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Notes: Background  A multicentre, centrally randomized, open-labelled study with temozolomide and interferon (IFN)-α2b was carried out to study the therapeutic effect in patients with metastatic melanoma stage IV.Objectives  The response rate, efficacy, side-effects, reasons for discontinuation of therapy and survival rate of 47 patients treated with temozolomide in combination with two different dosing regimens of IFN-α2b were documented.Patients/methods  Twenty-nine male and 18 female patients (mean age 57·6 years, range 34–74) were centrally randomized to two different arms: 20 patients received a treatment schedule with temozolomide 150 mg m−2 on days 1–5 orally every 28 days in combination with IFN-α2b 10 MIU m−2 every other day and 27 patients received temozolomide 150 mg m−2 on days 1–5 every 28 days in combination with IFN-α2b in a fixed dose of 10 MIU every other day.Results  We observed an overall response rate of 27·6% comprising five complete remissions (10·6%: one patient group A, four patients group B), in two of these five patients at the last follow-up in the study (4·3%, both in group B); and eight partial remissions (17%: six patients in group A, two patients in group B), in three of these eight patients at the last follow-up in the study (6·4%, two patients in group A, one patient in group B). Three patients showed stable disease (6·4%: one patient in group A, two patients in group B). Mean survival was 14·5 months [95% confidence interval (CI) 10–19] with no significant differences between treatment groups. However, there was a significant correlation with response after three cycles (log rank test, P 〈 0·03). Within the 32 patients who completed at least three cycles of therapy, seven patients (three in group A and four in group B) with a partial or complete response showed a significantly better mean survival of 30·6 months (95% CI 19·1–42) compared with 25 patients who did not respond (13·7 months 95% CI 9·2–18·3). In total, patients with at least one complete remission showed the longest survival (37·1 months 95% CI 26·3–47·9), followed by patients with at least one partial response (17·4 95% CI 10·9–23·9). Major side-effects of the treatment were nausea, vomiting, headache, leucopenia, thrombopenia, elevation of liver function parameters and neurological symptoms. In five patients, the side-effects led to a discontinuation of treatment: neurological symptoms (two patients), sepsis (one patient), brain haemorrhage (one patient) and exanthema (one patient). There were no treatment-related deaths.Conclusions  The combination of temozolomide and IFN-α2b can easily be administered and shows tolerable toxicity. When an objective response occurs after three cycles, it indicates a significant survival advantage.

Notes: Summary Background  Most leg ulcers occur in patients with venous insufficiency. However, not all patients with venous insufficiency develop leg ulcers. Recent studies have found that factors causing clotting abnormalities, e.g. anticardiolipin antibody (ACA), are associated with leg ulcers. Although lupus anticoagulant, like ACA, belongs to the group of antiphospholipid antibodies, its presence in patients with venous leg ulceration has not been previously reported.Objectives  To determine the presence of lupus anticoagulant in patients with venous leg ulceration.Methods  We investigated the presence of lupus anticoagulant in 27 patients with venous leg ulcers and compared these data with controls. Lupus anticoagulant was evaluated in all subjects by the Russell's viper venom test.Results  Of 27 patients with venous leg ulceration, 16 (59%) were shown to have lupus anticoagulant, while only one of 32 controls (3%) was found to have lupus anticoagulant. Thus, lupus anticoagulant was significantly more frequent in patients with venous leg ulcers than in controls (P 〈 0·001).Conclusions  We suggest that lupus anticoagulant could be a hitherto unknown factor contributing to the development of venous leg ulcers.