British journal of cancer
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British journal of cancer · Jul 1999
Randomized Controlled Trial Clinical TrialOral topotecan: bioavailablity and effect of food co-administration.
The aims of the study were twofold: (1) to evaluate the effect of food on the relative oral bioavailability of topotecan gelatin capsules in patients with solid tumours, and (2) to determine the absolute bioavailability of oral topotecan with reference to the intravenous (i.v.) formulation. The study had a randomized two-period cross-over design. On day 1 of the first treatment course patients were administered 2.3 mg m(-2) day(-1) of oral topotecan with or without a high-fat breakfast. ⋯ The apparent terminal half-life was significantly longer after administration of oral topotecan (3.9+/-1.0 h) than after i.v. administration (2.7+/-0.4 h) (P < 0.001). Topotecan demonstrates suitable bioavailability for oral treatment. Co-administration of the topotecan gelatin capsules with a high-fat breakfast leads to a small decrease in absorption rate but does not affect the extent of absorption.
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British journal of cancer · Jul 1999
Clinical TrialAssessment of long-term quality of life in patients with anal carcinomas treated by radiotherapy with or without chemotherapy.
This study was conducted to assess long-term Quality of Life (QOL) in patients treated by radiotherapy with or without chemotherapy for anal carcinomas. Patients with a maximum age of 80 years, and who were alive at least 3 years following completion of treatment with a functioning anal sphincter and without active disease, were selected for this study. Of 52 such patients identified, 41 (79%) were evaluable. ⋯ None of the functional and symptom scale scores seemed to be better in patients with longer follow-up. In patients treated with sphincter conservation for anal carcinomas, long-term QOL as measured by the EORTC QLQ-C30 and QLQ-CR38 appears to be acceptable, with the exception of diarrhoea and perhaps sexual function. Moreover, the subset of patients who presented with severe complications and/or anal dysfunction showed poorer scores in most scales.