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PubMedDate not supplied

A randomized multicentre trial of insulin glargine compared with NPH insulin in people with type 1 diabetes.

BACKGROUND: To compare insulin glargine with NPH human insulin for basal insulin supply in adults with type 1 diabetes. METHODS: People with type 1 diabetes (n = 585), aged 17-77 years, were randomized to insulin glargine once daily at bedtime or NPH insulin either once- (at bedtime) or twice-daily (in the morning and at bedtime) according to their prior treatment regimen and followed for 28 weeks in an open-label, multicentre study. Both groups continued with pre-meal unmodified human insulin. RESULTS: There was no significant difference between the two insulins in change in glycated haemoglobin from baseline to endpoint (insulin glargine 0.21 +/- 0.05% (mean +/- standard error), NPH insulin 0.10 +/- 0.05%). At endpoint, self-monitored fasting blood glucose (FBG) had decreased similarly in each group (insulin glargine -1.17 +/- 0.12 mmol/L, NPH insulin -0.89 +/- 0.12 mmol/L; p = 0.07). However, people on >1 basal insulin injection per day prior to the study had a clinically relevant decrease in FBG on insulin glargine versus NPH insulin (insulin glargine -1.38 +/- 0.15 mmol/L, NPH insulin -0.72 +/- 0.15 mmol/L; p < 0.01). No significant differences in the number of people reporting >or=1 hypoglycaemic episode were found between the two groups, including severe and nocturnal hypoglycaemia. Insulin glargine was well tolerated, with a similar rate of local injection and systemic adverse events versus NPH insulin. CONCLUSIONS: A single, bedtime, subcutaneous dose of insulin glargine provided a level of glycaemic control at least as effective as NPH insulin, without an increased risk of hypoglycaemia.

Adolescent↗

PubMed2001

Attempted and completed suicide in older subjects: results from the WHO/EURO Multicentre Study of Suicidal Behaviour.

OBJECTIVE: The authors present an analysis of findings for the 65 years and over age group from the WHO/EURO Multicentre Study of Suicidal Behaviour (1989-93). METHODS: Multinational data on non-fatal suicidal behaviour is derived from 1518 subjects in 16 European centres. Local district data on suicide were available from 10 of the collaborating centres. RESULTS: Stockholm (Sweden), Pontoise (France) and Oxford (UK) had the highest suicide attempts rates. In most centres, the majority of elderly who attempted suicide were widow(er)s, often living alone, who used predominantly voluntary drug ingestion. Non-fatal suicidal behaviour decreased with increasing age, whereas suicide rates rose. The ratio between fatal and non-fatal behaviours was 1:2, that for males/females almost 1:1. In the years considered, substantial stability in suicide and attempted suicide rates was observed. As their age increased, suicidal subjects displayed only a limited tendency to repeat self-destructive acts. Moreover, there was little correlation between attempted suicide and suicide rates, which carries different clinical implications for non-fatal suicidal behaviour in the elderly compared with younger subjects in the same WHO/EURO study.

Age Distribution↗

PubMedDate not supplied

Multicentric squamous-cell carcinoma of the upper aerodigestive tract.

In an attempt to define the true frequency of multiple primary squamous-cell carcinomas of the upper aerodigestive tract, 3 separate population groups were studied. The results of this investigation confirmed the high incidence of multicentric carcinomas in the upper aerodigestive tract, lung, and esophagus. The clinical significance of this phenomenon is discussed, particularly its effect on patient survival and its possible relationship to local tumor recurrence. The value of routine panendoscopy in the initial assessment is stressed as well as the need for a lifelong follow-up of these patients.

Carcinoma, Squamous Cell↗

PubMedDate not supplied

Sequential versus alternating chemotherapy for high grade non-Hodgkin's lymphomas: a randomized multicentre trial.

In a multicentre phase III trial 146 previously untreated patients with high grade non-Hodgkin's lymphomas stage II-IV were randomized to receive either four cycles of CHOEP (cyclophosphamide 750 mg/m2 iv d 1, doxorubicin 50 mg/m2 iv d 1, vincristine 2 mg iv d 1, etoposide 100 mg/m2 iv d 3-5, prednisolone 100 mg po d 1-5) (treatment arm A), or four cycles of chemotherapy with hCHOP (cyclophosphamide 1200 mg/m2 iv d 1, doxorubicin 40 mg/m2 iv d 1 + 2, vincristine 2 mg iv d 1, prednisolone 100 mg po d 1-5) alternating with IVEP (ifosfamide 1500 mg/m2 iv d 1-5, vindesine 3 mg/m2 iv d 1, etoposide 120 mg/m2 iv d 3-5, prednisolone 100 mg po d 1-5) (treatment arm B). After four cycles of chemotherapy an involved field irradiation with a total dose of 35 Gy was given to all patients in complete or partial remission without persisting extranodal disease. A complete response (CR) was seen in 124/146 patients (86 per cent) with 87 per cent CR in arm A versus 83 per cent CR in arm B. During a median follow-up of 17 months (range 2-40) 30 patients relapsed (16 patients arm A, 14 patients arm B). The overall survival at 40 months is projected to be 71 per cent versus 70 per cent for arm A and B, respectively. Disease-free survival is projected to be 68 per cent in arm A and 59 per cent in arm B at 40 months. So far, the differences in CR, survival and disease-free survival are not statistically significant.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

PubMed2003

Fluvoxamine as effective as clomipramine against symptoms of severe depression: results from a multicentre, double-blind study.

BACKGROUND: Although selective serotonin reuptake inhibitors (SSRIs) are better tolerated than tricyclic antidepressants, their efficacy in severe depression remains to be further elucidated. METHOD: A double-blind, multicentre study was conducted in 86 severely depressed inpatients (>or= 25 on the 17-item Hamilton depression rating scale [HAMD] total score) to compare the efficacy and safety of fluvoxamine with that of clomipramine. Following placebo run-in, 86 patients were randomised to receive fluvoxamine or clomipramine (100-250 mg/day) for 8 weeks. RESULTS: Fluvoxamine and clomipramine both resulted in marked improvements; there were no statistically significant differences between them on the 17-item HAMD total score, the clinical global impression severity of illness or global improvement items or the Montgomery-Asberg depression rating scale, at any visit. At the end of the study, 71% in the fluvoxamine group and 69% in the clomipramine group were responders (>or= 50% decrease in 17-item HAMD total score). However, fluvoxamine was better tolerated than clomipramine. Clomipramine was associated with a higher incidence of overall and treatment-related adverse events. In addition, the percentage of patients discontinued prematurely due to adverse events was more than twice as high with clomipramine than with fluvoxamine (24% vs 11%). CONCLUSION: Fluvoxamine and clomipramine are equally effective in severe depression, but fluvoxamine has a better safety and tolerability profile.

Adult↗

PubMed2006

Occupational factors and risk of adult bone sarcomas: a multicentric case-control study in Europe.

We investigated the association between occupational factors and risk of bone sarcoma, a rare tumor with a largely unknown aetiology. A multicentric case-control study was conducted in 7 European countries in 1995-97. Ninety-six cases aged 35-69 years with a centrally reviewed diagnosis of bone sarcoma (68 chondrosarcomas and 28 osteosarcomas) were compared to 2,632 population (68%) or colon cancer (32%) controls. Subjects were interviewed to obtain information on occupational, medical and reproductive history, smoking and alcohol consumption and selected exposures including use of pesticides. Response proportions were 90% among cases and 66% among controls. Odds ratios (OR) and 95% confidence intervals (CI) were estimated for selected categories of job titles and branches of industry and for use of pesticides. We found an increased OR for bone sarcoma among blacksmiths, toolmakers, machine-tool operators (OR = 2.14, 95% CI 1.08-4.26), woodworkers (OR = 2.68, 95% CI 1.36-5.29) and construction workers (OR = 1.62, 95% CI 0.92-2.87). Ever users of pesticide had an OR of 2.33 (95% CI 1.31-4.13), with similar risks for exposure to insecticides and exposure to herbicides. Neither duration of employment in any of the analyzed occupational categories nor duration of use of pesticides showed an increasing trend in the risk of bone sarcoma. ORs of bone sarcoma were 1.03 (95% CI 0.23-4.57), 3.13 (95% CI 1.26-7.76) and 1.44 (95% CI 0.43-4.85) for the first, second and third tertile of days of use of pesticides. Our study suggests that novel and previously reported (woodworking) occupational factors play a role in the aetiology of bone sarcomas.

Adult↗

PubMed1995

Clinical validation of the new ELSA-CA 125 II assay: report of a European multicentre evaluation.

The ELSA-CA 125 II is a second-generation radioimmunoassay for the quantification of CA 125 in serum. In a multicentre study involving 49 follow-ups of patients with ovarian cancers, and 880 other patients, 2.8% of healthy persons, 25% of 149 patients with benign gynaecological diseases and 39% of 82 patients with benign non-gynaecological diseases had CA 125 levels above 35 U/ml. Using the 35 U/ml cut-off, sensitivities among epithelial ovarian cancers were found to be 85% in serous tumors, 41% in mucinous tumors and 83% in other types. During follow-up of patients with serous ovarian cancers, we observed an equivalent behaviour of both assays--first- and second-generation--with the clinical evolution. We also compared results obtained with other assays commercially available; these were significantly different when a polyclonal antibody was used in the sandwich assay.

Adolescent↗

PubMed2002

Quantification of human herpesvirus 8 by real-time PCR in blood fractions of AIDS patients with Kaposi's sarcoma and multicentric Castleman's disease.

Few studies have assessed human herpesvirus 8 (HHV8) viremia levels in different HHV8-related pathologies, using sensitive and reproducible molecular assays. Our objective was to compare the HHV8 DNA load in serial blood samples (collected every 3 months for 1 year) from acquired immunodeficiency syndrome (AIDS) patients with Kaposi's sarcoma (KS) and multicentric Castleman's disease (MCD). The HHV8 viral load was determined in both peripheral blood mononuclear cells (PBMC) and plasma fractions, using a competitive real-time polymerase chain reaction (PCR) assay developed in a LightCycler instrument (Roche Diagnostics). In six subjects with limited or extensive KS while on highly active antiretroviral therapy, the HHV8 DNA load was either undetectable (<50 copies/10(5) cells) or low (</=135 copies) in all PBMC samples. In contrast, the cellular HHV8 load was >1,000 copies in at least one of the samples from the two subjects with both KS and MCD. HHV8 DNA was detected in plasma only when the cellular viral load was >10,000 copies/10(5) cells. After chemotherapy, the HHV8 DNA load became undetectable in the MCD patients despite no changes in CD4 T-cell counts or highly active antiretroviral therapy (HAART) regimens. These results suggest that the pathogenesis of the two HHV8-associated diseases (i.e., KS and MCD) might be different, as only the latter was associated with important viremia in our patients.

AIDS-Related Opportunistic Infections↗

PubMed2003

Multicentric Castleman's disease treated with antivirals and immunosuppressants.

A patient negative for human immunodeficiency virus (HIV) developed multicentric Castleman's disease (MCD) and Kaposi's sarcoma (KS) associated with active human herpesvirus 8 (HHV-8) infection. He was treated with sequential antiviral therapy, chemotherapy, and corticosteroids. HHV-8 levels were monitored throughout the course of the patient's illness, and were found to rise on relapse. No consistent change in HHV-8 levels was found with antiviral therapy. We demonstrate that in this patient antiviral therapy was clinically ineffective, and did not alter HHV-8 levels, but that corticosteroid and combination chemotherapy led to clinical improvement. Despite the implication of HHV-8 as a cause of MCD, few studies have correlated HHV-8 levels with clinical response.

Aged↗

PubMed2003

Risk factors for multicentric occurrence of carcinoma in the upper aerodigestive tract-analysis with a serial histologic evaluation of the whole resected-esophagus including carcinoma.

BACKGROUND AND OBJECTIVES: We have reported that both lifestyle and family history might be related to multiplicity of carcinoma in the upper aerodigestive tract (UADT). The aim of this study was to elucidate the relationship between the number of carcinomas and risk factors. METHODS: A serial histologic evaluation of the entire non-irradiated esophagus was performed in 114 males with esophageal cancer who were divided into three groups (group I: 88 cases with solitary cancer, group II: 11 with double cancers, group III: 15 with three or more cancers). As controls, 228 males with benign diseases were selected. RESULTS: Among group III patients, both the incidence of heavy smoking and that of heavy drinking were 67% and 60%, which were significantly higher than those of group I (28% and 30%) and control subjects (14% and 10%, respectively). Heavy drinkers who were also heavy smokers were observed in 2, 10, 27, and 47% in control subjects, groups I, II, and III, respectively. Regarding family history, 27% of group III had a close relative with UADT or lung cancer, while the incidence was 7% in the control. CONCLUSIONS: These findings strongly support the hypothesis that heavy smoking and heavy drinking, as well as a family history of both UADT and lung cancer, might be risk factors for multicentric occurrence of UADT cancer.

Aged↗

PubMed1990

Multicentric adult secretory breast carcinoma: DNA flow cytometric findings, prognostic features, and review of the world literature.

A case of multicentric secretory breast carcinoma in a 39-year-old white female is described. Mammograms, DNA analysis, touch preparation cytology, and positive estrogen receptors are reported for the first time in this rare favorable mammary carcinoma. A review of the 33 reported cases with follow-up in adult females, including the present case, has revealed lymph node metastases in nine (27%), recurrence in four (12%), and distant metastases leading to death in two cases (6%). In patients treated with less than simple mastectomy there has been local recurrence in 4 (33%) of 12 cases and in three of the four cases (75%) greater than or equal to 2.0 cm. Increased size and lack of gross circumscription of the neoplasm and presentation in the adult age group appear to identify cases with an increased risk of disease progression. In patients over 20 years old, especially with neoplasms greater than 2 cm in diameter, modified radical mastectomy has to date achieved the most favorable outcome. Minimal experience (two cases) is available regarding treatment with limited surgery and radiation therapy, and there is no available data regarding possible benefit from adjuvant chemotherapy.

Adult↗

PubMed1985

Acute and chronic hepatitis in childhood leukemia: a multicentric study from the Italian Pediatric Cooperative Group for Therapy of Acute Leukemia (AIL-AIEOP).

The incidence of acute and chronic liver damage and its relation to hepatitis B virus (HBV) infection was evaluated in 164 consecutive children with acute leukemia seen in ten Italian hemato-pediatric units. Thirteen out of 164 children (7.9%) had acute hepatitis (AH) during treatment, while 8/90 (8.8%) showed an acute exacerbation of liver damage within 6 months after therapy withdrawal. Seven of the 13 children with AH while on therapy were HBsAg positive. In 12/13 cases, liver disease progressed to chronicity. Five of eight children who developed AH after completion of treatment were HBsAg positive. Eighty-nine patients (54.2%) developed biochemical evidence of chronic hepatitis during therapy; 48/89 were followed after cessation of treatment and 33 of them showed persisting evidence of liver cell necrosis. Thirty-three out of 133 children (24.8%) tested for serum HBsAg were found positive: 26 (78.7%) of them developed chronic hepatitis. Sixty-four out of 133 patients were evaluated after cessation of treatment: Chronic hepatitis persisted in 16/22 HBsAg-positive (72.7%) and in 17/42 HBsAg-negative (40.4%) children during follow-up. The outcome of these liver diseases after treatment withdrawal did not differ significantly in relation to HBV serology, suggesting that viral rather than toxic agents were responsible for liver damage also in most HBsAg-negative patients. The high incidence of chronic HBV infection in children with leukemia found in this multicentric study could suggest a need for active immunization with HBV vaccine, but the efficacy of such approach in this clinical setting is still to be validated.

Acute Disease↗

PubMed1985

Multicentric reticulohistiocytosis and cancer: a case report and review of the literature.

Multicentric reticulohistiocytosis (MR) is a syndrome characterized by papulonodular skin lesions, a debilitating polyarthritis, and characteristic histologic findings. It is a rare disorder with only 82 cases reported. Twenty-eight percent had an associated neoplasm. Hematologic malignancies (four) and neoplasms arising from the breast (four), cervix (three), stomach (three), ovary (two), colon (two), lung (one), pleura (one), and from an unknown source (two) were all seen associated with MR. Eleven cases (including our own) were available for review. The papulonodular skin involvement was the initial manifestation (alone or concurrent with the polyarthritis) in 90% of our cases. The diagnosis of MR preceded that of the associated neoplasm in 73% of the cases. A case report is presented illustrating the relapse of MR before the clinical relapse of the associated tumor, and the response of both the tumor and MR to combination chemotherapy with cyclophosphamide, methotrexate, 5-fluorouracil, and prednisone when prednisone and aspirin alone failed to relieve the symptoms of MR. Steroids were not beneficial in the patients reviewed. The best management of MR associated with a neoplasm is the best management of the primary neoplasm. Cytotoxic chemotherapy including cyclophosphamide should be considered if there is progression of the MR in order to control the symptoms of MR and prevent a progressive debilitating arthritis.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1989

Leukemic infiltration of the eye: results of therapy in a retrospective multicentric study.

A multicentric retrospective study on leukemic ophthalmopathy (LO) is reported, including 38 patients (21 males, 17 females) with acute leukemia (AL) observed from 1976 to 1985. LO developed in four patients at the time of diagnosis of AL; ten were in first complete remission (eight off therapy), 12 in second remission, and 12 in combined relapse. The children were treated according to different schedules of systemic and intrathecal chemotherapy with or without radiotherapy (RT) of the affected eye. Ocular remission occurred in 32 of 38 patients, but with subsequent ocular relapse in six of the 32. Complete remission after LO treatment lasting for more than 24, 30, 40, and 78 months was observed in four of the ten children with isolated LO in first AL marrow remission. The authors concluded that systemic and intrathecal chemotherapy probably is associated with RT (at least 30 Gy to the affected eye). Aggressive treatment is justified because children with isolated ocular relapse can still be cured.

Adolescent↗

PubMed2003

Determination of the molecular relationship between multiple tumour nodules in hepatocellular carcinoma differentiates multicentric origin from intrahepatic metastasis.

The purpose of this study was to determine the molecular relationship between multiple tumour nodules in hepatocellular carcinoma (HCC) within individual patients and to evaluate their clonality, which may bear prognostic significance. In 25 HCC nodules from 11 patients with multiple HCCs, the clonal relationships of the nodules within individual patients were determined using DNA fingerprinting with loss of heterozygosity (LOH) assay, comparative genomic hybridization (CGH), and hepatitis B virus (HBV) integration pattern. Both LOH assay and CGH indicated that in four (36%) of the 11 patients, the multiple HCCs had different clonalities and hence were of multicentric origin, whereas in the remaining seven (64%) patients, the multiple HCCs had similar clonal relationships and were intrahepatic metastases. In selected cases, the HBV integration pattern helped to confirm the clonality results. Gross appearance, size, location, and histology of the tumours could not accurately predict their clonal origin in every case. Assessment of DNA alterations allows precise determination of the clonality of multiple HCCs within one patient. Of these molecular methods, LOH analysis can be used to evaluate tumour clonality in most patients even before surgical resection, since this assay can be readily applied routinely to either liver biopsies or fine needle aspirates.

Adult↗

PubMed2004

Modelling clustered survival data from multicentre clinical trials.

In randomized clinical trials, subjects are recruited at multiple study centres. Factors that vary across centres may exert a powerful independent influence on study outcomes. A common problem is how to incorporate these centre effects into the analysis of censored time-to-event data. We survey various methods and find substantial advantages in the gamma frailty model. This approach compares favourably with competing methods and appears minimally affected by violation of the assumption of a gamma-distributed frailty. Recent computational advances make use of the gamma frailty model a practical and appealing tool for addressing centre effects in the analysis of multicentre trials.

Humans↗

PubMed2006

Analysing multicentre competing risks data with a mixed proportional hazards model for the subdistribution.

In the competing-risks setting, to test the effect of a covariate on the probability of one particular cause of failure, the Fine and Gray model for the subdistribution hazard can be used. However, sometimes, competing risks data cannot be considered as independent because of a clustered design, for instance in registry cohorts or multicentre clinical trials. Frailty models have been shown useful to analyse such clustered data in a classical survival setting, where only one risk acts on the population. Inclusion of random effects in the subdistribution hazard has not been assessed yet. In this work, we propose a frailty model for the subdistribution hazard. This allows first to assess the heterogeneity across clusters, then to incorporate such an effect when testing the effect of a covariate of interest. Based on simulation study, the effect of the presence of heterogeneity on testing for covariate effects was studied. Finally, the model was illustrated on a data set from a registry cohort of patients with acute myeloid leukaemia who underwent bone marrow transplantation.

Bone Marrow Transplantation↗

PubMed2007

Relative efficiency of unequal versus equal cluster sizes in cluster randomized and multicentre trials.

Cluster randomized and multicentre trials evaluate the effect of a treatment on persons nested within clusters, for instance, patients within clinics or pupils within schools. Optimal sample sizes at the cluster (centre) and person level have been derived under the restrictive assumption of equal sample sizes per cluster. This paper addresses the relative efficiency of unequal versus equal cluster sizes in case of cluster randomization and person randomization within clusters. Starting from maximum likelihood parameter estimation, the relative efficiency is investigated numerically for a range of cluster size distributions. An approximate formula is presented for computing the relative efficiency as a function of the mean and variance of cluster size and the intraclass correlation, which can be used for adjusting the sample size. The accuracy of this formula is checked against the numerical results and found to be quite good. It is concluded that the loss of efficiency due to variation of cluster sizes rarely exceeds 10 per cent and can be compensated by sampling 11 per cent more clusters.

Cluster Analysis↗