Neoadjuvant Therapy
Organization | Field Name | ID | Required |
|---|---|---|---|
KCR | Neoadjuvant Therapy (NeoadjuvantTherapy) | 31181 | Yes |
SEER | Neoadjuvant Therapy | Yes |
Neoadjuvant Therapy, effective for cases diagnosed 01/01/2021, or later, records whether the patient had neoadjuvant therapy prior to planned definitive surgical resection of the primary site.
This data item 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 during first course of treatment.
Code | Description |
0 | No neoadjuvant therapy, no treatment before surgery, surgical resection not part of first course of treatment plan Autopsy only |
1 | Neoadjuvant therapy completed according to treatment plan and guidelines |
2 | Neoadjuvant therapy started, but not completed OR unknown if completed |
3 | Limited systemic exposure when the intent was not neoadjuvant; treatment did not meet the definition of neoadjuvant therapy |
9 | Unknown if neoadjuvant therapy performed Death certificate only (DCO) |
Definitions
There are several related but distinct concepts that cover adjuvant therapy, neoadjuvant therapy, and primary therapy. This section contains definitions that can be used in the context of abstracting and coding.
Adjuvant therapy: Additional cancer treatment given after the primary treatment (usually surgery) to lower the risk that the cancer will come back. Adjuvant therapy may include radiation therapy and/or systemic therapy including chemotherapy, endocrine/hormone therapy, targeted therapy, immunotherapy, or biological therapy.
Neoadjuvant therapy: Systemic treatment (chemotherapy, endocrine/hormone therapy, targeted therapy, immunotherapy, or biological therapy) and/or radiation therapy given prior to surgical resection to improve outcomes. May also be called pre-surgical treatment or preoperative treatment.
Neoadjuvant therapy may be administered to
• Reduce the disease burden, which might allow surgical resection for previously unresectable disease or allow for less extensive surgical resection, organ preservation or function, or quality of life
• Eradicate or control undiscovered metastases and improve outcomes of overall survival and disease-free survival
• Provide prognostic information based on response. A clinical response to neoadjuvant therapy is associated with length of disease-free survival and overall survival in some cancer types
Note: Limited systemic therapy may be given prior to surgery, or may also occur in clinical trials with no expectation of the above-mentioned benefits and should not be coded as neoadjuvant therapy (code 1 or 2) for the purposes of this data item. See instructions for code 3 below.
Additional opportunities to use neoadjuvant therapy information
• Allow direct observation of therapeutic efficacy
• Allow time for appropriate genetic testing (if applicable)
• Test novel therapies and predictive biomarkers by providing tumor specimens and blood samples prior to and during systemic treatment
• Assist in determining the next steps for treatment
• Compare survival, rates of successful optimal reductive surgical resection, postoperative complications and quality of life
Limited systemic therapy may be given prior to surgery, or may also occur in clinical trials to study biology of cancer or in other circumstances to impact the biology of a cancer but is not a full course of neoadjuvant therapy with the intent to impact extent of surgical resection or other outcomes (organ preservation, function or quality of life).
• Do not code as neoadjuvant therapy (code 1 or 2) for the purposes of this data item. See instructions for code 3 below.
Primary therapy: The centerpiece of treatment given for a disease. It is often part of a standard set of treatments, such as surgical resection followed by chemotherapy and radiation. It may be used alone to remove or reduce the burden/progression of disease OR used along with additional treatments.
Surgical resection: For purposes of this data item, surgical resection is defined as the most definitive surgical procedure that removes some or all of the primary tumor or site. For many sites, this would be Surgical Codes 30-80; however, there are some sites where surgical codes less than 30 could be used (for example, code 22 for Breast (excisional biopsy or lumpectomy).
Coding Guidelines
Use this data item to record whether neoadjuvant therapy was administered. This data item captures a full course of neoadjuvant therapy (generally 4-6 months) or a limited exposure to systemic therapy prior to surgical resection. When part of the treatment plan, a full course of neoadjuvant therapy is recommended; however, there are specific scenarios in which the planned full course of neoadjuvant therapy is not carried out. Site-specific recommendations for neoadjuvant therapy are found in the NCCN guidelines, ASCO guidelines, or other treatment guidelines.
For purposes of this data item, the criteria for neoadjuvant therapy are
• 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 systemic therapy may vary depending on the primary site and/or histology, often from 4-6 months, but could be shorter, of neoadjuvant systemic therapy and/or radiation
• 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
Code neoadjuvant therapy in the corresponding treatment data items even when the treatment is partial (i.e., less than a full course of neoadjuvant therapy is administered) or limited (i.e., limited exposure to systemic therapy)
• Radiation Sequence and Surgery (if radiation given prior to surgical resection) as part of limited neoadjuvant therapy
• Systemic Treatment/Surgery Sequence (if systemic treatment given prior to surgical resection) as part of limited neoadjuvant therapy
• The appropriate treatment data items (Chemotherapy, Immunotherapy, Hormone Therapy, Hematologic Transplant and Endocrine Procedures, Radiation Treatment Modality--Phase I, II, III), and the associated date data item for each treatment type
Document information regarding neoadjuvant therapy in the text remarks field as needed.
Coding Instructions
1. Assign code 0
a. When neoadjuvant therapy or tumor-directed treatment prior to surgical resection is not part of treatment plan
i. For example, the patient’s only treatment was surgery
b. When surgical resection is not part of planned first course of treatment
Example: Patient with unresectable lung cancer (no surgical resection planned), chemotherapy and radiation planned.
c. When patient did not have neoadjuvant therapy based on the sequence of treatment
Example: Patient diagnosed with breast cancer via needle core biopsy, had surgical resection, and then had adjuvant chemotherapy/radiation.
d. For autopsy only cases
e. 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 (MF) 00811
6. Plasma Cell Disorders 00822
7. Plasma Cell Myeloma 00821
8. Primary Cutaneous Lymphomas (excluding MF and SS) 00812
2. Assign code 1
a. For any tumor-directed therapy meeting the definition of neoadjuvant therapy
i. Occurring prior to an intended or performed definitive surgical resection, AND
ii. Documented as neoadjuvant treatment by a treating physician or part of the patient’s documented treatment regimen/protocol.
b. When the patient completed the full course of neoadjuvant therapy with or without planned surgical resection
Example 1: Patient diagnosed with rectal cancer via biopsy. Patient received 6 cycles of chemotherapy with concurrent radiation and then had surgical resection.
Example 2: Patient diagnosed with rectal cancer, 6 cycles of chemotherapy and radiation recommended. After completion of neoadjuvant therapy, re-evaluation of tumor burden done, and no evidence of cancer found. The planned surgical resection was not performed.
Example 3: Patient diagnosed with pancreatic cancer; 6 cycles of chemotherapy recommended. During last cycle, patient developed heart issues due to the chemotherapy. Planned surgical resection not performed due to risk factors and patient placed on hospice.
Example 4: Patient completed neoadjuvant therapy, surgery recommended, but patient refused any further treatment or patient died prior to surgical resection.
Example 5: Patient had a full course of neoadjuvant therapy, surgical resection recommended, unknown if performed.
3. Assign code 2
a. When any tumor-directed therapy (excluding surgical resection) meeting the definition of neoadjuvant therapy whose intent was neoadjuvant, was begun and the patient did not complete the full course of neoadjuvant therapy
Example: Patient diagnosed with advanced breast cancer; 6 cycles of chemotherapy, followed by surgical resection recommended. 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).
4. Assign code 3
a. When any tumor-directed therapy (excluding surgical resection) not documented as neoadjuvant in the treatment plan and not meeting treatment guideline recommendations for neoadjuvant therapy was given
b. When patient receives some therapy prior to surgical resection, but not enough to qualify for a full course of neoadjuvant therapy
Example 1: Patient diagnosed with prostate cancer. Patient received one shot of Lupron followed by prostatectomy 2 weeks later.
i. For purposes of the Neoadjuvant Therapy data item, one shot of Lupron does not qualify as neoadjuvant therapy
1. Record this Lupron shot as hormone therapy
a. Hormone Therapy: Code 01-Hormone Therapy Administered
b. Date Hormone Therapy Started: Code date the Lupron was administered
c. Systemic Treatment/Surgery Sequence: Code 2-Systemic therapy before surgery
Example 2: Patient diagnosed with breast cancer. Due to scheduling, patient not able to have surgical resection for 3 weeks, patient given Tamoxifen, followed by mastectomy with sentinel lymph node biopsy.
ii. For purposes of the Neoadjuvant Therapy data item, a short course of Tamoxifen does not qualify as neoadjuvant therapy
1. Record the hormone therapy as treatment
1. Hormone Therapy: Code 01-Hormone Therapy Administered
2. Date Hormone Therapy Started: Code date the Tamoxifen was administered
3. Systemic Treatment/Surgery Sequence: Code 2-Systemic therapy before surgery
5. Assign code 9 when
a. It is unknown whether neoadjuvant therapy was administered
i. Planned, but unknown if given
ii. Death certificate only (DCO)
Note 1: Code 9 (unknown) should be used rarely.
Note 2: Use code 0 when it is clear that the patient did not have neoadjuvant therapy based on the sequence of diagnosis and treatment.