Abstract
Abstract
Assessing the response to oncological treatments is paramount for determining the prognosis and defining the best treatment for each patient. Several biomarkers, including imaging, can be used, but standardization is fundamental for consistency and reliability. Tumor response evaluation criteria have been defined by international groups for application in pharmaceutical clinical trials evaluating new drugs or therapeutic strategies. RECIST 1.1 criteria are exclusively based on unidimensional lesion measurements; changes in tumor size are used as surrogate imaging biomarkers to correlate with patient outcomes. However, increased tumor size does not always reflect tumor progression. The introduction of immunotherapy has led to the development of new criteria (iRECIST, Level of Evidence (LoE) Ib) that consider the possibility that an increase in disease burden is secondary to the immune response instead of progression, with the new concept of Unconfirmed Progressive Disease (a first progression event which must be confirmed on follow-up). Specific criteria were devised for HCC (mRECIST, LoE IV), which measure only enhancing HCC portions to account for changes after local therapy. For GIST treated with imatinib, criteria were developed to account for the possible increase in size reflecting a response rather than a progression by assessing both tumor size and density on CT (Choi, LoE II). This article provides concise and relevant practice recommendations aimed at general radiologists to help choose and apply the most appropriate criteria for assessing response to treatment in different oncologic scenarios. Though these criteria were developed for clinical trials, they may be applied in clinical practice as a guide for day-to-day interpretation.
Key Points
Response evaluation criteria, designed for use in clinical trials, might serve as a surrogate biomarker for overall survival.
RECIST 1.1 defines measurable and non-measurable disease among which target lesions and non-target lesions are selected at baseline as reference for follow-ups.
Some therapies and/or cancers require the use of different criteria, such as iRECIST, mRECIST, and Choi criteria.
Publisher
Springer Science and Business Media LLC
Reference20 articles.
1. Pazdur R (2008) Endpoints for assessing drug activity in clinical trials. Oncologist 13:19–21
2. Wilson MK, Karakasis K, Oza AM (2015) Outcomes and endpoints in trials of cancer treatment: the past, present, and future. Lancet Oncol 16:e32–e42
3. Ruchalski K, Braschi-Amirfarzan M, Douek M et al (2021) A primer on RECIST 1.1 for oncologic imaging in clinical drug trials. Radiol Imaging Cancer 3:e210008
4. World Health Organization. WHO offset publication no. 48. https://iris.who.int/bitstream/handle/10665/37200/WHO_OFFSET_48.pdf?se. Accessed 3 Apr 2024
5. Tirkes T, Hollar MA, Tann M, Kohli MD, Akisik F, Sandrasegaran K (2013) Response criteria in oncologic imaging: review of traditional and new criteria. Radiographics 33:1323–1341