Patients with chronic obstructive pulmonary disease (COPD) often have reduced physical activity, which can impair health status. Real-world data can provide valuable information on the health and functional status of patients with COPD treated with tiotropium/olodaterol.AERIAL® (NCT03165045) was a German, non-interventional study of patients with COPD receiving treatment with tiotropium/olodaterol under real-world conditions for approximately 6 weeks. The primary endpoint was the proportion of patients achieving a decrease of ≥0.4 points in Clinical COPD Questionnaire (CCQ) score. The CCQ-4 subdomain was used to assess functional status, and the Physician's Global Evaluation (PGE) scale to assess the patients’ general condition. Safety was also assessed, as well as patient satisfaction and willingness to continue treatment.Of 1351 screened patients, 1322 were treated and 1140 comprised the full analysis set. The primary endpoint was met: 66.3% of patients achieved a ≥0.4-point decrease in overall CCQ score (mean decrease±standard deviation [sd] 0.78±0.95). Mean decrease ±sd in CCQ symptoms and functional state subdomains were 0.84±1.06 and 0.75±1.05 points, respectively. PGE scores improved. One fatality (not treatment-related) and 23 drug-related adverse events were recorded, most commonly nausea and vertigo. Over 85% of patients were satisfied/very satisfied with tiotropium/olodaterol overall and with the Respimat device, both in terms of inhalation and handling. Most patients (95.2%) expressed willingness to continue treatment.Patients with COPD treated with tiotropium/olodaterol via Respimat in routine clinical practice had clinically relevant improvements in health and functional status compared with baseline.
The efficacy of treatment with fotemustine and interferon (IFN) alpha was evaluated in metastatic melanoma. A group of 50 patients with metastatic malignant melanoma were treated with a combination of IFNalpha2b and the nitrosourea fotemustine. The patients received 10 MU IFN three times weekly for 3 weeks and fotemustine at a dose of 100 mg/m2 on days 8, 15 and 22. After a 5-week rest period, patients with stabilized or responding disease received a maintenance therapy consisting of 10 MU IFN three times a week for 1 week followed by administration of fotemustine (100 mg/m2) on day 8. This cycle was repeated every 4 weeks until progression occurred. If there was complete remission (CR), treatment was stopped after an additional three cycles. Toxicity and clinical response were scored according to WHO criteria. Objective response was seen in 14 patients (28%; 95% confidence interval 15.6%-40.4%) with four CR and ten partial responses (PR). The median duration of CR was 73 weeks, that of PR 26 weeks. Toxicity was acceptable, enabling treatment on an outpatient basis. The combination of fotemustine with IFNalpha is effective and well tolerated, but there is no evident advantage over fotemustine monotherapy in the treatment of metastatic melanoma.
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