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      Prognostic Value and Efficacy Evaluation of Novel Drugs for Multiple Myeloma Patients with 1q21 Amplification (Amp1q21) Only: A Systematic Review of Randomized Controlled Trials

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          Abstract

          Background: Multiple myeloma (MM) is a heterogeneous disease characterized by chromosomal translocation, deletion, and amplification in plasma cells, resulting in a huge heterogeneity in its outcomes. Of all these cytogenetic abnormalities, Amp1q21 is most commonly detected, which is always associated with significantly shorter progression-free survival (PFS) and overall survival (OS) than normal 1q copy number status. In the era of novel agents such as bortezomib, ixazomib, lenalidomide, a head-to-head comparison of all these agents is still absent, especially in the patients with Amp1q21 alone. So, aiming to explore the optimum therapy to the patients with Amp1q21 only, we conduct this study.

          Patients and Methods: We searched the PubMed, the Cochrane Library, PMC and the Embase databases, and we selected all the randomized controlled trials (RCTs) in English about MM with Amp1q21 up to April, 2019. A total of 72 papers were full screened and finally 2 literatures can be included in our study.

          Results: Of the two studies, the one is about IRd (ixazomib, lenalidomide, dexamethasone) vs. placebo-Rd (HR, 0.781; 95% CI, 0.492-1.240), another is about VAD (vincristine, adriamycin, dexamethasone) vs. PAD (bortezomib, adriamycin, dexamethasone) (3-year survival rate: 59% vs. 83%, p=0.016).

          Conclusion: From this review, MM patients with Amp1q21 may somewhat benefit from ixazomib but the evidence is still stuffless. What's more, a head-to-head comparison between ixazomib and other agents among MM patients with Amp1q21 is also absent. So, we sincerely expect this review can attract some attention for the therapy of this special part of patients. This study was registered in https://www.crd.york.ac.uk/prospero/#recordDetails.

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          Most cited references21

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          Management of newly diagnosed symptomatic multiple myeloma: updated Mayo Stratification of Myeloma and Risk-Adapted Therapy (mSMART) consensus guidelines 2013.

          Multiple myeloma remains an incurable neoplasm of plasma cells that affects more than 20,000 people annually in the United States. There has been a veritable revolution in this disease during the past decade, with dramatic improvements in our understanding of its pathogenesis, the development of several novel agents, and a concomitant doubling in overall survival. Because multiple myeloma is a complex and wide-ranging disorder, its management must be guided by disease- and patient-related factors; emerging as one of the most influential factors is risk stratification, primarily based on cytogenetic features. A risk-adapted approach provides optimal therapy to patients, ensuring intense therapy for aggressive disease and minimizing toxic effects, providing sufficient but less intense therapy for low-risk disease. This consensus statement reflects recommendations from more than 20 Mayo Clinic myeloma physicians, providing a practical approach for newly diagnosed patients with myeloma who are not enrolled in a clinical trial. Copyright © 2013 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.
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            Frequent gain of chromosome band 1q21 in plasma-cell dyscrasias detected by fluorescence in situ hybridization: incidence increases from MGUS to relapsed myeloma and is related to prognosis and disease progression following tandem stem-cell transplantation.

            Using fluorescence in situ hybridization we investigated amplification of chromosome band 1q21 (Amp1q21) in more than 500 untreated patients with monoclonal gammopathy of undetermined significance (MGUS; n = 14), smoldering multiple myeloma (SMM; n = 31), and newly diagnosed MM (n = 479) as well as 45 with relapsed MM. The frequency of Amp1q21 was 0% in MGUS, 45% in SMM, 43% in newly diagnosed MM, and 72% in relapsed MM (newly diagnosed versus relapsed MM, P < .001). Amp1q21 was detected in 10 of 12 patients whose disease evolved to active MM compared with 4 of 19 who remained with SMM (P < .001). Patients with newly diagnosed MM with Amp1q21 had inferior 5-year event-free/overall survival compared with those lacking Amp1q21 (38%/52% versus 62%/78%, both P < .001). Thalidomide improved 5-year EFS in patients lacking Amp1q21 but not in those with Amp1q21 (P = .004). Multivariate analysis including other major predictors revealed that Amp1q21 was an independent poor prognostic factor. Relapsed patients who had Amp1q21 at relapse had inferior 5-year postrelapse survival compared with those lacking Amp1q21 at relapse (15% versus 53%, P = .027). The proportion of cells with Amp1q21 and the copy number of 1q21 tended to increase at relapse compared with diagnosis. Our data suggest that Amp1q21 is associated with both disease progression and poor prognosis.
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              A novel prognostic model in myeloma based on co-segregating adverse FISH lesions and the ISS: analysis of patients treated in the MRC Myeloma IX trial

              The association of genetic lesions detected by FISH with survival was analyzed in 1069 patients with newly presenting myeloma treated in the Medical Research Council (MRC) Myeloma IX trial, with the aim of identifying patients associated with the worst prognosis. A comprehensive FISH panel was performed, and the lesions associated with short PFS and OS in multivariate analysis were +1q21, del(17p13) and an adverse IGH translocation group incorporating t(4;14), t(14;16) and t(14;20). These lesions frequently co-segregated, and there was an association between the accumulation of these adverse FISH lesions and a progressive impairment of survival. This observation was used to define a series of risk groups based on number of adverse lesions. Taking this approach we defined a favorable risk group by the absence of adverse genetic lesions, an intermediate group with 1 adverse lesion and a high risk group defined by the co-segregation of >1 adverse lesion. This genetic grouping was independent of the ISS and so was integrated with the ISS to identify an ultra-high risk group defined by ISS II or III and >1 adverse lesion. This group constituted 13.8 % of patients and was associated with a median OS of 19.4 months.
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                Author and article information

                Journal
                J Cancer
                J Cancer
                jca
                Journal of Cancer
                Ivyspring International Publisher (Sydney )
                1837-9664
                2020
                19 February 2020
                : 11
                : 9
                : 2639-2644
                Affiliations
                Department of Hematology, Navy Medical Center of PLA, Shanghai, China
                Author notes
                ✉ Corresponding author: Rong Li, E- Mail address: lirong785@ 123456hotmail.com , Telephone number: 1366164996, ORCID iD: 0000-0001-7087-3382

                Competing Interests: The authors have declared that no competing interest exists.

                Article
                jcav11p2639
                10.7150/jca.40711
                7066010
                265adf14-a6c8-4c98-b244-a9d634581365
                © The author(s)

                This is an open access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/). See http://ivyspring.com/terms for full terms and conditions.

                History
                : 27 September 2019
                : 22 January 2020
                Categories
                Research Paper

                Oncology & Radiotherapy
                multiple myeloma,1q21 amplification,therapy strategy,novel agents,systematic review

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