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  • 1
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    Mito-FLAG with Ara-C as Bolus Vs. Continuous Infusion in Recurrent AML – Results of a Prospective Randomized Intergroup Study of the East German Study Group Hematology/Oncology (OSHO) and the Study Alliance Leukemias (SAL)
    American Society of Hematology ; 2008
    In:  Blood Vol. 112, No. 11 ( 2008-11-16), p. 2972-2972
    Details
    In: Blood, American Society of Hematology, Vol. 112, No. 11 ( 2008-11-16), p. 2972-2972
    Abstract: We started a prospective randomized multicenter trial to examine the importance of the infusion schedule of Ara-C as part of the Mito-FLAG regimen in patients (pts) with relapsed or primary refractory acute myeloid leukemia (AML). The treatment consisted of mitoxantrone (7 mg/m2, days 1/3/5), fludarabine (15 mg/m2, q-12h, days 1–5), Ara-C as bolus (B) (1000 mg/m2 over 1 h, q-12h, days 1–5) or continuous infusion (CI) (125 mg/m2 over 24 h, days 1–5) and G-CSF (5 μg/kg/day, day 0 until a neutrophile count of 0.5 × 109/μl). Since 11/1999, 253 pts from 36 centers in Germany entered the study (131 men, 122 women, aged 19–75 years, median 59 years). 131 pts (52%) showed a primary refractory AML or had relapsed within 6 months after 1st complete remission (CR), whereas 120 pts had suffered their 1st relapse after 6–18 months (79 pts/31%) or later (41 pts/16%). Only 2 pts with a 2nd relapse were enrolled. The diagnoses according to FAB criteria were as follows: M0 - 17 pts, M1 - 55 pts, M2 - 71 pts, M3 - 2 pts, M4 - 44 pts, M5 - 27 pts, M6 - 9 pts, M7 - 2 pts, 26 pts were not classified. 62 pts (25%) had a poor risk karyotype (defined as aberrations on the chromosomes 5, 7, 8 or multiple). In 50 pts (20%) an elevated leukocyte count ( & gt; 20 × 109/μl) was observed. 22 pts (9%) had relapsed after prior hematopoietic stem cell transplantation (HSCT). Currently 249 pts are evaluable for response and 231 pts for toxicity and survival. Following Mito-FLAG, 120 pts (48%) achieved CR and 43 pts (17%) partial remission (PR), for an overall response rate of 65%. 206 pts experienced at least one episode of febrile neutropenia with a median duration of 8 (1–53) days. 19 pts (8%) suffered an early death because of toxicity (n=11) or progressive AML (n=8). Out of 163 responders, 8 pts were consolidated by high-dose therapy with autologous HSCT and 48 pts underwent allogeneic HSCT after dose-reduced conditioning. With a median follow-up of 40.2 months (0–93), the probabilities of event-free survival (EFS) and overall survival (OS) after 3 years were 13% and 19%, respectively. In responding pts the median duration of EFS and OS were 8.4 and 10 months, the 3-year-rates of EFS and OS were 28% and 33%, respectively. In conclusion, Mito-FLAG is an effective and well tolerated regimen in the salvage therapy of pts with AML.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V112.11.2972.2972
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2008
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  • 2
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    Efficacy and safety of nerinetide for the treatment of acute ischaemic stroke (ESCAPE-NA1): a multicentre, double-blind, randomised controlled trial
    Elsevier BV ; 2020
    In:  The Lancet Vol. 395, No. 10227 ( 2020-03), p. 878-887
    Details
    In: The Lancet, Elsevier BV, Vol. 395, No. 10227 ( 2020-03), p. 878-887
    Type of Medium: Online Resource
    ISSN: 0140-6736
    URL: Article
    DOI: 10.1016/S0140-6736(20)30258-0
    RVK:
    XA 10000
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2020
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  • 3
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    Impact of initial chemotherapy regimen on outcomes for patients with double‐expressor lymphoma: A multi‐center analysis
    Wiley ; 2021
    In:  Hematological Oncology Vol. 39, No. 4 ( 2021-10), p. 473-482
    Details
    In: Hematological Oncology, Wiley, Vol. 39, No. 4 ( 2021-10), p. 473-482
    Abstract: Diffuse large B‐cell lymphoma featuring overexpression of MYC and B‐Cell Lymphoma 2 (double expressor lymphoma, DEL) is associated with poor outcomes. Existing evidence suggesting improved outcomes for DEL with the use of more intensive regimens than R‐CHOP is restricted to younger patients and based on limited evidence from low patient numbers. We retrospectively evaluated the impact of intensive frontline regimens versus R‐CHOP in a multicenter analysis across 7 academic medical centers in the United States. We collected 90 cases of DEL, 46 out of 90 patients (51%) received R‐CHOP and 44/90 (49%) received an intensive regimen, which was predominantly DA‐EPOCH‐R. Treatment cohorts were evenly balanced for demographics and disease characteristics, though the intensive group had a higher lactate dehydrogenase (LDH, 326 vs. 230 U/L p  = 0.06) and presence of B‐symptoms (50% vs. 22%, p  = 0.01) compared to the R‐CHOP cohort. There was no difference in PFS (median 53 vs. 38 months, p  = 0.49) or overall survival (67 vs. not reached months, p  = 0.14) between the R‐CHOP and intensive therapy cohorts, respectively. On multivariate analysis, intensive therapy was associated with a hazard ratio of 2.35 (95% CI 0.74–7.41), though this was not statistically significant. Additionally, a subgroup analysis of intermediate high‐risk lymphoma defined by IPI ≥3 did not identify a difference in survival outcomes between regimens. We conclude that in our multi‐center cohort there is no evidence supporting the use of intensive regimens over R‐CHOP, suggesting that R‐CHOP remains the standard of care for treating DEL.
    Type of Medium: Online Resource
    ISSN: 0278-0232 , 1099-1069
    URL: Issue
    URL: Article
    DOI: 10.1002/hon.v39.4
    DOI: 10.1002/hon.2902
    Language: English
    Publisher: Wiley
    Publication Date: 2021
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  • 4
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    Impact of circulating lymphoma cells at diagnosis on outcomes in marginal zone lymphoma: a multicenter cohort study
    American Society of Hematology ; 2023
    In:  Blood Advances
    Details
    In: Blood Advances, American Society of Hematology
    Type of Medium: Online Resource
    ISSN: 2473-9529 , 2473-9537
    URL: Article
    DOI: 10.1182/bloodadvances.2023011288
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2023
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  • 5
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    Transducin β-like protein 1 controls multiple oncogenic networks in diffuse large B-cell lymphoma
    Ferrata Storti Foundation (Haematologica) ; 2020
    In:  Haematologica Vol. 106, No. 11 ( 2020-09-14), p. 2927-2939
    Details
    In: Haematologica, Ferrata Storti Foundation (Haematologica), Vol. 106, No. 11 ( 2020-09-14), p. 2927-2939
    Abstract: Diffuse large B-cell lymphoma (DLBCL) is the most common non- Hodgkin lymphoma and is characterized by a remarkable heterogeneity with diverse variants that can be identified histologically and molecularly. Large-scale gene expression profiling studies have identified the germinal center B-cell (GCB-) and activated B-cell (ABC-) subtypes. Standard chemo-immunotherapy remains standard front-line therapy, curing approximately two thirds of patients. Patients with refractory disease or those who relapse after salvage treatment have an overall poor prognosis highlighting the need for novel therapeutic strategies. Transducin b-like protein 1 (TBL1) is an exchange adaptor protein encoded by the TBL1X gene and known to function as a master regulator of the Wnt signaling pathway by binding to β-CATENIN and promoting its downstream transcriptional program. Here, we show that, unlike normal B cells, DLBCL cells express abundant levels of TBL1 and its overexpression correlates with poor clinical outcome regardless of DLBCL molecular subtype. Genetic deletion of TBL1 and pharmacological approach using tegavivint, a first-in-class small molecule targeting TBL1 (Iterion Therapeutics), promotes DLBCL cell death in vitro and in vivo. Through an integrated genomic, biochemical, and pharmacologic analyses, we characterized a novel, β-CATENIN independent, post-transcriptional oncogenic function of TBL1 in DLBCL where TBL1 modulates the stability of key oncogenic proteins such as PLK1, MYC, and the autophagy regulatory protein BECLIN-1 through its interaction with a SKP1-CUL1-F-box (SCF) protein supercomplex. Collectively, our data provide the rationale for targeting TBL1 as a novel therapeutic strategy in DLBCL.
    Type of Medium: Online Resource
    ISSN: 1592-8721 , 0390-6078
    URL: Article
    DOI: 10.3324/haematol.2020.268235
    Language: Unknown
    Publisher: Ferrata Storti Foundation (Haematologica)
    Publication Date: 2020
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  • 6
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    A Strong Immune Effect by Allogeneic Stem Cell Transplantation May Improve Survival in AML Patients with a High Ratio of the FLT3-ITD Mutation to the Wt-FLT3 Allele: Results from an Analysis of 257 Patients Treated in the SAL AML-2003 Trial
    American Society of Hematology ; 2011
    In:  Blood Vol. 118, No. 21 ( 2011-11-18), p. 497-497
    Details
    In: Blood, American Society of Hematology, Vol. 118, No. 21 ( 2011-11-18), p. 497-497
    Abstract: Abstract 497 Background: The ratio of the FLT3-ITD mutation to the wt-FLT3 allele has significant prognostic importance in FLT3-ITD mutated acute myeloid leukemia (AML). Patients with a high mutant/wt ratio above 0.78 have significantly shorter overall (OS) and disease-free survival (DFS), whereas survival in patients with ratios below 0.78 did not differ from those without FLT3 aberrations (Thiede C et al, Blood 2002). There is still uncertainty about the role of allogeneic transplantation (allo-SCT) in the treatment of patients with FLT-ITD mutations (FLT3-ITD+). In order to prove the presence of an allogeneic effect, we compared the survival after allo-SCT in first remission in patients with a mutant rate 〈 0.8 with those ≥ 0.8. For comparison, the results in patient cohorts treated with chemotherapy alone were analyzed. Patients and Methods: Patients diagnosed with AML, aged 18–60 years, and treated in the AML-2003 trial of the SAL Study Alliance Leukemia were analyzed. According to the risk-adapted treatment strategy of the trial, cytogenetically intermediate-risk (IR) and adverse-risk (AR) patients should receive an allo SCT as consolidation treatment if an HLA-matched-sibling donor (IR) or HLA-matched related or unrelated donor (AR) was available. Patients with no available donor received high-dose cytarabine-based consolidation or autologous SCT. Survival analyses were performed using the Kaplan-Meier method including log-rank tests for significance testing. Results: Of 1182 patients enrolled in the AML-2003 trial between December 2003 and November 2009, 257 were FLT3-ITD+ (22%). The ratio of the FLT3-ITD mutation to the wt-FLT3 allele was 〈 0.8 in 182 patients (low-ratio) and ≥ 0.8 in 75 patients (high-ratio). 47 (26%) of the low-ratio group and 30 (40%) of the high-ratio group received an allogeneic transplantation. In the cohorts having received an allogeneic transplantation, the 3-year DFS in the low- and high-ratio groups was 58% and 50%, respectively (p=0.53). The 3-year OS was 61% and 59%, respectively (p=0.47). In the cohorts having chemotherapy as consolidation, the 3-year DFS in the low- and high-ratio groups was 36% and 10%, respectively (p 〈 0.001). The 3-year OS was 43% and 11%, respectively (p 〈 0.001). Conclusions: According to our results, allo-SCT in patients with a high allelic ratio of FLT3-ITD mutation led to an overall and event-free survival comparable with those with a low allelic ratio. In patients who received chemotherapy as consolidation and no allogeneic transplantation significant differences in DFS and OS could be shown between patients with a high vs. low ratio confirming our results obeserved in the previous AML96 study. These data point towards a strong graft versus leukemia effect after transplantation thus abrogating the negative impact of a high allelic ratio seen after conventional therapeutic appoaches. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V118.21.497.497
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2011
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  • 7
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    Acute Erythroleukemia Morphology Does Not Confer an Unfavourable Prognosis in Itself. Results of a Subgroup Analysis of the Prospective Randomized AML96-, AML2003 and AML60+ Studies of the Study Alliance Leukemia (SAL)
    American Society of Hematology ; 2012
    In:  Blood Vol. 120, No. 21 ( 2012-11-16), p. 1481-1481
    Details
    In: Blood, American Society of Hematology, Vol. 120, No. 21 ( 2012-11-16), p. 1481-1481
    Abstract: Abstract 1481 Introduction Acute erythroleukemia (AEL) represents a rare type of acute myeloid leukemia accounting for less than 5% of all cases. So far, according to WHO classification this AML entity is thought to have a poor prognosis in itself. Design 3267 patients with newly diagnosed AML were treated according to the protocols of the AML96, AML2003 or AML60+ studies of the Study Alliance Leukemia (SAL). 116 of these patients had acute erythroleukemia (AEL). The median age both for patients with AEL and non-AEL was 57 years. We assessed the influence of relevant clinical and demographic parameters, FLT3-ITD, NPM1 status and cytogenetics on complete remission rates (CR), overall survival (OS) and event free survival (EFS) separately in AEL and non-AEL patients. Results Compared to non-AEL AML, significantly more AEL were due to secondary causes than non-AEL AML (31% versus 20.4%; p=0.024). NPM1 mutations were found in 11.1% (out of 99) of the patients with AEL and in 32.8% (out of 2693) of the patients with non-AEL AML (p & lt;0.001). Surprisingly, both the FLT3-ITD mutation and high FLT3-ITD ratios & gt; 0.8 were found less frequently in AEL (FLT3-ITD mutation in 4.9% vs 23.3%; p=0.001; FLT3-ITD ratio & gt;0.8 in 0% vs. 33.4%; p & lt;0.001). The cytogenetic aberrations +8, −7 and complex aberrant karyotype ( & gt;/= 3 independent aberrations) were found more often in the AEL cohort (14.8%, 10.3% and 26.7%) than in the non-AEL AML cohort (8.9%, 5% and 13.2%) (p=0.036, p= 0.01 and p & lt;0.001, respectively). Despite these differences, no significant differences in CR rates, OS and EFS were found between both groups. This finding was confirmed in a multivariate analysis including cytogenetics, molecular markers and clinical parameters (LDH, WBC, blast count, platelet count and ECOG). According to the analysis, ALE morphology was not an independent prognostic factor for OS and EFS. With the AEL group, patients with monosomy 7 (n=12) had a higher median blast count (NEC) of 62% and shorter median OS with 5.7 months compared to patients with AEL and no monosomy 7 (n=104) with a median blast count (NEC) of 43% (p=0.013) and an median OS with 15.7 months (p=0.016). A complex aberrant karyotype was found more often in patients with secondary AEL than in patients with de novo AEL (p=0.037). Significant differences were also seen in patients with AEL and complex aberrant karyotype compared to AEL without complex aberrant karyotype with respect to CR rates (54.8% versus 77.6%; p=0.016), OS (6.2 versus 17.4 months; p & lt;0.000) and EFS (2.9 versus 6.2 months; p=0.007). In patients with AEL and abn17p/-17 (n=15), lower median platelet counts (31 versus 48 ×106/μl; p=0.017), a worse OS (6.4 vs 15.7 months; p=0.011) and EFS were observed (1.7 vs 5.7 months; p=0.046). Conclusions According to our data, the characteristic morphological features of acute erythroleukemia do not confer an unfavorable prognosis in itself. Furthermore, we can confirm the relevant influence of established prognostic factors such as cytogenetics and disease status within the AEL subgroup. Disclosures: Off Label Use: sorafenib for the treatment of acute myeloid leukemia.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V120.21.1481.1481
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2012
    detail.hit.zdb_id: 1468538-3
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  • 8
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    Allogeneic Stem Cell Transplantation Confers a Favorable Outcome in Patients with NPM1 Positive Acute Myeloid Leukemia: Results From a Donor Vs. No-Donor Analysis of 309 Patients Treated in the SAL AML-2003 Trial
    American Society of Hematology ; 2011
    In:  Blood Vol. 118, No. 21 ( 2011-11-18), p. 493-493
    Details
    In: Blood, American Society of Hematology, Vol. 118, No. 21 ( 2011-11-18), p. 493-493
    Abstract: Abstract 493 Background: According to retrospective analyses, the presence of a mutated Nucleophosmin-1 gene (NPM1+) in acute myeloid leukemia (AML) is associated with a favorable prognosis, particularly in the absence of an FLT3-ITD mutation (FLT3-ITD-). Therefore, AML with NPM1+/FLT3-ITD- and normal karyotype has been classified as favorable risk in current prognostic classifications. In order to assess the predictive value with regard to allogeneic stem cell transplantation (allo SCT), we compared the clinical course of 309 NPM1+ AML patients eligible for allo SCT in a donor versus no-donor analysis. Patients and Methods: Patients diagnosed with AML, aged 18–60 years, and treated in the AML 2003 trial of the Study Alliance Leukemia (SAL) were analyzed. According to the risk-adapted treatment strategy of the trial, cytogenetically intermediate-risk (IR) and adverse-risk (AR) patients should receive an allo SCT as consolidation treatment if an HLA-identical-sibling donor (IR) or HLA-matched related or unrelated donor (AR) was available. Patients with no available donor received high-dose cytarabine-based consolidation or autologous SCT. In order to avoid selection bias in an as-treated analysis of transplanted versus non-transplanted patients, we compared relapse-free survival (RFS) and overall survival (OS) depending on the availability of a suitable donor in a donor-no-donor analysis. Survival analyses were performed using the Kaplan-Meier method including log-rank tests for significance testing. Cox regression models and Wald tests were used for multivariate analyses on the influence of potential prognostic variables on the outcomes. Results: Of 1182 patients enrolled in the AML 2003 trial between December 2003 and November 2009, 375 were NPM1+ (32%), and 309 patients were eligible for evaluation for the donor vs. no-donor analysis. Their median age was 49 years, 304 patients had an intermediate-risk karyotype according to MRC criteria (98%), and amongst them there were 277 patients with a normal karyotype (90%). The FLT3-ITD mutation was present in 144 patients (37%). A donor was identified for 77 patients (25%), of whom 57 actually received allo SCT as first consolidation (74%). The no-donor group consisted of 232 patients. Age, disease status, cytogenetic profile, and FLT3-ITD incidence were equally distributed between the two groups. Median follow up was 41 months (3.4 years). The 3-year RFS in the donor and no-donor groups was 72% (95%–CI 61%–82%) and 47% (95%–CI 40%–55%), respectively. (p=0.007). The OS in the donor and no-donor groups were 70% (95%–CI 59%–81%) versus 60% (95%–CI 54%–67%) after 3 years, and 70% (95%–CI 59%–81%) versus 53% (95%–CI 45%–61%) after 5 years (p=0.138). In multivariate analyses, the presence of a donor as a prerequisite for allo SCT retained its statistically significant favorable influence on RFS (HR=0.56) even after adjustment for established risk factors such as FLT3-ITD, cytogenetic risk, WBC, LDH, age, and disease status. In patients with normal karyotype and NPM1+/FLT3-ITD- (n=152), the 3-year RFS in the donor and no-donor groups was 87% (95%–CI 77%–97%) and 53% (95%–CI 42%–63%), respectively (p=0.001). Conclusions: According to our results, allo SCT leads to a significantly prolonged RFS in NPM1+ AML patients with a pronounced effect even in NPM1+/FLT3-ITD- patients. The absence of a statistically significant difference in OS is most likely due to the fact that relapsed NPM1+ patients responded well to salvage treatment, particularly to allo SCT from an unrelated donor. Our data suggest that patients with NPM1+ AML who have a well-matched donor benefit from allo SCT in first remission. This hypothesis is currently being tested prospectively in a randomized controlled trial (“ETAL-1”, NCT01246752) evaluating allo SCT in all intermediate-risk AML patients with a well-matched sibling or unrelated donor identified until the achievement of first CR. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V118.21.493.493
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2011
    detail.hit.zdb_id: 1468538-3
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  • 9
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    Vision using multiple distinct rod opsins in deep-sea fishes
    American Association for the Advancement of Science (AAAS) ; 2019
    In:  Science Vol. 364, No. 6440 ( 2019-05-10), p. 588-592
    Details
    In: Science, American Association for the Advancement of Science (AAAS), Vol. 364, No. 6440 ( 2019-05-10), p. 588-592
    Abstract: Vertebrate vision is accomplished through light-sensitive photopigments consisting of an opsin protein bound to a chromophore. In dim light, vertebrates generally rely on a single rod opsin [rhodopsin 1 (RH1)] for obtaining visual information. By inspecting 101 fish genomes, we found that three deep-sea teleost lineages have independently expanded their RH1 gene repertoires. Among these, the silver spinyfin ( Diretmus argenteus ) stands out as having the highest number of visual opsins in vertebrates (two cone opsins and 38 rod opsins). Spinyfins express up to 14 RH1 s (including the most blueshifted rod photopigments known), which cover the range of the residual daylight as well as the bioluminescence spectrum present in the deep sea. Our findings present molecular and functional evidence for the recurrent evolution of multiple rod opsin–based vision in vertebrates.
    Type of Medium: Online Resource
    ISSN: 0036-8075 , 1095-9203
    URL: Article
    DOI: 10.1126/science.aav4632
    RVK:
    TA 1000
    RVK:
    WA 15000
    Language: English
    Publisher: American Association for the Advancement of Science (AAAS)
    Publication Date: 2019
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    SSG: 11
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  • 10
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    DataSheet_1.docx
    Frontiers Media SA ; 2023
    In:  Frontiers in Oncology Vol. 13 ( 2023-9-13)
    Details
    In: Frontiers in Oncology, Frontiers Media SA, Vol. 13 ( 2023-9-13)
    Abstract: Given the paucity of data surrounding the prognostic relevance of circulating lymphoma (CL) in Waldenström macroglobulinemia (WM), we sought to evaluate the impact of CL at diagnosis on outcomes in patients with WM. Patients were divided into CL+ and CL- based on the results of flow cytometry. The endpoints included assessing progression-free survival (PFS), overall survival (OS), and diagnosis-to-treatment interval (DTI) between the two groups. Among the 308 patients with WM, 69 met the eligibility criteria with 42 and 27 in CL+ and CL- groups, respectively. The two groups were well balanced in regard to all the baseline characteristics. The ORR was numerically higher in the CL+ group compared to the CL-group (81% versus 61%, respectively), however, the CR+VGPR rates were similar between the two groups. The median PFS was not significantly different between the two groups (6.3 years in the CL- group versus not reached [NR] in the CL+ group) regardless of the first-line therapy. There was no significant difference in median OS between the CL- and CL+ groups (13 years versus NR). Although the median DTI was shorter in the CL+ group compared to CL- group, the significance was lost in the multivariable analysis. In this study (largest-to-date) evaluating the impact of CL on outcomes in patients with newly diagnosed WM, we did not find the prognostic utility of CL in WM. Future studies should explore the correlation of CL with other biological factors that impact the outcomes in WM patients.
    Type of Medium: Online Resource
    ISSN: 2234-943X
    URL: Article
    URL: Article
    DOI: 10.3389/fonc.2023.1264387
    DOI: 10.3389/fonc.2023.1264387.s001
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2023
    detail.hit.zdb_id: 2649216-7
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