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Uracil-tegafur and tamoxifen vs cyclophosphamide, methotrexate, fluorouracil, and tamoxifen in post-operative adjuvant therapy for stage I, II, or IIIA lymph node-positive breast cancer: a comparative study.

Park Y, Okamura K, Mitsuyama S, Saito T, Koh J, Kyono S, Higaki K, Ogita M, Asaga T, Inaji H, Komichi H, Kohno N, Yamazaki K, Tanaka F, Ito T, Nishikawa H, Osaki A, Koyama H, Suzuki T - Br. J. Cancer (2009)

Bottom Line: No statistically significant difference between the two groups was observed with regard to the 5-year RFS rate (72.2% in the UFT and 76.3% in the CMF).Adverse event profiles differed between the two groups, with a significantly lower incidence of leukopenia and anaemia in the UFT group, as well as anorexia, nausea/vomiting, stomatitis, and alopecia, which have implications for quality of life.On stratified analysis, the recurrence rate in the UFT group was found to be better in oestrogen receptor (ER)-positive patients.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Toho University School of Medicine, Sakura Hospital, 564-1 Shimoshizu, Sakura 285-8741, Japan. youngjinpark@sakura.med.toho-u.ac.jp

ABSTRACT

Background: It has been reported that treatment with uracil-tegafur (UFT) has shown significantly better survival and relapse-free survival (RFS) than surgery alone. Therefore, we compared UFT with a combination therapy of cyclophosphamide, methotrexate, and fluorouracil (CMF) in patients who had undergone curative surgery for axillary lymph node-positive breast cancer.

Methods: A total of 377 node-positive patients with stage I, II, or IIIA disease were registered from September 1996 through July 2000 and were randomly assigned to either 6 cycles of CMF or 2 years of UFT. In both arms, tamoxifen (TAM) was concurrently administered for 2 years. The primary end point in this study was the non-inferiority of UFT to CMF.

Results: No statistically significant difference between the two groups was observed with regard to the 5-year RFS rate (72.2% in the UFT and 76.3% in the CMF). Adverse event profiles differed between the two groups, with a significantly lower incidence of leukopenia and anaemia in the UFT group, as well as anorexia, nausea/vomiting, stomatitis, and alopecia, which have implications for quality of life.

Conclusion: UFT administered in combination with TAM holds promise in the treatment of lymph node-positive early breast cancer. On stratified analysis, the recurrence rate in the UFT group was found to be better in oestrogen receptor (ER)-positive patients. Tegafur-based treatment should be evaluated by a prospective randomised trial conducted in ER-positive patients.

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Related in: MedlinePlus

Study design. ER, oestrogen receptor; CMF, cyclophosphamide–methotrexate–fluorouracil; TAM, tamoxifen; UFT, uracil-tegafur; W, week; Y, year; Surg, surgery; po, per os; CPA, cyclophosphamide; d, day; MTX, methotrexate; 5-FU, fluorouracil; i.v., intravenous.
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fig1: Study design. ER, oestrogen receptor; CMF, cyclophosphamide–methotrexate–fluorouracil; TAM, tamoxifen; UFT, uracil-tegafur; W, week; Y, year; Surg, surgery; po, per os; CPA, cyclophosphamide; d, day; MTX, methotrexate; 5-FU, fluorouracil; i.v., intravenous.

Mentions: The study scheme is shown in Figure 1. The UFT (Taiho Pharmaceuticals Co. Ltd., Tokyo, Japan) group received tamoxifen (TAM, AstraZeneca K.K., Osaka, Japan) (20 mg day−1) in combination with UFT (270 mg m−2 day−1) for 2 years. The CMF group received TAM (20 mg day−1) for 2 years in combination with 6 cycles of CPA (Shionogi & Co. Ltd., Osaka, Japan) (65 mg m−2: days 1–14), MTX (Wyeth K.K., Tokyo, Japan) (40 mg m−2: days 1 and 8), and 5-FU (Kyowa Hakko Kirin Co. Ltd., Tokyo, Japan) (500 mg m−2: days 1 and 8), with the cycle repeated every 4 weeks.


Uracil-tegafur and tamoxifen vs cyclophosphamide, methotrexate, fluorouracil, and tamoxifen in post-operative adjuvant therapy for stage I, II, or IIIA lymph node-positive breast cancer: a comparative study.

Park Y, Okamura K, Mitsuyama S, Saito T, Koh J, Kyono S, Higaki K, Ogita M, Asaga T, Inaji H, Komichi H, Kohno N, Yamazaki K, Tanaka F, Ito T, Nishikawa H, Osaki A, Koyama H, Suzuki T - Br. J. Cancer (2009)

Study design. ER, oestrogen receptor; CMF, cyclophosphamide–methotrexate–fluorouracil; TAM, tamoxifen; UFT, uracil-tegafur; W, week; Y, year; Surg, surgery; po, per os; CPA, cyclophosphamide; d, day; MTX, methotrexate; 5-FU, fluorouracil; i.v., intravenous.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2736822&req=5

fig1: Study design. ER, oestrogen receptor; CMF, cyclophosphamide–methotrexate–fluorouracil; TAM, tamoxifen; UFT, uracil-tegafur; W, week; Y, year; Surg, surgery; po, per os; CPA, cyclophosphamide; d, day; MTX, methotrexate; 5-FU, fluorouracil; i.v., intravenous.
Mentions: The study scheme is shown in Figure 1. The UFT (Taiho Pharmaceuticals Co. Ltd., Tokyo, Japan) group received tamoxifen (TAM, AstraZeneca K.K., Osaka, Japan) (20 mg day−1) in combination with UFT (270 mg m−2 day−1) for 2 years. The CMF group received TAM (20 mg day−1) for 2 years in combination with 6 cycles of CPA (Shionogi & Co. Ltd., Osaka, Japan) (65 mg m−2: days 1–14), MTX (Wyeth K.K., Tokyo, Japan) (40 mg m−2: days 1 and 8), and 5-FU (Kyowa Hakko Kirin Co. Ltd., Tokyo, Japan) (500 mg m−2: days 1 and 8), with the cycle repeated every 4 weeks.

Bottom Line: No statistically significant difference between the two groups was observed with regard to the 5-year RFS rate (72.2% in the UFT and 76.3% in the CMF).Adverse event profiles differed between the two groups, with a significantly lower incidence of leukopenia and anaemia in the UFT group, as well as anorexia, nausea/vomiting, stomatitis, and alopecia, which have implications for quality of life.On stratified analysis, the recurrence rate in the UFT group was found to be better in oestrogen receptor (ER)-positive patients.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Toho University School of Medicine, Sakura Hospital, 564-1 Shimoshizu, Sakura 285-8741, Japan. youngjinpark@sakura.med.toho-u.ac.jp

ABSTRACT

Background: It has been reported that treatment with uracil-tegafur (UFT) has shown significantly better survival and relapse-free survival (RFS) than surgery alone. Therefore, we compared UFT with a combination therapy of cyclophosphamide, methotrexate, and fluorouracil (CMF) in patients who had undergone curative surgery for axillary lymph node-positive breast cancer.

Methods: A total of 377 node-positive patients with stage I, II, or IIIA disease were registered from September 1996 through July 2000 and were randomly assigned to either 6 cycles of CMF or 2 years of UFT. In both arms, tamoxifen (TAM) was concurrently administered for 2 years. The primary end point in this study was the non-inferiority of UFT to CMF.

Results: No statistically significant difference between the two groups was observed with regard to the 5-year RFS rate (72.2% in the UFT and 76.3% in the CMF). Adverse event profiles differed between the two groups, with a significantly lower incidence of leukopenia and anaemia in the UFT group, as well as anorexia, nausea/vomiting, stomatitis, and alopecia, which have implications for quality of life.

Conclusion: UFT administered in combination with TAM holds promise in the treatment of lymph node-positive early breast cancer. On stratified analysis, the recurrence rate in the UFT group was found to be better in oestrogen receptor (ER)-positive patients. Tegafur-based treatment should be evaluated by a prospective randomised trial conducted in ER-positive patients.

Show MeSH
Related in: MedlinePlus