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SEER Inquiry System - Report
Produced: 11/26/2025 12:24 AM
Question 20220048
Inquiry Details
References:
#1: 2022 SEER Manual, 222-224; 242-244. Immunotherapy; Other Therapy
#2: SEER*Rx
Question:
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.
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.
Answer:
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.
