[New guidelines to evaluate the response to treatment in solid tumors]

Area of Science:

• Oncology
• Clinical Trial Design
• Biostatistics

Context:

• Established World Health Organization (WHO) criteria for evaluating anticancer agent efficacy have been in use since the late 1970s.
• Clinical cancer research organizations convened to revise these criteria based on accumulated experience and knowledge.
• A new model for deriving response rates from unidimensional measurements was developed, contrasting with the traditional bidimensional approach.

Purpose:

• To introduce updated guidelines for evaluating tumor response to anticancer agents, replacing the previous WHO criteria.
• To provide a philosophic background for response evaluation and clarify its diverse purposes.
• To propose a refined model for assessing overall treatment response using both target and nontarget lesions.

Summary:

• New guidelines integrate the Response Evaluation Criteria in Solid Tumors (Recist) model, which utilizes unidimensional measurements for response rate derivation.
• The updated criteria offer a more codified approach to assessing tumor lesions, including target and nontarget lesions.
• These guidelines represent a significant revision, incorporating advancements in clinical cancer research and evaluation methodologies.

Impact:

• The revised criteria aim to standardize and improve the accuracy of antitumor activity assessment in clinical trials.
• Implementation of Recist guidelines is expected to enhance the comparability and reliability of cancer drug efficacy data.
• This evolution in response evaluation supports more informed decision-making in cancer drug development and clinical practice.