Lennartz Simon, Diederich Stefan, Doehn Christian, Gebauer Bernhard, Grünwald Viktor, Notohamiprodjo Mike, Sommer Wieland, Schlemmer Heinz-Peter, Persigehl Thorsten
University of Cologne, Faculty of Medicine and University-Hospital Cologne, Department of Diagnostic and Interventional Radiology.
Else-Kröner-Forschungskolleg Clonal Evolution in Cancer, University-Hospital Cologne, Cologne, Germany.
Rofo. 2020 Mar;192(3):235-245. doi: 10.1055/a-1015-6869. Epub 2020 Jan 28.
Immunotherapy represents an effective therapeutic approach for many malignant diseases that were previously difficult to treat. However, since immunotherapy can lead to atypical therapy response patterns in the form of pseudo-progression or mixed responses and comprise an altered spectrum of adverse reactions, they present a new challenge for oncologic imaging. Detailed knowledge in this area is essential for oncologic clinical radiologists, since the radiological report is a cornerstone of response assessment, and increasingly influences therapy regimens and coverage by health insurances.
This white paper is based on an expert meeting in Frankfurt am Main and subsequent discussions between the authors. Based on the iRECIST criteria, it is intended to provide orientation for a response assessment of oncologic patients undergoing immunotherapy that can be applied in the clinical routine.
Radiological therapy monitoring outside clinical studies is subject to inherent limitations, but should be performed based on iRECIST criteria, according to the opinion of the expert panel. It should be taken into account that immunotherapies can in principle lead to pseudo-progression and autoimmunological side effects. Since radiological follow-up is currently the only method to accurately distinguish real progressive disease from pseudo-progression, clinically stable patients with disease progression under immunotherapy should undergo additional short-term follow-up imaging according to the suspected diagnosis. Biopsy should be used cautiously and predominately in curative settings.
For response assessment of immunotherapy in clinical studies, the new iRECIST criteria were published in 2017. Outside studies, the application of iRECIST criteria in the clinical routine is subject to several limitations. The recommendations implied in these criteria can, however, be used in conjunction with the current literature as a guideline in clinical practice and outside studies.
· Novel immunotherapies can cause atypical response patterns like pseudo-progression. · Compared to real progressive disease, pseudo-progression occurs rather rarely, yet can influence therapy. · Short-term follow-up according to iRECIST can help to distinguish pseudo-progression from real progression. · Hence, radiological follow-up outside clinical studies should be oriented towards iRECIST criteria.
· Lennartz S, Diederich S, Doehn C et al. Radiological Monitoring of Modern Immunotherapy: A Novel Challenge for Interdisciplinary Patient Care. Fortschr Röntgenstr 2020; 192: 235 - 244.
免疫疗法是治疗许多既往难以治疗的恶性疾病的有效方法。然而，由于免疫疗法可能导致以假性进展或混合反应形式出现的非典型治疗反应模式，并包括不良反应谱的改变，它们给肿瘤影像学带来了新的挑战。这一领域的详细知识对肿瘤临床放射科医生至关重要，因为放射学报告是疗效评估的基石，并越来越多地影响治疗方案和医疗保险覆盖范围。
本白皮书基于在美因河畔法兰克福举行的一次专家会议以及作者随后的讨论。基于iRECIST标准，旨在为接受免疫疗法的肿瘤患者的疗效评估提供可应用于临床常规的指导。
根据专家小组的意见，临床研究之外的放射治疗监测存在固有局限性，但应基于iRECIST标准进行。应考虑到免疫疗法原则上可导致假性进展和自身免疫性副作用。由于目前放射学随访是准确区分真正进展性疾病与假性进展的唯一方法，免疫疗法下疾病进展但临床稳定的患者应根据疑似诊断进行额外的短期随访成像。活检应谨慎使用，主要用于治愈性情况。
对于临床研究中免疫疗法的疗效评估，新的iRECIST标准于2017年发布。在研究之外，iRECIST标准在临床常规中的应用存在若干局限性。然而，这些标准中隐含的建议可与当前文献结合使用，作为临床实践和研究之外的指导原则。
·新型免疫疗法可导致假性进展等非典型反应模式。·与真正的进展性疾病相比，假性进展很少发生，但可影响治疗。·根据iRECIST进行短期随访有助于区分假性进展与真正进展。·因此，临床研究之外的放射学随访应遵循iRECIST标准。
·Lennartz S, Diederich S, Doehn C等。现代免疫疗法的放射学监测：跨学科患者护理的新挑战。Fortschr Röntgenstr 2020; 192: 235 - 244。
