Comparing RECIST 1.1 and iRECIST in advanced melanoma patients treated with pembrolizumab in a phase II clinical trial View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2020-09-30

AUTHORS

Firas S. Ahmed, Laurent Dercle, Gregory V. Goldmacher, Hao Yang, Dana Connors, Ying Tang, Sanja Karovic, Binsheng Zhao, Richard D. Carvajal, Caroline Robert, Michael L. Maitland, Geoffrey R. Oxnard, Lawrence H. Schwartz

ABSTRACT

ObjectivesTo 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).MethodsA 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.ResultsOf 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 post-progression, 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).ConclusionsEffectiveness 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. More... »

PAGES

1853-1862

References to SciGraph publications

  • 2017-11-13. The diverse functions of the PD1 inhibitory pathway in NATURE REVIEWS IMMUNOLOGY
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    http://scigraph.springernature.com/pub.10.1007/s00330-020-07249-y

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    http://dx.doi.org/10.1007/s00330-020-07249-y

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    https://app.dimensions.ai/details/publication/pub.1131290249

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/32995974


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