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Tilmann Steinmetz

Publications and source records attributed to Tilmann Steinmetz.

2 recordsLinked to original sources

Sensitivity analysis of cost factors for various therapy options in the treatment of follicular lymphoma.

BACKGROUND: In Germany, patients with relapsed follicular non-Hodgkin's lymphoma do not all receive the same treatment. In this study, 3 therapy regimens were analyzed which were considered to be similar. With the goal of determining the treatment option with the lowest direct costs whilst maintaining the same degree of effectiveness, a cost analysis model was established and applied by way of example to the existing illness constellation. METHODS: The German doctors' fee scale (Einheitlicher Bewertungsmassstab, EBM) valid until 2005 served as the basis for the calculation of medical services within the scope of the present statutory health insurance guidelines. A virtual standard patient was constructed for the cost model and treated with the different therapy regimens. The incidences of individual adverse events described in literature served as the basis for the characterization of the average toxicity of the respective treatment methods. RESULT: The overall costs result from the sum of the treatment costs and the toxicity-related costs. The effect of additional interventions on the overall cost was also examined. CONCLUSION: Whereas the accompanying documentation of costs in clinical studies is organizationally complex and very tedious, the model applied here offers a reliable method of quantifying the costs of the different therapy regimens. It permits the comparison of different treatment alternatives, and it enables, by means of a cost variance analysis, the identification of cost drivers and less expensive measures within a therapy method.

Antibodies, Monoclonal↗

Prospective, double-blind, placebo-controlled, multicenter, randomized phase III study with orally administered budesonide for prevention of irinotecan (CPT-11)-induced diarrhea in patients with advanced colorectal cancer.

BACKGROUND: Unpredictable and severe diarrhea (NCI grade > or =3) remains a life-threatening adverse event in patients treated with irinotecan (CPT-11). The aim of this study was to evaluate the efficacy and safety of orally administered budesonide for prevention of CPT-11-induced delayed diarrhea in patients with advanced colorectal cancer. PATIENTS AND METHODS: A total of 56 patients with advanced colorectal cancer receiving CPT-11 therapy (125 mg/m2 once weekly) were enrolled in this multicenter trial. Patients were randomly treated with 3 mg budesonide orally 3 times daily versus placebo. Detailed assessment of diarrhea by monitoring stool frequency, stool consistency and loperamide rescue medication was made by keeping a diary. RESULTS: Diarrhea, defined as number of stools >4 occurring on a single day during the study period, could be prevented in 58.3% of the budesonide-treated patients compared to 38.5% of the patients under placebo. Patients in the budesonide group had less episodes (0.7 vs. 2.2 episodes) and a considerably shorter total duration of diarrhea (1.8 vs. 4.2 days) episodes than patients in the placebo group. Loperamide use was more frequent in the placebo than in the budesonide arm (55.6 vs. 41.7%). Also, exposure to rescue medication of loperamide was higher for placebo (36.2 capsules) than for budesonide (24.9 capsules). A superior prevention of diarrhea was observed for budesonide compared to placebo in the first cycle (14 vs. 10; p = 0.257), with more failures observed in the placebo group (16 vs. 10). CONCLUSION: This double-blind randomized trial failed to show that budesonide has a significant benefit in preventing CPT-11-induced diarrhea. While a trend exists, further trials are warranted.

Administration, Oral↗