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Evidence produced in Japan: tegafur-based preparations for postoperative chemotherapy in breast cancer.

Watanabe T - Breast Cancer (2013)

Bottom Line: UFT is an oral preparation that was designed to achieve and maintain high concentrations of 5-FU in plasma by combining tegafur, a prodrug of 5-FU, with uracil.UFT is characterized by mild adverse events, allowing long-term treatment.The prolonged maintenance of high plasma 5-FU concentrations has been suggested to inhibit micrometastases after surgery.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Hamamatsu Oncology Center, 3-6-13 Chuo, Naka-ku, Hamamatsu, Shizuoka, 430-0929, Japan, twatanab@oncoloplan.com.

ABSTRACT
Oral fluoropyrimidine anticancer agents (oral 5-fluorouracil [5-FU]) able to be used as chemotherapy for breast cancer include tegafur-uracil (UFT), tegafur-gimeracil-oteracil potassium (S-1), doxifluridine, and capecitabine. Since the 1980s, UFT has been most widely used for postoperative chemotherapy in breast cancer. UFT is an oral preparation that was designed to achieve and maintain high concentrations of 5-FU in plasma by combining tegafur, a prodrug of 5-FU, with uracil. UFT is characterized by mild adverse events, allowing long-term treatment. The prolonged maintenance of high plasma 5-FU concentrations has been suggested to inhibit micrometastases after surgery. Recently, large clinical trials conducted in Japan have shown that UFT-based postoperative chemotherapy is therapeutically useful in patients with node-negative (n0), high-risk breast cancer. We review the results of clinical trials of postoperative chemotherapy with UFT in Japan and discuss its roles and future prospects.

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Related in: MedlinePlus

Relapse-free survival (RFS) and overall survival (OS) in the N·SAS-BC01 trial. a RFS and b OS of the total patients treated with uracil and tegafur (UFT) or cyclophosphamide, methotrexate, and fluorouracil. CMF cyclophosphamide, methotrexate, and 5-fluorouracil, HR hazard ratio, CI confidence interval
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Fig2: Relapse-free survival (RFS) and overall survival (OS) in the N·SAS-BC01 trial. a RFS and b OS of the total patients treated with uracil and tegafur (UFT) or cyclophosphamide, methotrexate, and fluorouracil. CMF cyclophosphamide, methotrexate, and 5-fluorouracil, HR hazard ratio, CI confidence interval

Mentions: The N·SAS-BC01 trial was designed to establish the noninferiority of UFT to CMF in patients with node-negative (n0), high-risk breast cancer. The primary endpoint was relapse-free survival. Six cycles of classic CMF, given to the control group, were compared with 2 years of treatment with UFT. Patients whose tumors were positive for ER, progesterone receptor, or both concurrently received tamoxifen (20 mg/day) for 5 years. A total of 733 patients were enrolled in both groups combined. The hazard ratio of the UFT group to the CMF group was 0.98 (95 % CI 0.66–1.45). In patients with n0 high-risk breast cancer, the noninferiority of the UFT group to the CMF group was not demonstrated statistically, but the relapse-free survival curves and survival curves appear to be superimposable, strongly suggesting that both treatments are similarly effective [5] (Fig. 2). Grade 3 or 4 adverse events occurred in fewer than 10 % of the patients in both arms. The incidence of grade 3 or 4 leucopenia was significantly higher in the CMF arm, and the incidences of grade 3 or 4 diarrhea, anemia, elevated AST, and elevated serum total bilirubin were significantly higher in the UFT arm. The incidence of alopecia (any grade) was lower in the UFT group (9.7 %) than in the CMF group (55.2 %).Fig. 2


Evidence produced in Japan: tegafur-based preparations for postoperative chemotherapy in breast cancer.

Watanabe T - Breast Cancer (2013)

Relapse-free survival (RFS) and overall survival (OS) in the N·SAS-BC01 trial. a RFS and b OS of the total patients treated with uracil and tegafur (UFT) or cyclophosphamide, methotrexate, and fluorouracil. CMF cyclophosphamide, methotrexate, and 5-fluorouracil, HR hazard ratio, CI confidence interval
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3824200&req=5

Fig2: Relapse-free survival (RFS) and overall survival (OS) in the N·SAS-BC01 trial. a RFS and b OS of the total patients treated with uracil and tegafur (UFT) or cyclophosphamide, methotrexate, and fluorouracil. CMF cyclophosphamide, methotrexate, and 5-fluorouracil, HR hazard ratio, CI confidence interval
Mentions: The N·SAS-BC01 trial was designed to establish the noninferiority of UFT to CMF in patients with node-negative (n0), high-risk breast cancer. The primary endpoint was relapse-free survival. Six cycles of classic CMF, given to the control group, were compared with 2 years of treatment with UFT. Patients whose tumors were positive for ER, progesterone receptor, or both concurrently received tamoxifen (20 mg/day) for 5 years. A total of 733 patients were enrolled in both groups combined. The hazard ratio of the UFT group to the CMF group was 0.98 (95 % CI 0.66–1.45). In patients with n0 high-risk breast cancer, the noninferiority of the UFT group to the CMF group was not demonstrated statistically, but the relapse-free survival curves and survival curves appear to be superimposable, strongly suggesting that both treatments are similarly effective [5] (Fig. 2). Grade 3 or 4 adverse events occurred in fewer than 10 % of the patients in both arms. The incidence of grade 3 or 4 leucopenia was significantly higher in the CMF arm, and the incidences of grade 3 or 4 diarrhea, anemia, elevated AST, and elevated serum total bilirubin were significantly higher in the UFT arm. The incidence of alopecia (any grade) was lower in the UFT group (9.7 %) than in the CMF group (55.2 %).Fig. 2

Bottom Line: UFT is an oral preparation that was designed to achieve and maintain high concentrations of 5-FU in plasma by combining tegafur, a prodrug of 5-FU, with uracil.UFT is characterized by mild adverse events, allowing long-term treatment.The prolonged maintenance of high plasma 5-FU concentrations has been suggested to inhibit micrometastases after surgery.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Hamamatsu Oncology Center, 3-6-13 Chuo, Naka-ku, Hamamatsu, Shizuoka, 430-0929, Japan, twatanab@oncoloplan.com.

ABSTRACT
Oral fluoropyrimidine anticancer agents (oral 5-fluorouracil [5-FU]) able to be used as chemotherapy for breast cancer include tegafur-uracil (UFT), tegafur-gimeracil-oteracil potassium (S-1), doxifluridine, and capecitabine. Since the 1980s, UFT has been most widely used for postoperative chemotherapy in breast cancer. UFT is an oral preparation that was designed to achieve and maintain high concentrations of 5-FU in plasma by combining tegafur, a prodrug of 5-FU, with uracil. UFT is characterized by mild adverse events, allowing long-term treatment. The prolonged maintenance of high plasma 5-FU concentrations has been suggested to inhibit micrometastases after surgery. Recently, large clinical trials conducted in Japan have shown that UFT-based postoperative chemotherapy is therapeutically useful in patients with node-negative (n0), high-risk breast cancer. We review the results of clinical trials of postoperative chemotherapy with UFT in Japan and discuss its roles and future prospects.

Show MeSH
Related in: MedlinePlus