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20240049 | First Course Treatment/Neoadjuvant Therapy--Breast: When are pre-operative therapies given as part of a clinical trial coded as neoadjuvant treatment versus limited systemic exposure in the Neoadjuvant Therapy data item? See Discussion. |
The SEER Manual seems to give somewhat conflicting instructions for clinical trial therapies under the Neoadjuvant Therapy data item. One section states that limited systemic therapy may occur in clinical trials 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 for the purposes of this data item. Then another section states for purposes of this data item, the criteria for neoadjuvant therapy include that treatment must follow recommended guidelines for the type and duration of treatment for that particular cancer site and/or histology, and that neoadjuvant therapy may be given as part of a clinical trial. For example, a patient was diagnosed with invasive ductal carcinoma of the breast, 6 cm in size; treatment planning conference recommended neoadjuvant chemotherapy. The patient elected to participate in a clinical trial and was assigned to a group given the antibody drug conjugate datopotamab deruxtecan (Dato-DXd) plus durvalumab for 12 weeks. There was no physician documentation of intent or expected outcomes, nor yC staging or statement of clinical response. Post-therapy imaging showed no residual mass, and post-therapy mastectomy path report showed only residual ductal carcinoma in situ, stating "Treatment Effect (after neoadjuvant): Residual Cancer Burden - pCR, In the breast - complete response." The medical oncologist stated post-therapy stage was ypTis ypN0 cM0. The trial drugs this patient were given do not appear to be approved or standard neoadjuvant/pre-operative drugs in SEER*Rx or NCCN guidelines for this type of cancer; however, the duration of treatment was fairly substantial, and although we don't have clear documentation from physicians as recommended in the SEER manual (which is usually not stated, in our experience), it seems like they may be considering it as neoadjuvant therapy. How should the Neoadjuvant Therapy data item be coded for cases like this? What is the best way to differentiate between clinical trial therapies that are "limited systemic exposure" (code 3) versus true neoadjuvant therapy (code 1)? |
When pre-operative therapies are given as part of a clinical trial, code as neoadjuvant treatment in the Neoadjuvant Therapy data item when the intent is neoadjuvant and/or when surgical resection follows the clinical trial therapies. In the example, neoadjuvant chemotherapy was recommended in the treatment planning and the patient had the planned resection after neoadjuvant treatment. The treatment effect outcome is based on imaging that reported no mass and as documented by the physician, pathologist in this case as complete response to the neoadjuvant therapy based on the resection. Use code 3 (limited systemic exposure) when treatment does not meet the definition of neoadjuvant therapy in the data item, Neoadjuvant Therapy. Limited exposure occurs when the patient receives some therapy prior to surgical resection, but the treatment is not enough to qualify for a full course of neoadjuvant therapy with the intent to impact extent of surgical resection or other outcomes. While this type of treatment may given as part of a clinical trial, it mostly refers to short term treatments such as hormone therapy. When neoadjuvant therapy is given prior to surgical resection that is planned (intended) or performed to improve outcomes, use Code 1 or 2. Because a clinical trial is a type of research study that tests new methods of screening, prevention, diagnosis, or treatment of a disease, the treatment regimens likely will not be incorporated in recommended guidelines until all phases of the trial are completed and approved by the U.S. Food and Drug Administration. ClinicalTrials.gov is available to learn more about clinical studies around the world. |
2024 |
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20240039 | Update to Current Manual/Race: For the Example #15 under Race Coding Examples in the 2024 SEER manual, could coding these as 97 result in an under-reporting of Native Hawaiians? See Discussion. |
The race category in some hospital electronic medical record systems includes a combined category of “Native Hawaiian/Pacific Islander.” What race code should be used in a situation where the only available information is “Native Hawaiian/Pacific Islander?” |
Change to current instructions. We will update this example in the next edition of the manual. The new example will instruct registrars to look for other descriptions of the patient’s race. When no other information is available, assign 07, Native Hawaiian, in Race 1 and assign 97, Pacific Islander, NOS in Race 2. Begin following this new instruction now. |
2024 |
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20240029 | Solid Tumor Rules/Multiple Primaries--Head and Neck: Is a 11/2023 diagnosis of invasive squamous cell carcinoma (SCC) in lower gum (C031) a new primary and what rules apply for a patient with 09/2017 invasive SCC of lower gum (C031) and 05/2022 invasive SCC of lateral tongue (C023)? See Discussion. |
The 11/2023 lower gum tumor is a separate tumor occurring after a disease-free interval, so we know the Head and Neck Multiple Tumors Module applies. However, our staff is having difficulty applying the rules to this particular scenario with consistent results. Is the 11/2023 SCC a non-reportable recurrence per M12, since M4 is ignored due to patient’s prior 2017 C031 (lower gum) primary, and then M6 is ignored due to patient’s prior 05/2022 C023 primary? Or is the 11/2023 SCC a new primary per M4, since the last diagnosis was in a site differing at the third character (C03 vs C02)? If M4 does not apply due to patient's previous C03 primary, then does M6 apply since it has been more than 5 years since the previous C03 primary? |
Abstract three primaries for the scenario you describe.
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2024 |
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20240022 | Solid Tumor Rules/Histology: When should the designation of “poorly differentiated” be used to further specify histology for carcinoma, NOS (8010) as undifferentiated carcinoma (8020)? See Discussion. |
The term “poorly differentiated carcinoma (NOS)” is listed as related to “undifferentiated carcinoma (NOS)” in the ICD-O 3.2. It is also listed in the Solid Tumor Rules for Urinary Table 2 (Urinary subtypes), Other Sites Table 16 (uterine corpus primaries) and Table 19 (vulvar primaries). Are these the only sites in which one should code “poorly differentiated carcinoma (NOS)” as 8020 (undifferentiated carcinoma)? How is histology coded if the only microscopic confirmation is from a metastatic site showing “poorly differentiated carcinoma” (NOS) or “invasive carcinoma, poorly differentiated” (NOS)? Example 1: Primary pancreatic cancer diagnosed on imaging and confirmed with liver mets core biopsy showing “poorly differentiated carcinoma.” Immunostaining pattern was non-specific. No further workup or treatment was planned. Other Sites - Table 11 (Pancreas Histologies) includes undifferentiated carcinoma (8020/3) as a valid histology; however, the synonyms/subtypes/variants do not mention poorly differentiated carcinoma. How should histology be coded for this case? Example 2: Hemicolectomy with cecal tumor final diagnosis of “invasive carcinoma, poorly differentiated” and synoptic summary listing “Histologic type: Invasive carcinoma. Histologic grade: G3 of 4: poorly differentiated.” Colorectal Table 1 (Specific Histologies and Subtypes/Variants) includes undifferentiated adenocarcinoma/carcinoma 8020 as a subtype of adenocarcinoma NOS. There is no mention of poorly differentiated in this context. How should histology be coded for this case? |
Assign code 8020/3 when the histologic type specifically includes the term of poorly differentiated, dedifferentiated, undifferentiated, or anaplastic undifferentiated carcinoma along with carcinoma as terms vary depending on the primary site. When the term poorly differentiated is included in the grade section only of the pathology report or only mentions poorly differentiated carcinoma without further substantiation from a pathology report as in examples 1 and 2, do not use code 8020/3. The histology code 8020/3 and terms may be used for selected primary sites as included in the Solid Tumor Rules, WHO Classification of Tumors series (latest versions), and the Site/Morphology Validation List including Nasal cavity Nasopharynx Salivary glands Urinary sites Colon, rectosigmoid, rectum Esophagus Stomach Gallbladder and extrahepatic bile duct Pancreas Thyroid Ovary Uterine corpus Vagina Uterine cervix (also referred to as unclassifiable in WHO Classification of Female Genital Tumors, 5th ed.) For sites other than those listed, if the diagnosis is poorly differentiated carcinoma, code 8010/3 and poorly differentiated in the grade field. |
2024 |
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20240021 | Solid Tumor Rules/Reportability/Histology--Digestive Sites: Is a diagnosis of “high grade dysplasia” (not specified to be squamous or glandular) reportable for esophagus, stomach, and small intestine for cases diagnosed beginning in 2024? If so, how should histology be coded? See Discussion. |
SEER Program Coding and Staging Manual indicates high grade dysplasia of esophagus, stomach, and small intestine are reportable. The ICD-O-3.2 does not include “high grade dysplasia” as equivalent to “high grade squamous dysplasia.” If reportable, would high grade dysplasia (NOS) that originates in the stomach and small intestine default to 8148/2, while esophageal high grade dysplasia (NOS) default to 8077/2? |
Report these high grade dysplasia of the following organs as stated below. Stomach: Assign code 8148/2 glandular intraepithelial neoplasia, high grade using the Other Sites Solid Tumor Rules, Table 6: Stomach Histologies and as described in the WHO Classification of Digestive Tumors, 5th edition. Small intestine and Esophagus: Assign code 8148/2 glandular intraepithelial neoplasia, high grade, using the Other Sites Solid Tumor Rules, Other Sites Histology Rules, Rule H4/H26. The following note is listed for both of these rules. Note: This list may not include all reportable neoplasms for 8148/2. See SEER Program Coding and Staging Manual or STORE manual for reportable neoplasms The Other Sites Solid Tumor Rules, Table 5: Esophagus Histologies and Table 7: Small Intestine and Ampulla of Vater Histologies will be updated to reflect this code as time permits. |
2024 |
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20240031 | Reportability/Histology: Is a diagnosis of non-lung neuroendocrine tumorlet reportable? See Discussion. |
Patient was diagnosed March 2023 with a neuroendocrine tumorlet of the rectum measuring 0.8 mm via excisional biopsy during colonoscopy. Prior SINQ 20160011 (stomach specific) indicates microcarcinoid and carcinoid tumors are reportable. Microcarcinoid is a designation for neuroendocrine tumors of the stomach when they are less than 0.5 cm. in size. Is the current rectal tumor a reportable gastrointestinal neuroendocrine tumor if it is less than 5 mm (i.e., is a neuroendocrine tumorlet equivalent to a microcarcinoid)? |
Do not report neuroendocrine tumorlet of lung and non-lung sites. Microcarcinoid and carcinoid tumors are reportable. Tumorlet is a tumor of neuroendocrine differentiation, defined by size < 5 mm in diameter, mitotic count < 2 mitoses/2 mm², and absence of necrosis. Microcarcinoid is a designation for neuroendocrine tumors when they are less than 0.5 cm. in size. The term "tumorlet" is used in a number of other settings, referring to small tumors (usually < 0.5 cm), and does not necessarily mean carcinoid tumor. The term microcarcinoid tumor is not equivalent to neuroendocrine tumorlet. |
2024 |
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20240054 | EOD 2018/Primary Tumor--Breast: We are having difficulty deciding when we can or cannot use physician-assigned TNM staging to code EOD data items if the medical record or hospital abstract documentation is unclear. As a central registry, we are unable to query physicians for clarification. Please advise what is a “discrepancy” in the EOD General Instructions to “Use the medical record documentation to assign EOD when there is a discrepancy between the T, N, M information and the documentation in the medical record.” See Discussion. |
We know that physician TNM staging is not always accurate, and we also know that doctors sometimes use information in assigning their TNM which may not be available to registrars. Is it a discrepancy when the documentation in the chart is unclear or not definitive, yet the physician assigns a TNM that seems to incorporate that documentation? Or is a discrepancy an obvious conflict between chart documentation and the doctor’s staging – such as a mis-assignment of TNM category that doesn’t at all match with clear and complete medical record documentation, or the physician’s use of criteria that should be excluded from the TNM assignment per AJCC guidelines? A real case example is a patient with breast carcinoma, imaging states 12 cm tumor with thickening of dermis, and thickening of morphologically suspicious internal mammary and level 1-2 axillary lymph nodes. Medical oncologist states locally advanced breast cancer with extensive changes involving skin thickening associated with the mass, at least stage IIIC based on imaging and exam findings, cT4 N3b. Only axillary nodes were sampled and found to be positive. Post-neoadjuvant therapy resection showed only focal DCIS. Per EOD guidelines, would the oncologist’s staging be a discrepancy with the chart documentation and therefore ignored, with EOD-Primary Tumor coded 200 for skin thickening, and EOD-Lymph Nodes 200 for involvement of axillary nodes only? Or would the doctor’s TNM be a clarification/confirmation of documentation terms that we otherwise would not code, with EOD-PT coded 400 for extensive skin involvement and EOD-LNs 600 for internal mammary + axillary nodes? |
Use all information available in the medical record. EOD is a combination of the most precise clinical and pathological documentation of the extent of disease as instructed in the EOD 2018 General Instructions, Extent of Disease section. EOD 2018 General Instructions, General Coding Instructions section advises to use the medical record documentation to assign EOD when there is a discrepancy between the T, N, M information and the documentation in the medical record. When there is doubt that the documentation in the medical record is complete, code the EOD corresponding to the physician staging. A discrepancy can exist within the medical record when the information in the chart is unclear, incomplete, or conflicting, for example, the TNM staging from pathology differs from the medical oncologist’s TNM staging. In the scenario provided, use the medical oncologist stage information that takes into account imaging and exam findings. Based on the stage cT4 N3b, assign EOD Primary Tumor: 400 Extensive skin involvement WITHOUT a stated diagnosis of inflammatory carcinoma WITH or WITHOUT dermal lymphatic filtration EOD Regional Nodes: 600 Internal mammary node(s), ipsilateral, clinically apparent (On imaging or clinical exam) WITH axillary (level I, II, or III) lymph node(s), ipsilateral including infraclavicular |
2024 |
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20240003 | Solid Tumor Rules/Histology--Head & Neck: How is histology coded for laryngeal intraepithelial neoplasia II-III (LIN II or LIN III)? See Discussion. |
Laryngeal intraepithelial neoplasia II-III is not included in the ICD-O-3.2 and, while the SEER Program Coding and Staging Manual (SPCSM) confirms this is reportable, neither the SPCSM nor the Solid Tumor Rules Manual provide the specific histology to use for LIN II or LIN III. Should this be coded as 8077/2 since this is most like a high grade squamous dysplasia? |
Assign histology code, 8077/2 (squamous intraepithelial neoplasia, high grade) for LIN III and for LIN II. ICD-O-3.2 lists squamous intraepithelial neoplasia, grade II and grade III as 8077/2 indicating it is reportable. ICD-O-3.2 does not list every site-specific type of intraepithelial neoplasia. Check the SEER manual for reportable and non-reportable examples. |
2024 |
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20240027 | Solid Tumor Rules/Multiple Primaries--Brain and CNS: How many primaries are accessioned when a 2005 diagnosis of glioblastoma multiforme is followed by a 2024 diagnosis of astrocytoma, IDH-mutant, WHO grade 4? See Discussion. |
The patient underwent a gross total resection of the 2005 glioblastoma multiforme (9440/3). The patient was subsequently diagnosed with a 2024 diagnosis of astrocytoma, IDH-mutant, WHO grade 4 (9445/3). Should Rule M13 apply to the new 2024 diagnosis and a new primary be accessioned because astrocytoma, IDH-mutant, WHO grade 4 is listed on a different row than glioblastoma? It is unclear whether histology 9445 should be classified as being on a different row because it is also listed as a subtype/variant for glioblastoma in Table 3. Table 3 lists histology 9445 as both “Astrocytoma, IDH-mutant, WHO grade 4” and as “Glioblastoma IDH-mutant.” |
Abstract two primaries using the 2024 Malignant Central Nervous System (CNS) and Peripheral Nerves Solid Tumor Rules, Rule M13. Glioblastoma, IDH-wild-type (9440/3) and astrocytoma, IDH-mutant, grade 4 (9445/3) are on two separate rows in Table 3 of the Malignant CNS and Peripheral Nerves Solid Tumor Rules. WHO Classification of Central Nervous System, 5th edition, lists the subtypes of glioblastoma, IDH-wild-type as giant cell glioblastoma; gliosarcoma; and epithelioid glioblastoma. The term glioblastoma multiforme is not recommended for glioblastoma, IDH-wildtype in the 5th edition, and lists astrocytoma, IDH-mutant, grade 4 as a subtype of astrocytoma, IDH-mutant. |
2024 |
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20240008 | Solid Tumor Rules/Histology--Brain and CNS: Should the term “diffuse” be added to Note 2 in the Non-Malignant Central Nervous System (CNS) Solid Tumor Rules, Table 6: Specific Histologies, NOS, and Subtypes/Variants, for the papillary glioneuronal tumor 9509/1? See Discussion. |
Should Note 2 state, "Beginning with cases diagnosed 1/1/2023 forward, diffuse leptomeningeal glioneuronal tumor is coded 9509/3? See the Malignant CNS rules." Currently the Note only states, "leptomeningeal glioneuronal tumor," but the histology that changed behavior is listed in both Table 6, Column 1 (Non-Malignant CNS) and Table 3 (Malignant CNS) as, "Diffuse leptomeningeal glioneuronal tumor." |
The correct term is diffuse leptomeningeal glioneuronal tumor listed as a synonym in Column 2. We will add the term diffuse in Note 2, Column 1 with the 2025 updates. In the meantime, you can add "diffuse" to your pdf version until the update is published. |
2024 |