| Background: Treatment for metastatic breast cancer(MBC) in patients who have relapsed from anthracycline or taxane is difficult. S-1 and capecitabine are bose oral 5-FU derivatives, the clinical application of capecitabine is limited due to the high incidence rate of hand-foot syndrome,and there is not enough information of s-1 applying in chinese MBC patients,we designed this randomized and phase II study to compare the efficacy and safety of the two fluorinated pyrimidines as second or third-line chemotherapy in women with MBC in chinese patients.And we analysised the prognostic factors that affect the efficacy of treated with fluorinated pyrimidines.Methods: The study enrolled MBC patients who had previously relapsed from one or two chemotherapy regimens.Patients were randomly assigned to receive S-1 40-60 mg twice daily according to body surface area(40 mg twice daily if BSA < 1.25 m2; 50 mg twice daily if 1.25 m2 ≤ BSA ≥ 1.5 m2; and 60 mg twice daily if BSA > 1.5 m2),on days 1–28 every 6 weeks or capecitabine 2500 g/m2 twice daily on days 1–21 every 4 weeks.We did response assessment every 6 weeks,safty assessment every cycle.The median progression-free survival(PFS) was the primary end point. All data analysised by using SPSS19.0 software.Results: A total of 63 patients were enrolled and randomized to either S-1(N =32) or capecitabine(N = 31).Median PFS was 5.5 months for S-1 and 4.0 months for capecitabine(P = 0.683 by log-rank), The confirmed objective response rates were 31.2 % for S-1 and 32.2% for capecitabine, disease control rates were 65.6 % for S-1 and 67.8% for capecitabine, difference had no statistically significant. The most common treatment-related adverse events were grade 1–2 in intensity in the two groups,both were well-tolerated and had no statistically significant.The most common adverse reactions were hyperbilirubinemia(40.6%),leukopenia(37.1%),anorexia(34.3%)and fatigue(31.2%) for S-1,The most common adverse reactions were leukopenia(45.1%),hand-foot syndrome(45.1%),anorexia(38.7%)and fatigue(25.8%)for capecitabine, hyperbilirubinemia(S-1:40.6%,capecitabine: 6.4%,p=0.006)were more frequent in the S-1 group,while hand-foot syndrome occurred more often in the capecitabine group(S-1: 9 %, capecitabine: 45.1 %; P = 0.004).In univariate analysis,age,HRe status,HER-2 status,ki-67,the score of ECOG,the number of previious chemotherapy,PFS of first-line chemotherapy were not correlated with PFS treated with the two orally administered fluorinated pyrimidines.DFS over 3.5 years(6.0 months vs 3.8months,p=0.02),without liver metastatics(5.3 months vs 5.0months, p=0.038),the few number of metastatic sites(one metastatic sites:6.5 months,2-3 metastatic sites:5.2 months, ≥4metastatic sites:3.2 months, p=0.012) were the prognostic factor for PFS.In multivariate analysis,only long initial disease-free interval and few number of metastatic sites were independently associated with nice PFS.Conclusions:The results of the current study demonstrate that both S-1 and capecitabine are effective and well-tolerated as second or third-line treatments in chinese patients with MBC, while their adverse events were different and were manageable. Bilirubin monitoring is recommended during S-1 treatment,especial patients with live metastasis.The low incidence rate of hand-foot syndrome in S-1 treatment group due to the improvement of the quality of life,and worth to further study and popularize.Long initial disease-free interval and few number of metastatic sites were independently associated with time to orally administered fluorinated pyrimidines treatment progress. |
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