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      Single response assessment of transplant-ineligible multiple myeloma: a supplementary analysis of JCOG1105 (JCOG1105S1)

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          Abstract

          Background

          The International Myeloma Working Group response criteria require two consecutive assessments of paraprotein levels. We conducted an exploratory analysis to evaluate whether a single response assessment could be a substitute for the International Myeloma Working Group criteria using data from JCOG1105, a randomized phase II study on melphalan, prednisolone and bortezomib.

          Methods

          Of 91 patients with transplant-ineligible newly diagnosed multiple myeloma, 79 patients were included. We calculated the kappa coefficient to evaluate the degree of agreement between the International Myeloma Working Group criteria and the single response assessment.

          Results

          Based on the International Myeloma Working Group criteria, 11 (13.9%), 20 (25.3%), 36 (45.6%) and 12 (15.2%) patients had stringent complete response/complete response, very good partial response, partial response and stable disease, respectively. Based on the single response assessment, 17 (21.5%), 19 (24.1%), 35 (44.3%) and 8 (10.1%) patients had stringent complete response/complete response, very good partial response, partial response and stable disease, respectively. The kappa coefficient was 0.76 (95% confidence interval, 0.65–0.88), demonstrating good agreement. The single response assessment was not inferior to the International Myeloma Working Group criteria in the median progression-free survival (3.8 and 2.9 years) in stringent complete response/complete response patients, suggesting that the single response assessment was not an overestimation.

          Conclusions

          The single response assessment could be a substitute for the current International Myeloma Working Group criteria for transplant-ineligible newly diagnosed multiple myeloma.

          Abstract

          The single response assessment could be a substitute for the current International Myeloma Working Group criteria with two consecutive assessments in patients with transplant-ineligible newly diagnosed multiple myeloma.

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          Most cited references12

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          Interrater reliability: the kappa statistic

          The kappa statistic is frequently used to test interrater reliability. The importance of rater reliability lies in the fact that it represents the extent to which the data collected in the study are correct representations of the variables measured. Measurement of the extent to which data collectors (raters) assign the same score to the same variable is called interrater reliability. While there have been a variety of methods to measure interrater reliability, traditionally it was measured as percent agreement, calculated as the number of agreement scores divided by the total number of scores. In 1960, Jacob Cohen critiqued use of percent agreement due to its inability to account for chance agreement. He introduced the Cohen’s kappa, developed to account for the possibility that raters actually guess on at least some variables due to uncertainty. Like most correlation statistics, the kappa can range from −1 to +1. While the kappa is one of the most commonly used statistics to test interrater reliability, it has limitations. Judgments about what level of kappa should be acceptable for health research are questioned. Cohen’s suggested interpretation may be too lenient for health related studies because it implies that a score as low as 0.41 might be acceptable. Kappa and percent agreement are compared, and levels for both kappa and percent agreement that should be demanded in healthcare studies are suggested.
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            International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma.

            Treatment of multiple myeloma has substantially changed over the past decade with the introduction of several classes of new effective drugs that have greatly improved the rates and depth of response. Response criteria in multiple myeloma were developed to use serum and urine assessment of monoclonal proteins and bone marrow assessment (which is relatively insensitive). Given the high rates of complete response seen in patients with multiple myeloma with new treatment approaches, new response categories need to be defined that can identify responses that are deeper than those conventionally defined as complete response. Recent attempts have focused on the identification of residual tumour cells in the bone marrow using flow cytometry or gene sequencing. Furthermore, sensitive imaging techniques can be used to detect the presence of residual disease outside of the bone marrow. Combining these new methods, the International Myeloma Working Group has defined new response categories of minimal residual disease negativity, with or without imaging-based absence of extramedullary disease, to allow uniform reporting within and outside clinical trials. In this Review, we clarify several aspects of disease response assessment, along with endpoints for clinical trials, and highlight future directions for disease response assessments.
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              Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma

              The combination of bortezomib, melphalan, and prednisone is a standard treatment for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation. Daratumumab has shown efficacy in combination with standard-of-care regimens in patients with relapsed or refractory multiple myeloma.
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                Author and article information

                Contributors
                Journal
                Jpn J Clin Oncol
                Jpn J Clin Oncol
                jjco
                Japanese Journal of Clinical Oncology
                Oxford University Press
                0368-2811
                1465-3621
                July 2021
                06 May 2021
                06 May 2021
                : 51
                : 7
                : 1059-1066
                Affiliations
                Department of Hematology and Infectious Disease , Gifu University Hospital, Gifu, Japan
                Department of Hematology Oncology , Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
                JCOG Data Center/Operations Office , National Cancer Center Hospital, Tokyo, Japan
                Department of Hematology and Oncology , Hiroshima University Research Institute for Radiation Biology and Medicine, Hiroshima, Japan
                Department of Hematology , Kyorin University School of Medicine, Tokyo, Japan
                Department of Clinical Oncology and Hematology , The Jikei University Daisan Hospital, Tokyo, Japan
                Department of Hematology/Oncology , Tokai University School of Medicine, Isehara, Japan
                Department of Hematology , Nagasaki University Hospital, Nagasaki, Japan
                Department of Hematology , Imamura General Hospital, Kagoshima, Japan
                Division of Hematology , Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan
                Department of Hematologic Oncology , National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan
                Department of Hematology , National Hospital Organization Okayama Medical Center, Okayama, Japan
                Department of Hematology , National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan
                Department of Hematology , Saitama Cancer Center, Saitama, Japan
                Department of Hematology , University of Occupational and Environmental Health, Kitakyushu, Japan
                Department of Hematology and Oncology , Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan
                Department of Hematology and Cell Therapy , Aichi Cancer Center, Nagoya, Japan
                Department of Hematology , Nephrology and Rheumatology, Akita University School of Medicine, Akita, Japan
                Department of Hematology , Toyota Kosei Hospital, Toyota, Japan
                Department of Hematology , Saitama Medical Center, Saitama Medical University, Kawagoe, Japan
                First Department of Internal Medicine , Ehime University Hospital, Toon, Japan
                Department of Hematology , National Cancer Center Hospital, Tokyo, Japan
                Department of Hematology and Oncology , Nagoya City University Hospital, Nagoya, Japan
                Department of Hematology , National Hospital Organization Nagoya Medical Center, Nagoya, Japan
                Author notes
                For reprints and all correspondence: Dai Maruyama, Department of Hematology Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan. E-mail: dai.maruyama@ 123456jfcr.or.jp

                N. Nakamura and D. Maruyama contributed equally to this article.

                Article
                hyab066
                10.1093/jjco/hyab066
                8246272
                33959770
                1bc6a409-f4a4-4f9b-b948-ce07ab510e92
                © The Author(s) 2021. Published by Oxford University Press.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 28 January 2021
                : 14 April 2021
                : 15 April 2021
                : 19 April 2021
                Page count
                Pages: 8
                Funding
                Funded by: Ministry of Health, Labour and Welfare, Japan, DOI 10.13039/501100003478;
                Award ID: JP19ck0106348
                Award ID: JP16ck0106077
                Funded by: National Cancer Center, DOI 10.13039/100008746;
                Award ID: 2020-J-3
                Award ID: 29-A-3
                Award ID: 26-A-4
                Categories
                AcademicSubjects/MED00300
                Original Article

                Oncology & Radiotherapy
                bortezomib,melphalan,multiple myeloma,response criteria
                Oncology & Radiotherapy
                bortezomib, melphalan, multiple myeloma, response criteria

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