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      • Record: found
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      Enhancing Radioiodine Incorporation into Radioiodine-Refractory Thyroid Cancer with MAPK Inhibition (ERRITI): A Single-Center Prospective Two-Arm Study

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          Abstract

          Purpose:

          Restoration of iodine incorporation (redifferentiation) by MAPK inhibition was achieved in previously radioiodine-refractory, unresectable thyroid carcinoma (RR-TC). However, results were unsatisfactory in BRAF V600E-mutant (BRAF-MUT) RR-TC. Here we assess safety and efficacy of redifferentiation therapy through genotype-guided MAPK-modulation in patients with BRAF-MUT or wildtype (BRAF-WT) RR-TC.

          Patients and Methods:

          In this prospective single-center, two-arm phase II study, patients received trametinib (BRAF-WT) or trametinib + dabrafenib (BRAF-MUT) for 21 ± 3 days. Redifferentiation was assessed by 123I-scintigraphy. In case of restored radioiodine uptake, 124I-guided 131I therapy was performed. Primary endpoint was the redifferentiation rate. Secondary endpoints were treatment response (thyroglobulin, RECIST 1.1) and safety. Parameters predicting successful redifferentiation were assessed using a receiver operating characteristic analysis and Youden J statistic.

          Results:

          Redifferentiation was achieved in 7 of 20 (35%) patients, 2 of 6 (33%) in the BRAF-MUT and 5 of 14 (36%) in the BRAF-WT arm. Patients received a mean (range) activity of 300.0 (273.0–421.6) mCi for 131I therapy. Any thyroglobulin decline was seen in 57% (4/7) of the patients, RECIST 1.1 stable/partial response/progressive disease in 71% (5/7)/14% (1/7)/14% (1/7). Peak standardized uptake value (SUV peak) < 10 on 2[ 18F]fluoro-2-deoxy-D-glucose (FDG)-PET was associated with successful redifferentiation ( P = 0.01). Transient pyrexia (grade 3) and rash (grade 4) were noted in one patient each.

          Conclusions:

          Genotype-guided MAPK inhibition was safe and resulted in successful redifferentiation in about one third of patients in each arm. Subsequent 131I therapy led to a thyroglobulin (Tg) decline in more than half of the treated patients. Low tumor glycolytic rate as assessed by FDG-PET is predictive of redifferentiation success.

          See related commentary by Cabanillas et al., p. 4164

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          Most cited references57

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          Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

          Paul A Harris, Robert Taylor, Robert Thielke … (2009)
          Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.
          Article 0 comments Cited 11735 times – based on 0 reviews     Review now
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            New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).

            E A Eisenhauer, P Therasse, J Bogaerts … (2009)
            Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics: both tumour shrinkage (objective response) and disease progression are useful endpoints in clinical trials. Since RECIST was published in 2000, many investigators, cooperative groups, industry and government authorities have adopted these criteria in the assessment of treatment outcomes. However, a number of questions and issues have arisen which have led to the development of a revised RECIST guideline (version 1.1). Evidence for changes, summarised in separate papers in this special issue, has come from assessment of a large data warehouse (>6500 patients), simulation studies and literature reviews. HIGHLIGHTS OF REVISED RECIST 1.1: Major changes include: Number of lesions to be assessed: based on evidence from numerous trial databases merged into a data warehouse for analysis purposes, the number of lesions required to assess tumour burden for response determination has been reduced from a maximum of 10 to a maximum of five total (and from five to two per organ, maximum). Assessment of pathological lymph nodes is now incorporated: nodes with a short axis of 15 mm are considered measurable and assessable as target lesions. The short axis measurement should be included in the sum of lesions in calculation of tumour response. Nodes that shrink to <10mm short axis are considered normal. Confirmation of response is required for trials with response primary endpoint but is no longer required in randomised studies since the control arm serves as appropriate means of interpretation of data. Disease progression is clarified in several aspects: in addition to the previous definition of progression in target disease of 20% increase in sum, a 5mm absolute increase is now required as well to guard against over calling PD when the total sum is very small. Furthermore, there is guidance offered on what constitutes 'unequivocal progression' of non-measurable/non-target disease, a source of confusion in the original RECIST guideline. Finally, a section on detection of new lesions, including the interpretation of FDG-PET scan assessment is included. Imaging guidance: the revised RECIST includes a new imaging appendix with updated recommendations on the optimal anatomical assessment of lesions. A key question considered by the RECIST Working Group in developing RECIST 1.1 was whether it was appropriate to move from anatomic unidimensional assessment of tumour burden to either volumetric anatomical assessment or to functional assessment with PET or MRI. It was concluded that, at present, there is not sufficient standardisation or evidence to abandon anatomical assessment of tumour burden. The only exception to this is in the use of FDG-PET imaging as an adjunct to determination of progression. As is detailed in the final paper in this special issue, the use of these promising newer approaches requires appropriate clinical validation studies.
            Article 0 comments Cited 6194 times – based on 0 reviews     Review now
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              2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer.

              Bryan Haugen, Erik Alexander, Keith Bible … (2016)
              Thyroid nodules are a common clinical problem, and differentiated thyroid cancer is becoming increasingly prevalent. Since the American Thyroid Association's (ATA's) guidelines for the management of these disorders were revised in 2009, significant scientific advances have occurred in the field. The aim of these guidelines is to inform clinicians, patients, researchers, and health policy makers on published evidence relating to the diagnosis and management of thyroid nodules and differentiated thyroid cancer.
              Article 0 comments Cited 3044 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): Clin Cancer Res
                Journal ID (iso-abbrev): Clin Cancer Res
                Title: Clinical Cancer Research
                Publisher: American Association for Cancer Research
                ISSN (Print): 1078-0432
                ISSN (Electronic): 1557-3265
                Publication date (Print): 03 October 2022
                Publication date (Electronic): 20 May 2022
                Volume: 28
                Issue: 19
                Pages: 4194-4202
                Affiliations
                [1 ]Clinic for Nuclear Medicine, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
                [2 ]German Cancer Consortium (DKTK) partner site Essen, Essen, Germany.
                [3 ]Department of Nuclear Medicine, University Hospital Münster, Münster, Germany.
                [4 ]Department of Endocrinology and Metabolism, Division of Laboratory Research, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
                [5 ]Department of Nuclear Medicine, University Hospital Frankfurt, Frankfurt, Germany.
                [6 ]Clinic of Radiology and Nuclear Medicine, University Hospital Magdeburg, Magdeburg, Germany.
                [7 ]Department of General, Visceral and Transplantation Surgery, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
                [8 ]Institute of Pathology, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
                [9 ]Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, New York.
                [10 ]Department of Medical Imaging, Radboud University Medical Center, Nijmegen, Netherlands.
                Author notes
                [#]

                M. Weber, D. Kersting, J. Nagarajah, and W.P. Fendler contributed equally to this article.

                [* ] Corresponding Author: Manuel Weber, German Cancer Consortium (DKTK) partner site Essen, Hufelandstraße 55, 45147 Essen, Germany. Phone: 49-201-723-2032; Fax: 49-201-723-5658; E-mail: manuel.weber@ 123456uk-essen.de

                Clin Cancer Res 2022;28:4194–202

                Author information
                https://orcid.org/0000-0002-8649-5977
                https://orcid.org/0000-0002-8451-1830
                https://orcid.org/0000-0001-5905-6015
                https://orcid.org/0000-0002-5545-8487
                https://orcid.org/0000-0002-3555-0809
                Article
                Publisher ID: CCR-22-0437
                DOI: 10.1158/1078-0432.CCR-22-0437
                PMC ID: 9527501
                PubMed ID: 35594174
                SO-VID: 25ddfa95-8ff3-4479-b59d-fd745df3d92d
                Copyright © ©2022 The Authors; Published by the American Association for Cancer Research
                License:

                This open access article is distributed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) license.

                History
                Date received : 09 February 2022
                Date revision received : 04 April 2022
                Date accepted : 17 May 2022
                Related
                Page count
                Pages: 9
                Categories
                Subject: Clinical Trials: Targeted Therapy

                Data availability:

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