Response evaluation criteria in solid tumors


Response evaluation criteria in solid tumors is a set of published rules that define when tumors in cancer patients improve, stay the same, or worsen during treatment. The criteria were published in February 2000 by an international collaboration including the European Organisation for Research and Treatment of Cancer, National Cancer Institute of the United States, and the National Cancer Institute of Canada Clinical Trials Group. Today, the majority of clinical trials evaluating cancer treatments for objective response in solid tumors use RECIST. These criteria were developed and published in February 2000, and subsequently updated in 2009.
The criteria are specifically not meant to determine whether patients have improved or not, as these are tumor-centric, not patient centric criteria. This distinction must be made by both the treating physicians and the cancer patients themselves. Many oncologists in their daily clinical practice follow their patients' malignant disease by means of repeated imaging studies and make decisions about continuing therapy on the basis of both objective and symptomatic criteria. It is not intended that these RECIST guidelines play a role in that decision making, except if determined appropriate by the treating oncologist.

Features

The RECIST specification establishes a minimum size for measurable lesions, limits the number of lesions to follow and standardizes unidimensional measures.

Eligibility

Measurable disease – the presence of at least one measurable lesion. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology.
Measurable lesions – lesions that can be accurately measured in at least one dimension with longest diameter ≥20 mm using conventional techniques or ≥10 mm by spiral CT scan.
Non-measurable lesions – all other lesions, including small lesions, i.e., bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, cystic lesions, and also abdominal masses that are not confirmed and followed by imaging techniques.
Evaluation of target lesions
Evaluation of non-target lesions
Evaluation of best overall response
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria
Duration of overall response
Response review
Reporting of results
The RECIST criteria present problems for immunotherapies so around 2009 the immune-related response criteria were developed and are used in some immunotherapy clinical trials.

History

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. These new criteria have been widely adopted and embraced by the regulatory authorities.