PURPOSE: In the integrated analysis of phase III head-to-head trials in patients with advanced solid tumors, denosumab demonstrated superiority over zoledronic acid in preventing skeletal-related events (SREs). Regular and continued drug use (persistence) is a precondition of clinical efficacy; persistence in real-life is yet undetermined for denosumab. METHODS: This was a single-arm, prospective, observational, non-interventional study in 598 patients with bone metastases from breast, prostate, lung, or other solid tumors treated with denosumab every four weeks in real-world clinical practice in Austria, Czech Republic, Hungary, Slovakia, and Bulgaria. Persistence was defined as denosumab administration at ≤ 35-day intervals over 24 or 48 weeks, respectively. RESULTS: Previous SREs were found in 10.9% of patients. 62.6% were persistent over 24 weeks and 40.1% over 48 weeks. The Kaplan-Meier median (95% CI) time to non-persistence was 274.0 days (232.0, 316.0). The most frequent reason for non-persistence was delayed administration. There was a trend towards weaker analgesics over time, with approximately 60% of patients not requiring any analgesics. Serum calcium remained within the normal range throughout the study. Adjudicated osteonecrosis of the jaw was documented in three patients with an incidence per patient-year (95% CI) of 0.012 (0.004, 0.029). CONCLUSIONS: Most patients received denosumab regularly once every four weeks over 24 weeks of treatment. Non-persistence was mainly due to delayed administration. The incidence of adverse drug reactions, especially of osteonecrosis of the jaw, was in line with expectations from previous studies.
- MeSH
- denosumab aplikace a dávkování škodlivé účinky MeSH
- dospělí MeSH
- inhibitory kostní resorpce aplikace a dávkování škodlivé účinky MeSH
- kohortové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- nádory kostí farmakoterapie sekundární MeSH
- nádory farmakoterapie patologie MeSH
- osteonekróza chemicky indukované MeSH
- prospektivní studie MeSH
- rozvrh dávkování léků MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
PURPOSE: Prophylaxis for febrile neutropenia (FN) is recommended for the duration of myelosuppressive chemotherapy in high-risk patients; yet, granulocyte-colony-stimulating factor (G-CSF) discontinuation occurs frequently in clinical practice. The objective of this study was to investigate the incidence of FN in real-world settings and the extent and impact of early pegfilgrastim discontinuation. METHODS: This prospective, observational study enrolled patients with any-stage non-Hodgkin's lymphoma (NHL) or breast cancer initiating a new chemotherapy course with a high (> 20%) FN risk, with pegfilgrastim in cycle 1. During routine clinical visits, data were collected on FN events, discontinuation of pegfilgrastim (defined as administration of G-CSF other than pegfilgrastim for ≥ 1 cycle) and all G-CSF (and reasons), neutropenic complications and adverse drug reactions (ADRs). RESULTS: Overall, 943 patients were enrolled; 844 met the eligibility criteria (full analysis set) and 814 (86%) completed the study. Twenty-eight patients (3%) had 31 FN events (NHL, n = 17; breast cancer, n = 11). Twenty-six patients (3%) discontinued pegfilgrastim. Forty-four patients (5%) discontinued G-CSF. The most common reason for pegfilgrastim discontinuation was physician preference for daily G-CSF (n = 14 [2%]), and for discontinuation of all G-CSFs was reduced FN risk (n = 14 [2%]). Patients who continued G-CSF prophylaxis were less likely to experience neutropenic complications (odds ratio [95% confidence interval]: 0.26 [0.09-0.80]). Suspected ADRs to pegfilgrastim occurred in 43 patients (5%) and serious ADRs in 5 (1%). CONCLUSIONS: FN rates were consistent with previous reports with pegfilgrastim in clinical practice. No new ADRs were observed. G-CSF discontinuation was uncommon but appeared to increase the likelihood of neutropenic complications.
- MeSH
- chemoprofylaxe metody MeSH
- dospělí MeSH
- faktor stimulující kolonie granulocytů terapeutické užití MeSH
- febrilní neutropenie vyvolaná chemoterapií * epidemiologie prevence a kontrola MeSH
- filgrastim terapeutické užití MeSH
- incidence MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory prsu farmakoterapie epidemiologie patologie MeSH
- nehodgkinský lymfom farmakoterapie epidemiologie patologie MeSH
- polyethylenglykoly terapeutické užití MeSH
- protokoly antitumorózní kombinované chemoterapie aplikace a dávkování škodlivé účinky MeSH
- rizikové faktory MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
PURPOSE: Serum procalcitonin (PCT) has become a routinely utilized parameter with a high prediction value of the severity of bacterial infectious complications and their immediate outcomes. Whereas the utility of PCT in differentiating between bacterial and viral infection is generally accepted, its significance in fungal infections has yet to be determined. The aim of the study was to determine the role of PCT testing in patients at high risk for invasive fungal infections. METHODS: Immunocompromised hematological patients undergoing cyclic chemotherapy treatment or allogeneic hemopoietic stem cell transplantation with infectious complications in which the infectious agents were identified during the disease course were evaluated. In patients with bacterial infection, positive hemocultures were documented, and in patients with fungal infection, the presence of either proven or probable disease was confirmed according to Ascioglu criteria. C-reactive protein (CRP) and PCT were prospectively assessed from the day following fever onset, for four consecutive days. RESULTS: Overall, 34 patients were evaluated, 21 with bacterial and 13 with fungal infections. Significant elevations of CRP concentrations (i.e., above the upper normal limit) were observed in all patients, with a tendency toward higher levels in bacterial (both gram-positive [Gr+] and Gr-negative [Gr-]) than in fungal infections. PCT levels were significantly elevated in patients with bacterial infections (e.g., predominantly in Gr- compared to Gr+), whereas in patients with fungal infections, we identified minimal or no PCT elevations, p < 0.01. For the fungal infections, according to constructed receiver operating characteristic curves, a combination of PCT <0.5 μg/L and CRP 100-300 mg/L offers the best specificity, sensitivity and positive and negative predictive values (81, 85, 73, and 89 %, respectively). CONCLUSION: Altogether, our data suggest that the finding of substantially elevated CRP combined with low PCT in immunocompromised patients may indicate systemic fungal infection. The use of this combination might simplify the diagnostic process, which otherwise can often be lengthy and arduous.
- MeSH
- bakteriální infekce krev imunologie MeSH
- C-reaktivní protein metabolismus MeSH
- dospělí MeSH
- hematologické nádory krev imunologie mikrobiologie MeSH
- horečka krev imunologie mikrobiologie MeSH
- hostitel s imunodeficiencí MeSH
- kalcitonin krev MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mykózy krev imunologie MeSH
- nemoc štěpu proti hostiteli krev imunologie mikrobiologie MeSH
- prediktivní hodnota testů MeSH
- proteinové prekurzory krev MeSH
- ROC křivka MeSH
- senioři MeSH
- transplantace hematopoetických kmenových buněk MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
INTRODUCTION: Only a minimum is known about clinical effect of antimicrobial-coated central venous catheters (CVC) in stem cell transplantation settings, where CVC-related infections impose major threat to severely immunocompromised patients.
- MeSH
- antiinfekční látky lokální terapeutické užití MeSH
- biokompatibilní potahované materiály MeSH
- chlorhexidin terapeutické užití MeSH
- dospělí MeSH
- hodnocení výsledků zdravotní péče MeSH
- homologní transplantace MeSH
- katetrizace centrálních vén přístrojové vybavení MeSH
- kontrola infekce metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- prospektivní studie MeSH
- senioři MeSH
- stříbrná sůl sulfadiazinu terapeutické užití MeSH
- transplantace kmenových buněk MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
INTRODUCTION: Cetuximab is a chimeric antibody registered for the therapy of advanced colorectal carcinoma after failure of standard chemotherapy. Rare infusion reactions that resulted in the cessation of therapy have been described after cetuximab administration. CASE DESCRIPTION: We have observed severe infusion reactions accompanied by a loss of consciousness in two patients. The patients were transferred to intensive care unit, and the treatment was continued after administration of corticosteroids under careful monitoring of vital signs without any further serious reactions. In both cases, benefit of therapy with cetuximab could be demonstrated. CONCLUSION: This experience indicates that cetuximab can be continued in patients who experience infusion reactions. Surveillance in the intensive care unit is mandatory during readministration of the drug.
- MeSH
- adenokarcinom farmakoterapie sekundární MeSH
- antitumorózní látky aplikace a dávkování škodlivé účinky MeSH
- dexamethason terapeutické užití MeSH
- financování organizované MeSH
- glukokortikoidy terapeutické užití MeSH
- infuzní pumpy škodlivé účinky MeSH
- léková alergie farmakoterapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- metastázy nádorů MeSH
- monoklonální protilátky aplikace a dávkování škodlivé účinky MeSH
- nádory jater farmakoterapie sekundární MeSH
- nádory sigmoidea farmakoterapie patologie MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- Publikační typ
- kazuistiky MeSH
BACKGROUND: The authors conducted a retrospective study to determine whether dexrazoxane (ICRF-187) would reduce late anthracycline-induced cardiotoxicity in patients treated in childhood for hematological malignancy. PATIENTS AND METHODS: The authors examined 108 patients (63 male, 45 female) 5-29 years old, (median 15 years). All patients were in long-term remission of their malignancy. The cardioprotection was given to 68 patients (39 male, 29 female), and standard treatment was used in 40 patients (24 male, 16 female). Dexrazoxane (cardioxane, Chiron Company, The Netherlands) was given in 20:1 ratio to anthracycline. The follow-up time was 2-20 years (mean 7 years). The control group consisted of 41 volunteers (22 males, 19 females) 4-31 years old (median 18 years). The cardiotoxicity has been defined as the presence of heart failure or the decline of shortening fraction below 30% or ejection fraction (EF) below 55%. The end-systolic wall stress (ESS), myocardial performance index (MPI; Tei index), and parameters of left ventricular diastolic filling were also assessed. RESULTS: The anthracycline cardiomyopathy with the presence of heart failure was diagnosed in only one patient treated with a standard regimen. The pathological decline of fractional shortening was present in three (5%) and six (15%) patients with and without cardioprotection given, respectively. Similarly, none of the patients with cardioprotection revealed a pathological value of EF, while four (10%) patients without cardioprotection showed an EF decrease. Finally, ESS and isovolumic relaxation time were pathologically increased in the group without cardioprotection in comparison to the controls and to the group with cardioprotection. However, the MPI was significantly increased in both groups of patients. CONCLUSIONS: Dexrazoxane reduces the risk of late clinical and subclinical cardiotoxicity and does not affect the response rates to chemotherapy and overall survival during the median follow-up period of 7 years (follow-up period 2-20 years).
- MeSH
- analýza přežití MeSH
- antibiotika antitumorózní škodlivé účinky terapeutické užití MeSH
- antracykliny škodlivé účinky terapeutické užití MeSH
- dítě MeSH
- dospělí MeSH
- echokardiografie MeSH
- financování organizované MeSH
- hematologické nádory farmakoterapie MeSH
- kardiomyopatie chemicky indukované prevence a kontrola MeSH
- kardiovaskulární látky farmakologie terapeutické užití MeSH
- lidé MeSH
- mladiství MeSH
- následné studie MeSH
- předškolní dítě MeSH
- razoxan farmakologie terapeutické užití MeSH
- retrospektivní studie MeSH
- srdeční selhání chemicky indukované prevence a kontrola MeSH
- tepový objem účinky léků MeSH
- výsledek terapie MeSH
- Check Tag
- dítě MeSH
- dospělí MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- předškolní dítě MeSH
- ženské pohlaví MeSH
- Publikační typ
- klinické zkoušky MeSH
A 55-year-old female presented with recurring episodes of loss or decline in the quality of consciousness due to hypoglycaemia caused by insulin overproduction in hormonally active metastatic pancreatic insulinoma. All standard anticancer treatment modalities including chemotherapy, radiation, interferon alpha 2b, and lanreotide failed to achieve symptomatic control. The patient became dependent on continuous intravenous glucose supply. Based on anecdotal reports in literature, prednisone therapy was started in order to increase insulin resistance, reduce glucose utilization, increase hepatic glucose production, and impair insulin secretion. After 10 days of therapy, the patient was released from continuous intravenous glucose infusion. After several weeks, administration of prednisone was lowered to a daily maintenance dose of 2.5 mg with excellent symptomatic effects. In conclusion, prednisone therapy may be considered as a valid option to achieve symptomatic control in hormonally active therapeutically resistant insulinomas.
- MeSH
- antitumorózní látky hormonální terapeutické užití MeSH
- financování organizované MeSH
- glukokortikoidy terapeutické užití MeSH
- hypoglykemie prevence a kontrola radiografie MeSH
- inzulinom farmakoterapie radiografie sekundární MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory slinivky břišní farmakoterapie patologie radiografie MeSH
- počítačová rentgenová tomografie MeSH
- prednison terapeutické užití MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- ženské pohlaví MeSH
Antimicrobial solutions are widely used in the nursing care of chemotherapy induced oral mucositis (OM). There is little evidence, however, supporting their use for reducing mucosal damage. In our study, 132 patients were randomized to use normal saline (n=65) or povidone-iodine diluted 1:100 (n=67) mouthwashes for OM prophylaxis and treatment after high-dose chemotherapy comprising BEAM or HD-L-PAM followed by autologous peripheral stem cell transplantation. The study groups were well balanced in respect of age, sex, chemotherapy and the number of CD34+ cells in the graft. No significant difference was found between the groups in respect of OM characteristics, fever of unknown origin (FUO) and other infections. The antimicrobial solution was less tolerable for patients. OM occurred significantly more often in females than in males (86% vs 60%, P=0.0016) and was worse and of longer duration. The mechanical effect of mouthwashes might have a certain importance in FUO prevention. When indicating oral rinses, the patient's individual preference and tolerance of solutions offered should be considered.
- MeSH
- antiinfekční látky lokální aplikace a dávkování terapeutické užití MeSH
- autologní transplantace MeSH
- chlorid sodný aplikace a dávkování terapeutické užití MeSH
- cytarabin aplikace a dávkování MeSH
- dospělí MeSH
- etoposid aplikace a dávkování MeSH
- jodovaný povidon aplikace a dávkování terapeutické užití MeSH
- karmustin aplikace a dávkování MeSH
- lidé středního věku MeSH
- lidé MeSH
- melfalan aplikace a dávkování MeSH
- protokoly antitumorózní kombinované chemoterapie aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- senioři MeSH
- stomatitida farmakoterapie MeSH
- ústní sliznice patologie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- MeSH
- antifungální látky terapeutické užití MeSH
- dítě MeSH
- dospělí MeSH
- fungemie epidemiologie etiologie terapie MeSH
- lidé MeSH
- nádory komplikace MeSH
- Check Tag
- dítě MeSH
- dospělí MeSH
- lidé MeSH
- Publikační typ
- srovnávací studie MeSH
