SEER Inquiry System - Search

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)?

Table 1 of the 2018 Kidney Solid Tumor Rules (STR) lists succinate dehydrogenase-deficient renal cell carcinoma as histology code 8312, but in the ICD-O-3.2 Coding Table it is listed as histology code 8311.

No changes were made in the Kidney STR. As a result, the histology change described in the ICD-O-3.2 Coding Table conflicts with Table 1. Succinate dehydrogenase-deficient renal cell carcinoma (SDHD) is listed in Table 1 as a synonym for renal cell carcinoma, NOS (8312). However, the ICD-O-3.2 Coding Table lists this as a related term for histology code 8311/3. This related term was not discussed in the Implementation Guidelines, and no change was noted in the STR.

While it seems we should continue to follow the STR, without clarification as to why this histology change was not implemented in STR, achieving consistency will be problematic if registrars jump straight to the ICD-O-3.2 Coding Table to code histology for cases diagnosed 2021 and later. If this code cannot be used for cases diagnosed prior to 2021, should that clarification be included in the STR?

This question was prompted from preparing SEER*Educate coding exercises. We will use the answer as a reference in the rationales.

A patient with liver cancer becomes transplant eligible when the tumor is 2 cm in size. Frequently, liver tumors will be watched (no biopsy) for months until they meet the 2 cm size criteria. In the meantime, multiple scans will describe the tumor using variations of ambiguous terms that drift in and out of reportablility. One day the tumor is labeled "presumed hepatocellular carcinoma." Weeks later it is back to "worrisome for hepatoma." A single scan will use different terms in different sections of the report.

Example case: Abdominal CT reveals a 1 cm liver lesion. Per the discussion portion of the scan, the lesion is consistent with hepatocellular carcinoma. Per final diagnosis: 1 cm liver lesion, possibly hepatocellular carcinoma. Is this report diagnostic of cancer? Would the date of this report be the date of diagnosis? (Patient did receive a liver transplant for hepatocellular carcinoma months later.)

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.

Our pathologists have starting to use a new prostate cancer grading system that was adopted by WHO in 2016. The new grading scheme correlates with the prior Gleason grading scheme as follows:

Grade Group 1 = Gleason score 6 or less

Grade Group 2 = Gleason score 3+4=7

Grade Group 3 = Gleason score 4+3 = 7

Grade Group 4 = Gleason score 8

Grade Group 5 = Gleason score 9-10

Our pathologists are no longer dictating the Gleason Primary and Secondary Pattern values nor the Gleason's Score. Reverse correlation from the new grade groups to the required patterns and score are difficult with Grade Groups 2 and 3 needing to be distinguished from one another and Grade Group 5 including two unique scores.

The prostate-related fields include:

Collaborative Site Specific Factor 7: Gleason's Primary Pattern and Secondary Pattern Values on Needle Core Biopsy/TURP

Collaborative Site Specific Factor 8: Gleason's Score On Needle Core Biopsy/TURP

Collaborative Site Specific Factor 9: Gleason's Primary Pattern and Secondary Pattern Values on Prostatectomy/Autopsy

Collaborative Site Specific Factor 10: Gleason's Score on Prostatectomy/Autopsy

We included this histology in SEER Workshop Case 12 and the histology coding accuracy was less than 40%. From emails we received, it is clear that registrars are unaware that the "somatic type malignancy" can vary but code 9084 applies when the diagnosis is teratoma WITH any non-germ cell tumor component. It may be helpful to add a definition for "teratoma with somatic-type malignancy" (9084) to the Solid Tumor Manual.