Response Evaluation Criteria in Solid Tumors

Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment. The criteria were published in February 2000 by an international collaboration including the European Organisation for Research and Treatment of Cancer (EORTC), 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. They 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 patient's 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.

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 (longest diameter <20 mm with conventional techniques or <10 mm with spiral CT scan), 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.

Methods of Measurement

Baseline documentation of “Target” and “Non-Target” lesions

Response Criteria

'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 (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria

Confirmation

Duration of overall response

Duration of stable disease

Response review

Reporting of results

See also

Citation

New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).Guidelines (version 1.1)