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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

Relapse-free survival by age, number of involved nodes and ER, PgR, and ER/PgR status.
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fig3: Relapse-free survival by age, number of involved nodes and ER, PgR, and ER/PgR status.

Mentions: Both RFS and survival curves are shown in Figure 2. The 5-year RFS rates in the UFT and CMF groups were 72.2 and 76.3%, respectively, with no statistically significant difference between them (log-rank test, P=0.46). The HR for the UFT group relative to the CMF group in terms of RFS rate was 1.18 (95% CI: 0.77–1.80). Five-year survival rates in the UFT and CMF groups were 87.0 and 88.4%, respectively, showing no statistically significant difference between them, and the HR was 1.15 (log-rank test, P=0.66). Subset analysis showed that there were non-significant tendencies of interaction between RFS and age, number of involved lymph nodes and ER status (Figure 3).


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)

Relapse-free survival by age, number of involved nodes and ER, PgR, and ER/PgR status.
© Copyright Policy
Related In: Results  -  Collection

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

fig3: Relapse-free survival by age, number of involved nodes and ER, PgR, and ER/PgR status.
Mentions: Both RFS and survival curves are shown in Figure 2. The 5-year RFS rates in the UFT and CMF groups were 72.2 and 76.3%, respectively, with no statistically significant difference between them (log-rank test, P=0.46). The HR for the UFT group relative to the CMF group in terms of RFS rate was 1.18 (95% CI: 0.77–1.80). Five-year survival rates in the UFT and CMF groups were 87.0 and 88.4%, respectively, showing no statistically significant difference between them, and the HR was 1.15 (log-rank test, P=0.66). Subset analysis showed that there were non-significant tendencies of interaction between RFS and age, number of involved lymph nodes and ER status (Figure 3).

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