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At least 919 records · Page 51Linked to original sources
PubMed1998

Cytogenetic analysis of hepatoblastoma: hypothesis of cytogenetic evolution in such tumors and results of a multicentric study.

Hepatoblastoma is a rare pediatric malignant tumor of the liver. Previous cytogenetic reports are sporadic. We karyotyped nine consecutive hepatoblastomas from the Italian centers participating in a multicentric study on hepatic tumors (SIOPEL 1). Six cases showed abnormal karyotypes. The most common abnormalities were trisomies of chromosomes 2 and 20. Four cases showed abnormalities of chromosome 1. On the basis of findings, we speculate the possibility of a cytogenetic evolutive pattern of hepatoblastomas.

Child, Preschool↗
PubMed2000

Lessons from a multicentre study of the detectability of viral genomes based on a two-round quality control of GB virus C (GBV-C)/hepatitis G virus (HGV) polymerase chain reaction assay.

The aim of this study was to determine whether multicentre quality controls for the detectability of viral genomes could contribute to the improvement of diagnostic performance in the participating laboratories. The study was carried out during two successive rounds, during which 18 laboratories specialized in nucleic acid testing analyzed, through a polymerase chain reaction (PCR) assay, a common panel of GB virus C (GBV-C)/hepatitis G virus (HGV) RNA-positive and -negative samples. During the first round, the laboratories used either an 'in-house' PCR procedure or a partly standardized commercial test. After decoding the results of the first round, the procedures of the participating laboratories were compared in order to establish a consensus procedure deduced from those of the laboratories which provided the best results. During the second round, each participating laboratory could use the resulting consensus procedure, or its own procedure, or both. The results of this quality control study indicated that, whatever method used, even specialized and trained laboratories may give false-negative or false-positive results. The commercial assay did not guarantee a systematic high quality level of results. The striking heterogeneity of results observed among laboratories using the same commercial assay confirm that molecular biology methods need skilled technicians. The results of this quality control study suggest that full standardization of viral genome detection, including all steps of the procedure, is necessary and that the laboratories performing PCR should participate in repeated quality control studies, whatever technique is being used.

Flaviviridae↗
PubMed1999

Safety of oral propafenone in the conversion of recent onset atrial fibrillation to sinus rhythm: a prospective parallel placebo-controlled multicentre study.

AIM: Oral propafenone is effective in restoring sinus rhythm however the proarrhythmic effects are still unknown. The Safety Antiarrhythmic Therapy Evaluation (SATE) trial was a prospective randomized placebo-controlled multicentre study which evaluated the safety of acute oral loading dose of propafenone in patients with recent onset atrial fibrillation. Secondary end-points were to evaluate the effect of digitalis added to propafenone in ventricular rate control and the efficacy of propafenone alone or added to digitalis compared with efficacy of digitalis plus quinidine. METHODS AND RESULTS: 246 patients (126 male; 58+/-11 years) with atrial fibrillation of <48 h duration were randomly allocated to one of four groups: digitalis 0.75-1 mg i.v. plus quinidine 1100 mg (D+Q, 70 patients); propafenone 450-600 mg orally (PNF, 66 patients); propafenone 450-600 mg orally plus digitalis 0.750-1 mg i.v. (PNF+D, 70 patients); placebo (Pl, 40 patients). All patients underwent 24-h ECG Holter monitoring. Safety was assessed by evaluating the appearance of adverse events classified as mild, moderate and severe. No severe adverse events were reported. Short lasting asymptomatic atrial flutter episodes with atrio-ventricular conduction > or =2:1 were observed in 14% of the D+Q group, 21% PNF, 18% PNF+D and in 8% Pl. One patient in the D+Q group and four in the PNF+D group showed asymptomatic runs of 3-4 ventricular ectopic beats. Reversible sinus atrial blocks (<3 s) were detected in two patients of the D+Q group and in two of the PNF group. In patients with persistent atrial fibrillation the ventricular rate was similar in the four study groups. At 3 h the high efficacy of propafenone was confirmed. At the 24th hour no differences were found between active treatment and placebo arms. CONCLUSION: Propafenone in a single oral loading dose is safe and promptly effective in patients with recent onset atrial fibrillation.

Administration, Oral↗
PubMed2000

Three-dimensional dose distribution of tangential breast irradiation: results of a multicentre phantom dosimetry study.

BACKGROUND AND PURPOSE: One aspect of good radiotherapeutic practice is to achieve dose homogeneity. Dose inhomogeneities occur with breast tangent irradiation, particularly in women with large breasts. MATERIALS AND METHODS: Ten Australian radiation oncology centres agreed to participate in this multicentre phantom dosimetry study. An Alderson radiation therapy anthropomorphic phantom with attachable breasts of two different cup sizes (B and DD) was used. The entire phantom was capable of having thermoluminescent dosimeters (TLD) material inserted at various locations. Nine TLD positions were distributed throughout the left breast phantom including the superior and inferior planes. The ten centres were asked to simulate, plan and treat (with a prescription of 100 cGy) the breast phantoms according to their standard practice. Point doses from resultant computer plans were calculated for each TLD position. Measured and calculated (planning computer) doses were compared. RESULTS: The dose planning predictability between departments did not appear to be significantly different for both the small and large breast phantoms. The median dose deviation (calculated dose minus measured dose) for all centres ranged from 2. 3 to 5.3 cGy on the central axis and from 2.1 to 7.5 cGy for the off-axis planes. The highest absolute dose was measured in the inferior plane of the large breast (128.7 cGy). The greatest dose inhomogeneity occurred in the small breast phantom volume (median range 93.2-105 cGy) compared with the large breast phantom volume (median range, 100.1-107.7 cGy). There was considerable variation in the use (or not) of wedges to obtain optimized dosimetry. No department used 3D compensators. CONCLUSION: The results highlight areas of potential improvement in the delivery of breast tangent radiotherapy. Despite reasonable dose predictability, the greatest dose deviation and highest measured doses occurred in the inferior aspects of both the small and large breast phantoms.

Breast Neoplasms↗
PubMed2003

Radiotherapy with or without mitomycin c in the treatment of locally advanced head and neck cancer: results of the IAEA multicentre randomised trial.

BACKGROUND AND PURPOSE: Single agent mitomycin c (MMC) has been shown to improve the outcome of radiotherapy in single institution trials. In order to confirm these findings in a broader worldwide setting, the International Atomic Energy Agency (IAEA) initiated a multicentre trial randomising between radiotherapy alone versus radiotherapy plus MMC. MATERIAL AND METHODS: Patients with advanced head and neck cancer were treated with primary curative radiotherapy (66 Gy in 33 fractions with five fractions per week) +/-a single injection (15 mg/m(2)) of MMC at the end of the first week of radiotherapy. Stratification parameters were tumour localization, T-stage, N-stage, and institution. A total of 558 patients were recruited in the trial from February 1996 to December 1999. Insufficient accrual and reporting led to the exclusion of three centres. The final study population consisted of 478 patients from seven centres. Patients had stage III (n=223) or stage IV (n=255) squamous cell carcinoma of the oral cavity (n=230), oropharynx (n=140), hypopharynx (n=65) or larynx (n=43). Prognostic factors like age, gender, site, size, differentiation and stage were well balanced between the two arms. RESULTS: The haematological side effects of MMC were very modest (<5% grade 3-4) and did not require any specific interventions. Furthermore, MMC did not enhance the incidence or severity of acute and late radiation side effects. Confluent mucositis and dry skin desquamation was common, occurring in 56% and 62% of patients, respectively. The overall 3-year primary locoregional tumour control, disease-specific and overall survival rates were 19, 36 and 30%, respectively. Gender, haemoglobin drop, tumour site, tumour and nodal stage were significant parameters for loco-regional tumour control. There was no significant effect of MMC on locoregional control or survival, except for the 161 N0 patients, where MMC resulted in a better loco-regional control (3-year estimate 16% vs. 29%, P=0.01). CONCLUSIONS: The study did not show any major influence of MMC on loco-regional tumour control, survival or morbidity after primary radiotherapy in stage III-IV head and neck cancer except in N0 patients where loco-regional control was significantly improved.

Adult↗
PubMed1997

A randomised multicentre trial of CHART versus conventional radiotherapy in head and neck cancer.

BACKGROUND AND PURPOSE: Continuous, hyperfractionated, accelerated radiotherapy (CHART) has shown promise of improved tumour control and reduced late morbidity in pilot studies and has now been tested in a multicentre randomised controlled clinical trial. MATERIAL AND METHODS: Patients with squamous cell cancer in the main sites within the head and neck region with the general exception of early T1 N0 tumours were entered into the study by 11 centres. There was a 3:2 randomisation to either CHART, where a dose of 54 Gy was given in 36 fractions over 12 days, or to conventional therapy where 66 Gy was given in 33 fractions over 6.5 weeks. A total of 918 patients were included over a 5 year period from March 1990. RESULTS: ACUTE MORBIDITY: Acute radiation mucositis was more severe with CHART, occurred earlier but settled sooner and was in nearly all cases healed by 8 weeks in both arms. Skin reactions were less severe and settled more quickly in the CHART treated patients. TUMOUR CONTROL AND SURVIVAL: Life table analyses of loco-regional control, primary tumour control, nodal control, disease-free interval, freedom from metastasis and survival showed no evidence of differences between the two arms. In exploratory subgroup analyses there was evidence of a greater response to CHART in younger patients (P = 0.041) and poorly differentiated tumours appeared to fare better with conventional radiotherapy (P = 0.030). In the larynx there was evidence of a trend towards increasing benefit with more advanced T stage (P = 0.002). LATE TREATMENT RELATED MORBIDITY: Osteoradionecrosis occurred in 0.4% of patients after CHART and 1.4% of patients after conventional radiotherapy. The incidence of chondritis or cartilage necrosis was similar in both arms. Life table analysis showed evidence of reduced severity in a number of late morbidities in favour of CHART. These were most striking for skin telangiectasia, superficial and deep ulceration of the mucosa and laryngeal oedema. CONCLUSION: Similar local turnout control was achieved by CHART as compared with conventional radiotherapy despite the reduction in total dose from 66 to 54 Gy supporting the importance of repopulation as a cause of radiation failure. The effects seen in advanced laryngeal cancer and those related to histological differentiation need further study. Reduced late morbidity is a factor which together with patient preference should be considered in the decision as to the programme of radiotherapy to employ in the curative treatment of head and neck cancer.

Adult↗
PubMed1997

Acarbose in ambulatory treatment of non-insulin-dependent diabetes mellitus associated to imminent sulfonylurea failure: a randomised-multicentric trial in primary health-care. Diabetes and Acarbose Research Group.

To assess the efficacy and safety of acarbose as an adjunct to high sulfonylurea (SU) doses in patients with imminent SU failure, a randomised, multicentric, 6 month double-blind, parallel and placebo-controlled trial was performed in primary healthcare. Entry criteria were: NIDDM patients in concomitant dietary follow-up, age > 40 year-old, more than 3 years of diagnosed diabetes, baseline HbAlc levels between 8-12% (N: 4-6%), stable body mass index < 35 kg m-2 and glibenclamide daily dose > 10 mg. After 1 month placebo run-in period all patients were randomly allocated into two groups of treatment (acarbose 100 mg t.i.d. vs placebo). HbAlc levels, the main efficacy variable, lipid profile, fasting and postprandial blood glucose levels were performed and adverse events were also recorded. A total number of 65 patients were randomised, 36 in acarbose and 29 in a placebo group. No statistical differences were found on age (60.2/61.7 year-old), BMI (28.7/27.4 kg m-2), glibenclamide dose (14.5/14.0 mg/day) and baseline HbAlc (9.0/8.8%). Acarbose-treated patients significantly reduced HbAlc levels (9.0/7.9 vs 8.8/8.5%; P < 0.01), based upon a marked decrease, but statistically not significant, in mean postprandial plasma glucose levels (11.9/9.6 vs 12.4/11.1 mmol l-1). No significant differences between fasting plasma glucose and lipid profile were detected. A total of 31 patients (47.7%) reported adverse events, 20 (55.5%) and 11 (37.9%) in acarbose and placebo treatment group respectively. Relationship with drug was estimated as possible or probable in 16 (44.4%) of acarbose-treated patients. None of them were excluded from study participation due to insulin requirement. Only seven patients (10.7%), six with acarbose (16.6%) and one with placebo (3.8%), withdrew the study because of the adverse events. Thus, acarbose seems to be a useful option in order to improve HbAlc levels in non-insulin-dependent diabetes mellitus with imminent sulfonylurea failure.

Acarbose↗
PubMed1998

Effects of acarbose (Glucobay) in persons with type 1 diabetes: a multicentre study.

The aim of this multicentre study was to investigate the effect--in everyday life--of long term administration of acarbose on parameters of glycaemic control, daily insulin requirements, lipid parameters and tolerability in ambulant type 1 diabetic subjects insufficiently controlled with diet and insulin. Furthermore, effects on lipid parameters were to be studied. A total of 16 patients withdrew from the study, 13 of these during the acarbose medication period. For four of these 13 patients the adverse event started during the placebo run-in period. The data of 62 patients (35 men and 27 women, mean age 38 (range 18-64) years, median duration of diabetes 10 (range 1-40) years) were valid for statistical analysis. The median daily dose of acarbose at the final assessment (i.e. after 16 weeks of active treatment) was 200 (range 75-300) mg. During the placebo run-in period HbA1c levels tended to decrease from 8.9 +/- 1.1 to 8.5 +/- 0.9%. After 8 and 16 weeks of acarbose treatment the mean level had decreased further to 8.1 +/- 0.9 and 8.2 +/- 0.9%, respectively (both P < 0.001). After stopping acarbose HbA1c levels increased again to a mean level of 8.6 +/- 0.9%. Mean levels of HbA1c per centre followed the same profile. Seven-point blood glucose profiles followed the same pattern. None of these changes over time reached statistical significance except for a significant drop during acarbose treatment of the time-point 90 min after lunch (P < 0.01). After stopping acarbose treatment values returned to pre-study levels. For total cholesterol, HDL-cholesterol, triglycerides, Apo A1 and Apo B, and Lp(a) no significant changes were observed. Daily insulin dose was 48 (range 26-92) U at the start of the study and did not change. The most frequent reported adverse events were flatulence (43%), diarrhoea (27%), and abdominal pain (11%). We conclude that acarbose up to 3 x 100 mg/day can be a valuable adjunct to insulin in improving metabolic control in persons with type 1 diabetes.

Acarbose↗
PubMed2003

Diagnosis of intrahepatic metastasis and multicentric carcinogenesis by microsatellite loss of heterozygosity in patients with multiple and recurrent hepatocellular carcinomas.

BACKGROUND/AIMS: The prognosis of hepatocellular carcinoma (HCC) is poor because of frequent intrahepatic metastasis (IM) or multicentric carcinogenesis (MC). We compared the effectiveness of loss of heterozygosity (LOH) analysis in the diagnosis of these two forms with that of histopathological diagnosis. METHODS: Using LOH analysis of 15 specific DNA microsatellite loci, tumor clonality was assessed in 37 cases. RESULTS: LOH was observed in 30% of seven solitary tumors. According to these results, the selected threshold to diagnose MC was a difference in the LOH status at more than 30% of the analyzed loci, when comparing two samples in the same liver. In nine multiple HCCs, identical genetic and histopathological diagnoses were found in four (IM: 2, MC: 2). Of 21 recurrent tumors, 19 showed LOH for at least one marker. IM and MC were genetically diagnosed in five and ten patients, respectively. Genetic and histopathological diagnoses were identical in ten of 19 patients (IM: 5. MC: 5). Five genetic MC were histopathologically diagnosed as IM (3) and 'undetermined' (2). CONCLUSIONS: Genetic diagnosis by LOH analysis may be more strict and specific than histopathological diagnosis in the differential diagnosis of IM and MC.

Adult↗
PubMed2001

Gemcitabine plus vinorelbine in stage IIIB or IV non-small cell lung cancer (NSCLC): a multicentre phase II clinical trial.

A phase II study in patients with stage IIIB/IV non-small cell lung cancer (NSCLC) was carried out to evaluate the clinical activity and toxicity of the chemotherapeutic combination of gemcitabine+vinorelbine (GEM/VNR). Forty-five patients (40 male, 5 female) with a median age of 67 years (range 37-73) and a median ECOG performance status of 1 (range 0-2) were enrolled into the trial. Twenty patients had stage IIIB (two positive supraclavicular nodes and 20 cytologically positive pleural effusion), and 25 had stage IV NSCLC. GEM 1000 mg/m(2) diluted in 250 cc(3) of normal saline was administered iv on days 1, 8, and 15, while VNR was given 30 mg/m(2) on days 1 and 8 every 4 weeks. The median number of courses/patient was 4 (range 3-7). According to an intent-to-treat analysis 2 (4%) patients had a complete response and 16 (36%; 95% CL 22-52%) had a partial response for an overall response rate of 40% (95% CL 26-56%). Twelve (27%) patients had stable disease and 15 (33%) were considered as treatment failures. Median overall survival of the whole series was 8+ months with 33% of patients alive at 1 year. Toxicity was generally mild. WHO grade 3-4 neutropenia was recorded in 22% of cases, grade 1-3 liver toxicity in 6% of patients and neutropenia-unrelated fever in 9%. This multicentre phase II study suggests that the GEM/VNR combination regimen is an active and well tolerated regimen in patients with stage IIIB/IV NSCLC. Larger studies comparing cisplatin-based regimens to new schedules without cisplatin are warranted.

Adult↗
PubMed2002

Carboplatin plus vinorelbine plus G-CSF in elderly patients with extensive-stage small-cell lung cancer: a poorly tolerated regimen. Results of a multicentre phase II study.

PURPOSE AND METHODS: A multicentre phase II trial (single-stage design) was undertaken to test the activity and toxicity of carboplatin (AUC 5 according to Calvert, day 1) plus vinorelbine (25 mg/m(2) days 1 and 8) with lenograstim support, every 3 weeks in the first line treatment of elderly patients, aged 65 or more, affected by extensive small-cell lung cancer (SCLC). The primary end-point of the trial was the objective response rate. Twenty-three responses among 37 patients were considered necessary to proceed to a phase III trial. RESULTS: Twenty-eight patients were enrolled (median age 70 years). Treatment was remarkably toxic. Three patients died while on treatment. Eleven patients (39.3%, 95% exact confidence interval (CI): 21.5-59.4) had an objective response, that was complete in 2 cases. Median time to progression was 5.1 months (95% CI: 3.3-6.7). Median survival was 7.9 months (95% CI: 4.8-14.4). CONCLUSION: Carboplatin plus vinorelbine is poorly tolerated and not sufficiently active to warrant phase III comparison with standard chemotherapy regimens in elderly patients with extensive SCLC.

Aged↗
PubMed2003

Three-week schedule of irinotecan and cisplatin in advanced non-small cell lung cancer: a multicentre phase II study.

A phase II multicentre study of a 3-week schedule of irinotecan (CPT-11) and cisplatin providing the highest recommended dose intensity of both agents in combination, was conducted in patients with advanced non-small cell lung cancer (NSCLC). Seventy-four stage IIIB (not suitable for radiotherapy) or stage IV NSCLC patients were enrolled to receive CPT-11 200 mg/m(2) i.v. and cisplatin 80 mg/m(2) i.v. on day 1 every 3 weeks. Relative dose-intensities for CPT-11 and cisplatin were 92 and 95%, respectively. No complete responses were observed. Twenty-five patients out of 73 obtained a partial response (34.2%). Partial responses were confirmed in 18 patients (24.7%: 95% CI, 15.3-36.1%). Median survival overall was 8.2 months, 9.7 months for patients with baseline performance status (PS) 0 and 1, and 4 months for patients with PS 2. The 1-year survival rate was 31%. Major clinical toxicities were grade 3 and 4 delayed diarrhoea (29% of patients) and febrile neutropenia (14% of patients). In conclusion, the present once-every-3-week schedule of CPT-11 and cisplatin is feasible and active in PS 0-1 advanced NSCLC patients, but results do not seem superior to those reported with other schedules.

Adenocarcinoma↗
PubMed1999

Treatment with paclitaxel 1-h infusion and carboplatin of patients with advanced non-small-cell lung cancer: a phase II multicentre trial. Joint Lung Cancer Study Group.

The primary aim of this phase II study was to determine the response rate of a combination of paclitaxel and carboplatin in advanced non-small cell lung cancer (NSCLC) in a multicentre setting. The secondary aim was to determine time to progression (TTP), 1-year survival rate and toxicity. 65 patients were treated and all of them were included in the follow up for survival and toxicity. 60 patients were followed for response rate and time to progression. 55% were stage IV patients and 45% stage IIIB patients. The treatment consisted of paclitaxel 200 mg/m2 given as a 1-h i.v. infusion and carboplatin given as a 30 min i.v. infusion and the latter was dosed by using the Calvert formula at an area under the concentration time curve (AUC) of 5. The glomerular filtration rate (GFR) was determined by iohexol clearance and was not calculated from the serum creatinine level. The chemotherapy courses were given every third week with a maximum number of six or eight courses for patients who responded late. As premedication we used 8 mg betamethasone 40 min prior to infusion and then 10 min later clemastin and cimetidine. One complete response and 18 partial responses were seen giving a response rate of 29%. 40% of the patients progressed during the treatment and 28% had stable disease. The median TTP was 22 weeks. At a minimum follow up of 1 year, the 1-year survival rate was 38% and the median survival rate was 41 weeks. Haematological toxicity was mild with no grade 4 leucopenia and only seven patients (11%) had grade 3 leucopenia. There was no grade 4 toxicity. Grade 3 toxicity was seen as myalgia 5%, allergic reaction 3% and peripheral neuropathy 6%. 15% of the patients had a dose reduction due to neurotoxicity. The haematological toxicity was much milder than we expected, probably because of more exact determination of the GFR. This trial confirms the results of earlier reported trials of the efficacy and the ease of the regimen as an out-patient treatment option in advanced NSCLC. The main problem with this treatment is peripheral neuropathy.

Adult↗
PubMed2003

Multicentric reticulohistiocytosis with pulmonary involvement.

Multicentric reticulohistiocytosis (MRH) is a rare and possibly devastating systemic disorder characterized by tissue infiltration by histiocytes and multinucleated giant cells. The disease commonly involves the skin, joints, and mucous membranes, with the rare involvement of other organ systems. We describe a patient with MRH presenting with papules and nodules on both hands and a rapidly progressive arthritis who may have had pulmonary involvement of the disease.

Aged↗
PubMed1983

Multicentric reticulohistiocytosis with salivary gland involvement and pericardial effusion.

A 60-year-old Palestinian woman developed extensive cutaneous lesions of multicentric reticulohistiocytosis. She also developed a pericardial effusion and involvement of the submandibular salivary glands. Soft tissue gallium images demonstrated this systemic involvement, and this procedure is proposed as a screening method to assess the extent of the disease. The patient showed partial remission after being treated with prednisone, vincristine sulfate, and cyclophosphamide.

Female↗
PubMed1984

Multicentric reticulohistiocytosis.

Multicentric reticulohistiocytosis is a histiocytic disorder affecting primarily skin and joints but occasionally involving other organ systems as well. A case is presented and the disease is reviewed, including discussion of historical, clinicopathologic, radiologic, etiologic, therapeutic, and prognostic aspects.

Adolescent↗
PubMed1986

A case of multicentric reticulohistiocytosis with thyroid involvement.

A case of multicentric reticulohistiocytosis with thyroid involvement is reported. This systemic condition has an unknown cause and is manifested by the development of nodules containing an infiltrate of characteristic histiocytic and multinucleated giant cells in the synovium, skin, subcutaneous tissues, and occasionally bone or other tissues.

Adenocarcinoma↗
PubMed1989

Multicentric reticulohistiocytosis in a child with sclerosing lesion of the leg. Immunohistopathologic studies and therapeutic trial with systemic cyclosporine.

Multicentric reticulohistiocytosis affecting a 13-year-old boy induced a sclerosing change of the leg. The cellular infiltrate comprising activated T lymphocytes and macrophages and human lymphocyte antigen (HLA)-DR expression by keratinocytes in lesional skin all suggest the involvement of cellular immune reactions. We administered systemic cyclosporine but could not obtain a favorable effect without a concomitant low dosage of prednisone.

Adolescent↗