Summary A total of 535 chemotherapy naive, hospitalised patients (263 male/272 female) scheduled to receive cisplatin (50-120mg m-2)-containing regimens participated in a randomised, double-blind, parallel group study to evaluate the efficacy and safety of three intravenous dose schedules of ondansetron in the prophylaxis of acute nausea and emesis. One hundred and eighty two patients received a loading dose of 8 mg of ondansetron followed by a 24 h infusion of 1 mg h-I (group 1); 180 and 173 patients received single doses of 32mg (group II) and 8 mg (group III) respectively, followed by a 24 h placebo infusion. Complete and major control ( < 2 emetic episodes) of acute emesis was achieved in 74% of patients in group I, 78% in group II and 74% in group III. Seventy seven per cent of the patients in group I, and 75% of patients in groups II and III respectively experienced no or mild nausea during the 24 h observation period. A retrospective stratification of the efficacy data on the basis of patient gender showed the response rate in females to be significant lower (43% vs 67%; <0.001). Ondansetron was well tolerated; mild headache was the most commonly reported adverse event (11 % of patients) with a similar incidence in the three groups of patients. In conclusion, a single intravenous dose of 8 mg of ondansetron given prior to chemotherapy is as effective as a 32 mg daily dose given as either a single dose or a continuous infusion in the prophylaxis of acute cisplatin-induced emesis.
BackgroundBullous pemphigoid (BP) is the most frequent autoimmune blistering disease mainly affecting elderly patients. Among several published risk factors, a recent post hoc analysis linked anti‐BP180 autoantibodies (AABs) to fatal outcomes in BP. To date, this finding has not been confirmed independently.ObjectiveTo investigate the potential of anti‐BP180‐AAB levels as a marker of prognosis and to identify a cut‐off level indicative of an increased risk for early death. Secondly, to characterize parameters associated with mortality.MethodsRetrospective, single‐centre study of BP patients diagnosed between 2001 and 2012. Analyses included epidemiological and patient‐ and disease‐specific characteristics as well as immunological parameters at diagnosis and during follow‐up. Standardized mortality ratios as well as uni‐ and multivariate regression analyses were calculated.ResultsOne hundred patients (56 women, 44 men) with a median age of 81 years (interquartile range 74–86) were followed up for a median of 775 days (interquartile range 162–1617). One‐year mortality rates were 25.0% implying a 2.4‐fold increased risk of death compared with the general population. High anti‐BP180 autoantibody levels at diagnosis (CI95 1.30–2.89; P = 0.001), dementia (CI95 1.13–6.72; P =0.03), length of hospitalization (CI951.16–2.41; P = 0.01) and age (CI95 1.23–4.19; P = 0.009) correlated significantly with 1‐year mortality. BP180‐AAB concentrations of ≥61 U/mL characterized a subgroup of patients with a particular higher risk for early death compared with the general population (CI95 1.81–3.81; P < 0.0001).ConclusionIn bullous pemphigoid, serum concentrations of BP180 autoantibodies at diagnosis could help to identify patients at risk for death within the first year after diagnosis (cut‐off value 61 U/mL).
Background. Chemotherapy‐induced emesis is one of the most disturbing side effects in cancer therapy. Thus, antiemetic treatment is a mandatory adjunct in emetogenic chemotherapy.
Methods. Tropisetron (Navoban, Sandoz Pharma Ltd., Basel, Switzerland), a new 5‐HT3 receptor antagonist, was compared in a randomized multicenter trial with a high‐dose metoclopramide‐dexamethasone cocktail for the prevention of nausea and emesis during cisplatin‐containing chemotherapy. Two hundred fifty‐nine chemotherapy‐naive patients were included and followed during two consecutive courses. The main cancer types were gynecologic tumors, followed by lung cancer, head and neck cancer, and bladder cancer. The cisplatin dose usually was in the range of 50–89 mg/m2. The efficacy and quality of life assessments and the safety recordings were done during the first 6 days of both courses of chemotherapy.
Results. Acute vomiting was prevented in 63–64% of patients by both antiemetic regimens. The total rate of control of vomiting increased from 63% on day 1 to 93% on day 6 in the group receiving tropisetron. Acute nausea was prevented in 40% of the patients with tropisetron monotherapy and in 61% of patients receiving the antiemetic cocktail. With regard to delayed nausea, there were no significant differences between the two antiemetic regimens. Mild headache and constipation were more frequently associated with tropisetron, and extrapyramidal side effects and sedation were associated with the antiemetic cocktail.
Conclusions. Tropisetron was easier to administer and better tolerated than the cocktail, and it seems to be a highly efficacious and safe new antiemetic drug. Cancer 1994; 73:445–54.
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