Phyllodes tumours - a retrospective review of 83 clinical cases.

INTRODUCTION: Phyllodes tumours are rare, accounting for 0.3-1.0% of all primary breast tumours. According to biological behaviour, they are divided into three categories: benign, borderline and malignant. Due to the rare incidence, the requirements for the radicality of surgical treatment are not well known. According to respected foreign recommendations, resection with a free margin of 10 mm or more is desirable. METHODS: A retrospective review of patients, who underwent surgical treatment due to phyllodes tumour in the Masaryk Memorial Cancer lnstitute in 2003-2014. RESULTS: 83 patients were evaluated with a median follow-up of 68.0 months. Benign tumours accounted for 62.3%, borderline tumours accounted for 16.9% and malignant accounted for 20.8% of all tumours. Malignant phyllodes tumours reached a bigger average size (84.9 mm) than borderline (41.4 mm) and benign tumours (33.3 mm) and occurred in older patients (mean 56.4 years) than benign (mean 42.5 years). Results from preoperative core-cut biopsy were often inaccurate. In 70 cases, the primary resection was breast preserving, but the free margin above 1 mm was achieved only in 13 cases. The width of the resection edge never exceeded the recommended 10 mm. Nevertheless, there was a relapse in benign tumours in two cases and in the borderline tumours only in one case. Malignant tumours recurred more frequently, even after total mastectomy. Four patients with malignant tumours experienced distant metastases. There has never been a death caused by benign or borderline tumour. CONCLUSION: The 10 mm resection margin is unachievable in our conditions. However, it seems that such radicality is not necessary in benign tumours, because they rarely recur even with close margins. Conversely, neither total mastectomy of the malignant phyllodes tumours will protect against local progression or distant metastasis.

Raising standards in clinical research - The impact of the ECRIN data centre certification programme, 2011-2016.

The nature and the purpose of the ECRIN Data Centre Certification Programme are summarised, and a very brief description is given of the underlying standards (129 in total, divided into 19 separate lists). The certification activity performed so far is described. In a pilot phase 2 centres were certified in 2012. Calls in 2014 and 2015 resulted in a further 8 certified centres, with 2 certifications still in progress, and the 2016 call has generated several additional applications. The impact and benefits of the programme are listed, divided into a) the effects of the introduction of the standards, b) the effects of the certification programme in general, and c) the effects of the certification programme on individual units. The discussion emphasises the generally positive impact of the programme so far but stresses the need to better clarify the perspective and role of the programme.

Randomized study of interferon beta-1a, low-dose azathioprine, and low-dose corticosteroids in multiple sclerosis.

BACKGROUND: Studies evaluating interferon beta (IFNbeta) for multiple sclerosis (MS) showed only partial efficacy. In many patients, IFNbeta does not halt relapses or disability progression. One strategy to potentially enhance efficacy is to combine IFNbeta with classical immunosuppressive agents, such as azathioprine (AZA) or corticosteroids, commonly used for other autoimmune disorders. OBJECTIVE: The Avonex-Steroids-Azathioprine study was placebo-controlled trial and evaluated efficacy of IFNbeta-1a alone and combined with low-dose AZA alone or low-dose AZA and low-dose corticosteroids as initial therapy. METHODS: A total of 181 patients with relapsing-remitting MS (RRMS) were randomized to receive IFNbeta-1a 30 microg intramuscularly (IM) once weekly, IFNbeta-1a 30 microg IM once weekly plus AZA 50 mg orally once daily, or IFNbeta-1a 30 microg IM once weekly plus AZA 50 mg orally once daily plus prednisone 10 mg orally every other day. The primary end point was annualized relapse rate (ARR) at 2 years. Patients were eligible for enrollment in a 3-year extension. RESULTS: At 2 years, adjusted ARR was 1.05 for IFNbeta-1a, 0.91 for IFNbeta-1a plus AZA, and 0.73 for combination. The cumulative probability of sustained disability progression was 16.8% for IFNbeta-1a, 20.7% for IFNbeta-1a plus AZA, and 17.5% for combination. There were no statistically significant differences among groups for either measure at 2 and 5 years. Percent T2 lesion volume change at 2 years was significantly lower for combination (+14.5%) versus IFNbeta-1a alone (+30.3%, P < 0.05). Groups had similar safety profiles. CONCLUSION: In IFNbeta-naïve patients with early active RRMS, combination treatment did not show superiority over IFNbeta-1a monotherapy.

[Raloxifene in clinical practice. Results of the non-interventional study CORAL (COmpliance with RALoxifene)]. / Raloxifen v klinické praxi. Výsledky neintervencní klinické studie CORAL (COmpliance with RALoxifene).

UNLABELLED: Osteoporosis is a disease causing higher bone fragility and bone ruptures occurring even in minimal traumas. Good patient compliance is the prerequisite for long-term efficacy of osteoporosis treatment. Compliance data from randomised clinical studies may not provide reliable information about compliance in clinical practice which is usually lower. CORAL (COmpliance with RALoxifene therapy) is a local, Slovak, non-interventional, open, prospective, uncontrolled and multicentre study of woman patients on raloxifen therapy in current clinical practice. Raloxifen is a selective estrogen receptor modulator (SERM) indicated for the treatment and prevention of postmenopausal osteoporosis. OBJECTIVES: The primary objective of the study was to assess compliance with raloxifen therapy in the conditions of current clinical practice. The secondary objectives were the assessment of the impact of therapy on the quality of life, of treatment satisfaction and treatment safety. PATIENTS AND METHODS: A total of 1497 patients with proven postmenopausal osteoporosis were enrolled in the 18-month study performed in 40 centres. Compliance was evaluated on the basis of the number of omissions in the use of the evaluated drug. Treatment satisfaction was evaluated by the patients who used a 0-100 visual analogue scale (VAS). Quality of life was evaluated by means of an EQ-5D quality of life questionnaire. In order to measure treatment safety, all adverse events were recorded by the supervising physician in a dedicated questionnaire at every visit. Statistical methods used: The non-parametrical Mann-Whitney test was used to assess the relation between raloxifen treatment compliance and the selected parametres (quality of life, treatment satisfaction, changes in health condition, premature discontinuation of therapy). The maximum likelihood ratio chi2 test and Fisher's exact test (for 2 x 2 tables) were used to analyse the ratio between compliance and reasons for enrolment in the study. Changes in treatment satisfaction in the course of the study were analysed using the Wilcoxon test. All the used tests were bilateral and data was assessed at a 5 % level of significance. RESULTS: The mean age of the patients enrolled in the study was 63.4 +/- 8.0 years. 58 % of patients were enrolled on the basis ofdensitometric evidence of osteoporosis, 74% of patients were enrolled for proven osteoporosis which had been manifested by a fracture, and osteoporotic fracture as such was the reason to start therapy in 10 % of patients. The majority of patients enrolled in the study (77%) had natural menopause. The mean period from menopause to the study was 15 years. Acceptable cooperation (> or =80% of medication used) was recorded for more than 90% of patients during the study, and total dosing adherence was recorded more than 58 % of patients. A significantly higher satisfaction with pharmacotherapy was observed in the patients who adhered to the prescribed dosing schedule. Adherence to the prescribed dosing schedule was also associated with a considerable better health condition and a higher quality of life. In a total of 1,497 evaluated patients, treatment was prematurely discontinued in 87 (5.8 %) women. The attending physician's decision, adverse events or the patient's request were relatively evenly distributed among the reasons for the discontinuation of therapy. Premature discontinuation of therapy was mostly recorded in patients who were not satisfied with the pharmacotherapy of osteoporosis as such, in women who were less satisfied with their overall health condition and who had a lower quality of life. DISCUSSION: The study showed very good patient compliance with raloxifen. The above findings associate with a significant correlation between the degree of adherence to therapy, treatment satisfaction and the overall health condition and quality of life. Premature discontinuation of therapy was observed in a very low number of women. It can be concluded that raloxifen therapy provides effective treatment of osteoporosis based on long-term cooperation of patients. CONCLUSION: Effective treatment of postmenopausal osteoporosis with raloxifen is related to excellent cooperation of patients on a long-term basis.

Influence of chemotherapy to hormonal levels in postmenopausal breast cancer patients.

Targeting and tailoring of therapy is the latest trend in breast cancer treatment. The efficacy of the available treatment must be estimated and the probable benefit for the patient determined. The aim of this project was to find out wether also in postmenopausal women chemotherapy can affect hormonal levels in serum and if even the levels of IGF-1 and IGFBP-3 can be changed. In the group of 72 postmenopausal breast cancer patients blood samples were taken before, during and after adjuvant chemotherapy and levels of estradiol, progesterone, LH, FSH, IGF-1 and IGFBP-3 were evaluated. We did not find any statistically significant dependence on tumor stage, expression of hormonal receptors or HER-2 and treatment regimen with studied hormones. Serum levels before treatment in comparison with status during treatment were significantly different in LH, FSH and progesterone value. Hormone levels after the treatment in comparison with status during treatment were significantly different only in levels of estradiol. Significant differences in all parameters were found except IGF-1. There was not any statistical dependence on the menopausal gap, age, weight or type of chemotherapy. We can conclude, that also in postmenopausal women hormonal changes can take part in the final effect of adjuvant treatment.

Dendritic cell counts and their subsets during treatment of multiple myeloma.

Human dendritic cells have distinct roles in the regulation of immunity. In this study we analysed the kinetics and the proportion of myeloid and plasmacytoid subsets of dendritic cells (DC) in peripheral blood of 15 patients with multiple myeloma (MM) before and during treatment that included autologous transplantation. Control group of 15 healthy volunteers was evaluated by using the same approaches. Flowcytometric determination of relative and absolute cell counts in unmanipulated peripheral blood was based on the expression of surface antigens CD83 and HLA-DR. Depending on the expression of CD11c or CD123, we divided these cells into CD11c+ dendritic cells type 1 (DC1) and CD123+ DC type 2 (DC2). Significant differences were found in initial relative counts of CD83+ cells and of the DC2 subtype between the group of controls and the group of patients before treatment. In absolute counts, there was a difference only in the DC2 subtype. After induction treatment (vincristine, doxorubicin, and dexamethasone), the mean percentage of CD83+ DC and the DC1 percentage were significantly higher than initially, but there was no significant difference in absolute counts. Administration of G-CSF again increased the total DC numbers. Intermediate DC counts were found in the apheresis products. After engraftment, we found the highest relative DC numbers, but absolute counts were not very high because of leukopenia. Within six months after transplantation, normal relative and absolute DC counts were found in patients. Untreated patients with MM have significantly lower relative numbers of peripheral blood DC in comparison with healthy volunteers. The highest number of total DC was found after engraftment. The DC1/DC2 ratio showed relative predominance of DC1 subtype and the lowest DC1/DC2 ratio was found in the apheresis products. DC counts comparable with those of healthy volunteers were found in patients six months after transplantation.

Radiographic progression of rheumatoid arthritis in patients from the Czech National Registry receiving infliximab treatment.

OBJECTIVE: To evaluate the clinical status and radiographic progression in patients with rheumatoid arthritis (RA) being followed by the Czech National Registry of biological treatments. METHODS: Patients who failed at least two disease-modifying antirheumatic drugs and had high disease activity (DAS28 > 5.1) were treated with infliximab. Radiographic progression was measured with a modified version of the Sharp score (TSS) after 54 weeks of treatment. RESULTS: Ninety-nine patients with an average disease duration of 13.7 years were enrolled. The DAS28 dropped from 6.66 to 4.07 (p < 0.001). Before treatment the mean TSS was 90.1 and the mean estimated yearly disease progression was 8.56. After 54 weeks of infliximab, radiographic progression was 4.15 times slower than the estimated rate before treatment and 63 patients did not show any radiographic progression at all. In the remaining 36 patients, the progression rate slowed to 3.8 +/- 0.9 from the estimated TSS of 10.9 +/- 6.9 before the initiation of treatment (p = 0.011). CONCLUSION: Data derived from the Czech National Registry, which reflect general clinical practice, show a significant retardation of radiographic progression in patients treated with anti-TNF and the magnitude of the improvement seen is similar to results from clinical trials.

Simple variables predict survival after autologous transplantation: a single centre experience in 181 multiple myeloma patients.

Autologous stem cell transplantation (ASCT) has an important role in the treatment of multiple myeloma (MM) patients. The aim of our study was to analyse retrospectively the impact of selected simple parameters on the survival of patients with MM after ASCT, including age, type of M-protein, stage of MM, treatment response, and presence of renal impairment. A total of 181 MM patients were transplanted in our centre between 1995 and 2004. The median follow-up from transplant was 59 months. Following ASCT, 29% of patients were in complete remission (CR) and 62% in partial remission (PR); 35% of patients had very good partial response (VGPR). Median time to progression (TTP) and overall survival (OS) from start of therapy were 33.0 and 78.3 months, respectively. Significant prognostic parameters for poor survival after ASCT were: age at transplant > 60 years (P < 0.001), TTP < 20 months (P < 0.001), IgA type of monoclonal immunoglobulin (P = 0.045), renal impairment with serum creatinine > 177 micromol/l (> 2 mg/dl; P = 0.004), clinical stage III according to ISS (P = 0.002) and no achievement of CR and/or VGPR after ASCT (P < 0.001). The stage of the disease before ASCT did not significantly affect OS after ASCT.

[Acute situation in the National Program of Breast Cancer Screening in the Czech Republic]. / Akutní stav národního programu skríninku rakoviny prsu v Ceské republice.

Czech National Breast Cancer Screening Program started in September 2002. Currently, a total of 59 accredited screening centres are involved in the program. Central data management and statistical processing of the data is performed. During the period of July 2003-December 2005 a total of 646,056 women were screened and 2,926 breast cancer cases were detected. A total of 2666 (91.1 %) cancer cases were invasive. Of these, 855 (32.1 %) were < or = 10 mm in size and 1624 (60.9 %) were node negative. A high rate of detection of early stages of the disease is the main objective of the screening process and a good indicator of long-term decrease in mortality rates. The central system of data management is based on annual data analysis. This system is in line with international standards for such systems.

[The effect of patient's body weight, gender and baseline viral load on the efficacy of hepatitis C therapy]. / Ovlivnení uspesnosti lécby chronické hepatitidy C hmotností a pohlavím pacienta a výsí vstupní viremie.

UNLABELLED: Today, the standard therapy of patients with chronic HCV (hepatitis C virus) infection is based on combination of pegylated interferon alpha (PEG-IFN) and ribavirin. THE STUDY OBJECTIVE: The aim of the study is to find correlations between patient's body weight, gender and baseline viral load and the efficacy of antiviral therapy in terms of achieving end-of-treatment viral response (ETVR) and sustained viral response (SVR). METHODS AND PATIENT SAMPLE: We enrolled 133 patients with chronic HCV infection. All of them were treated by combination of PEG-IFN alpha-2a (180 microg once a week) and ribavirin. Ribavirin doses were the following: For body weight < or = 74 kg - 800 mg daily in patients infected by genotype 2 (G2 - 3 patients) or G3 (18 patients), 1000 mg in patients infected by G1 (106 patients), G4 (1 patient) or G6 (1 patient); for body weight > or = 75 kg - 1200 mg daily in case of infection by G1. RESULTS: To date, 122 patients completed the therapy; 107 of them completed their therapy at least 24 weeks ago, so they can be assessed for SVR. ETVR was achieved in 76% and SVR in 60% patients. Statistically higher proportion of SVR was observed in women (p = 0.039), patients with relatively lower body weight (p = 0.034), patients in lower baseline viral load (p = 0.010) and patients with genotypes 2 and 3 (p = 0,008). Correlation analysis of individual predictive factors showed the statistically significant correlation between body weight and gender (p < 0.001), gender and baseline viral load (p = 0.027) and body weight and virus genotype (p = 0.003). Therefore, the only independent predictive factor of ETVR (p = 0.020) and SVR (p = 0.010) was the level of baseline viral load. CONCLUSION: Efficacy of PEG-IFN therapy is significantly influenced by the level of baseline viral load. According to the results of this study, patient's body weight and gender are not independent predictive factors that affect the therapy efficacy.

[The meaning of viral kinetics in the beginning of the pegylated interferon-alpha and ribavirin therapy for chronic hepatitis C]. / Význam virové kinetiky v pocátcích lécby chronické hepatitidy C pegylovaným interferonem alpha a ribavirinem.

UNLABELLED: Pegylated interferon alpha (PEG-IFN) and ribavirin combination therapy is the contemporary standard therapy of the patients chronically infected with hepatitis C virus (HCV). OBJECTIVE OF THE STUDY: The study is monitoring the changes in viremy through the changes of HCV RNA in serum before and during antiviral therapy and it attempts to find a relationship between the viral kinetics in the beginning of the therapy and the sustained virologic response. SET OF THE PATIENTS AND THE METHODICS: The study involved 133 patients with chronic infection with HCV, of the average age of 38 years (ranged 18-68 years). 86 of them were men. There were 88 patients who had not been treated before (naive patients), 19 of them were relabing and 26 were non-responders to the previous therapy with conventional IFNalpha and ribavirin. 106 patients (80%) were infected with genotype (G) 1, 3 (2%) with G2, 18 (14%) with G3, 1 patient with G4 and 1 with G6 (under 1%), in 4 (3%) the genotype could not be determined. All of them were treated with the combination of PEG-IFNalpha-2a (180 microg once a week) and ribavirin (800 mg per day in the infection with G2 or G3, 1000 mg at the infection with G1 and the weight up to 74 kg, 1200 mg per day at the infection with G1 and the weight 75 kg and higher). RESULTS: Up to now, 122 patients completed the therapy and 93 of them (76%) had negative HCV RNA in serum at the time of completion of the therapy. Negative HCV RNA after 24 weeks (sustained virologic response SVR) after the completion of the therapy had 64/107 (60%) of the treated patients. In the course of 12 weeks of the therapy the viremy decreased by at least 2 decadic logarithms (early virologic response - EVR) in 87 patients (82%) and in 63 of them (72%) also SVR was noted. Only 19 patients had not EVR and just 1 one of them, nevertheless, achieved SVR (5%). CONCLUSION: The achievement of EVR is a prerequisite to the successful therapy for chronic infection with HCV with the combination of PEG-IFNalpha and ribavirin. Quantitative determination of HCV RNA in serum before and during antiviral therapy is a prerequisite to the modern antiviral therapy for chronic infection with HCV.

Age dependency and mutual relations in T and B lymphocyte abnormalities in common variable immunodeficiency patients.

Common variable immunodeficiency (CVID) is primary hypogammaglobulinaemia with an unknown aetiopathogenesis. Although various abnormalities of T and B cells have been described, their pathogenetic roles are unclear. We determined T and B lymphocyte subsets known to be abnormal in CVID in order to disclose possible relations between numerical abnormalities in those cells. Markers associated with B cell development (CD21, CD27, IgM, IgD) were determined on B lymphocytes (CD19+); T lymphocyte development (CD45RA, CD45RO, CD62L) and activation markers (CD25, CD27, CD28, CD29, CD38, CD57, HLA-DR) were determined on CD4+ and CD8+ T lymphocytes in 42 CVID patients and in 33 healthy controls. Abnormalities in CD4+ T lymphocyte activation markers (increase in CD29, HLA-DR, CD45RO, decrease in CD27, CD62L, CD45RA) were observed particularly in patients with a decreased number of memory (CD27+) and mature (CD21+) B cells (group Ia according to the Freiburg group's classification), while abnormalities observed in CD8+ cells (increase in CD27 and CD28 and decrease in HLA-DR, CD57 and CD38) did not depend upon grouping patients together according to B lymphocyte developmental subpopulations. We observed correlations between immature B cells (IgM+ CD21-) and expression of CD27, CD62L, CD45RA, CD45RO and HLA-DR on CD4+ T cells in CVID patients but not in the control group. The expression of CD27 and CD45RA on CD4+ T lymphocytes, such as the percentage of IgD+ CD27- and IgD+ CD27+ cells in B lymphocytes, showed age dependency to be more significant than in the control group. Our study demonstrates that T and B lymphocyte abnormalities in CVID are partially related to each other. Some of those abnormalities are not definite, but may evolve with age of the patient.

[Comparison of standard prognostic factors with the deletion of 13q14 detected by interphase fluorescence in situ hybridization on separated and unseparated bone marrow cells in multiple myeloma]. / Porovnání standardních prognostických faktoru u pacientu s mnohocetným myelomem s delecí 13q14 stanovenou metodou interfázní fluorescencní in situ hybridizace na separovaných a neseparovaných bunkách kostní direne.

BACKGROUND: Cytogenetic abnormalities of chromosome 13 are emerging as important prognostic factors in multiple myeloma and have been associated with poor prognosis. METHODS AND RESULTS: The occurrence of 13q14 deletion and other standard laboratory parameters were determined in 40 patients with multiple myeloma. We found that interphase fluorescence in situ hybridization using a locus specific probe for RB1 gene on immunomagnetically selected myeloma cells was more sensitive than non selected cells. The 13q14 deletion was found in 10 of 40 (25.0%) of bone marrow samples without cell selection and in 25 of 40 (62.5%) of samples with CD138+ enriched myeloma cells. Negative correlation was found between albumin and the 13q14 deletion in separated (p = 0.003) as well as in cells without selection (p = 0.010). No significant correlation was found in overall survival of separated and unseparated cells (p = 0.830; p = 0.260) and a similar result was obtained for treatment response after transplantation of separated cells (p = 0.520) or non-separated cells (0.190). CONCLUSIONS: Our results confirm that immunomagnetic selection of CD138+ cells increases the probability of detection of the 13q14 deletion in bone marrow samples. The correlation was found between albumin and the 13q14 deletion in both of type of cells.

[Changes in leptin, leptin receptor and fatty acids levels during chemoradiotherapy for oesophageal cancer]. / Zmeny leptinu, leptinového receptoru a mastných kyselin v prubehu chemoradioterapie u nemocných s karcinomem jícnu.

BACKGROUND: Oesophageal cancer patients with substantial weight loss have worse prognosis. Weight loss is often refractory to the nutritional support. Causes of the weight loss are multiple: oesophageal stricture, frequent alcohol abuse, cancer related cachexia. It may be a consequence of metabolic changes mediated by cytokines, hormones and tumour derived products. Leptin, a protein produced by adipocytes, is an important signalling molecule in energy regulation, metabolism of fatty acids and it can also augment tumour growth of various cancer cell lines. Enhanced intake of poly-unsaturated fatty acids may play an important role in the reversal of cancer related weight loss. METHODS AND RESULTS: In this study we examined the nutritional status (pre-treatment weight-loss, actual weight, body mass index), serum levels of leptin, soluble leptin receptor, TNF-alpha, IGF-1 and plasma phosphatidyl-cholin fatty acids before the beginning of treatment, after the onset of treatment and shortly before its completion. In the group of 38 pts (33 men, 5 women), mean age 58 years, statistically significant mean pre-treatment weight-loss 8 kg and significant mean weight loss 2 kg after chemoradiotherapy was observed. Concomitant chemoradiation led to transient elevation of serum leptin level despite the weight loss during chemoradiotherapy. Significant changes in the distribution of fatty acids in plasmatic phosphatidyl-cholin were observed. CONCLUSIONS: Our results show the possibility for direct influence of chemoradiotherapy on body weight regulation in advanced oesophageal cancer patients.

Prognostic factors for survival after autologous transplantation: a single centre experience in 133 multiple myeloma patients.

Autologous stem cell transplantation (ASCT) has an established role in the treatment of symptomatic multiple myeloma (MM). Our aim was to analyse the impact of selected prognostic parameters on the survival of patients with MM after ASCT. The new International Staging System (ISS) was also evaluated. A total of 133 MM patients were transplanted in our centre between 1995 and 2002. Following ASCT, 35% of patients were in complete remission (CR) and 60% were in partial remission (PR). The median progression-free (PFS) and overall (OS) survival from transplantation were 29.5 and 68.8 months, respectively. Transplant-related mortality (TRM) was 3%. On multivariate analysis, factors associated with significantly shorter OS were lack of CR after transplant (P = 0.002, hazard ratio (HR): 3.1), stage 3 according to ISS (P = 0.001, HR: 3.0) and age at transplant over 60 years (P = 0.035, HR: 2.0). The status of disease before ASCT did not significantly affect PFS and OS after transplantation. We conclude that ASCT is a safe and effective procedure in MM patients, associated with low TRM. The survival after ASCT was dependent on response after ASCT, stage according to ISS and age.

[Specific complications in the treatment with implantable cardioverter-defibrillators]. / Specifické komplikace terapie implantabilními kardiovertery defibrilátory.

BACKGROUND: Using implantable cardioverter-defibrillators in treatment of malignant ventricular arrhythmias revealed new complications specific to this therapy. Inappropriate therapy, arrhythmic storm and device related proarrhythmia belong to the most significant complications. The authors describe specific complications in a group of ICD patients, analyze their etiology and prognostic value. There are some recommendations for the management of specific complications. METHODS AND RESULTS: 138 consecutive patients underwent ICD implantation between 1994-2001. Median follow-up was 47,35 months. Average left ventricular ejection fraction was 38 +/- 14% and 71% of patients suffered from coronary artery disease. From the total of 2490 arrhythmic episodes 1490 were evaluated in detail. 253 episodes (17%) were classified as inappropriate therapy. The most common etiology of inappropriate therapy was atrial fibrillation with rapid ventricular response (68%), atrial flutter (13%) and sinus tachycardia (11%). After the therapeutic intervention, 65% of them remained free of inappropriate therapy. There were 38 arrhythmic storms in 19 patients as another serious complication. CONCLUSIONS: All the observed arrhythmic episodes were ventricular tachycardias (p<0.04). Patients with arrhythmic storm in history had significantly lower survival (p<0.05). The risk factors of cardiac nonsudden death were: age >66 years, left ventricular ejection fraction <35% and arrhythmic storm history. The authors present recommendations for the treatment of the most common specific ICD complications.

[Multiple-level instrumented anterior cervical fusion: a risk factor for pseudoarthrosis? A prospective study with a minimum of 3-year follow-up]. / Je víceetázová instrumentovaná prední krcní fúze rizikovým faktorem vzniku pseudoartrozy? Prospektivní studie s minimálne 3letou délkou sledování.

PURPOSE OF THE STUDY: This prospective study with minimal 3-year follow-up was performed to compare fusion rates, course of fusion, collapse incidence and occurrence of subsidence in one- and two-level instrumented anterior cervical fusions (ACDF) and thus to proof the hypothesis that use of internal fixation decreases the risk of non-union in bi-segmental ACDFs to the same level that can be expected in mono-segmental procedure. MATERIAL: In 79 consecutive patients operated upon by the Smith-Robinson technique for degenerative process of cervical spine in one or two levels was applied single instrumentation system in order to ensure ideal condition for solid bone fusion of 113 grafts (45 in one and 68 in two levels). All the patients were invariably followed for a minimum of 3 years. METHODS: Radiological criteria were used for evaluation of intervertebral fusion, graft collapse and its subsidence and results were statistically analyzed using M-L Chi-square test for the comparison of fusion and collapse incidence and further Chi-square test for the analysis of fusion course. All these figures were calculated at the level of significance 0.05 (alpha=0.05). RESULTS: Overall, no significant difference was observed in achieving solid bone fusion 3 years after the surgery in one- and two-level procedures (95.6% vers. 92.6%, p=0.522), neither the bone graft collapse rate was of significant difference (2.2% vers. 7.6%, p=0.208). In single-level group the time to bone fusion was significantly shorter (p<0.001). When pooling the data into autologous and allogenic graft subgroup, there was observed no statistically significant difference in achieving union in autologous subgroup (100% vers. 90.9%, p=0.142); in allogenic subgroup this situation was similar: no significant difference in fusion rate (93.3% vers. 93.5%, p=0.980) was observed. In both auto- and allogenic subgroups monosegmentally implanted grafts fused more readily (p<0.001). There was no case of graft subsidence in any investigated group. DISCUSSION: Our prospective study did not find any statistically significant difference in graft collapse and fusion rate when comparing one- and two-level instrumented ACDFs 3 years after the surgery. Plating system used in our patients brings more stability to operated segments and thus presumably prevents micromotions in postoperative period. Micromovements seems to be the major risk factor for non-union in non-instrumented multilevel cervical fusion. Other risk factor that should be considered in non-instrumented procedure is increase in compressive forces that are also partially eliminated by the semirigid internal fixation. Significantly delayed time to union observed in two level fusions shows most probably on increased number of surfaces that must be consolidated during the bone-healing process. CONCLUSION: This study demonstrates that internal fixation used in multilevel ACDF decreases risk of pseudoarthrosis to the same level that can be expected in monosegmental procedures.

Second autologous transplantation for multiple myeloma patients relapsing after the first autograft -- a pilot study for the evaluation of experimental maintenance therapies. Report of the prospective non-randomized pilot study of the Czech Myeloma Group.

BACKGROUND: High-dose chemotherapy followed by autologous stem cell transplantation (AT) is accepted as first-line therapy for patients with multiple myeloma (MM), with very good tolerance and low mortality (2-3%). STUDY DESIGN: We tested repeated transplantation with different experimental maintenance therapies in patients with MM relapsing/progressing after first AT. Results were compared using intra-individual analyses, therefore inter-individual differences are excluded (T2 model). PATIENTS AND METHODS: Between January 1997 and January 2003, 32 patients with relapsing/progressing MM after first AT were included in the pilot study, median follow-up was 75.2 months. They received the following experimental therapies: IL-2-activated PBSC (10 pts), pamidronate (4 pts), thalidomide (15 pts), consolidation chemotherapy CED (3 pts). RESULTS: Sensitivity to C-VAD reinduction chemotherapy (4 cycles) was 50%, response to the second AT compared to the first was better in 7, the same in 16 and worse in 9 patients. Toxicity of the first and second transplantation was similar and usually did not exceed grade II (SWOG). Transplant-related mortality was 3% (1/32). Event-free survival after second AT (EFS II) is known in 22 patients; 7 have achieved prolongation of EFS II versus EFS I. In the whole group median EFS I was 15.7 months, median EFS II was 12.9 months, median overall survival (OS) was 79.1 months; 20/32 patients were alive at the time of analysis. CONCLUSIONS: Repeated AT is a feasible and successful strategy in treatment of relapsing MM; response to second AT and toxicity were acceptable and similar to the first AT in our assessment.

Treatment of early diagnosed HCV infection in hemodialyzed patients with interferon-alpha. Treatment of hepatitis C.

BACKGROUND: Acute and early diagnosed hepatitis C virus (HCV) infections are rare diagnoses. Patients on regular dialysis treatment (RDT) are at risk of acquiring HCV infection. AIMS OF THE STUDY: (1) To determine the efficacy and safety of two-phase induction treatment of acute and early diagnosed HCV infections in patients on RDT, and (2) to establish the importance of serum HCV RNA testing at defined time points of treatment for the prediction of the therapeutic effect. THERAPEUTIC PROTOCOL: Antiviral treatment consisted of two different phases: phase A therapy was interferon (IFN)-alpha 2b 10 million units (MU) s.c. administered daily for 21 days followed by phase B with IFN-alpha 2b 3 MU s.c. administered 3 times weekly for 12 weeks. RESULTS: (1) Efficacy of the treatment: A sustained virological response (SVR) was achieved in a total of 13/18 patients (72%). SAFETY: We did not observe any serious side effects of the treatment. The most pronounced side effect was the myelosuppression caused by IFN-alpha. (2) SVR prediction: Patients with negative serum HCV RNA at day 6 achieve SVR more frequently than those with positive HCV RNA at day 6 (p = 0.074). CONCLUSIONS: Treatment of acute and early diagnosed HCV infections in hemodialyzed patients is much more effective than treatment of chronic infection. Even relatively high doses of IFN at the beginning of therapy (10 MU daily) are tolerated well by the patients.

[Do we comply with the standard classification of staging in colorectal carcinoma after curative resection?]. / Respektujeme standard klasifikace stadia kolorektálního karcinomu po kurativní resekci?

BACKGROUND: Lymph node status is the most important prognostic and predictive factor in curatively resected colorectal cancer. According to TNM staging system, a minimum number of 12 regional lymph nodes is to be examined for the correct staging. In addition to the status of lymph nodes other important prognostic factors should be reported by the pathologist. METHODS: A retrospective study was performed to analyze how many of regional lymph nodes were examined in colorectal cancer specimens in two hospitals (Czech Republic) during the last few years. Availability of other prognostic factors important for the management of the disease after surgery was always investigated. RESULTS: In the hospital "A", the examination of lymph nodes were not sufficient in 43.8% of 121 cases analyzed, in the hospital "B", the number of examined lymph nodes was less than a minimum of 12 in all 162 cases. There were often no data available regarding to a histological examination of resection margins, grading and angioinvasion. CONCLUSION: Reporting of the standard and most important prognostic factors in colorectal cancer was not sufficient in two selected hospitals and it may not be much better in others. It might have a deteriorating influence on the outcomes despite of successfully performed primary surgery. Search for the new prognostic and predictive factors, that would help us to stratify the patients for the optimal tailored therapy is surely needed, but the standard staging parameters, as are the lymph node involvement, resection margins, grading and angioinvasion, must not be forgotten as occurred to be in many cases of our study.