Purpose The general outlook for patients with diffuse large B-cell lymphoma (DLBCL) in first remission is important information for patients and for planning post-treatment follow-up. The purpose of this study was to evaluate the survival of patients with DLBCL in remission compared with a matched general population. Methods A total of 1,621 patients from the Danish Lymphoma Registry who were newly diagnosed with DLBCL between 2003 and 2011 were included in this study. All patients were ≥ 16 years of age at diagnosis and had achieved complete remission or complete remission unconfirmed after first-line rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or R-CHOP-like therapy. Results The 5-year post-treatment DLBCL survival was inferior to survival in the matched general population (78%; 95% CI, 76 to 80; v 87%; standardized mortality ratio, 1.75; P < .001). Excess mortality was present but reduced for patients achieving post-treatment event-free survival for 24 months (pEFS24; standardized mortality ratio, 1.27; P < .001). In age-stratified analyses, the survival of patients < 50 years of age was normalized to the general population after achieving pEFS24 ( P = .99). During the first 8 years after pEFS24, the average loss of lifetime was 0.31 mo/y (95% CI, 0.11 to 0.50 mo/y). Excess mortality diminished when analyzing death from lymphoma as competing event to death from other causes, suggesting that early and late relapse is responsible for increased mortality in patients with DLBCL. Conclusion Although this population-based study does not support complete normalization of survival for patients with DLBCL achieving pEFS24, the estimated loss of residual lifetime was low for patients in continuous remission 2 years after ending treatment. Therefore, pEFS24 is an appealing and relevant milestone for patient counseling and could be a surrogate end point in clinical trials.
Purpose: YKL-40 is secreted by cancer cells, macrophages, and neutrophils. It may be a growth or differentiation factor, play a role in angiogenesis, or protect against apoptosis. High serumYKL-40 is associated with poor prognosis in solid carcinomas. The aim was to examine serumYKL-40 in patients with acute myeloid leukemia (AML). Experimental Design:YKL-40 was measured by ELISA in serum from 77 patients recently diagnosed with AML before and during the first month of chemotherapy. Results: Forty (52%) of the AML patients had elevated serum YKL-40 (compared with agematched healthy subjects) and their survival was shorter than in patients with normal serum YKL-40 (median, 128 days; interquartile range, 18-629 days versus 386 days; interquartile range, 180-901; P = 0.018 Mann-Whitney test). Univariate analysis of serum YKL-40 (logarithmically transformed and treated as a continuous covariate) showed significant association with survival within the first month after start of chemotherapy [hazard ratio (HR), 1.7; 95% confidence interval (CI), 1.2-2.4; P = 0.002], first 12 months (HR, 1.6; 95% CI, 1.2-2.0; P = 0.0002), and overall survival (HR, 1.3; 95% CI, 1.1-1.6; P = 0.003). Multivariate Cox analysis showed that serum YKL-40 was an independent prognostic variable for survival (first month: HR,1.7; P = 0.011;12 months: HR, 1.6; P = 0.0002; overall survival: HR, 1.4; P = 0.002). High serum YKL-40 at start of chemotherapy was a risk factor for pneumonia within the first month, and serumYKL-40 increased (P = 0.002) at time of pneumonia and was unchanged in patients without infections. Conclusions: SerumYKL-40 is a prognostic biomarker of survival in AML patients. Its role in AML and infections needs to be determined.
The purpose of the study was to determine the prevalence of acute oral infections and to estimate their role as a possible cause of fever in immunocompromised patients with haematologic malignancies. Seventy-eight febrile episodes in 46 patients were analyzed prospectively and consecutively. An association between a rise in the leukocyte and platelet counts and normalization of the temperature was found. Acute infections were present in 92% of the febrile episodes no infectious cause could be demonstrated in the remaining 8%. Acute oral infections were present during 78% and acute extraoral infections during 73% of the febrile episodes. Acute candidiasis and infected mucosal ulcers were the most prevalent oral infections, occurring in about one-half and one-third of the episodes, respectively. Septicaemia and pneumonia were the most prevalent extraoral infections, each present in about one-fourth of the febrile episodes. Acute oral infections were a probable cause of fever in 14% of the febrile episodes and a possible or a contributing cause of fever in a further 26%. The results suggest that effective treatment or prevention of acute oral infections may reduce the morbidity and perhaps even the mortality in immunocompromised patients.
MBL levels have no discernible influence on the occurrence or course of infections in AML patients during the initial hospitalisation. The predominant immunodeficiency during this phase is the profound granulocytopenia, which also compromises important effector functions of MBL. The finding in most AML patients of elevated MBL concentrations on admission is most likely because of the role of MBL as an acute phase reactant.
AimIn 2008, the Danish National Chronic Lymphocytic Leukemia Registry was founded within the Danish National Hematology Database. The primary aim of the registry is to assure quality of diagnosis and care of patients with chronic lymphocytic leukemia (CLL) in Denmark. Secondarily, to evaluate adherence to national guidelines and to provide source data for research purposes.Study populationAll patients diagnosed with CLL in Denmark from 2008 onward are included in the registry. Patients are followed in one of nine hematology centers. All centers participate in the registry and are all obliged to collect data.Main variablesPredefined data are collected at the time of diagnosis, and follow-up at the time of significant events: treatment, progression, transplantation, and death. Parameters included in the International Workshop on Chronic Lymphocytic Leukaemia criteria for diagnosis, and for decision on treatment initiation as well as characteristics included in the CLL International Prognostic Index are collected.Descriptive dataTo ensure full coverage of Danish CLL patients in the registry, both continuous queries in case of missing data, and cross-referencing with the Danish National Patient Registry are performed. Data from the registry are published in an annual report summarizing the collected data, the overall survival for yearly cohorts, and the degree of data coverage. Per year approximately 450 new patients with CLL are registered in the registry, cumulative as of July 1, 2015, 3,082 patients have been registered.ConclusionThe Danish National CLL Registry is based within the Danish National Hematology Database. The registry covers a cohort of all patients diagnosed with CLL in Denmark since 2008. It forms the basis for quality assessment of CLL treatment in Denmark and offers a unique opportunity for population-based research.
Ibrutinib has now been approved for treatment of chronic lymphocytic leukemia (CLL) in both front-line setting and as later-line treatment. However, knowledge about the outcomes and adverse events (AE) among patients at a population-based level is still limited. Objectives: To report outcomes and AEs in a population-based cohort treated with ibrutinib outside clinical trials. Methods: We conducted a multicenter, retrospective cohort study including all patients with CLL treated with ibrutinib. Results: In total, 205 patients were included of whom 39 (19%) were treatment-naïve. The median follow-up was 21.4 months (interquartile range (IQR), 11.9, 32.8), the estimated overall survival at 12 months was 88.8% (95% confidence interval (CI); 84.3%, 93.3%), and the estimated progression-free survival at 12 months was 86.3% (95% CI; 81.3%, 91.2%). During follow-up, 200 (97.6%) patients had at least one AE and 100 (48.8%) patients had at least one grade ≥3 AE. Eighty-six patients (42.0%) discontinued ibrutinib, hereof 47 (54.7%) due to AEs and 19 (22.1%) had progression of CLL or Richter transformation. Conclusions: In our study, we find comparable, though slightly inferior, overall, and progression-free survival, and discontinuation due to toxicity was higher compared with clinical trials. Patient training and information may improve treatment adherence outside clinical trials.
To investigate changes in the aerobic and facultatively anaerobic oral microflora during remission-induction chemotherapy in patients with acute myeloid leukaemia, 10 consecutive patients were studied during a period of 28 days. During antineoplastic treatment, the concentration of microorganisms in saliva doubled from day 0 to day 2, presumably as a result of a concurrent 64% decrease in the salivary flow rate. No changes in the relative proportion of individual microorganisms or acquisition of new microorganisms occurred during antineoplastic treatment. During antibacterial treatment, which was subsequently initiated in all patients, a 100-fold decline occurred in the median salivary concentration of microorganisms within the first 7 days. During this period, members of the normal flora became undetectable in 5 patients, and Enterobacteriaceae, Enterococcus faecalis or Candida spp. became parts of the quantitatively predominant oral microflora in 7 patients. Apart from Candida spp., these potentially pathogenic microorganisms were acquired only after the initiation of the antibacterial treatment. After termination of the antibacterial treatment, the median concentration of microorganisms increased again to the original level and normal flora became reestablished within a period of 8 days. Clinically, 10/20 acute oral infections emerged before day 8, i.e. within the period with increased concentrations of microorganisms in saliva. Specifically, the clinical diagnosis of acute oral candidiasis was associated with a rise in the concentration of Candida spp. above a critical value of 1,000 CFU/ml. Herpes simplex virus (HSV) type 1 was detected in 4/9 HSV-seropositive patients on days 14 and 21, and HSV-1 was in all 4 cases isolated simultaneously with the emergence of an intraoral ulcer. The results suggest that chemotherapy-induced xerostomia plays a significant role in the pathogenesis of acute oral infections and transmission of potentially pathogenic microorganisms is of importance mainly after initiated antibiotic treatment in these patients.
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