Neoadjuvant Therapy-Treatment Effect
Description
This data item records the pathologist’s statement of neoadjuvant treatment effect on the primary tumor from the surgical pathology report. Whenever treatment effect definitions are recommended by or available in CAP Cancer Protocols, this data item follows the CAP definitions indicating absent or present effect. When specific CAP definitions are not available, registrars should use treatment effect general use categories.
Rationale
This data item provides information related to the quality of care and describes the pathological outcomes after neoadjuvant therapy. This data item provides prognostically relevant information by quantifying the extent of therapy-induced tumor regression. Therefore, this data 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.
Additional Info
**Source documents**: surgical pathology report
For further information, refer to the applicable cancer protocol(s) published by the College of American Pathologists
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:** **Treatment effect**
* Treatment effect is evaluated after primary systemic and/or radiation therapy is administered AND a surgical resection of the primary site is done
* Information is based on the **post-neoadjuvant surgical pathology report only**
**Note 3:** **Criteria for coding**
* Patient must have a surgical resection AFTER neoadjuvant therapy for codes 0-5.
* See code 6 if planned surgical resection was cancelled
* See code 9 if unknown if planned surgical resection performed
* Record the pathological response (treatment effect) to preoperative adjuvant treatment as documented in the post-neoadjuvant surgical pathology report.
* Treatment effect should only be assessed on the primary tumor.
**Note 4:** **Related data items**
* There are two other Neoadjuvant Data items. Make sure that the coding of these data items agree
* Neoadjuvant Therapy-Clinical Response [NAACCR Data Item#1633]
* Neoadjuvant Therapy-Treatment Effect [NAACCR Data Item#1634]
Coding Guidelines
**See the Neoadjuvant Therapy section in the SSDI manual for additional coding examples.**
1. **Codes 0-3: Preferred terminology**
* Based on the **post-neoadjuvant surgical pathology report**
* Physicians must use the **exact terminology** documented in codes 0-3
* If the physician uses other terminology (such as significant, excellent, good, fair, etc.), see code 4
2. **Code 4: Treatment effect, NOS**
* Treatment effect is present but cannot be classified to codes 0-3.
* ***Examples:*** Significant response, good response, fair response, excellent response, etc.
3. **Code 5: Treatment effect not documented**
* Surgical resection is performed, but treatment effect is not documented in the **post neoadjuvant surgical pathology report.**
4. **Code 6: Planned surgical resection cancelled/not done**
* Patient had complete response to neoadjuvant therapy, and the surgical resection was cancelled
* Patient had neoadjuvant therapy, didn't complete it and then refused surgical resection
* ***Excludes:*** Unknown if surgical resection done (code 9).
5. **Code 7: No neoadjuvant therapy**
* Neoadjuvant Therapy [NAACCR Item #1632] is coded to 7.
* ***Excludes:*** surgical resection cancelled (code 6) or unknown if planned surgical resection was performed (code 9)
* Non-invasive neoplasm (behaviors /0, /1, /2)
* Autopsy only
6. **Code 9: Unknown**
* Neoadjuvant Therapy [NAACCR Item #1632] is coded to 9.
* Unknown if neoadjuvant therapy administered
* Unknown if planned surgical resection performed after neoadjuvant therapy.
* ***Excludes:*** surgical resection done, treatment effect unknown (code 5), surgical resection cancelled (code 6).
Default
9
Metadata
SSDI 2021–
| Code |
Description |
| 0 |
Treatment effect present: No viable cancer cells/no residual invasion carcinoma identified
* Complete pathological response |
| 1 |
Treatment effect present: Single cells or rare small groups of invasive cancer cells
* Near complete pathological response |
| 2 |
Treatment effect present: Residual invasive cancer with evident tumor regression, but more than single cells or rare small groups of cancer cells
* Partial or minimal pathological response |
| 3 |
Treatment effect absent: Extensive residual cancer with no evident tumor regression
* Poor or no pathological response |
| 4 |
Treatment effect present, but not documented using the preferred terminology (codes 0-3)
* ***Examples:*** Pathologist states significant response, good response, excellent response, fair response, poor response, etc. |
| 5 |
Neoadjuvant therapy administered and surgical resection performed, treatment effect not documented or unknown;
* Results cannot be determined |
| 6 |
Neoadjuvant therapy administered and planned surgical resection not performed |
| 7 |
No neoadjuvant therapy
Non-invasive neoplasm (behaviors /0, /1, /2)
Autopsy only |
| 8 |
Not applicable: Information not collected for this case
If this item is required by your standard setter, use of code 8 will result in an edit error |
| 9 |
Unknown if neoadjuvant therapy administered
Unknown if planned surgical procedure performed after neoadjuvant therapy |
| <BLANK> |
Must be blank if diagnosis year is before 2021 |
