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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)?

The Reportable Diagnosis List indicates "Lobular neoplasia grade II (LN II)/lobular intraepithelial neoplasia grade II (LIN II) breast (C500-C509)" is reportable.

The ICD-O-3.2 lists “Glandular intraepithelial neoplasia, grade II” and “Glandular intraepithelial neoplasia, low grade” as histology code 8148 with behavior of /0 (benign).

10/2017 Bladder cancer diagnosed as invasive papillary urothelial bladder carcinoma (8130/3) (submucosal invasion).

12/2017 Surveillance scope and transurethral resection of bladder tumor (TURBT) finds “recurrent” bladder tumor, non-invasive papillary urothelial bladder carcinoma (8130/2) - same primary per 2007 Multiple Primaries/Histology, Rule M6, (both papillary urothelial bladder carcinomas).

4/2018 Radical nephrectomy found focally invasive urothelial carcinoma (8120/3) in the renal pelvis.

Is this a new primary per 2018 and forward STR, Rule M6, because it was more than 60 days since the 12/2017 in situ bladder recurrence? Or would one compare the 2018 diagnosis to the original invasive bladder tumor in 10/2017, and continue on to Rule M11, which says to abstract a single primary for urothelial carcinomas in multiple organs, regardless of behavior?

SINQ #20120080 said to compare to the original diagnosis and disregard intervening recurrences, but that pertained to the 2007 MP/H rules. Does this still apply for 2018 forward? STR, Rule M10, Note 3, states when there is a recurrence within three years of diagnosis, the “clock” starts over. The time interval is calculated from the date of last recurrence. Comparing each recurrence for urothelial carcinomas using Rule M6 could result in over-counting them. Can the instructions on how to calculate the 60-day interval be clarified in Rule M6?

It appears there was some confusion about finding this new malignant HGAP tumor (2023+) code. If this is not a specific subtype/variant of astrocytoma, can clarification be added to the “New for 2023” entry for HGAP?

The patient had neoadjuvant chemotherapy (Carboplatin and Paclitaxel) concurrent with radiation per the managing physician. The physician stated the patient completed the neoadjuvant therapy; however, it was also noted that patient completed five cycles of chemotherapy, but the sixth cycle was held due to neutropenia.

The SEER Manual does not address how to code Neoadjuvant Therapy when the patient completed almost all the planned neoadjuvant therapy. It seems inappropriate to code Neoadjuvant Therapy as 2 (Started but not completed) simply because the patient did not have one cycle of chemotherapy but is otherwise felt to have completed neoadjuvant therapy per the managing physician. Does the managing physician’s statement of “completion” impact how this scenario is coded?

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.

Example 4:  Esophageal biopsy with diagnosis of “focal areas suspicious for adenocarcinoma in situ.” Diagnosis on partial esophagectomy specimen “with foci of high grade dysplasia; no invasive carcinoma identified.” Do not accession the case. The esophagectomy proved that the suspicious biopsy result was false.

Appendix E2 #32 of the SEER Manual states high grade dysplasia in site other than stomach, small intestines, and esophageal primary sites are not reportable. Does this mean high grade dysplasia is reportable for esophagus primaries?

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?

An 80-year-old post-menopausal female (status post hysterectomy for benign reasons) presents with a retroperitoneal mass on imaging. The pre-operative imaging shows the cervix and uterus are absent. Patient undergoes a robotic left salpingo-oophorectomy with biopsy of the retroperitoneal mass.

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?