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      Comparison of the Diagnostic Performance of Response Evaluation Criteria in Solid Tumor 1.0 with Response Evaluation Criteria in Solid Tumor 1.1 on MRI in Advanced Breast Cancer Response Evaluation to Neoadjuvant Chemotherapy

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          Abstract

          Objective

          To compare the diagnostic performance in evaluating the response of neoadjuvant chemotherapy (NAC), between the response evaluation criteria in solid tumor (RECIST) 1.0 and RECIST 1.1, on magnetic resonance imaging (MRI) for advance breast cancer patients.

          Materials and Methods

          Breast cancer patients, who underwent NAC between 2005 and 2010, were included. Both prechemotherapy and post-chemotherapy MRIs were performed within 1-4 weeks before and after NAC. Only the patients with subsequent surgery were included. The response to NAC was assessed by using RECIST 1.0 and RECIST 1.1. Patients with a complete or partial response on MRI were considered as responders, and those with stable or progressive disease were considered as non-responders. Tumor necrosis > 50% on pathology was defined as responders and necrosis < 50% was defined as non-responders. The diagnostic accuracy of both RECIST 1.0 and RECIST 1.1 was analyzed and compared by receiver operating characteristic curve analysis.

          Results

          Seventy-nine females (mean age 51.0 ± 9.3 years) were included. Pathology showed 45 responders and 34 non-responders. There were 49 responders and 30 non-responders on RECIST 1.0, and in 55 patients, RECIST 1.0 results agreed with pathologic results (69.6%). RECIST 1.1 showed 52 responders and 27 non-responders. In 60 patients, RECIST 1.1 results were in accordance with pathology results (75.9%). The area under the ROC curve was 0.809 for RECIST 1.0 and 0.853 for RECIST 1.1.

          Conclusion

          RECIST 1.1 showed better diagnostic performance than RECIST 1.0, although there was no statistically significant difference between the two.

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          Most cited references20

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          From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors.

          The purpose of this article is to review the status and limitations of anatomic tumor response metrics including the World Health Organization (WHO) criteria, the Response Evaluation Criteria in Solid Tumors (RECIST), and RECIST 1.1. This article also reviews qualitative and quantitative approaches to metabolic tumor response assessment with (18)F-FDG PET and proposes a draft framework for PET Response Criteria in Solid Tumors (PERCIST), version 1.0. PubMed searches, including searches for the terms RECIST, positron, WHO, FDG, cancer (including specific types), treatment response, region of interest, and derivative references, were performed. Abstracts and articles judged most relevant to the goals of this report were reviewed with emphasis on limitations and strengths of the anatomic and PET approaches to treatment response assessment. On the basis of these data and the authors' experience, draft criteria were formulated for PET tumor response to treatment. Approximately 3,000 potentially relevant references were screened. Anatomic imaging alone using standard WHO, RECIST, and RECIST 1.1 criteria is widely applied but still has limitations in response assessments. For example, despite effective treatment, changes in tumor size can be minimal in tumors such as lymphomas, sarcoma, hepatomas, mesothelioma, and gastrointestinal stromal tumor. CT tumor density, contrast enhancement, or MRI characteristics appear more informative than size but are not yet routinely applied. RECIST criteria may show progression of tumor more slowly than WHO criteria. RECIST 1.1 criteria (assessing a maximum of 5 tumor foci, vs. 10 in RECIST) result in a higher complete response rate than the original RECIST criteria, at least in lymph nodes. Variability appears greater in assessing progression than in assessing response. Qualitative and quantitative approaches to (18)F-FDG PET response assessment have been applied and require a consistent PET methodology to allow quantitative assessments. Statistically significant changes in tumor standardized uptake value (SUV) occur in careful test-retest studies of high-SUV tumors, with a change of 20% in SUV of a region 1 cm or larger in diameter; however, medically relevant beneficial changes are often associated with a 30% or greater decline. The more extensive the therapy, the greater the decline in SUV with most effective treatments. Important components of the proposed PERCIST criteria include assessing normal reference tissue values in a 3-cm-diameter region of interest in the liver, using a consistent PET protocol, using a fixed small region of interest about 1 cm(3) in volume (1.2-cm diameter) in the most active region of metabolically active tumors to minimize statistical variability, assessing tumor size, treating SUV lean measurements in the 1 (up to 5 optional) most metabolically active tumor focus as a continuous variable, requiring a 30% decline in SUV for "response," and deferring to RECIST 1.1 in cases that do not have (18)F-FDG avidity or are technically unsuitable. Criteria to define progression of tumor-absent new lesions are uncertain but are proposed. Anatomic imaging alone using standard WHO, RECIST, and RECIST 1.1 criteria have limitations, particularly in assessing the activity of newer cancer therapies that stabilize disease, whereas (18)F-FDG PET appears particularly valuable in such cases. The proposed PERCIST 1.0 criteria should serve as a starting point for use in clinical trials and in structured quantitative clinical reporting. Undoubtedly, subsequent revisions and enhancements will be required as validation studies are undertaken in varying diseases and treatments.
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            Reporting results of cancer treatment.

            On the initiative of the World Health Organization, two meetings on the Standardization of Reporting Results of Cancer Treatment have been held with representatives and members of several organizations. Recommendations have been developed for standardized approaches to the recording of baseline data relating to the patient, the tumor, laboratory and radiologic data, the reporting of treatment, grading of acute and subacute toxicity, reporting of response, recurrence and disease-free interval, and reporting results of therapy. These recommendations, already endorsed by a number of organizations, are proposed for international acceptance and use to make it possible for investigators to compare validly their results with those of others.
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              Pathologic response to induction chemotherapy in locally advanced carcinoma of the breast: a determinant of outcome.

              The prognosis for patients with locally advanced carcinoma of the breast remains poor. This study examines the pathologic evidence of response of the mammary tumor and axillary nodes after preoperative chemotherapy. We sought to determine if there was a relationship between the histologic response and clinical outcome. Between 1987 and 1992, 36 patients with locally advanced carcinoma of the breast received three cycles of chemotherapy after incisional biopsy. Modified radical mastectomy was then performed. The breast and axillary nodes were examined pathologically for therapeutic effect and a grading scale was assigned. Postoperatively, patients received completion chemotherapy with the same agents used preoperatively followed by radiation therapy to the chest wall. Fourteen tumors (39 percent) showed near total therapeutic effect, five (14 percent) showed greater than 50 percent but less than total effect, 12 (33 percent) showed less than 50 percent effect, and five (14 percent) showed no effect. Nodal positivity was seen in 61 percent of the patients. Overall clinical response to induction chemotherapy was seen in 86 percent of the patients. There was poor correlation between clinical and pathologic response. Only 50 percent of the patients with complete clinical response were pathologically free of disease. Patients with excellent pathologic therapeutic response had a 79 percent overall five-year survival rate compared with 34 percent for tumors with a lesser response. This was irrespective of nodal status. While pathologic response was critical in determining outcome, clinical response was not. These results indicate that patients whose tumors have the best pathologic response to induction chemotherapy experience the best outcome.
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                Author and article information

                Journal
                Korean J Radiol
                Korean J Radiol
                KJR
                Korean Journal of Radiology
                The Korean Society of Radiology
                1229-6929
                2005-8330
                Jan-Feb 2013
                28 December 2012
                : 14
                : 1
                : 13-20
                Affiliations
                [1 ]Department of Radiology, Hallym University College of Medicine, Seoul 150-950, Korea.
                [2 ]Department of Radiology, The Catholic University of Korea College of Medicine, Seoul 137-701, Korea.
                Author notes
                Corresponding author: Sung Hun Kim, MD, Department of Radiology, Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine, 222 Banpo-daero, Seocho-gu, Seoul 137-701, Korea. Tel: (822) 2258-1455, Fax: (822) 599-6771, rad-ksh@ 123456catholic.ac.kr
                Article
                10.3348/kjr.2013.14.1.13
                3542297
                23323026
                d40559c8-3bb6-499a-8158-bcee44add0be
                Copyright © 2013 The Korean Society of Radiology

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 29 February 2012
                : 21 August 2012
                Categories
                Breast
                Original Article

                Radiology & Imaging
                breast neoplasm,chemotherapy,magnetic resonance imaging,response evaluation criteria in solid tumor

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