Trial reportEuropean radiology2021
Comparing RECIST 1.1 and iRECIST in advanced melanoma patients treated with pembrolizumab in a phase II clinical trial.
Trial report in European radiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.
- Optimizing the clinical assessment of pseudoprogression in patients with solid tumors treated with checkpoint inhibitors: a systematic literature review and meta-analysis of associated features.Cancer immunology, immunotherapy : CII · 2026Pooled it
- Review
- Ketogenic Diet as an Adjuvant in Epithelial Cancers: Mechanisms, Model Systems, and Translational Opportunities.Cancers · 2026Review
- Medical imaging in immunotherapy response evaluation: from RECIST to AI-driven longitudinal models, and the distinction between risk prediction and kinetic diagnosis.Frontiers in medicine · 2026Review
- Immune Checkpoint Inhibitors Beyond Progression in Various Solid Tumors: A Systematic Review and Pooled Analysis.Journal of clinical medicine · 2025Review
- Metastatic renal cell carcinoma disease response in the era of immune checkpoint inhibitor-based combinations.Translational andrology and urology · 2025Article
- Real-world response assessment of immune checkpoint inhibition: comparing iRECIST and RECIST 1.1 in melanoma and non-small cell lung cancer patients.European radiology · 2025Article
- MR perfusion characteristics of pseudoprogression in brain tumors treated with immunotherapy - a comparative study with chemo-radiation induced pseudoprogression and radiation necrosis.Journal of neuro-oncology · 2025Article
- Case Report: Pseudoprogression of pancreatic acinar cell carcinoma after PD-1 blockade integrated treatment.Frontiers in immunology · 2025Article
- [Advancements in Radiomics for Immunotherapy of Non-small Cell Lung Cancer].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2024Review
- A comprehensive neuroimaging review of the primary and metastatic brain tumors treated with immunotherapy: current status, and the application of advanced imaging approaches and artificial intelligence.Frontiers in immunology · 2024Review
- Artificial Intelligence and Radiomics: Clinical Applications for Patients with Advanced Melanoma Treated with Immunotherapy.Diagnostics (Basel, Switzerland) · 2023Review
- Article
- Improved Survival Prediction by Combining Radiological Imaging and S-100B Levels Into a Multivariate Model in Metastatic Melanoma Patients Treated With Immune Checkpoint Inhibition.Frontiers in oncology · 2022Article
- Carboxypeptidase N1 is anticipated to be a synergy metrics for chemotherapy effectiveness and prognostic significance in invasive breast cancer.Cancer cell international · 2021Article
- Lung Nodules in Melanoma Patients: Morphologic Criteria to Differentiate Non-Metastatic and Metastatic Lesions.Diagnostics (Basel, Switzerland) · 2021Article
- Clinical application effect of Pembrolizumab in the treatment of advanced cutaneous malignant melanoma.American journal of translational research · 2021Article
Corrections and comments
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Authors and funding
13 authors at 6 institutions in 2 countries.
Funding
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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.