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The MP/H Rules do not specifically cover how to process urothelial carcinomas with a more specific type of carcinoma.

Patient 1: Diagnosed in April 2010 with invasive urothelial carcinoma with signet ring features of the bladder. Site and histology are coded as C679 [bladder] and 8490/3 [signet ring cell carcinoma]. In January 2012 a subsequent diagnosis of invasive urothelial carcinoma of the bladder is made [C679, 8120/3].

Patient 2: Diagnosed in November 2009 with invasive papillary urothelial carcinoma with micropapillary and mucinous features of the bladder. Site and histology are coded C679 [bladder] and 8480/3 [mucinous carcinoma]. In April 2012 a subsequent diagnosis of high grade papillary and flat urothelial carcinoma without evidence of invasion is made [C679, 8130/2].

Does rule M9 apply and these are new primaries?

The MP/H rule general information section states that we do not accession a second primary unless a pathologist compares the current tumor to the original tumor and states that the current tumor is a recurrence of cancer from the previous primary. In our experience it is rare that a pathologist speaks so bluntly. They frequently hedge somewhat.

Are the following statements worded strongly enough for us to make the assumption that the current tumor is a recurrence of patient's previous cancer?

Example 1: Pathologist states: Patient's prior lung tumor reviewed. The tumor in the current case (left lower lobe) shows similarities to some areas of the patient's prior left lower lobe tumor.

Example 2: Pathologist states: The focus of ductal carcinoma in the mastectomy specimen does resemble the carcinoma in the previous partial mastectomy specimen. (Slides reviewed).

The MP/H rules do not address the concept of "cell type" for melanomas when the pathologist uses the CAP protocol to report findings and the cell type listed in that section of the report differs from the specific cell type mentioned in the final diagnosis. Does a case have two specific cell types when the final diagnosis and the "cell type" sections of a single pathology report indicate two more specific melanoma histologies?

Pre-2007 SINQ entries indicate the cell type should be coded. However, if it differs from the specific cell type listed in the final diagnosis does it matter? Do the MP/H rules still take the cell type into account?

The MRI states "Lhermitte-Duclos disease" but does not include "dysplastic gangliocytoma of cerebellum"; is this the same as "Lhermitte-Duclos dysplastic gangliocytoma of cerebellum (C716)"?

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).

The SEER Coding and Staging Manual instructs one to code the primary site to the location where the tumor originated, in this case the liver. However, there is no CS Extension code for in situ tumors found in the CS Manual Liver Schema.

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 SEER Manual states that Marriage is self-reported for the instruction in code 2, but it does not indicate if all other marital statuses are self-reported.

Examples: How is Marital Status reported for the following situations?

1. Patient with multiple tumors in the database, for the first tumor marital status is reported as married (code 2), for the subsequent tumor, marital status is reported as single (code 1).

2. Patient self- reports as single, but also has children.

3. Patient states they are in common law marriage, but our state is not a common law marriage state.

The SEER Manual states that the Other Therapy data item identifies treatments given that cannot be classified as surgery, radiation, systemic therapy, or ancillary treatment; and the instructions for code 2, Other-Experimental, say to assign this for any experimental or newly developed treatment, such as a clinical trial, that differs greatly from proven types of cancer therapy.  Does this mean that only unclassifiable treatments should be coded in Other Therapy, even if given as part of a clinical trial? 

For example, if a patient is given a drug as part of a trial that is categorized in SEER*Rx as immunotherapy, should it be assigned both Immunotherapy (NAACCR #1410) code 1 and Other Therapy code 2, or only coded in Immunotherapy since it is classified as such?  How should a clinical trial drug be coded if it has a treatment classification in SEER*Rx, but the type of cancer being treated is not listed under the Primary Site or Remarks sections as being FDA approved?  A real case scenario is atezolizumab given for colon cancer as part of a trial; this drug's category is Immunotherapy in SEER*Rx but colon is not listed under Primary Sites or in the Remarks detailing FDA approvals.

The SEER Manual states to assign Tumor Size--Pathological code 000 when EOD Primary Tumor is coded to 800 (No evidence of primary tumor) for any schema. However, the definition of Tumor Size--Pathologic states that it records the size of a solid primary tumor that has been resected.

If the primary site has not been resected (does not meet the pathologic staging criteria), then it seems that Tumor Size Pathologic should be 999 when EOD Primary Tumor is coded as 800.