European journal of cancer : official journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)
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Multicenter Study Clinical Trial
Extended phase II study of paclitaxel as a 3-h infusion in patients with ovarian cancer previously treated with plantinum.
An extended phase II study was performed to evaluate single-agent paclitaxel as salvage chemotherapy for ovarian cancer. The aim of this study was to evaluate the 3-h infusion schedule of paclitaxel in terms of toxicity and antitumour efficacy. Furthermore, we analysed the impact on response and survival of the extent of prior chemotherapy and status of resistance against platinum. ⋯ Platinum resistance did not predict response to treatment. Paclitaxel 175 mg/m2 given as a 3-h infusion is an appropriate treatment for patients with platinum-resistant ovarian cancer who have not previously received more than two chemotherapy regimens. Paclitaxel did not show results superior to historical data for platinum retreatment in patients with platinum-sensitive, recurrent ovarian cancer.
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Clinical Trial
EO9 phase II study in advanced breast, gastric, pancreatic and colorectal carcinoma by the EORTC Early Clinical Studies Group.
In a phase II trial, the activity of EO9, a new bioreductive alkylating agent, was assessed. EO9 was used as second-line chemotherapy in breast cancer patients and as first-line chemotherapy for patients with gastric, pancreatic and colorectal cancer. EO9 was given as a 5 min i.v. infusion at a weekly dose of 12 mg/m2. 92 patients were entered; 22 with breast cancer, 26 with colon cancer, 24 with pancreatic cancer and 20 with gastric cancer. ⋯ Reversible proteinuria was the main toxicity occurring in 45% of courses. Antitumour activity was not observed. At this dose and schedule, EO9 is not an active drug in the type of tumour studied.
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Multicenter Study
Development of an EORTC questionnaire module to be used in quality of life assessment for patients with oesophageal cancer. The EORTC Quality of Life Study Group.
Quality of life (QOL) assessments in patients with oesophageal cancer should provide clinically meaningful data that can assist management decision making. This study describes the development of a specific module for oesophageal cancer to use with the European Organisation into Research and Treatment of Cancer (EORTC) QOL questionnaire, the EORTC QLQ-C30. Relevant QOL issues were generated from a literature search and interviews with patients and oesophageal cancer specialists. ⋯ The provisional module was pretested in patients from the United Kingdom, Spain and Sweden. The resulting module, the QLQ-OES 24, includes 24 items conceptualised as containing six scales and five single items. The addition of an oesophageal cancer-specific module to the core questionnaire should improve the sensitivity and specificity of the core instrument to allow detection of even small benefits accrued from new treatment modalities.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
An increased loading dose of ondansetron: a north european, double-blind randomised study in children, comparing 5 mg/m2 with 10 mg/m2.
A North European, randomised, double-blind study, comparing a loading-dose of ondansetron of 5 mg/m2 with 10 mg/m2, administered intravenously before highly emetogenic chemotherapy, was carried out in 187 chemotherapy-naïve children. In the first 24 h, both groups received further ondansetron intravenously at a dose of 5 mg/m2 8-hourly. Thereafter, ondansetron was given at an oral dose of 4 or 8 mg depending on the surface area of the child, three times a day and continued for at least 3 days after the last day of chemotherapy. ⋯ Ondansetron provided good control of emesis and nausea on day 1 with 71-72% of patients experiencing two or fewer emetic episodes (complete or major responders) and 90-86% of patients reporting nausea as none or mild. There was also no difference in the efficacy of the treatment arms in the control of emesis and nausea on subsequent days of the study period. Both anti-emetic regimens were well-tolerated.