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  • 1
    In: The Lancet Neurology, Elsevier BV, Vol. 19, No. 2 ( 2020-02), p. 115-122
    Type of Medium: Online Resource
    ISSN: 1474-4422
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2020
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  • 2
    Online Resource
    Online Resource
    Inderscience Publishers ; 2014
    In:  International Journal of Technology Management Vol. 65, No. 1/2/3/4 ( 2014), p. 240-
    In: International Journal of Technology Management, Inderscience Publishers, Vol. 65, No. 1/2/3/4 ( 2014), p. 240-
    Type of Medium: Online Resource
    ISSN: 0267-5730 , 1741-5276
    RVK:
    Language: English
    Publisher: Inderscience Publishers
    Publication Date: 2014
    SSG: 3,2
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  • 3
    In: SSRN Electronic Journal, Elsevier BV
    Type of Medium: Online Resource
    ISSN: 1556-5068
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2022
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  • 4
    Online Resource
    Online Resource
    Elsevier BV ; 2023
    In:  Computers and Electronics in Agriculture Vol. 210 ( 2023-07), p. 107881-
    In: Computers and Electronics in Agriculture, Elsevier BV, Vol. 210 ( 2023-07), p. 107881-
    Type of Medium: Online Resource
    ISSN: 0168-1699
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2023
    detail.hit.zdb_id: 2016151-7
    SSG: 23
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  • 5
    In: Journal for ImmunoTherapy of Cancer, BMJ, Vol. 11, No. 9 ( 2023-09), p. e007366-
    Abstract: Over 70% of the patients with hepatocellular carcinoma (HCC) are diagnosed at an advanced stage and lose the opportunity for radical surgery. Combination therapy of tyrosine kinase inhibitors (TKIs) and anti-programmed cell death protein-1 (PD-1) antibodies has achieved a high tumor response rate in both the first-line and second-line treatment of advanced HCC. However, few studies have prospectively evaluated whether TKIs plus anti-PD-1 antibodies could convert unresectable intermediate-advanced HCC into resectable disease. Methods This single-arm, phase II study enrolled systemic therapy-naïve adult patients with unresectable Barcelona Clinic Liver Cancer stage B or C HCC. Patients received oral lenvatinib one time per day plus intravenous anti-PD-1 agents every 3 weeks (one cycle). Tumor response and resectability were evaluated before the fourth cycle, then every two cycles. The primary endpoint was conversion success rate by investigator assessment. Secondary endpoints included objective response rate (ORR) by independent imaging review (IIR) assessment per modified RECIST (mRECIST) and Response Evaluation Criteria in Solid Tumors, V.1.1 (RECIST 1.1), progression-free survival (PFS) and 12-month recurrence-free survival (RFS) rate by IIR per mRECIST, R0 resection rate, overall survival (OS), and safety. Biomarkers were assessed as exploratory objectives. Results Of the 56 eligible patients enrolled, 53 (94.6%) had macrovascular invasion, and 16 (28.6%) had extrahepatic metastasis. The median follow-up was 23.5 months. The primary endpoint showed a conversion success rate of 55.4% (31/56). ORR was 53.6% per mRECIST and 44.6% per RECIST 1.1. Median PFS was 8.9 months, and median OS was 23.9 months. Among the 31 successful conversion patients, 21 underwent surgery with an R0 resection rate of 85.7%, a pathological complete response rate of 38.1%, and a 12-month RFS rate of 47.6%. Grade ≥3 treatment-related adverse events were observed in 42.9% of patients. Tumor immune microenvironment analysis of pretreatment samples displayed significant enrichment of CD8 + T cells (p=0.03) in responders versus non-responders. Conclusion Lenvatinib plus anti-PD-1 antibodies demonstrate promising efficacy and tolerable safety as conversion therapy in unresectable HCC. Pre-existing CD8 + cells are identified as a promising biomarker for response to this regimen. Trial registration number Chinese Clinical Trial Registry, ChiCTR1900023914.
    Type of Medium: Online Resource
    ISSN: 2051-1426
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2719863-7
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  • 6
    In: Blood, American Society of Hematology, Vol. 116, No. 21 ( 2010-11-19), p. 684-684
    Abstract: Abstract 684 Background: Disease relapse is one of the leading causes of death following allogeneic hematopoietic stem cell transplantation (allo-HSCT). Donor T lymphocytes play a critical role in alloimmune recognition and their ability to detect non-self-antigens can lead to graft-versus-host disease (GVHD) or contribute to relapse prevention through recognition and elimination of minimal residual disease. CD28 is the primary T-cell costimulatory molecule constitutively expressed on the majority of T cells. Upon interaction with its ligands B7, CD28 transduces a signal that enhances the activation and proliferation of T cells. Another member of the CD28 family is inducible co-stimulator (ICOS). Although not constitutively expressed, ICOS is rapidly upregulated on T lymphocytes upon activation. Cytotoxic T-lymphocyte antigen 4 (CTLA-4), a homologous molecule of CD28, is a key factor in regulating and maintaining self-tolerance, providing a negative signal to T cells. Although several single-nucleotide polymorphisms (SNPs) within those costimulatory molecule genes have been identified to be associated with the risk of autoimmune disease, their association with outcome after allo-HSCT has yet to be explored. This present study was designed to investigate the influence of CD28, ICOS and CTLA-4 genes polymorphisms on the outcome of patients with acute myeloid leukemia (AML) after allo-HSCT. Methods: The entire study population consisted of 86 consecutive AML patients and their donors who were transplanted from 2001 to 2009 in our Unit. Genomic DNA was extracted from peripheral blood samples obtained from recipients and donors before transplantation. Five SNPs of CD28 -594(A/G), ICOS -693(G/A) and CTLA-4 -1722(A/G), +49(A/G) and CT60(A/G) were analyzed. Results: (1) The media age of the patients was 27 years (range, 12–49 years). At the time of transplantation, 70 patients were in first complete remission (CR), 10 patients in second CR, 3 patients in third CR and 3 patients in progressive status. 33 patients underwent HLA-matched sibling HSCT and 53 patients underwent unrelated HSCT. All patients received myeloablative conditioning based on busulfan/cyclophosphamide (BuCy) without total body irradiation (TBI). The GVHD prophylaxis is consisted of cyclosporin A, a short-term methotrexate and mycophenolate mofetil. (2) Only one patient experienced engraftment failure. 18(20.9%), 20(23.3%) and 3(3.5%) patients respectively developed grade I, II and severe acute GVHD (aGVHD). 16(18.6%) and 15(17.4%) patients developed limited and extensive chronic GVHD (cGVHD). (3) 17 patients (19.8%) experienced relapse, the media time was 15.6 months after allo-HSCT (range, 2–24 months). (4) Patients receiving stem cells from a donor with AA genotype in position +49 or CT60 of CTLA-4 gene relapsed more frequently than those with AG/GG genotypes (for +49: 50% vs 14.1%, P=0.012; for CT60: 80% vs 16%, P 〈 0.0001). (5) Patients receiving stem cells from a donor with CD28 -594 AA genotype had a lower incidence of relapse than those with other genotypes (0 vs 25%, P=0.04), due to a higher incidence of aGVHD (83.3% vs 38.2%, P=0.004). (6) In multivariate analysis, donor with CTLA-4 CT60 AA genotype (RR=13.411, 95%CI: 3.808–47.233, P 〈 0.0001), and absence of cGVHD (RR=2.12, 95%CI: 1.112–4.042, P=0.022) were found to significantly contribute to the risk of relapse after allo-HSCT. Furthermore, patients receiving CTLA-4 CT60 AA genotype donor had worse overall survival at 7 years (20% vs 77.8%, RR=10, 95%CI: 3.761–16.239, P 〈 0.0001). The polymorphic sites CTLA-4 -1722 and ICOS -693 did not correlate with the risk of relapse. Nor did patient 5 polymorphic sites genotype. Conclusions: These results, which is the first report of T-cell costimulatory molecule genes polymorphic features with the risk of leukemia relapse in AML patients after allo-HSCT, suggest an interaction between donor CTLA-4 CT60 AA genotype and the risk of relapse. The CTLA-4 CT60 AA genotype has been reported to increase the production of soluble form of CTLA-4, suggesting that increased expression of CTLA-4 would be associated with a decrease ability of the immune system to detect and eliminate tumor associated antigens. According to our results, anti-CTLA-4 antibodies may be a promising therapeutic strategy in leukemia relapse after allo-HSCT at least in patients receiving CTLA-4 CT60 AA genotype donor. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2010
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 7
    In: Blood, American Society of Hematology, Vol. 126, No. 23 ( 2015-12-03), p. 3130-3130
    Abstract: Introduction: Standard first-line therapy for the treatment of acute graft-versus-host disease (aGVHD) involves corticosteroids. However, fewer than half of patients have durable complete response. Steroid refractory aGVHD (SR-aGVHD) is associated with increased mortality, and long-term mortality rate remains around 70%. Second-line treatments included antithymoglobulin (ATG), mycophenolate mofetil (MMF), tacrolimus (FK), IL-2R antibodies, alemtuzumab, etanercept, infliximab, sirolimus and others. The overall complete remission (CR) rate from the 28 published retrospective studies that evaluating agents for second-line therapy of SR-aGVHD was 32%, the median survival was only about 6 months and no agent was clearly superior. To date, no consensus has been reached regarding the optimal secondary treatment of SR-aGVHD. Based on the pivotal roles of T cells and inflammatory cascade in aGVHD induction, since 2009 we performed a multicenter prospective study to assess the efficacy and safety of an approach to treat severe (grades III-IV) SR-aGVHD by the combination of basiliximab (anti-IL2-R) and etanercept (anti-TNFα). Methods: We conducted an open-label, non-randomized, phase II study at three centers, Bone Marrow Transplantation Center, the First Affiliated Hospital, Zhejiang University School of Medicine (Hangzhou), Department of Hematology, Zhejiang Provincial People's Hospital (Hangzhou), and Department of Hematology, Guangzhou General Hospital of Guangzhou Military Command (Guangzhou), between January 2009 and October 2013. Patients fulfilled one of the following criteria were included: (1)when newly diagnosed with grades III-IV aGVHD or overlap syndrome and showed progression after 3 days, or no improvement after at least 7 days of treatment or partial response at 14 days with 2 mg/kg per day prednisolone; or (2) de novo grades I-II aGVHD but eventually evolved into grades III-IV during treatment with prednisolone. Basiliximab was given intravenously at 20mg/d on days 1, 4, 8, 15, 22, 29, 36 (if necessary). Etanercept was given subcutaneously at 25mg per dose twice a week for 4 weeks and then pursued at 25mg once a week for another 4 weeks. During combined therapy all patients received cyclosporine and maintained on therapeutic level. Prednisolone was tapered by 10% of the total dose twice weekly. Results: (1) Forty-one patients with steroid-refractory grades III-IV aGVHD were included. Acute GVHD occurred at a median time of 13 days post-transplantation (range: 5-85). First-line treatment with 2 mg/kg/day steroids was initiated at GVHD diagnosis. Thirty patients (73.2%) were diagnosed as grade II aGVHD but evolved into severe aGVHD during treatment with prednisolone, and 11 patients (26.8%) were severe aGVHD at onset. Median time from diagnosis of aGVHD to study enrollment was 12 days (range 3-49). Fifteen patients (36.6%) presented with overall grade III aGVHD and 63.4% with grade IV. (2) Median number of infusions of basiliximab was 4 (range 2-7) and median number of etanercept was 8 (range 1-11). At day 28 after treatment by the combination therapy of basiliximab and etanercept was initiated, overall response (CR+PR) to second-line treatment was 92.7% with 78% of CR. The incidences of CR per organ was 100%, 80.5% and 85.4% for skin, gut and liver involvement, respectively. Nine of 24 evaluable patients developed chronic GVHD (cGVHD), in which 4 cases were with mild cGVHD and 5 with extensive cGVHD. (3)The cumulative incidence of a invasive pulmonary fungal infection at 12 months post-transplantation was 42.4%. Although twenty-eight patients (69.3%) experienced at least 1 cytomegalovirus (CMV) reactivation, all patients developed CMV-positive antigenemia without CMV disease. One patient developed viral encephalitis by human herpesvirus 6 (HHV6). No case of Epstein-Barr virus (EBV) reactivation was reported. Five-year overall survival (OS) rate after the combination therapy was 55.2% . A total of 17 patients died and causes of death ordered by the number of patients were invasive pulmonary fungal infection, (n=8, 47.1%), relapse (n=4, 23.5%), aGVHD (n=4, 23.5%), and arrhythmia (n=1, 5.9%). Conclusions: Here we developed a novel salvage treatment approach for grades III-IV SR-aGVHD by using the combination of basiliximab and etanercept, which achieved a clinically meaningful response in approximately more than 90% of patients and 55.2% of 5-year OS. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2015
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 8
    In: Blood, American Society of Hematology, Vol. 116, No. 21 ( 2010-11-19), p. 2377-2377
    Abstract: Abstract 2377 Background: Mycophenolate mofetil (MMF) has been widely used in the prophylaxis and treatment of graft-versus-host disease (GVHD) in allogeneic hematopoietic stem cell transplantation (allo-HSCT). Inosine monophosphate dehydrogenase (IMPDH) is the target of mycophenolic acid (MPA), the active metabolite of MMF. IMPDH is the key enzyme in the de-novo synthesis of nucleotides and induces the rate-limiting step in this synthesis. There are two isoforms of IMPDH, IMPDH1 is constructively expressed in all cell types, whereas IMPDH2 is only expressed in particular cell types. The proliferation of lymphocytes depends on the synthesis of nucleotides by IMPDH, whereas other types of cells have a salvage pathway for the synthesis of nucleotides. This makes MPA a drug that specifically inhibits the proliferation of the lymphocytes. Interindividual variability in IMPDH activity has been observed in healthy volunteers as well as transplant patients. The considerable variability in baseline IMPDH activity and MPA response may logically be under the control of genetic variation within the IMPDH gene or in gene expression. Analysis of genetic variants could provide the explantation for the variability of IMPDH activity and MMF response in transplant patients. The single nucleotide polymorphism (SNP) of IMPDH1 gene has recently reported to be relevant to acute rejection in renal transplant patients receiving MMF. There are no data about the impact of the polymorphisms of IMPDH1 gene on the outcome of allo-HSCT. The objective of this study was to investigate IMPDH1 genetic variants in allo-HSCT patients and to retrospectively look for the association of these polymorphisms with aGVHD. Methods: The entire study population consisted of 240 consecutive pairs of transplant recipients and their donors who were transplanted from 2001 to 2009 in our Center, including 138 pairs of recipients and their unrelated donors and 102 pairs of recipients and their HLA-identical sibling donors. Both in the unrelated and sibling transplantation cohorts, the patients received the same GVHD prophylaxis consisting of cyclosporin A, a short-term methotrexate and MMF. Genomic DNA was extracted from peripheral blood samples obtained from recipients and donors before transplantation. Four SNPs of IVS7 +125 G 〉 A (rs2278293), IVS8-106 G 〉 A (rs2278294), Exon15 1572 G 〉 A (rs2228075) and 5` flanking region C 〉 T (rs714510) in IMPDH1 gene were analyzed by Multiplex SnaPshot. Results: (1) The IMPDH1 IVS8 -106 G/G genotypes in recipients were significantly associated with a higher incidence of aGVHD than recipients with other genotypes either in the unrelated transplantation cohort or in the sibling transplantation cohort (in the unrelated cohort: 83.3% vs 63.9%, P=0.048; in the sibling cohort: 47.6% vs17.3%, P=0.008). Furthermore, in the unrelated transplantation cohort, the IMPDH1 IVS8 -106 G/G genotypes in recipients were also associated with a higher incidence of grades II-IV aGVHD (63.3% vs 38.0%, P=0.021). However donor IMPDH1 IVS8 -106 genotype had no significant influence on the incidence of aGVHD. (2) In the combined cohort, multivariate analysis confirmed that recipients with the IVS8 -106 G/G genotype were significantly associated with higher risk of developing aGVHD (RR=2.018, 95%CI: 1.354–3.009, P=0.001). Other three variables associated with the risk of aGVHD were myeloablative conditioning (RR=3.309, 95%CI: 1.538–7.121, P=0.002), donor female and recipient male (RR=1.679, 95%CI: 1.139–2.475, P=0.009), and unrelated donor (RR=4.633, 95%CI: 2.934–7.315, P 〈 0.001). (3) The genotypes of IVS7 +125, Exon15 1572 and 5` flanking region were not found to be associated with the risk of aGVHD. Conclusions: These results, which is the first report of IMPDH1 gene polymorphic features of Chinese population with the risk of aGVHD, suggest an interaction of the recipient IMPDH1 IVS8 -106 genotypes on the risk of aGVHD. These results are helpful for predicting allo-HSCT outcome, monitoring MMF therapy on an individual patient basis. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2010
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 9
    In: American Journal of Hematology, Wiley
    Type of Medium: Online Resource
    ISSN: 0361-8609 , 1096-8652
    Language: English
    Publisher: Wiley
    Publication Date: 2023
    detail.hit.zdb_id: 1492749-4
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  • 10
    In: Journal of Human Evolution, Elsevier BV, Vol. 182 ( 2023-09), p. 103411-
    Type of Medium: Online Resource
    ISSN: 0047-2484
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2023
    detail.hit.zdb_id: 1469645-9
    SSG: 12
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