‘Tomudex’ (ZD1694): Results of a randomised trial in advanced colorectal cancer demonstrate efficacy and reduced mucositis and leucopenia
Identifieur interne : 00D415 ( Main/Curation ); précédent : 00D414; suivant : 00D416‘Tomudex’ (ZD1694): Results of a randomised trial in advanced colorectal cancer demonstrate efficacy and reduced mucositis and leucopenia
Auteurs : D. Cunningham [Royaume-Uni] ; J. R. Zalcberg [Australie] ; U. Rath [Allemagne] ; I. Olver [Australie] ; E. Van Cutsem [Belgique] ; C. Svensson [Suède] ; J. F. Scitz [France] ; P. Harper [Royaume-Uni] ; D. Kerr [Royaume-Uni] ; G. Perez-Manga [Espagne] ; M. Azab [Royaume-Uni] ; L. Seymour [Royaume-Uni] ; K. Lowery [Royaume-Uni]Source :
- European Journal of Cancer [ 0959-8049 ] ; 1995.
Descripteurs français
- Wicri :
- topic : Organisation européenne.
English descriptors
- KwdEn :
- Adjuvant chemotherapy, Adverse events, Appetite loss, Baseline, Biochemical modulation, Cancer deaths, Cancer research, Chemotherapy, Clin, Clin oncol, Colorectal, Colorectal cancer, Colorectal clin, Complete response, Complete responses, Consecutive days, Convenient dosing schedule, Diarrhoea, Disease progression, Dose reductions, Dosing, Efficacy analyses, Eurj cancer, European community, European organisation, Evaluable disease, Financial impact, Fluorouracil, Folinic acid, Hazard ratio, High dose, High dose leucovorin, Inhibitor, Leucopenia, Leucovorin, Liver metastases, Lower incidences, Lung metastases, Mayo clinic, Mayo regimen, Measurable disease, Measurable lesions, Median, Median time, Metastatic colorectal cancer, Mucositis, Nat1 cancer inst, Novel approaches, Objective response, Objective response rate, Objective responses, Objective tumour response, Odds ratio, Oral effects, Overall objective response, Partial responses, Performance status, Plenum press, Progression, Randomised, Randomised trial, Range cycles, Regimen, Response rate, Royal marsden hospital, Significant difference, Significant differences, Source data, Specific thymidylate synthase, Thymidylate synthase inhibitor, Tomudex, Toxicity, Toxicity symptoms, Transaminase, Transaminase levels, Treatment administration, Treatment group, Treatment groups, Trial therapy, Tumour, Victoria prof, Weight gain, World health organisation, Zeneca pharmaceuticals.
- Teeft :
- Adjuvant chemotherapy, Adverse events, Appetite loss, Baseline, Biochemical modulation, Cancer deaths, Cancer research, Chemotherapy, Clin, Clin oncol, Colorectal, Colorectal cancer, Colorectal clin, Complete response, Complete responses, Consecutive days, Convenient dosing schedule, Diarrhoea, Disease progression, Dose reductions, Dosing, Efficacy analyses, Eurj cancer, European community, European organisation, Evaluable disease, Financial impact, Fluorouracil, Folinic acid, Hazard ratio, High dose, High dose leucovorin, Inhibitor, Leucopenia, Leucovorin, Liver metastases, Lower incidences, Lung metastases, Mayo clinic, Mayo regimen, Measurable disease, Measurable lesions, Median, Median time, Metastatic colorectal cancer, Mucositis, Nat1 cancer inst, Novel approaches, Objective response, Objective response rate, Objective responses, Objective tumour response, Odds ratio, Oral effects, Overall objective response, Partial responses, Performance status, Plenum press, Progression, Randomised, Randomised trial, Range cycles, Regimen, Response rate, Royal marsden hospital, Significant difference, Significant differences, Source data, Specific thymidylate synthase, Thymidylate synthase inhibitor, Tomudex, Toxicity, Toxicity symptoms, Transaminase, Transaminase levels, Treatment administration, Treatment group, Treatment groups, Trial therapy, Tumour, Victoria prof, Weight gain, World health organisation, Zeneca pharmaceuticals.
Abstract
Abstract: ‘Tomudex’ (ZD1694), a direct and specific thymidylate synthase (TS) inhibitor entered phase III studies in November 1993. We present here the first analysis of a randomised multicentre, international phase III study. 439 patients with previously untreated advanced colorectal cancer were randomised to Tomudex 3.0 mg/m2 given once every 3 weeks or 5-fluorouracil (5-FU) 425 mg/m2 and leucovorin (LV) 20 mg/m2 for 5 days (the Mayo regimen), given every 4–5 weeks. Patients were evaluated weekly for toxicity and every 12 weeks for objective response. The two groups were well matched in terms of demographic characteristics. The mean age of the patients was 61 years and most had either liver (78%) or lung (25–29%) metastases. Ninety seven per cent of patients allocated to Tomudex and 94% of those allocated to 5-FU plus LV had measurable disease. Response was assessed using WHO/UICC criteria; all response data were source validated; 19.8% of patients who received Tomudex and 12.7% of patients who received 5-FU plus LV had complete or partial responses (P = 0.059, odds ratio 1.7,95% confidence limits 0.98–2.81). There were no statistically significant differences in time to progression or survival between the two groups. Patients who received Tomudex spent a substantially shorter time in hospital for dosing and had significantly lower rates of grade 3 and 4 toxicities such as leucopenia and mucositis. Patients who received Tomudex had a significantly higher incidence of reversible grade 3 or 4 increase in transaminases, which appear to be of limited clinical significance. Improvement in quality of life, weight gain and performance status was seen in both groups. Tomudex has benefits in terms of higher response rates, reduced toxicity and more frequent palliative benefits when compared with 5-FU plus LV in the management of advanced colorectal cancer, and has a more convenient administration schedule.
Url:
DOI: 10.1016/0959-8049(95)00502-1
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<term>Adverse events</term>
<term>Appetite loss</term>
<term>Baseline</term>
<term>Biochemical modulation</term>
<term>Cancer deaths</term>
<term>Cancer research</term>
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<term>Folinic acid</term>
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<term>High dose leucovorin</term>
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<term>Liver metastases</term>
<term>Lower incidences</term>
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<term>Median time</term>
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<term>Cancer deaths</term>
<term>Cancer research</term>
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<term>Mayo clinic</term>
<term>Mayo regimen</term>
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<term>Median time</term>
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<front><div type="abstract" xml:lang="en">Abstract: ‘Tomudex’ (ZD1694), a direct and specific thymidylate synthase (TS) inhibitor entered phase III studies in November 1993. We present here the first analysis of a randomised multicentre, international phase III study. 439 patients with previously untreated advanced colorectal cancer were randomised to Tomudex 3.0 mg/m2 given once every 3 weeks or 5-fluorouracil (5-FU) 425 mg/m2 and leucovorin (LV) 20 mg/m2 for 5 days (the Mayo regimen), given every 4–5 weeks. Patients were evaluated weekly for toxicity and every 12 weeks for objective response. The two groups were well matched in terms of demographic characteristics. The mean age of the patients was 61 years and most had either liver (78%) or lung (25–29%) metastases. Ninety seven per cent of patients allocated to Tomudex and 94% of those allocated to 5-FU plus LV had measurable disease. Response was assessed using WHO/UICC criteria; all response data were source validated; 19.8% of patients who received Tomudex and 12.7% of patients who received 5-FU plus LV had complete or partial responses (P = 0.059, odds ratio 1.7,95% confidence limits 0.98–2.81). There were no statistically significant differences in time to progression or survival between the two groups. Patients who received Tomudex spent a substantially shorter time in hospital for dosing and had significantly lower rates of grade 3 and 4 toxicities such as leucopenia and mucositis. Patients who received Tomudex had a significantly higher incidence of reversible grade 3 or 4 increase in transaminases, which appear to be of limited clinical significance. Improvement in quality of life, weight gain and performance status was seen in both groups. Tomudex has benefits in terms of higher response rates, reduced toxicity and more frequent palliative benefits when compared with 5-FU plus LV in the management of advanced colorectal cancer, and has a more convenient administration schedule.</div>
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