SEER Inquiry System - Search

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 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)?

1) In the SEER Manual's code definitions for Neoadjuvant Therapy - Treatment Effect, some sites specify the percentage of viable tumor. Pathology reports often list this along with the percentage of necrosis (e.g., 10% necrosis and 90% viable tumor). If only the percent necrosis is stated, is it acceptable to infer the percent viable tumor? For example, pathology report states only "treatment effect: present, necrosis extent: 30%" - could we then deduce that the percent viable tumor in this case would be 70%?

2) Can statements of Residual Cancer Burden (RCB) Class be used?  For example, pathology report states Treatment Effect: Residual Cancer Burden Class II, with no further description of partial vs. complete response. It appears that RCB Class II is a "moderate burden" of residual tumor after neoadjuvant therapy; could this be interpreted as a partial response in the Neoadjuvant Therapy--Treatment Effect code definitions?

According to the 2018 SEER Manual, Sentinel Lymph Nodes (SLNs) Examined and SLNs Positive are included in Regional Nodes (RNs) Examined and RNs Positive when both a sentinel node biopsy procedure and a subsequent dissection procedure are performed or a sentinel node biopsy procedure is performed during the same procedure as the regional node dissection.

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.

IMC-A12 (Cixutumumab) is listed as a BRM agent in SEER*Rx, but the Remarks section indicates it should be coded as Other Therapy until there is FDA approval. It is unclear if FDA approval was ever given for this agent. We are mainly seeing it given for prostate primaries.

In the Hematopoetic Manual, page 22, it is states: "The use of donor leukocyte infusions for treatment of hematopoietic neoplasms, specifically leukemias, is increasing.  Abstract as bone marrow transplant when a reportable hematopoietic neoplasm is treated with donor leukocyte infusion, even if it is not listed in the treatment section of the Heme db for the specific neoplasm."  Question 20110048 in the SEER Inquiry, it is stated "Donor lymphocyte infusion (DLI) is coded as immunotherapy."  Donor lymphocyte infusion and donor leukocyte infusions are the same procedure.  Please clarify discrepancy as coding is needed for a case treated with donor lymphocytic infusion.