Budesonide/formoterol maintenance and reliever therapy versus conventional best standard treatment in asthma in an attempted 'real life' setting.

AIMS: The purpose of this study was to compare the efficacy of budesonide/formoterol maintenance and reliever therapy (Symbicort® SMART®, AstraZeneca AB, Södertälje, Sweden) with conventional best standard treatment (CBST) in patients with persistent asthma in an attempted 'real life' setting. METHODS: In total, 1835 patients from Denmark, Finland and Norway were randomized to 26 weeks treatment with budesonide/formoterol 160/4,5 µg twice daily plus budesonide/formoterol 160/4,5 µg for symptom relief or CBST according to the Global Initiative for Asthma guidelines. The study was randomized, open-label and designed to reflect 'real life' asthma management. Efficacy variables were time to first severe asthma exacerbation, rate of severe asthma exacerbations, asthma control (Asthma Control Questionnaire-5) and use of inhaled glucocorticosteroids (IGCS). RESULTS: Treatment with budesonide/formoterol maintenance and reliever therapy led to a 21% reduction in time to first severe asthma exacerbation compared with CBST, although not statistically significant (hazard ratio 0.794, P = 0.189). A trend towards a reduction in the rate of severe exacerbations in the budesonide/formoterol maintenance and reliever therapy group was observed (16 vs 22 events/100 patient years; P = 0.058). The percentage of patients with well-controlled asthma increased significantly among those treated with budesonide/formoterol maintenance and reliever therapy compared with CBST (45% vs 40%; odds ratio 1.39; P < 0.01), in spite of a significant 31% reduction in total mean daily IGCS dose (P < 0.0001). No difference in mean as-needed medication use was seen (P = 0.98). All treatments were well tolerated. CONCLUSION: Budesonide/formoterol maintenance and reliever therapy resulted in a better overall asthma control with a significant lower daily IGCS dose compared with CBST.

Cisplatin and etoposide regimen is superior to cyclophosphamide, epirubicin, and vincristine regimen in small-cell lung cancer: results from a randomized phase III trial with 5 years' follow-up.

PURPOSE: To investigate whether chemotherapy with etoposide and cisplatin (EP) is superior to cyclophosphamide, epirubicin, and vincristine (CEV) in small-cell lung cancer (SCLC). PATIENTS AND METHODS: A total of 436 eligible patients were randomized to chemotherapy with EP (n = 218) or CEV (n = 218). Patients were stratified according to extent of disease (limited disease [LD], n = 214; extensive disease [ED], n = 222). The EP group received five courses of etoposide 100 mg/m(2) intravenously (IV) and cisplatin 75 mg/m(2) IV on day 1, followed by oral etoposide 200 mg/m(2) daily on days 2 to 4. The CEV group received five courses of epirubicin 50 mg/m(2), cyclophosphamide 1,000 mg/m(2), and vincristine 2 mg, all IV on day 1. In addition, LD patients received thoracic radiotherapy concurrent with chemotherapy cycle 3, and those achieving complete remission during the treatment period received prophylactic cranial irradiation. RESULTS: The treatment groups were well balanced with regard to age, sex, and prognostic factors such as weight loss, and performance status. The 2- and 5-year survival rates in the EP arm (14% and 5%, P =.0004) were significantly higher compared with those in the CEV arm (6% and 2%). Among LD patients, median survival time was 14.5 months versus 9.7 months in the EP and CEV arms, respectively (P =.001). The 2- and 5-year survival rates of 25% and 10% in the EP arm compared with 8% and 3% in the CEV arm (P =.0001). For ED patients, there was no significant survival difference between the treatment arms. Quality-of-life assessments revealed no major differences between the randomized groups. CONCLUSION: EP is superior to CEV in LD-SCLC patients. In ED-SCLC patients, the benefits of EP and CEV chemotherapy seem equivalent, with similar survival time and quality of life.