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Biomedical subjects

D Ukena

Publications and source records attributed to D Ukena.

At least 19 recordsLinked to original sources
PubMed2005

[Ciclesonide -- a new inhaled corticosteroid].

Ciclesonide is a novel inhaled corticosteroid delivered as inactive prodrug via a hydrofluoroalkane metered-dose inhaler with a deposition rate of 50 - 60 %. At its target sites, the lungs, ciclesonide is converted to an active metabolite, desisobutyryl-ciclesonide (des-CIC) [so-called on-site activation]. High lipophilicity and formation of local depot prolong pulmonary duration of action, explaining once-daily administration of ciclesonide. High protein binding and rapid clearance reduce systemic interactions. In long-term studies, ciclesonide at doses as high as 1280-1600 microg/d did not suppress biochemical markers of adrenal function. Since ciclesonide is not being activated in the oropharynx, the incidence of local adverse effects is comparable to that of placebo. Compared to other ICS, ciclesonide shows a improved therapeutic index and can, therefore, be regarded as prototype of a new, third generation of inhaled corticosteroids.

Administration, Inhalation↗
PubMed2004

Value of FDG PET in the management of NSCLC.

Metabolic imaging with positron emission tomography (PET) using 18F-fluoro-2-deoxy-glucose (FDG) has been accepted as an important imaging modality in lung cancer. FDG PET may have important impacts on the management of lung-cancer patients, for instance by improvement of locoregional (mediastinal) and extrathoracic staging (unexpected metastases). Interesting findings have now been reported in the response assessment to induction therapy providing results of greater prognostic significance than that obtained by conventional imaging methods. In the field of thoracic irradiation, FDG PET may provide advantages in terms of reduced toxicity, treatment intensification, better local tumour control and increased survival.

Carcinoma, Non-Small-Cell Lung↗
PubMed2004

Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma.

OBJECTIVES: This study evaluated the efficacy and safety of a novel asthma management strategy--budesonide/formoterol for both maintenance and symptom relief (Symbicort Single Inhaler Therapy)--compared with a higher maintenance dose of budesonide in patients with moderate to severe asthma. METHODS: This was a 12-month, randomised, double-blind, parallel-group study. Symptomatic patients with asthma (n = 1890; mean age 43 years [range 11 years-80 years], mean baseline forced expiratory volume in 1 s [FEV(1)] 70% of predicted, mean inhaled corticosteroid [ICS] dose 746 microg/day) received either budesonide (160 microg, 2 inhalations twice daily) plus terbutaline 0.4 mg as needed or a daily maintenance dose of budesonide/formoterol (160/4.5 microg, 2 inhalations once daily) with additional inhalations of budesonide/formoterol 160/4.5 microg as needed. Time to first severe exacerbation (hospitalisation/emergency room [ER] treatment or systemic steroids due to asthma worsening or a fall in morning peak expiratory flow [PEF] to < or = 70% of baseline on 2 consecutive days) was the primary outcome variable. RESULTS: A total of 1890 patients were randomised, of whom 1563 (83%) had severe asthma. The time to first severe exacerbation was prolonged by budesonide/formoterol single inhaler therapy (p < 0.001) compared with a higher dose of budesonide. The risk of having a severe exacerbation was 39% lower with budesonide/formoterol single inhaler therapy compared with budesonide (p < 0.001). The number needed to treat to prevent one severe exacerbation per year with budesonide/formoterol compared with budesonide was 5. The budesonide/formoterol group had 45% fewer severe exacerbations requiring medical intervention per patient compared with the budesonide group (p < 0.001). Budesonide/formoterol patients had fewer hospitalisations/ER treatments (15 vs 25 events, respectively [descriptive statistics]) and fewer treatment days with systemic steroids (1776 days vs 3177 days, respectively [descriptive statistics]) compared with budesonide patients. Budesonide/formoterol single inhaler therapy patients used less as-needed medication compared with budesonide patients (0.90 vs 1.42 inhalations/day; p < 0.001). The mean daily ICS dose was lower in the budesonide/formoterol group than in the budesonide group (466 microg/day vs 640 microg/day). Over the 12-month study period, the budesonide/formoterol group achieved asthma control sufficient to not require any additional as-needed medication on 60% of days. Overall, budesonide/formoterol single inhaler therapy gave 31 more asthma control days (a night and day with no asthma symptoms and no as-needed medication use) per patient-year and 12 additional undisturbed nights per patient-year compared with a higher dose of budesonide. Both treatments were well tolerated. CONCLUSION: Budesonide/formoterol single inhaler therapy has the potential to provide a complete asthma management approach with one inhaler, demonstrating a high level of efficacy in patients with moderate to severe asthma.

Administration, Inhalation↗
PubMed2003

[Pulmonary diseases in the elderly. Problems of pharmacotherapy].

In asthma, inhaled corticosteroids (ICS) can be regarded as disease-modifying drugs. They represent the mainstay of pharmacotherapy of asthma. In elderly, ICS are currently underused. In chronic obstructive pulmonary disease (COPD), there is recent evidence to suggest that ICS may reduce the rate and severity of COPD exacerbations and may improve health-related quality of life. Particularly patients with moderate-to-severe COPD appear to benefit from ICS therapy. In both asthma and COPD, fixed combinations of ICS and long-acting beta 2-agonists may provide clinically meaningful benefits to patients and may represent a further therapeutic advantage.

Aged↗
PubMed2002

[Optimization of radiotherapy planning for non-small cell lung cancer (NSCLC) using 18FDG-PET].

AIM: In recent years, FDG-PET examinations have become more important for problems in oncology, especially in staging of bronchogenic carcinoma. In the retrospective study presented here, the influence of PET on the planning of radiotherapy for patients with non-small-cell lung cancer (NSCLC) was investigated. METHODS: The study involved 39 patients with NSCLC who had been examined by PET for staging. They received radiotherapy on the basis of the anterior/posterior portals including the primary tumour and the mediastinum planned according to CT- and bronchoscopic findings. The results of the PET examination were not considered in initial radiotherapy planning. The portals were retrospectively redefined on the basis of FDG uptake considering the size and localization of the primary tumour; and FDG activities outside the mediastinal part of the portals. RESULTS: In 15 out of 39 patients, the CT/PET-planned portals differed from the CT-planned ones. In most causes (n = 12) the CT/PET field was smaller than the CT field. The median geometric field size of the portals was 179 cm2, after redefinition using PET 166 cm2. In 20 patients with disturbed ventilation caused by the tumour (atelectasis, dystelectosis), a correction of the portal was suggested significantly more frequently than in the other patients (p = 0.03). CONCLUSIONS: Our results demonstrate the synergism of topographical (CT) and metabolic (FDG-PET) information, which could be helpful in planning radiotherapy of bronchial carcinoma, especially for patients with disturbed ventilation.

Carcinoma, Non-Small-Cell Lung↗
PubMed2001

IL-2 in combination with IFN- alpha and 5-FU versus tamoxifen in metastatic renal cell carcinoma: long-term results of a controlled randomized clinical trial.

We conducted a prospectively randomized clinical trial to compare the efficacy and safety of subcutaneous interferon-alpha2a, subcutaneous interleukin-2 and intravenous 5-fluorouracil as home therapy against oral tamoxifen in 78 patients with progressive metastatic renal cell carcinoma. Treatment courses consisted of interferon-alpha2a 5 x 10(6) IU m(-2), day 1 weeks 1 + 4; days 1, 3, 5 weeks 2 + 3; 10 x 10(6) IU m(-2), days 1, 3, 5 weeks 5-8; interleukin-2 10 x 10(6) IU m(-2), twice daily days 3-5 weeks 1 + 4; 5 x 10(6) IU m(-2), days 1, 3, 5 weeks 2 + 3; and 5-fluorouracil 1000 mg m(-2), day 1 weeks 5-8. The tamoxifen group received tamoxifen 80 mg twice daily over 8 weeks. Among 41 patients treated with interleukin-2, interferon-alpha2a and 5-fluorouracil there were 7 complete (17.1%) and 9 partial responders (21.9%), with an overall objective response rate of 39.1% (95% CI, 24.2-55.5). An additional 15 patients (36.6%) were stable throughout therapy. The overall survival was 24 months (range 5-76+). In 37 patients receiving tamoxifen no objective remissions occurred. 13 patients (35.1%) had stable disease and 24 patients (64.9%) showed continued disease progression. The overall survival was 13 months (range 3-73+). In summary, this home-based therapy regimen of interferon-alpha2a, interleukin-2 and 5-fluorouracil demonstrated significant therapeutic efficacy in patients with progressive renal cell carcinoma when compared to hormonal therapy.

Adult↗
PubMed2001

Chemotherapy in stage I+II non-small cell lung cancer.

Although surgical resection offers the best chance for long-term survival for patients with non-small cell lung cancer (NSCLC), the limited number of resectable patients and the presence of micrometastatic disease is limiting the effectiveness of this modality as sole treatment. Results of randomized trials demonstrated a survival benefit for preoperative (neoadjuvant) cisplatin-based chemotherapy in patients with stage IIIA NSCLC compared to surgery alone. In stage I+II NSCLC preoperative chemotherapy, although still experimental, clearly offers encouraging results. However, there is no evidence of its superiority over adjuvant chemotherapy. Moreover, for adjuvant therapy a benefit has not been established yet. Possibly current ongoing or recently finished trials may change the recommendations on adjuvant or neoadjuvant therapy for completely resected or resectable early disease in the future.

Antineoplastic Agents↗
PubMed2001

[Accuracy of positron emission tomography with fluorine-18-fluoro-deoxyglucose].

BACKGROUND: : FDG-PET is a powerful tool for the diagnostic workup of patients with lung cancer. A reduced sensitivity of FDG-PET for the evaluation of lung lesions was reported for bronchioloalveolar carcinoma (BAC). No literature exists about the diagnostic efficacy of FDG-PET in the staging of BAC. METHODS: : Out of a series of subsequent 630 untreated patients with the final diagnosis of lung cancer, who underwent FDG-PET, all patients with BAC were evaluated with respect to tumour detection, N-staging, and M-staging. RESULTS: : 35 patients (5.6 %) had BAC, 22 in a localized form (8 x pT1, 14 x pT2), 13 in a disseminated stage. FDG-PET correctly identified 19/22 cases with localized forms. Two of the missed one were classified as pT1. All disseminated forms of BAC were detected. Standardized uptake values (SUV) ranged from 0.9 to 23.3 (mean +/- SD: 11.6 +/- 5.1). Accuracy of N-staging was comparable to known results in lung cancer (FDG-PET 80 %, CT 64 %). With respect to M-staging, sensitivity of FDG-PET was as follows: M1(HEP): 2/3 (67 %), M1(PUL): 7/8 (88 %), M1(OSS): 1/1 (100 %). CONCLUSIONS: : With some limitations in small localized tumours FDG-PET can detect and stage BAC with an accuracy which is identical to that for other histological types of non-small cell lung cancer.

Carcinoma, Non-Small-Cell Lung↗
PubMed2001

[Meta-analysis of the efficacy of positron emission tomography with F-18-fluorodeoxyglucose in lung tumors. Basis for discussion of the German Consensus Conference on PET in Oncology 2000].

BACKGROUND: : To analyse current literature on FDG-PET for evaluation of lung lesions, N-staging, M-staging, and recurrence of lung cancer for the third German Consensus Conference on PET in oncology. METHODS: Specialists in nuclear medicine, pneumology, radiation oncology, diagnostic radiology, and thoracic surgery reviewed the relevant literature as listed in MEDLINE from 1985 to 1999 for further analysis. Out of the published data cumulative test parameters and summary receiver operating characteristic curves (sROC curves) were computed. RESULTS: Sensitivity, specificity, and accuracy of FDG-PET are 96 %, 80 %, 91 % for evaluating lung lesions (15 studies with at least 35, in total 1144 patients). With corresponding values of 88 %, 92 %, 91 % (20 studies, 1292 patients) for N-staging FDG-PET is superior to CT with 65 %, 76 %, 73 % (19 studies, 1268 patients). With 94 %, 97 %, 96 % (4 studies, 336 patients) M-staging with FDG-PET is very accurate and changed therapeutic management in 18 % of the cases (8 studies, 695 patients), unexpected extrathoracic metastases were found in 12 % (7 studies, 581 patients). FDG-PET is the most accurate non-invasive method to evaluate suspected adrenal metastases (3 studies, 263 patients, sensitivity 96 %, specificity 99 %, accuracy 98 %). Recurrence is detected accurately (4 studies, 224 patients, sensitivity 99 %, specificity 89 %, accuracy 95 %). CONCLUSIONS: Studies with in total more than 1000 patients show the high diagnostic efficacy of FDG-PET and its superiority to conventional imaging in lung cancer. Based on this analysis the third German Consensus Conference on PET in oncology evaluated FDG-PET on lung cancer. 1a-indications are evaluation of lung nodules in patients at risk for complications during surgery, N-staging, M-staging (except brain), and detection of recurrence.

Fluorodeoxyglucose F18↗
PubMed2000

A palliative accelerated irradiation regimen for advanced non-small-cell lung cancer vs. conventionally fractionated 60 GY: results of a randomized equivalence study.

PURPOSE: Radiation oncologists are often faced with patients with advanced non-small-cell lung cancer (NSCLC), who are not suitable candidates for state-of-the-art radical treatment, but who also are not judged to have a very short life expectancy. Some physicians treat these patients palliatively, whereas others advocate more intensive treatment. To find out if there is a substantial difference in outcome between these approaches, we performed a randomized prospective study. METHODS AND MATERIALS: Between 1994 and 1998, 152 eligible patients with advanced NSCLC Stage III (n = 121) or minimal Stage IV (n = 31) were randomized to receive conventionally fractionated (cf; A: 60 Gy, 6 weeks, n = 79) or short-term treatment (PAIR; B: 32 Gy, 2 Gy b.i.d.; n = 73) of tumor and mediastinum. RESULTS: One-year survival rate for all patients was 37% with no significant difference between the two treatment arms (A: 36%; B: 38%; p = 0.76). As far as can be judged from limited data available, palliation was adequate and similar for the two treatment arms. Apart from expected differences in the time course of esophagitis, acute side effects were moderate and equally distributed. No severe late effects were observed. CONCLUSIONS: In the present randomized trial, survival and available data on palliation were not different after cf to 60 Gy compared to the palliative PAIR regimen. Therefore, for patients who are not suitable for radical treatment approaches, the prescription of a palliative short-term irradiation appears preferable compared to cf over several weeks.

Adenocarcinoma↗
PubMed2000

Bronchial and bronchovascular sleeve resection for treatment of central lung tumors.

BACKGROUND: To improve postoperative pulmonary reserve, we have employed parenchyma-sparing resections for central lung tumors irrespective of pulmonary function. The results of lobectomy, pneumonectomy, and sleeve resection were analyzed retrospectively. METHODS: From October 1995 to June 1999, 422 typical lung resections were performed for lung cancer. Of these, 301 were lobectomies (group I), 81 were sleeve resections (group II), and 40 were pneumonectomies (group III). RESULTS: Operative mortality was 2% in group I, 1.2% in group II, and 7.5% in group III (group I and II vs. group III, p<0.03). Mean time of intubation was 1.0+/-4.1 days in group I, 0.9+/-1.3 days in group II, and 3.6+/-11.2 days in group III (groups I and II vs. group III, p<0.01). The incidence of bronchial complications was 1.3% in group I, none in group II, and 7.5% in group III (group I and II vs group III, p<0.001). After 2 years, survival was 64% in group I, 61.9% in group II, and 56.1% in group III (p = NS). Freedom from local disease recurrence was 92.1% in group I, 95.7% in group II, and 90.9% in group III after 2 years (p = NS). CONCLUSIONS: Sleeve resection is a useful surgical option for the treatment of central lung tumors, thus avoiding pneumonectomy with its associated risks. Morbidity, early mortality, long-term survival, and recurrence of disease after sleeve resection are similar to those seen after lobectomy.

Aged↗
PubMed2000

[Interferon alpha-2a in the treatment of diffuse thoracic angiomatosis in adulthood--a ase report].

A diffuse angiomatosis affecting thoracal organs is a rare, frequently fatal disorder occurring mainly in childhood. The definite diagnosis is usually made by autopsy. A specific treatment does not exist. In the case report presented here we describe the course of an 37-year old patient presenting initially with dyspnea and hemoptysis. Radiological investigations showed a mass lesion in the anterior superior mediastinum, bihilar masses and a periesophageal mass with soft tissue density and a pericardial effusion. Bilateral interstitial infiltrations were also present. CT-guided mediastinal biopsies and bronchial mucosal biopsies were nonspecific. Open-lung biopsy revealed the diagnosis of an extensive diffuse angiomatosis affecting mediastinum, pericardium and pleura. During the 18-month monotherapy with interferon-alpha 2a the patient showed significant improvements of clinical as well as laboratory and radiological parameters. The presented case confirms the experience of several authors, that the diagnosis of a diffuse thoracal authors can only be made by open lung biopsy or autopsy. The presented case also underlines the possibility of a palliative therapy of aggressive angiomatous diseases with interferon-alpha 2a.

Adult↗