Comparison of primary percutaneous coronary intervention in real-world populations versus clinical trial populations.

The efficacy of primary percutaneous coronary intervention (PPCI) has been documented in several randomized-controlled trials. We sought to examine the clinical outcome after PPCI of real-world patients eligible and ineligible for inclusion in a randomized trial (DANAMI-2) and to compare it to the outcome of the DANAMI-2 population. We did a population-based follow-up study comparing 1,320 consecutive real-world patients treated with PPCI from 2004 to 2006 to 686 patients treated with PPCI in the DANAMI-2 trial. By reviewing medical records we determined whether the real-world patients were eligible in the DANAMI-2 trial. The real-world population had a more adverse baseline risk profile. Cumulative incidences of the composite end point of all-cause mortality, reinfarction, and stroke after 1 year and 2 years were 17.8% and 22.0%, respectively, in the real-world population compared to 13.6% and 17.3% in the DANAMI-2 population. After adjustment for differences in baseline characteristics and treatment, differences persisted after 1 year (adjusted hazard ratio 1.8, 95% confidence interval 1.3 to 2.6) and 2 years (adjusted hazard ratio 1.7, 95% confidence interval 1.2 to 2.3). Results for the real-world patients eligible according to DANAMI-2 criteria were comparable to the results from the DANAMI-2 trial. In conclusion, real-world patients had a more adverse baseline prognostic profile and a poorer clinical outcome compared to the DANAMI-2 patients. However, clinical outcome in the real-world patients eligible in the DANAMI-2 trial was comparable to that for the DANAMI-2 patients after invasive and medical treatment.

Increasing incidence of ophthalmic lymphoma in Denmark from 1980 to 2005.

PURPOSE: To evaluate patient characteristics and incidence of ophthalmic lymphoma in Denmark during the period 1980 to 2005. METHODS: All patients in Denmark with a diagnosis of ophthalmic lymphoma during the period 1980 to 2005 were retrieved from three different population-based registries. Specimens from all patients were collected and reclassified according to the World Health Organization (WHO) classification system. Incidence rates were calculated by using Poisson regression models. RESULTS: A total of 228 patients with a histologically verified diagnosis of ophthalmic lymphoma were included. There was an equal distribution of males and females. The most frequent lymphoma subtype was extranodal marginal zone B-cell lymphoma (MALT [mucosa-associated lymphoid tissue] lymphoma, 55.5%) and most cases were located in the orbit (56.8%). High-grade lymphoma subtypes were found more frequently in males than in females. Incidence rates were highly dependent on the patient's age. For all ages, a statistically significant annual average increase of 3.4% during the 26-year period was found. This increase was primarily due to a rise in the incidence of MALT lymphoma. CONCLUSIONS: In the Danish population ophthalmic lymphoma consists primarily of orbital MALT lymphoma. Although it is a rare disease in mostly elderly patients, the incidence of ophthalmic lymphoma is increasing at a rapid pace.

Conditional survival of patients with diffuse large B-cell lymphoma.

BACKGROUND: Prognosis of lymphoma patients is usually estimated at the time of diagnosis and the estimates are guided by the International Prognostic Index (IPI). However, conditional survival estimates are more informative clinically, as they consider those patients only who have already survived a period of time after treatment. Conditional survival data have not been reported for lymphoma patients. METHODS: Conditional survival was estimated for 1209 patients with diffuse large B-cell lymphoma (DLBCL) from the population-based LYFO registry of the Danish Lymphoma Group. The Kaplan-Meier method was used to estimate conditional survival at 0-5 years after diagnosis. RESULTS: The probability of surviving 5 years increases with each year survived for the first 3 years after diagnosis, after which the increase is minimal. The median survival increases from 38 months for all patients to between 108 and 120 months, conditioned on survival for at least 3-5 years. The prognostic capacity of the IPI and the age-adjusted IPI was high at diagnosis, but the significance gradually declined in the first years after diagnosis. Furthermore, the prognostic impact of the individual clinical variables of the IPI was also significant at diagnosis, but 2 years after diagnosis only age had prognostic impact. Multivariate analysis of patients who survived > or = 3 years identified only age as a prognostic factor. CONCLUSION: For patients with DLBCL who have survived more than 1 year after diagnosis, the conditional survival probability provides more accurate prognostic information than the conventional survival rate estimated from the time of diagnosis.

Diffuse large B-cell lymphoma: clinical implications of extranodal versus nodal presentation--a population-based study of 1575 cases.

Differences in genetic origin between nodal and extranodal diffuse large B-cell lymphomas (DLBCL) exist. Using population-based data from the registry of the Danish Lymphoma Group, the present study is the first to analyse clinical implications of nodal versus extranodal presentation of DLBCL. Of 4786 newly diagnosed non-Hodgkin's lymphoma patients in a 16-year period, 1575 (33%) had DLBCL. The annual incidence rate was 2.9 per 100 000; 40% were extranodal. The clinical profile of patients with extranodal DLBCL was different from the nodal DLBCL patients. Extranodal DLBCL was associated with older age and poorer performance score, but also lower tumour burden. In extranodal DLBCL, 51% of the cases were stage I and 36% were stage IV, whereas the patients were relatively equally distributed between the four stages in nodal DLBCL. For stage I patients, extranodal DLBCL was independently associated with poor survival (P = 0.003). In contrast, among stage IV patients those with extranodal DLBCL survived longer (P = 0.009). We conclude that there are important clinical differences between nodal and extranodal DLBCL. The addition of these clinical results to the existing aetiological and genetic data suggests that the distinction between nodal and extranodal DLBCL is not only pathogenetically but also clinically important.

Cytogenetic findings in adult de novo acute myeloid leukaemia. A population-based study of 303/337 patients.

During a 10-year period (1992-2001) in the region of Southern Denmark, 337 patients aged 15 years or older (range 16-93 years, median 67 years) were diagnosed with acute myeloid leukaemia (AML). Cytogenetic analysis was carried out in 90%, of whom 53% had clonal chromosome aberrations. Some 24% and 31% had only numerical or structural abnormalities respectively. The remaining patients showed both types of abnormalities. Ploidy levels in decreasing order were: pseudodiploidy, 41%; hyperdiploidy, 32%; and hypodiploidy, 27%. Pseudodiploidy characterizes type M3 (70%) and hypodiploidy M6 (56%). Recurrent cytogenetic abnormalities--t(8;21), t(15;17) and inv(16)--were found in 3.3%, 3.3% and 2.0% of all patients respectively. Prognostically intermediate and adverse aberrations were found in 39% and 44%, respectively, of those with an abnormal karyotype. Rare recurrent aberrations were found in two patients in this material. A previously described non-recurrent abnormality was found to be recurrent in one patient [der(20)t(11;20)(q13.2;p13)]. New, previously undescribed abnormalities were found in 41 patients. Statistically significant correlations were found between t(15;17) and young age (P < 0.001), inv(16) and young age (P < 0.006), -17 and M6 (P = 0.007), and M6 and complex karyotype with five or more unrelated aberrations (P = 0.004). We conclude that this truly population-based cytogenetic study of adult AML showed distributions of chromosome abnormalities that differ from those described so far.

Factors predicting long-term survival in low-risk diffuse large B-cell lymphoma.

The International Prognostic Index (IPI) is widely used for risk stratification of patients with diffuse large B-cell lymphoma (DLBCL). However, even among patients with low-risk disease, according to the IPI a substantial proportion of patients ultimately succumb to their disease. Using mature population-based data from the Danish Lymphoma Group, we analyzed if prognostic clinical pretreatment factors could be identified in patients with low-risk DLBCL. One hundred seventy-seven patients, all with a prognostic profile as favorable as possible according to the IPI and treated with anthracycline-based combination chemotherapy (92%) or loco-regional radiotherapy/surgery (8%) with curative intent were included. The median age was 50 years and 170 achieved complete remission. The median follow-up time was 11 years. Twenty-six patients relapsed, with a median time to relapse of 12.1 months. Overall survival at 5 years and 10 years was 85% and 75%, respectively. Stage II was associated with poor response to treatment (P=0.044). In a multivariate analysis, Stage II (P=0.001) and age >50 years (P=0.043) were independently associated with poor outcome. Patients without these adverse factors had an excellent prognosis, with a survival at 5 and 15 years of 90% and 80%, respectively. In contrast, patients with both adverse factors had poor outcome, with survival at 5 and 15 years of 70% and 29%, respectively (P<0.001). The present data suggest that risk stratification of DLBCL patients with a favorable IPI score can be improved by the simple use of two clinical pretreatment factors.

Prognosis of localized diffuse large B-cell lymphoma in younger patients.

BACKGROUND: The International Prognostic Index (IPI) is widely used as a predictive model in diffuse large B-cell lymphoma (DLBCL) patients of all ages and stages. To determine the optimal IPI-based prognostic system at the time of diagnosis in younger patients with limited-stage DLBCL, the authors evaluated the age-adjusted IPI and the recently proposed stage-adjusted IPI, and constructed an IPI-based model adjusted for both age and stage. METHODS: From the population-based LYFO registry of the Danish Lymphoma Group, 233 patients not older than 60 years with Stage I-II DLBCL treated with anthracycline-based chemotherapy with or without involved-field irradiation were identified. The primary endpoint of analysis was overall survival. RESULTS: At the end of the observation period, 151 patients were alive with a median follow-up time of 8.3 years. All the variables in the age-adjusted and the stage-adjusted IPI had major prognostic significance (P < or = 0.0001). Log-rank analyses of survival showed highly significant differences between the subgroups in each model (P < 0.0001); however, the stage-adjusted IPI was more powerful (chi-square test = 44.99) than the age-adjusted IPI (chi-square test = 36.27). By using the median age of the cohort (50 years) as a cutoff point, age was found to be a strong prognostic factor (P = 0.0036). An age-/stage-adjusted IPI was constructed, the predictive power of which was equal to the stage-adjusted IPI (chi-square test = 44.16) but with different distribution of patients between the risk groups, making the proposed model better suited to identify poor-risk patients. CONCLUSIONS: The data from the current study suggest that the proposed age-/stage-adjusted IPI is the superior IPI-based model in predicting outcome in younger patients with localized DLBCL.