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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.

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.

(http://cinj.org/rutgers-cancer-institute-new-jersey-and-robert-wood-johnson-university-hospital-are-first-state ).

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.

The SEER*Rx Database lists Sirolimus as an ancillary agent under the Category section, but as an mTOR inhibitor under the Subcategory. The Remarks section indicates Sirolimus (AKA Rapamycin) is an immunosuppressant, but is also a type of serine/threonine kinase inhibitor. Other types of kinase inhibitors (including Temsirolimus) are types of Chemotherapy. Although the Coding section states this drug should not be coded, Primary Sites (NSCLC and glioblastoma) are listed for this drug.

The SEER*Rx Database page for this drug is confusing. Please address the following.

1) Should Sirolimus not be coded when it is being given as a kinase inhibitor or an immunosuppressant?

2) If Sirolimus is ever treatment, should it be coded only for the primary sites listed?

3) If Sirolimus is given as part of a non-blind clinical trial for another site other than NSCLC or glioblastoma, should the Other Therapy field be coded to 2 [experimental - other treatment]?

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.  

Is the instruction under #4.b. on page 114 of the 2014 SEER Program Coding and Staging Manual incorrect? It says to code Rituxan as chemotherapy.