Low-dose oral fluorouracil with eniluracil as first-line chemotherapy against advanced breast cancer: A phase II study
Authors: Smith, I.E., Johnston, S.R.D., O'Brien, M.E.R., Hickish, T.F., De Boer, R.H., Norton, A., Cirkel, D.T. and Barton, C.M.
Journal: Journal of Clinical Oncology
Volume: 18
Issue: 12
Pages: 2378-2384
ISSN: 0732-183X
DOI: 10.1200/JCO.2000.18.12.2378
Abstract:Purpose: Eniluracil (776C85) is an effective inactivator of dihydropyrimidine dehydrogenase that allows continuous low-dose oral fluorouracil (5-FU) to be given with predicable oral bioavailability. We have assessed this as first-line oral chemotherapy for patients with advanced/metastatic breast cancer. Patients and Methods: Patients with histologically proven, locally advanced or metastatic breast cancer without previous chemotherapy for advanced disease were entered onto this open-label phase II study. Patients received oral 5-FU 1.0 mg/m2 with eniluracil 10 mg/m2, both given twice daily for the first 28 days of each 35-day cycle, continuing until disease progression or unmanageable toxicity. Results: Thirty-three patients were entered, with a median age of 53 years. Sixteen partial responses were seen in twenty-nine assessable patients (55%; 95% confidence interval, 37% to 73%), including responses in four (40%) out of 10 patients who had received prior adjuvant 5-FU. Seven patients had stable disease for at least 3 months with symptom improvement. Median response duration was 14 months (range, 10 to 18+ months). Toxicity was low. There were only two episodes of drug-related grade 3 nonhematologic toxicity (diarrhea and infection), and only 6%, 3%, and 3% of patients developed granulocytopenia, thrombocytopenia, and neutropenic sepsis, respectively. Mild (grade 1/2) diarrhea occurred in 39% of patients, hand-foot syndrome in 15%, nausea in 27%, and mucositis in 18%. Toxicity-associated delay and dose reduction occurred in only 2% and 5% of courses, respectively. Conclusion: First-line treatment with the combination of oral 5-FU and eniluracil has high activity in patients with advanced breast cancer comparable with the most active conventional cytotoxic agents but with strikingly less toxicity. (C) 2000 by American Society of Clinical Ontology.
Source: Scopus
Low-dose oral fluorouracil with eniluracil as first-line chemotherapy against advanced breast cancer: a phase II study.
Authors: Smith, I.E., Johnston, S.R., O'Brien, M.E., Hickish, T.F., de Boer, R.H., Norton, A., Cirkel, D.T. and Barton, C.M.
Journal: J Clin Oncol
Volume: 18
Issue: 12
Pages: 2378-2384
ISSN: 0732-183X
DOI: 10.1200/JCO.2000.18.12.2378
Abstract:PURPOSE: Eniluracil (776C85) is an effective inactivator of dihydropyrimidine dehydrogenase that allows continuous low-dose oral fluorouracil (5-FU) to be given with predicable oral bioavailability. We have assessed this as first-line oral chemotherapy for patients with advanced/metastatic breast cancer. PATIENTS AND METHODS: Patients with histologically proven, locally advanced or metastatic breast cancer without previous chemotherapy for advanced disease were entered onto this open-label phase II study. Patients received oral 5-FU 1.0 mg/m(2) with eniluracil 10 mg/m(2), both given twice daily for the first 28 days of each 35-day cycle, continuing until disease progression or unmanageable toxicity. RESULTS: Thirty-three patients were entered, with a median age of 53 years. Sixteen partial responses were seen in twenty-nine assessable patients (55%; 95% confidence interval, 37% to 73%), including responses in four (40%) out of 10 patients who had received prior adjuvant 5-FU. Seven patients had stable disease for at least 3 months with symptom improvement. Median response duration was 14 months (range, 10 to 18+ months). Toxicity was low. There were only two episodes of drug-related grade 3 nonhematologic toxicity (diarrhea and infection), and only 6%, 3%, and 3% of patients developed granulocytopenia, thrombocytopenia, and neutropenic sepsis, respectively. Mild (grade 1/2) diarrhea occurred in 39% of patients, hand-foot syndrome in 15%, nausea in 27%, and mucositis in 18%. Toxicity-associated delay and dose reduction occurred in only 2% and 5% of courses, respectively. CONCLUSION: First-line treatment with the combination of oral 5-FU and eniluracil has high activity in patients with advanced breast cancer comparable with the most active conventional cytotoxic agents but with strikingly less toxicity.
Source: PubMed
Low-dose oral fluorouracil with eniluracil as first-line chemotherapy against advanced breast cancer: A phase II study
Authors: Smith, I.E., Johnston, S.R.D., O'Brien, M.E.R., Hickish, T.F., de Boer, R.H., Norton, A., Cirkel, D.T. and Barton, C.M.
Journal: JOURNAL OF CLINICAL ONCOLOGY
Volume: 18
Issue: 12
Pages: 2378-2384
eISSN: 1527-7755
ISSN: 0732-183X
DOI: 10.1200/JCO.2000.18.12.2378
Source: Web of Science (Lite)
Low-Dose Oral Fluorouracil With Eniluracil as First-Line Chemotherapy Against Advanced Breast Cancer: A Phase II Study
Authors: Smith, I.E., Johnston, S.R.D., O Brien, M.E.R., Hickish, T.F., de Boer, R.H., Norton, A., Cirkel, D.T. and Barton, C.M.
Journal: Journal of Clinical Oncology
Volume: 18
Pages: 2378-2384
ISSN: 0732-183X
Abstract:PURPOSE: Eniluracil (776C85) is an effective inactivator of dihydropyrimidine dehydrogenase that allows continuous low-dose oral fluorouracil (5-FU) to be given with predicable oral bioavailability. We have assessed this as first-line oral chemotherapy for patients with advanced/metastatic breast cancer.
PATIENTS AND METHODS: Patients with histologically proven, locally advanced or metastatic breast cancer without previous chemotherapy for advanced disease were entered onto this open-label phase II study. Patients received oral 5-FU 1.0 mg/m2 with eniluracil 10 mg/m2, both given twice daily for the first 28 days of each 35-day cycle, continuing until disease progression or unmanageable toxicity.
RESULTS: Thirty-three patients were entered, with a median age of 53 years. Sixteen partial responses were seen in twenty-nine assessable patients (55%; 95% confidence interval, 37% to 73%), including responses in four (40%) out of 10 patients who had received prior adjuvant 5-FU. Seven patients had stable disease for at least 3 months with symptom improvement. Median response duration was 14 months (range, 10 to 18+ months). Toxicity was low. There were only two episodes of drug-related grade 3 nonhematologic toxicity (diarrhea and infection), and only 6%, 3%, and 3% of patients developed granulocytopenia, thrombocytopenia, and neutropenic sepsis, respectively. Mild (grade 1/2) diarrhea occurred in 39% of patients, hand-foot syndrome in 15%, nausea in 27%, and mucositis in 18%. Toxicity-associated delay and dose reduction occurred in only 2% and 5% of courses, respectively.
CONCLUSION: First-line treatment with the combination of oral 5-FU and eniluracil has high activity in patients with advanced breast cancer comparable with the most active conventional cytotoxic agents but with strikingly less toxicity.
http://jco.ascopubs.org/cgi/content/abstract/18/12/2378
Source: Manual
Preferred by: Tamas Hickish
Low-dose oral fluorouracil with eniluracil as first-line chemotherapy against advanced breast cancer: a phase II study.
Authors: Smith, I.E., Johnston, S.R., O'Brien, M.E., Hickish, T.F., de Boer, R.H., Norton, A., Cirkel, D.T. and Barton, C.M.
Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume: 18
Issue: 12
Pages: 2378-2384
eISSN: 1527-7755
ISSN: 0732-183X
DOI: 10.1200/jco.2000.18.12.2378
Abstract:Purpose
Eniluracil (776C85) is an effective inactivator of dihydropyrimidine dehydrogenase that allows continuous low-dose oral fluorouracil (5-FU) to be given with predicable oral bioavailability. We have assessed this as first-line oral chemotherapy for patients with advanced/metastatic breast cancer.Patients and methods
Patients with histologically proven, locally advanced or metastatic breast cancer without previous chemotherapy for advanced disease were entered onto this open-label phase II study. Patients received oral 5-FU 1.0 mg/m(2) with eniluracil 10 mg/m(2), both given twice daily for the first 28 days of each 35-day cycle, continuing until disease progression or unmanageable toxicity.Results
Thirty-three patients were entered, with a median age of 53 years. Sixteen partial responses were seen in twenty-nine assessable patients (55%; 95% confidence interval, 37% to 73%), including responses in four (40%) out of 10 patients who had received prior adjuvant 5-FU. Seven patients had stable disease for at least 3 months with symptom improvement. Median response duration was 14 months (range, 10 to 18+ months). Toxicity was low. There were only two episodes of drug-related grade 3 nonhematologic toxicity (diarrhea and infection), and only 6%, 3%, and 3% of patients developed granulocytopenia, thrombocytopenia, and neutropenic sepsis, respectively. Mild (grade 1/2) diarrhea occurred in 39% of patients, hand-foot syndrome in 15%, nausea in 27%, and mucositis in 18%. Toxicity-associated delay and dose reduction occurred in only 2% and 5% of courses, respectively.Conclusion
First-line treatment with the combination of oral 5-FU and eniluracil has high activity in patients with advanced breast cancer comparable with the most active conventional cytotoxic agents but with strikingly less toxicity.Source: Europe PubMed Central