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The World Health Organization published the first tumour response criteria in 1981. However the specification documents were unclear which led to criteria adjustments and inconsistent conclusions. In the mid-1990s, an International Working Party was created to simplify and standardize response criteria; it then published RECIST in 2000.
The immune-related response criteria (irRC) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug.
PET response criteria in solid tumors (PERCIST) is a set of rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, using positron emission tomography (PET). The criteria were published in May 2009 in the Journal of Nuclear Medicine (JNM). [1]
The response rate is the percentage of patients on whom a therapy has some defined effect; for example, the cancer shrinks or disappears after treatment. [9] When used as a clinical endpoint for trials of cancer treatments, this is often called the objective response rate (ORR).
In 1965, the English statistician Sir Austin Bradford Hill proposed a set of nine criteria to provide epidemiologic evidence of a causal relationship between a presumed cause and an observed effect. (For example, he demonstrated the connection between cigarette smoking and lung cancer.) The list of the criteria is as follows: [1]
However, strictly speaking, immunogenicity refers to the ability of an antigen to induce an adaptive immune response. Thus an antigen might bind specifically to a T or B cell receptor, but not induce an adaptive immune response. If the antigen does induce a response, it is an 'immunogenic antigen', which is referred to as an immunogen.
In cancer research and medicine, biomarkers are used in three primary ways: [19] To help diagnose conditions, as in the case of identifying early stage cancers (diagnostic) To forecast how aggressive a condition is, as in the case of determining a patient's ability to fare in the absence of treatment (prognostic)
For its predecessor I-SPY 1, 10 cancer centers and the National Cancer Institute (NCI SPORE program and the NCI Cooperative groups) collaborated to identify response indicators that would best predict survival for women with high-risk breast cancer. During 2002–2006, the study monitored 237 patients undergoing neoadjuvant therapy before surgery.