Response Criteria for Intratumoral Immunotherapy in Solid Tumors: itRECIST
A partir de l'analyse des critères d'imagerie RECIST 1.1 et iRECIST destinés à l'évaluation des immunothérapies par voie systémique, cet article identifie les modifications à apporter à ces critères pour standardiser l'évaluation de l'efficacité des immunothérapies intratumorales chez les patients atteints d'une tumeur solide
Intratumoral (IT) immunotherapy is approved for stage IIIB to IV melanoma1-5 and under evaluation in other malignancies with novel immune-stimulatory products.6-18 Standardized efficacy evaluation is essential for drug development. Current oncology response criteria, such as Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and guidelines for immunotherapeutic trials (iRECIST), were designed only to assess response to systemic therapy.19-25
RECIST is an evolving standardized framework for evaluating changes in tumor size, that is used in clinical trials to define treatment responses and disease progression.19 RECIST 1.1 and iRECIST are unsuitable for IT immunotherapy trials for several reasons. Because they were designed for systemic therapy, focal intervention renders treated lesions nonevaluable. RECIST 1.1 does not allow separate response assessment in injected and noninjected lesions, which is critical for IT immunotherapy trials. Moreover, there is no consensus on injected lesion assessment when lesions chosen for injection may change during treatment because of regression, loss of accessibility, or growth of other lesions. iRECIST has limited usefulness because the purpose of assessment after initial progression is solely to exclude pseudoprogression; it does not consider that the lesions selected for injection may change at progression.
Nevertheless, the experience of developing iRECIST by revising RECIST 1.1 for immunotherapy25 provides valuable guidance. Before the consensus effort of the RECIST Working Group, stakeholders devised divergent approaches to RECIST modification for immunotherapy, resulting in confusion and incomparability among trials.25 Without standardization, these issues may recur for IT therapy.
The goal of IT RECIST (itRECIST) is to create guidelines for capturing data and assessing response in IT immunotherapy trials. As with iRECIST, the standardized data collection and initial suggestions for response assessment of itRECIST will be refined based on collected data. We anticipate itRECIST will initially be used for exploratory analyses, with primary and secondary end points based on RECIST 1.1, until evidence indicates that itRECIST improves efficacy assessment.
Journal of Clinical Oncology , article en libre accès, 2019