| Report | Question ID | Question | Discussion | Answer | Year |
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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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20240037 | Solid Tumor Rules/Histology--Bladder: How is histology coded for a bladder tumor when the diagnosis is 95% large cell neuroendocrine carcinoma and 5% high grade urothelial carcinoma of no special type? See Discussion. |
In the 2024 Solid Tumor Rules update, the small cell neuroendocrine carcinoma row in Table 2 was changed. The NOS histology became neuroendocrine carcinoma, NOS (8246) and both large cell and small cell neuroendocrine carcinomas (8013 and 8041, respectively) became the subtype/variants. This change impacts Rule H4 but Rule H4 was not updated. Rule H4 still refers to small cell neuroendocrine carcinoma as being the NOS histology. In the prior STR versions, it was clear the tumor in question would be coded as 8045 per Rule H4 and Table 2. Considering Rule H4 was not updated according to the changes for Table 2, does histology 8045 still apply to this diagnosis? There is currently no way to arrive at a histology for this case. Does Rule H4, bullet 3 need to be updated to indicate, “subtype/variant of neuroendocrine carcinoma mixed with any other carcinoma (does not apply to sarcoma)”? |
Assign 8013/3 (combined large cell neuroendocrine carcinoma). There are two histologies present: large cell NEC and urothelial. Literature search found primary large cell NEC of the bladder is extremely rare with less than 20 reported cases. This case does not fall into the site-specific rules and given it's raity, a specific rule for this situation was not and will not be added to the Bladder rules. See #1, Example 2, in the general instructions for coding histology. |
2024 |
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20240059 | Update to the Current Manual/SEER*RSA--SEER Site-specific Factor 1: The 2024 SEER Manual and SEER*RSA say that Codes 10-51 are hierarchical; use the highest code that applies (10 is highest, 51 is lowest). Should the guidance say that 51 is highest, 10 is lowest since code 10 is a HPV negative p16 test? |
Assign the highest code with 51 as the highest and 10 the lowest when there is more than one test performed with differing results. The SEER Manual will be updated in the 2025 release. SEER*RSA will be updated in a future release, version 3.3 in 2026, as version 3.2 has been updated for 2025. |
2024 | |
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20240018 | Solid Tumor Rules/Histology--Head and Neck, Other Sites: Please provide clarification about effective dates for using p16 testing to assign HPV-related histology codes for various primary sites. See Discussion. |
1. The 2022 and 2023 SEER Program Coding Manuals state under Histologic Type ICD-O-3: Beginning with cases diagnosed 01/01/2022 forward, p16 test results can be used to code squamous cell carcinoma, human papilloma virus (HPV) positive (8085) and squamous cell carcinoma, HPV negative (8086). NAACCR 2023 Implementation Guidelines contain similar instructions on HPV histologies for cervix, vulva and vagina that are applicable back to 2022 (2021 for cervix). The current Other Sites Solid Tumor Rules state on the Histology tables for anus, cervix, vagina, vulva, and penis and scrotum: "p16 is a valid test to determine HPV status and can be used to code HPV associated and HPV independent histologies." Since Other Sites Solid Tumor Rules apply to cases diagnosed 2023+, can p16 results only be used from 2023 onward, to code HPV-related histologies for primaries that fall under the Other Sites module? Or per the 2022 SEER Manual statement and NAACCR 2023 Implementation Guidelines, could a p16-confirmed HPV histology code also apply to a 2022 Other Sites case and if so, is that only for cervix, vulva, and vagina? Further complicating the matter are the 2024 ICD-O-3.2 update documents indicating these codes are valid 1/1/2024+ for the “Other Sites” penis and scrotum. 2. Is using p16 testing for HPV-related histology codes ONLY allowed for sites in the Solid Tumor tables that contain the statements about p16 (Head & Neck Table 5, and the Other Sites tables noted above for anus, cervix, etc.)? Or could it apply to primary sites outside of those tables; for example, a 2022 pathology report from the ethmoid sinus C311 indicating an HPV-related histology based on p16 testing? The ICD-O-3 Annotated Histology lists include C310-C313 among the common site codes for 8085 and 8086. The Head and Neck Solid Tumor Rules “New for 2022” section and rule H1 Note 4 also mention that p16 can be used to code HPV histologies; these sections would seem to apply to all sites in that module, since only the more common histology codes are listed in the tables and if not, we are instructed to use ICD-O. |
Per 2024 Cancer PathCHART expert pathologist review, morphology codes 8085/3 and/or 8086/3 are valid and applicable to head and neck, oropharynx, cervix, vagina, vulva, fallopian tube, anus, and penis scrotum (reference: Cancer PathCHART: Product Downloads and Timelines). The Cancer PathCHART SMVL will be updated for C632, Scrotum, with the next release of the NAACCR Edits Metafile, currently scheduled for May 2024. Assign histology codes 8085 and 8086 for the sites listed in the Solid Tumor Rules histology tables. The codes 8085 and 8086 are applicable for a small group of sites according to the year they became valid for implementation as follows. Head and Neck Oropharynx, Base of Tongue, Tonsils, Adenoids (2022+) Other Sites Cervix (2021+) Anus (2023+) Vagina (2023+) Vulva (2023+) Penis (2024+) Scrotum (2024+) While ICD-O-3.2 and Cancer PathCHART list additional sites such as Accessory Sinuses, they have not yet been implemented in the U.S. |
2024 |
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20240057 | Solid Tumor Rules/Histology--Brain and CNS: What is the histology code for angiocentric glioma? See Discussion. |
We would like to confirm that the correct histology code is 9431/1 per ICD-O-3.2, as the Non-Malignant CNS Solid Tumor Manual lists the histology code as both 9431/1 (pages 301 and 303 of the combined manual), but also shows it as a synonym for 9421/1 – Diffuse astrocytoma, MYB- or MYBL1 altered (page 304). |
Assign code 9431/1 for angiocentric glioma. This has been corrected in the 2025 update. Angiocentric glioma was removed from the 9421/1 row and remains in its own row. |
2024 |
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20240066 | Histology--Heme & Lymphoid Neoplasms: How should histology be coded for a pathologic diagnosis of “Follicular lymphoma, diffuse pattern grade 3A of 3, equivalent to diffuse large B cell lymphoma (germinal center cell type)” when later referenced clinically as follicular lymphoma grade 3A? See Discussion. |
The WHO Classification of Hematopoietic Tumors (Blue Book), 5th edition states: “Rare cases of classic follicular lymphoma with cytological features of follicular lymphoma (FL) grade 3A can present with a prominent diffuse pattern. In the previous edition, such cases were defined as diffuse large B-cell lymphoma (DLBCL). Currently, it is uncertain whether such cases should be classified as FL or diffuse large B-cell lymphoma; and in such cases, individual treatment choices should be made in multidisciplinary conference settings taking into consideration clinical, laboratory, and imaging parameters. The presence of diffuse areas composed entirely or predominantly of large cells, however, warrants a diagnosis of diffuse large B-cell lymphoma.” Our concern is that the Hematopoietic (Heme) Manual and Database do not provide instruction for coding this scenario. We hesitate to interpret the terms “equivalent to” as ambiguous because one could argue it is unambiguous. Barring this argument, the M and H rules would indicate this is a diagnosis of diffuse large B-cell lymphoma. However, the physician does not seem to agree with the pathologist. |
Assign histology as DLBCL (9680/3) as supported by the WHO Classification of Hematolymphoid Tumors, 5th edition. It is consistent with how it would have been coded in the 4th edition. The Heme Manual and Database currently are based on the 4th edition. Physicians are using the 5th edition blue book, whereas the cancer registry field is not yet at this time. Regarding the Heme Manual and Database, this type of scenario is not covered because it is part of the 5th edition WHO Blue Book. The database cannot be updated until the 5th edition is approved for implementation (2026). |
2024 |
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20240047 | Reportability/Histology--Endometrium: Is “high grade serous intraepithelial neoplasm” of the endometrium reportable? See Discussion. |
The patient had a 2023 endometrial polypectomy and curettage with final diagnosis of “at least serous intraepithelial neoplasia arising in association with an endometrial polyp.” Diagnosis comment states, “There are multiple tissue fragments with highly atypical glandular lining consistent with a high-grade serous neoplasm. There are focal areas which are suspicious, but not conclusive, for stromal invasion.” Subsequent hysterectomy and BSO showed no residual carcinoma. According to previous SINQ 20210043, serous tubal intraepithelial neoplasm (STIN) is reportable when stated to be high grade. Does the same logic apply to a similar neoplasm in the endometrium and/or endometrial polyp? |
Report high grade serous intraepithelial neoplasm of the endometrium. |
2024 |
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20240045 | Reportability/Ambiguous Terminology--Prostate: Should cases be reported and abstracted based on ambiguous terminology, e.g., suspicious for prostate cancer, when the physician is not treating the case as malignant? See Discussion. |
Please comment on these specific scenarios.
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For each of your scenarios, the medical record information indicates that the case is not reportable based on physician opinion. Do not abstract these cases. Remember that the ambiguous terms list is to be used as a last resort. The ideal way to approach abstracting situations when the medical record is not clear is to follow up with the physician. If the physician is not available, the medical record, and any other pertinent reports (e.g., pathology, etc.) should be read closely for the required information. See page 19 in the SEER Manual, https://seer.cancer.gov/manuals/2024/SPCSM_2024_MainDoc.pdf |
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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20240007 | Histology--Brain and CNS: Provide clarification about the priority order of histology coding sources and an explanation of why the annotated histology lists are not the same as the WHO IARC ICD-O-3.2 Excel Table (adopted 1/1/2021). See Discussion. |
We have had multiple users unable to find the applicable histology in the ICD-O-3.2 (i.e., the site-specific table did not include the histology) because they were using the annotated histology list and could not find the complete list of related terms or synonyms for the histology code. For example, the ICD-O-3.2 lists Medulloblastoma, SHH-activated, NOS as a related term for 9471/3, but many users were unable to find this valid histology because they were using the annotated histology list, not the ICD-O-3.2. |
The NAACCR Annotated Histology List (AL) serves as an aid to registry software vendors for implementing annual histology changes. This file has been maintained by the Registry Plus team at CDC’s NPCR for several years and reflects modifications to ICD-O-3 implemented by North American cancer registries over time. Although this list is reviewed multiple times prior to posting, there is no guarantee of 100% accuracy. As such, the AL is not a substitute for referring to various standard-setter documents and implementation guidelines. In this instance, Medulloblastoma Desmoplastic SHH-activated and TP53-wildtype 9471 is across several resources: the Solid Tumor Rules, Malignant CNS and Peripheral Nerves module in Table 3, column 3 as a subtype/variant of Medulloblastoma NOS 9470; in the CNS WHO 5th Edition BB; and in the WHO IARC ICD-O-3.2 posted to ICD O 3 Coding Updates (naaccr.org). Although the exact related term of Medulloblastoma, SHH-activated, NOS is not listed, the NAACCR Implementation Guidelines for 2024 recommend checking the 2024 ICD-O-3 Update Table 1 or 2 to determine if the histology is listed. If the histology is not included in the update, then review ICD-O-3.2 and/or Hematopoietic and Lymphoid Database and/or Solid Tumor Rules (MP/H). The Cancer PathCHART initiative has been undertaken to address gaps such as this between standard setting resources. Having all the standard histology coding resources included in a single all-inclusive database enables alignment of morphology codes & terms included in the CPC*SMVL (Cancer PathCHART Site-Morphology Validation List), Solid Tumors Rules, ICD-O-3 Annual Updates, NAACCR Annotated Histology List as well as the WHO 5th edition Blue Books. Please see Cancer PathCHART - Tumor Site-Morphology Surveillance Standards Initiative for more information on the Cancer PathCHART initiative, and more specifically, see Transitioning the Annotated Histology List to Cancer PathCHART (naaccr.org). |
2024 |
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