Zamboni Giulia A, Cappello Giovanni, Caruso Damiano, Gourtsoyianni Sofia, Cyran Clemens, Schlemmer Heinz-Peter, D'Anastasi Melvin, Fournier Laure, Neri Emanuele
Department of Diagnostics and Public Health, Institute of Radiology, University of Verona, Policlinico GB Rossi, P.Le LA Scuro 10, 37134, Verona, Italy.
Radiology Unit, Candiolo Cancer Institute, FPO-IRCCS, Str. Prov.le 142 km 3.95, 10060, Candiolo (Turin), Italy.
Eur Radiol. 2025 Feb;35(2):674-683. doi: 10.1007/s00330-024-11006-w. Epub 2024 Aug 13.
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.
评估肿瘤治疗反应对于确定预后和为每位患者确定最佳治疗方案至关重要。可以使用多种生物标志物，包括影像学检查，但标准化对于一致性和可靠性至关重要。国际组织已经定义了肿瘤反应评估标准，用于评估新药或治疗策略的药物临床试验。RECIST 1.1标准完全基于一维病变测量；肿瘤大小的变化被用作替代影像学生物标志物，以与患者预后相关联。然而，肿瘤大小增加并不总是反映肿瘤进展。免疫疗法的引入导致了新标准（iRECIST，证据级别（LoE）Ib）的制定，该标准考虑到疾病负担增加可能是免疫反应而非进展的结果，引入了未确认进展性疾病的新概念（首次进展事件必须在随访中得到确认）。针对肝癌制定了特定标准（mRECIST，LoE IV），该标准仅测量肝癌强化部分，以考虑局部治疗后的变化。对于接受伊马替尼治疗的胃肠道间质瘤，制定了标准，通过在CT上评估肿瘤大小和密度来考虑大小增加可能反映的是反应而非进展（Choi标准，LoE II）。本文为普通放射科医生提供了简明且相关的实践建议，以帮助在不同肿瘤情况下选择和应用最合适的治疗反应评估标准。尽管这些标准是为临床试验制定的，但它们可在临床实践中作为日常解读的指南。要点：为临床试验设计的反应评估标准可作为总生存的替代生物标志物。RECIST 1.1定义了可测量和不可测量疾病，其中在基线时选择靶病变和非靶病变作为随访参考。一些治疗方法和/或癌症需要使用不同的标准，如iRECIST、mRECIST和Choi标准。
