Report | Question ID | Question | Discussion | Answer | Year |
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20240044 | First Course Treatment/Neoadjuvant Therapy--Esophagus: Should the Neoadjuvant Therapy data item be coded as 1 or 2 when the patient completes all but one cycle of the planned neoadjuvant therapy and the managing physician notes the patient completed the neoadjuvant therapy? See Discussion. |
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? |
Assign code 2, Neoadjuvant therapy started, but not completed OR unknown if completed, for the 2024 SEER Manual data item Neoadjuvant Therapy. Assign code 2 when neoadjuvant therapy was begun and the patient did not complete the full course of neoadjuvant therapy. See Coding Instruction #3 on page 230. The fact that the patient completed five cycles of the planned chemotherapy, but the sixth cycle was held due to neutropenia is important information and should be abstracted correctly and documented via text data items. |
2024 |
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20240049 | First Course Treatment/Neoadjuvant Therapy--Breast: When are pre-operative therapies given as part of a clinical trial coded as neoadjuvant treatment versus limited systemic exposure in the Neoadjuvant Therapy data item? See Discussion. |
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)? |
When pre-operative therapies are given as part of a clinical trial, code as neoadjuvant treatment in the Neoadjuvant Therapy data item when the intent is neoadjuvant and/or when surgical resection follows the clinical trial therapies. In the example, neoadjuvant chemotherapy was recommended in the treatment planning and the patient had the planned resection after neoadjuvant treatment. The treatment effect outcome is based on imaging that reported no mass and as documented by the physician, pathologist in this case as complete response to the neoadjuvant therapy based on the resection. Use code 3 (limited systemic exposure) when treatment does not meet the definition of neoadjuvant therapy in the data item, Neoadjuvant Therapy. Limited exposure occurs when the patient receives some therapy prior to surgical resection, but the treatment is not enough to qualify for a full course of neoadjuvant therapy with the intent to impact extent of surgical resection or other outcomes. While this type of treatment may given as part of a clinical trial, it mostly refers to short term treatments such as hormone therapy. When neoadjuvant therapy is given prior to surgical resection that is planned (intended) or performed to improve outcomes, use Code 1 or 2. Because a clinical trial is a type of research study that tests new methods of screening, prevention, diagnosis, or treatment of a disease, the treatment regimens likely will not be incorporated in recommended guidelines until all phases of the trial are completed and approved by the U.S. Food and Drug Administration. ClinicalTrials.gov is available to learn more about clinical studies around the world. |
2024 |
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20230044 | First Course Treatment/Neoadjuvant Therapy--Breast: What pathology report descriptions are permissible to use in coding the Neoadjuvant Therapy Treatment Effect data item? See Discussion. |
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? |
1) Do not infer the percent of viable tumor if only percent of necrosis is provided. For the example, assign code 6 when Neoadjuvant therapy was completed and the treatment effect in the breast is stated only as “Present". 2) Do not use the residual cancer burden (RCB) score from the pathology report to code the Neoadjuvant Therapy--Treatment Effect field for breast cancer. We do not have a crosswalk from RCB to neoadjuvant Therapy--Treatment Effect. RCB index is an accurate and reliable tool to assess patient prognosis. RCB is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. The data item Neoadjuvant Therapy--Treatment Effect records information on the primary tumor only. Document information in a text field in both examples. |
2023 |
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20220048 | First Course Treatment/Immunotherapy--Other Therapy: Should all therapies given as part of a clinical trial be coded as Other Therapy (NAACCR #1420), or only those that cannot be classified in one of the other treatment categories (systemic therapy, surgery, radiation) or as ancillary treatments? Does it matter what is listed in SEER*Rx under Primary Sites or Remarks regarding FDA approvals? See Discussion. |
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. |
When a drug is being administered as part of a clinical trial and it is not yet approved as treatment for the cancer site for which it is being administered, code in Other Therapy. Do not code it as Immunotherapy (for the example provided). While a drug may be approved to treat one type of malignancy, it may be in clinical trials to determine its value in treating other malignancies. Coding as immunotherapy is misinformation in this case since there are other types of approved immunotheraputic agents. |
2022 |
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20220046 | First Course Treatment/Immunotherapy--Other Therapy: Should IMC-A12 (Cixutumumab) be coded as Immunotherapy/Biological Response Modifier (BRM) treatment? See Discussion. |
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. |
Code Cixutumumab as Other Therapy. Cixutumumab is still in clinical trials and not approved by FDA yet. Though it is classified as an immunotherapy agent, it is not approved. |
2022 |
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20230069 | First Course Treatment/Immunotherapy--Colon: Is infliximab cancer directed treatment? See Discussion. |
While SEER*Rx does indicate infliximab should be coded as biological response modifier (BRM)/Immunotherapy, the manufacturer website for this medication indicates it is given for: Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. In addition, SEER*Rx does not indicate which primary sites this treatment may be given for. If it is indeed cancer directed treatment, can the typical primary sites be added for clarity? Case example: Patient is diagnosed with colorectal cancer and also has an existing diagnosis of Crohn’s disease; received surgery and FOLFOX6, as well as infliximab. There was no statement of what disease the infliximab was given to treat. |
infliximab is not cancer-directed treatment. This drug was last updated by the FDA 2/22/2023 with additional information on its approval to treat non-malignant neoplasms. To date, the FDA has not approved it for use in colon cancer. This drug was intially developed to treat colon cancer; however, found to be ineffective treating cancer. |
2023 |
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20230040 | First Course Treatment/Hormone Therapy--Prostate: Is Lupron first course therapy in a patient who initially elected active surveillance for prostate cancer and then consented to treatment with Lupron? See Discussion. |
in March, the patient with stage cT1c, Gleason grade 7, prostate cancer elected active surveillance. In April, the patient consented to treatment with Lupron. There was no evidence of disease progression. According to the rules on page 161 of the 2023 SEER manual, we think the answer is yes, but the reporting hospital states that this is second course therapy. |
Code Lupron as second course therapy and code active surveillance as first course therapy in this scenario. The 2023 SEER Manual states to code all treatment data items to 0 or 00 (Not done) when the physician opts for active surveillance, deferred therapy, expectant management, or watchful waiting. Assign code 2 to Treatment Status. Active surveillance is not the same as "refusing treatment." Active surveillance is a valid option offered to the patient. The patient chose this option and later changed their mind. This is not a refusal of recommended treatment. Document all the details in the appropriate treatment text fields. |
2023 |
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20190107 | First Course Treatment/Chemotherapy--Colon: Is maintenance therapy coded as part of the first course of treatment or as part of subsequent course of treatment? |
Patient was diagnosed with Stage IV colon cancer (liver metstasiss) and started on Folfox with Avastin. The medical oncologist decided to continue maintenance treatment with Xeloda and Avastin. Per Colon NCCN Guidelines Version 3.2019, interest in the use of maintenance therapy approach after first-line treatment of unresectable, metastatic colorectal cancer is growing. In general, this approach involves intensive first-line therapy, followed by less intensive therapy until progression in patients with good response to initial treatment. Colon Therapy 5/1/18 Colonoscopy biopsy: mod diff colon adenoca, MMR proficient, BRAF wild type 5/5/18 Liver biopsy: mets from colon cancer 6/18/18 " 11/20/2018 Med Onc: started 12 cycles Chemo - Folfox (Fluorouracil, leucovorin, Oxaliplatin) with Avastin 11/28/18 CT Pelvis: continued improvement in the liver mets; no residual tumor involving colon; no new mas or adenopathy in the chest, abdomen or pelvis 12/02/18 Med Onc follow up: Pt had tremendous response to chemotherapy and Avastin, cancer is not curable. Is amenable to maintenance therapy with Xeloda and Avastin; also amenable to descending colectomy in the future 1/7/19 Med Onc: starting maintenance treatment Xeloda + Avastin. |
Code the maintenance therapy as first course when the maintenance therapy includes at least one of the drugs from the original treatment. Use text fields to record the details. |
2019 |
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20220004 | First Course Treatment/Cancer-directed Treatment: What information can registrars use to determine disease progression and whether treatment counts as first course treatment? See Discussion. |
Is a physician’s statement of progressive disease adequate to determine disease progression in coding first vs. second course treatment? Can an increase in tumor burden (i.e., a change in overall stage) be used by the registrar to determine disease progression? Often, determining disease progression is difficult as there are no guidelines in the SEER Manual related to this topic. It seems a physician’s statement of progressive disease should always be accepted. However, that statement is not always available. While it seems an increase in tumor size alone would not be “progressive disease” as tumors will continue to grow, can registrars use an increase in tumor burden to make this determination? The instructions for coding first vs. second course treatment are clear when a treatment plan is changed, but determining whether there has been disease progression, recurrence, or treatment failure can be difficult without a physician’s assessment. For example, a patient was diagnosed with a newly diagnosed resectable pancreatic cancer; the documented treatment plan was for upfront chemotherapy, followed by repeat staging, followed by pancreatectomy. The patient completed 3 cycles of FOLFIRINOX, but the physician noted that the CT scan shows progressive disease, and the plan was to start a new treatment regimen with Abraxane, Gemzar, and stereotactic body radiation (SBRT) (Cyberknife). The patient completed the additional chemotherapy, radiation, and proceeded to the initially planned surgery. The pathologist staged this as yp disease, but the surgery appears to be second course treatment, and we would not code the surgery, or collect the staging (yp staging) since the physician stated this was progressive disease. The classification as yp staging can be misleading, since the resection is technically after neoadjuvant treatment, but is not collected per our guidelines. In this case, is it correct to code first course treatment as FOLFIRINOX only? |
Determining first course treatment is based on knowing the treatment plan and its course as to whether it was completed as initially planned. Read the medical record, scans, labs, and physician notes. First course of therapy ends when the treatment plan is completed as planned. Alternatively, first course of therapy ends when there is documented disease progression, recurrence, or treatment failure. A change to a drug in a different group or a change to a different treatment modality indicates the end of the first course of treatment. While a physician/clinician statement of progression, additional imaging, or other procedures that assess treatment efficacy, or increase in tumor burden can be used to denote progression, recurrence, or failure, a change to the initial treatment plan is a signal to to the registrar to suspect the end of first course of therapy. Once the initial treatment plan is changed, everything after the change is subsequent treatment. In the scenario provided, code FOLFIRINOX as first course of treatment. Based on the information provided, the Abraxane, Gemzar, and SBRT are second course and everything that followed that is second or subsequent course. The physician noted progressive disease and a new treatment regimen was started -- this is a clear indication of the end of the first course of treatment. The planned treatment course was FOLFINOX and surgery. Once that initial treatment plan is changed, everything after the change is no longer first course of treatment. Use text fields to document the details. |
2022 |
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20180106 | First Course Treatment--Other Therapy: Please explain how to code this new therapy, peptide receptor radionuclide therapy (PRRT) for rare neuroendocrine tumors. See Discussion. |
According to this article, PRRT treatment lutetium Lu 177 dotatate was approved earlier this year by the United States Food and Drug Administration for adult use. PRRT is a nuclear medicine therapy that travels throughout the body looking for a certain receptor within neuroendocrine tumors. These include pancreatic and small neuroendocrine tumors in the gastrointestinal tract. Once absorbed into the tumor, the radioactive material starts to break down tumor cells, killing them. It is the first radioactive drug approved for the targeted treatment of gastroenteropancreatic neuroendocrine tumors. |
For cases diagnosed prior to 2023: Code Peptide Receptor Radionuclide Therapy (PRRT) in the data item Other Therapy, code 1, Other. See SINQ 20220042 and 20230005 for information pertaining to cases diagnosed in 2023 or later. |
2018 |