Comparing RECIST 1.1 and iRECIST in advanced melanoma patients treated with pembrolizumab in a phase II clinical trial
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ONCOLOGY
Comparing RECIST 1.1 and iRECIST in advanced melanoma patients treated with pembrolizumab in a phase II clinical trial Firas S. Ahmed 1 & Laurent Dercle 1 & Gregory V. Goldmacher 2 & Hao Yang 1 & Dana Connors 3 & Ying Tang 4 & Sanja Karovic 5 & Binsheng Zhao 1 & Richard D. Carvajal 1 & Caroline Robert 6 & Michael L. Maitland 5 & Geoffrey R. Oxnard 7 & Lawrence H. Schwartz 1 Received: 24 April 2020 / Revised: 17 July 2020 / Accepted: 31 August 2020 # European Society of Radiology 2020
Abstract Objectives To compare tumor best overall response (BOR) by RECIST 1.1 and iRECIST, to explore the incidence of pseudoprogression in melanoma treated with pembrolizumab, and to assess the impact of pseudoprogression on overall survival (OS). Methods A total of 221 patients with locally advanced/unresectable melanoma who received pembrolizumab as part of KEYNOTE-002 trial were included in this study. Radiological assessment of imaging was centrally reviewed to assess tumor response. Incidence of discordance in BOR between RECIST 1.1 and iRECIST as well as rate of pseudoprogression were measured. OS of patients with pseudoprogression was compared with that of those with uncontrolled disease. Results Of the 221 patients in this cohort, 136 patients developed PD as per RECIST v1.1 and 78 patients with PD continued treatment and imaging beyond initial RECIST 1.1-defined PD. Among the 78 patients who continued therapy and imaging postprogression, RECIST 1.1 and iRECIST were discordant in 10 patients (12.8%) and pseudoprogression was encountered in 14 patients (17.9%). OS of patients with pseudoprogression was longer than that of patients with uncontrolled disease/true progression (29.9 months versus 8.0 months, p value < 0.001). Conclusions Effectiveness of immunotherapy in clinical trials depends on the criterion used to assess tumor response (RECIST 1.1 vs iRECIST) with iRECIST being more appropriate to detect pseudoprogression and potentially prevent premature termination of effective therapy. Pseudoprogression was associated with improved OS in comparison with that of patients with uncontrolled disease. Key Points • Discordance between iRECIST and RECIST 1.1 was found in 12.8% of unresectable melanoma patients on pembrolizumab who continued therapy beyond initial RECIST 1.1-defined progression. • Pseudoprogression, captured with iRECIST, occurred in 17.9% and was significantly associated with improved overall survival in comparison with uncontrolled disease. Keywords RECIST . Melanoma . Immunotherapy
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00330-020-07249-y) contains supplementary material, which is available to authorized users. * Firas S. Ahmed [email protected] 1
2
Columbia University Irving Medical Center, 622 W 168th Street, PHB-1, New York, NY 10032, USA Merck & Co. Pharmaceutical, Warrington, PA, USA
3
Foundation for the National Institute of Health, Bethesda, MD, USA
4
CCS Associates, San Jose, CA, USA
5
Inova Schar Cancer Institute, Washington,
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