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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)?

Appendix E1 in both the 2023 and 2024 SEER Program Coding and Staging Manual (SPCSM) lists these malignant spindle cell neoplasms, consistent with atypical fibroxanthoma, as reportable when other tumors have been ruled out with immunohistochemistry. This contradicts both SINQ 20190102 and the Solid Tumor Rules (STRs) general instructions indicating ambiguous terminology (e.g., “consistent with”) cannot be used to code the more specific histology when there is a NOS (malignant spindle cell neoplasm, 8004/3) and a more specific (malignant atypical fibroxanthoma, 8830/3) histology.

These tumors are typically diagnosed and treated in dermatology offices, so further chart review or confirmation by a physician is not possible for central registries.

As non-melanoma skin primaries are included in the Other Sites schema, and this schema was updated for cases diagnosed 2023 and later, which instruction applies to 2023+ diagnoses? Should these continue to be collected per Appendix E1 despite the conflict with the STR Manual and SINQ? If these are reportable, should the SINQ and STR Manual be updated to reflect this? Or should these be non-reportable per the STR Manual and SINQ?

The only Other Sites H Rule related to extramammary Paget disease is included in the Multiple Tumors Abstracted as a Single Primary module. Rule H28 instructs one to code the histology of the underlying tumor when there is extramammary Paget disease and an underlying tumor of the anus, perianal region, or vulva. Therefore, a vulvar extramammary Paget disease with underlying adenocarcinoma is coded as adenocarcinoma (8140/3), and not extramammary Paget disease (8542/3).

However, there is no M Rule confirming extramammary Paget disease and the underlying adenocarcinoma are a single primary (i.e., multiple tumors abstracted as a single primary) making it difficult for one to use the Multiple Tumors Abstracted as a Single Primary H rules module.

We recognize this is a longstanding histology coding rule, but how are registrars supposed to arrive at Rule H28 when the M Rules must be applied first and do not instruct one to accession a single primary? Moreover, if this is to be a single primary (per rule M2), why is there no H Rule in the Single Tumor module?

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.”

Patient was diagnosed in July 2022 with biopsy confirmed left kidney renal cell carcinoma. Initially, partial nephrectomy was planned for February 2023 but canceled at the last moment due to the patient’s “history of narcotic use.” The details of that cancellation were otherwise unclear. It appears the treatment plan was changed due to patient non-compliance.

Patient then had cryoablation of the tumor in May of 2023. Subsequent imaging in October found residual tumor, but no disease progression was noted. Again, additional ablation was offered but patient decided on surgical treatment which did not occur until December 2023.

Is the cryoablation second course due to a change of plan if there is no disease progression, recurrence, or treatment failure?

If the cryoablation is first course treatment, then would the partial resection also be first course treatment because it was documented as the treatment plan?

In the NAACCR Coding Pitfalls 2023 webinar, the example of DCIS, solid type is given. The webinar advised us to code 8230/2 (ductal carcinoma in situ, solid type). When going through the beginning of the solid tumor rules in the Changes from 2007 MPH Rules section it states "DCIS/Carcinoma NST in situ has a major classification change. Subtypes/variant, architecture, pattern, and features ARE NOT CODED. The majority of in situ tumors will be coded to DCIS 8500/2." In the equivalent or equal terms section it lists "Type, subtype, variant" can be used interchangeably.

Since the example has it listed as as ductal carcinoma in situ, solid "type," would we code 8500/2 or 8230/2? 

The 2022 ICD-O-3.2 Implementation Guidelines indicate “Tubulovillous adenoma, high grade” is 8263/2 and is not SEER reportable. However, the 2024 SEER Manual and clarification from recent SINQs (20240021 and 20240025) confirm high grade dysplasia in the esophagus, stomach, and small intestine is reportable (8148/2).

Which reportability reference applies to a diagnosis of a tubulovillous adenoma with high grade dysplasia in non-colorectal sites?

The CT findings identified a right kidney rim-enhancing centrally cystic lesion most suggestive of clear cell renal cell carcinoma measuring 3.2 cm.  The radiologist’s impression was “concerning for renal cell carcinoma.” The subsequent urologist’s consult states the right kidney lesion has a 75% chance of malignancy. The urologist discussed active surveillance, surgery, and ablation, and after discussion with the patient the plan was for active surveillance.

No further information is available, and we are unable to follow up with the physician regarding this case.

Should a lesion with a high percentage chance of malignancy (e.g., 75% chance) be considered a lesion “most likely” to be malignant?