoadjuvant Therapy-Treatment Effect [1634]).
**Note 3:** **Criteria for coding clinical response**
* Code this data item based on the **managing/treating physician’s interpretation/statement** of the clinical response to neoadjuvant therapy, whenever this interpretation/statement is available.
* Codes 00, 10, 20, 30, 40 can only be coded based on a managing physician’s documentation
**Note 4:** **Related data items**
* There are two other Neoadjuvant Data items. Make sure that the coding of these data items agree
* Neoadjuvant Therapy [NAACCR Data Item#1632]
* Neoadjuvant Therapy-Treatment Effect [NAACCR Data Item#1634]
Coding Guidelines
**See the Neoadjuvant Therapy section in the SSDI manual for additional coding examples.**
1. **A managing/treating physician statement is required to assign codes 00, 10, 20, 30, 40.**
* Physicians must use the **exact terminology** documented in codes 00-40.
* If the physician uses other terminology (such as excellent, good, fair, etc.), see code 50.
2. **Code 00: Complete Response**
* Neoadjuvant Therapy data item [NAACCR Item #1632] coded to 0 or 1 AND the managing/treating physician documents complete (or total) response (CR) based on clinical findings.
* ***Note:*** CR is defined as the disappearance of all known tumors/lesions and involved lymph nodes.
3. **Code 10: Partial Response**
* Neoadjuvant Therapy data item [NAACCR Item #1632] coded to 0 or 1 AND the managing/treating physician documents partial response (PR) based on clinical findings.
* PR is defined as a decrease in the site/extent of the tumor and/or presence of lymph nodes or metastatic disease.
* ***Example:*** Patient completed neoadjuvant therapy. Physician states 40% decrease in the size of the tumor at 12:00.
* Although physician does not state "partial response," physician has stated a decrease in the size of the tumor which is the definition of a partial response.
* OR documented as not being either complete response (CR) or progressive disease (PD).
* If the physician uses non-preferred terminology to describe the response, see code 50
4. **Code 20: Poor or no response**
* Neoadjuvant Therapy [NAACCR Item #1632] coded to 0 or 1 AND the managing/treating physician documents poor or no response (NR) based on clinical findings.
5. **Code 30: Stable disease**
* Neoadjuvant Therapy [NAACCR Item #1632] coded to 0 or 1 AND the managing/treating physician documents no clinical response due to stable disease (SD) based on clinical findings.
* Stable disease is defined as no changes in the size/extent of the tumor and/or presence of lymph nodes or metastatic disease.
6. **Code 40: Progressive disease**
* Neoadjuvant Therapy data item [NAACCR Item #1632] coded to 0 or 1 AND the managing/treating physician documents progressive disease based on clinical findings.
* Progressive disease is an increase in the size/extent of the tumor and/or presence of lymph nodes or metastatic disease.
* OR 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.
* ***Example:*** Treatment plan neoadjuvant therapy (6 cycles chemotherapy) followed by surgical resection. After 4th cycle of chemotherapy, patient's tumor was noted to be growing despite the chemotherapy and planned surgical resection not performed (neoadjuvant therapy failed).
7. **Code 50: Clinical response, NOS**
* Neoadjuvant Therapy data item [NAACCR Item #1632] coded to 0 or 1 AND statement by the managing physician not documented in the preferred terminology (see codes 0-3)
* ***Examples:*** Significant response, good response, fair response, excellent response
8. **Code 55: Clinical response based on imaging, biomarkers, yp stage**
* Neoadjuvant Therapy data item [NAACCR Item #1632] coded to 0 or 1 AND no statement from managing/treating physician. Response inferred from imaging, biomarkers or yc stage.
* ***Example 1:*** Patient completes neoadjuvant therapy. No documentation from the managing/treating physician. Patient presents to radiology for follow up scan. Per the radiology report, there is significant decrease in the size of the tumor.
* ***Example 2:*** Patient completes neoadjuvant therapy. No documentation from managing/treating physician. Case discussed at tumor board and staged using post-therapy clinical staging
9. **Code 60: Clinical response based on biopsy results**
* Neoadjuvant Therapy data item [NAACCR Item #1632] coded to 0 or 1 AND no statement from managing/treating physician. Biopsy of primary site. Pathology report states complete response.
* ***Example:*** Patient completes neoadjuvant therapy for a rectal case. No documentation from the managing/treating physician. Imaging does not identify residual tumor. Biopsy of the treated rectal tumor is negative for malignancy.
10. **Code 65: Clinical response not documented**
* Neoadjuvant Therapy data item [NAACCR Item #1632] coded to 0 or 1 AND there is no statement from the managing physician, imaging, or pathology.
* ***Example 1:*** Treatment plan neoadjuvant therapy (6 cycles chemotherapy) followed by surgical resection. Patient completed first cycle and then refused further treatment including surgical resection.
* ***Example 2:*** Patient completes neoadjuvant therapy; however, there is no clinical response information available.
* ***Example 3:*** Patient starts neoadjuvant therapy; however, due to rapid reporting of the case, the information is not yet available. Revise the code after treatment is completed.
11. **Code 70: No neoadjuvant therapy**
* Neoadjuvant Therapy [NAACCR Item #1632] is coded to 7.
* ***Excludes:*** Patient had complete response, surgery cancelled (code 00); patient didn't complete neoadjuvant therapy, refused surgical resection (code 65)
* Non-invasive neoplasm (behaviors /0, /1, /2)
* Autopsy only case
12. **Code 99** when
* Neoadjuvant Therapy [NAACCR Item #1632] is coded to 9.
* Neoadjuvant therapy was planned and it is unknown whether it was given.
* ***Excludes:*** Neoadjuvant therapy administered and response not known (see code 65)
* Unknown if neoadjuvant therapy administered.
Default
99
Metadata
SSDI 2021–
| Code |
Description |
| 00 |
Complete clinical response (CR) (per managing/treating physician statement) |
| 10 |
Partial or minimal clinical response (PR) (per managing/treating physician statement) |
| 20 |
Poor or no response (NR) (per managing/treating physician statement) |
| 30 |
Stable disease (SD) (per managing/treating physician statement) |
| 40 |
Progressive disease (PD) (per managing/treating physician statement) |
| 50 |
Clinical response to treatment, but not documented using the preferred terminology (see codes 00-40)
• ***Examples:*** Physician states significant response, good response, excellent response, fair response, response, NOS |
| 55 |
Neoadjuvant therapy administered, managing/treating physician interpretation of clinical response not available
* Clinical response inferred from imaging, biomarkers, or yc stage |
| 60 |
Neoadjuvant therapy administered, managing/treating physician interpretation of clinical response not available
* Complete clinical response based on biopsy results from a pathology report (per pathologist assessment) |
| 65 |
Neoadjuvant therapy administered, clinical response not documented or unknown |
| 70 |
No neoadjuvant therapy
Non-invasive neoplasm (behaviors /0, /1, /2)
Autopsy only |
| 88 |
Not applicable: Information not collected for this case
If this item is required by your standard setters, use of code 88 will result in an edit error |
| 99 |
Unknown if neoadjuvant therapy administered |
| <BLANK> |
Must be blank if diagnosis year is before 2021 |
