Neoadjuvant Therapy
Description
This data item records whether the patient had neoadjuvant therapy prior to planned definitive surgical resection of the primary site.
Rationale
This data items provides information related to the quality of care and describes whether a patient had neoadjuvant therapy.
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 before intended or performed surgical resection to improve local therapy and long-term outcomes.
Additional Info
* See the NCCN Guidelines-Treatment by Cancer Type (https://www.nccn.org/guidelines/category_1) for more information.
Physicians and/or pathologists may or may not document no neoadjuvant therapy given”, or "no known surgical pre-surgical treatment."
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:** **Criteria for neoadjuvant therapy**
* A physician’s treatment plan and/or statement of patient completing neoadjuvant therapy must be used
* Treatment must follow the recommended treatment guidelines for the type and duration of treatment for that primary site and/or histology
* The length of a full course of neoadjuvant therapy may vary depending on the primary site and/or histology, often from 4-6 months.
* Neoadjuvant therapy may include systemic therapy alone, radiation alone, or combinations of radiation and systemic therapy (for example, with rectal cancer, esophageal cancer, head and neck cancer)
* Neoadjuvant therapy data items are coded based on treatment/procedures that occur during first course of therapy
* Neoadjuvant therapy may be given as part of a clinical trial
**Note 3:** **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. **Code 0: Full course of neoadjuvant therapy completed**
* Any tumor-directed therapy **meeting the definition of neoadjuvant therapy**
* Occurs prior to an intended or performed definitive surgical resection AND
* Is documented as neoadjuvant therapy by a treating physician or part of the patient’s documented treatment regimen/protocol
* The patient completed the full course of neoadjuvant therapy WITH or WITHOUT planned surgical resection
* The patient starts neoadjuvant therapy on one chemotherapy regimen, and the regimen is changed due to poor tolerance or lack of response
* Applies as long as the patient completes the full course of treatment
* The physician evaluates the response and determines that the patient has achieved the desired outcome and discontinues the neoadjuvant therapy
2. **Code 1:** Full course of neoadjuvant therapy **NOT** completed
* Any tumor-directed therapy **meeting the definition of neoadjuvant therapy** AND the patient did not complete the full course of neoadjuvant therapy
* Neoadjuvant therapy stopped due to toxicity
* Neoadjuvant therapy failed, tumor progresses and treatment stopped
* Neoadjuvant therapy stopped, patient refuses to complete
* Neoadjuvant therapy stopped, reason not known
* ***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.
* Even though patient only completed one cycle of chemotherapy, **the intent of the chemotherapy was neoadjuvant therapy.**
* ***Example 2:*** 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, treatment stopped and planned surgical resection not performed (neoadjuvant therapy failed)
3. **Code 7: No neoadjuvant therapy**
* No neoadjuvant therapy is administered
* Patient did not have neoadjuvant therapy based on the sequence of diagnosis and treatment
* Therapy (chemotherapy, radiation, hormone) administered but does not qualify as neoadjuvant therapy (pre-surgical treatment) because surgical resection not planned
* Primary site is unknown and neoadjuvant therapy is given to treat another site
* Any tumor-directed therapy (excluding surgical resection) not documented as neoadjuvant in the treatment plan and not meeting treatment guideline recommendations for neoadjuvant therapy
* ***Example 1***: Prostate cancer patient, not involved in a clinical trial, receiving one or two doses of Lupron while determining their treatment options. In general, neoadjuvant therapy is not given for prostate patients outside of a clinical trial.
* ***Example 2***: Breast cancer patient, not involved in a clinical trial, may receive SERM (tamoxifen) or an aromatase inhibitor (Arimidex) to test whether that patient actually responds to the drugs to see if they should receive it as adjuvant treatment after their surgery.
* Non-invasive neoplasm (behaviors /0, /1, /2)
* Autopsy only case
4. **Code 9** when
* Unknown if neoadjuvant therapy administered
* ***Note***: Use code 7 when it is clear that the patient did not have neoadjuvant therapy based on the sequence of diagnosis and treatment. Code 9 (unknown) should rarely be used.
Default
9
Metadata
SSDI 2021–
| Code |
Description |
| 0 |
Neoadjuvant therapy completed according to treatment plan and guidelines |
| 1 |
Neoadjuvant therapy started, but not completed OR unknown if completed |
| 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 |
| <BLANK> |
Must be blank if diagnosis year is before 2021 |
