Background and Objective:The 6th edition American Joint Committee on Cancer(AJCC)staging system for breast cancer classifies ipsilateral supraclavicular lymph node metastasis(ISLM)downing stage from M1 to N3,suggesting more patients might receive radical treatment.The aim of this study was to analyze the effect of ISLM on the prognosis of N3 breast cancer and verify the rationality of modified staging.Methods:321 breast cancer patients with N3 according to the 6th edition AJCC staging system were retrospectively analyzed.Propensity Score Matching(PSM)was used to pair the different subgroups of N3.The primary end point was disease-free survival(DFS),the secondary end point was overall survival(OS).Kaplan-Meier method was used to calculate the DFS and OS.The differences between two groups were analyzed by the Log-rank test.Results:After PSM pairing,78 patients with none-ISLM of stage N3 and 78 patients with ISLM were enrolled in the first group,which the median DFS was 58.9 months and 32.1 months(P=0.101),the median OS was 87.4 and 140.4 months(P=0.277),respectively.53 patients with ipsilateral axillary lymph node metastasis(IALNM)of stage N3 and 53 patients with both IALNM of stage N3 and ISLM was compared in the second group which the median DFS was 48.8 months versus 52.4 months(P=0.807)and the median OS was 91.4 months versus 148.0 months(P=0.091)respectively.In the third group there were 51 patients with IALNM of stage N3 comparing to 51 patients with ISLM with the median DFS of 59.0 months versus 44.0 months(P=0.533)and the median OS of 87.4 months versus 137.1 months(P=0.289).However,there was no statistically significances in the data of three groups with all P-value>0.05.Conclusion:The prognosis of breast cancer patients with ISLM is similar to that of patients with none-ISLM in stage N3.It is reasonable to include ISLM in N3 in the 6th edition AJCC staging system.Yet,prospective studies with larger sample size are needed to further confirmation.Background:Currently,docetaxel combined with capecitabine is the standard first-line chemotherapy for advanced breast cancer,and TS-1 combined with docetaxel has b een proved to be effective in the treatment of a variety of solid tumors.In this prospective study,we compared the efficacy and safety of docetaxel/TS-1(TS)versus docetaxel/capecitabine(TX)in patients with advanced breast cancer.Methods:Patients with advanced metastatic breast cancer were randomly assigned to a TS(n=54)group and a TX(n=57)group for first-l ine chemotherapy,both of wh ich received maintenance therapy with TS-1 or capecitabine,respectively after 6 cycles of chemotherapy.The primary endpoint was progression-free survival(PFS).Results:The trial reached its primary endpoint,PFS,but not the secondary endpoint,overall survival(OS).Forty-two patients(77.8%)in the TS group and 37 patients(64.9%)in the TX group received maintenance medication.The median PFS(9.4 vs 7.4 months;P=0.221;95%confidence interval,0.52-1.17;hazard ratio,0.78)in the TS group appeared to be longer compared with those in the TX group,while the duration of response(DOR)was 7.6 vs 8.0 months(P=0.899,95%confidence interval,0.54-1.71;hazard ratio,0.96),but the differences were not statistically significant.In different treatment regimens,hormone receptor(HR)expression,visceral metastasis and metastasis sites(liver and lung)had no significant effect on PFS.Hand-foot syndrome was more common in the TX group than in the TS group(33.3%vs.7.4%;P<0.05),but the incidence of diarrhea was higher in the TS group(24.1%vs 1.8%;P<0.05),and the frequencies of other adverse effects were similar between the two groups.Conclusions:The efficacy of TS regimen in advanced breast cancer is not inferior to that of TX regimen,with slightly different adverse events,but both were tolerable.It can be considered as an alternative to TX regimen.It is necessary to carry out prospective phaseâ…¢ randomized clinical trial to further compare and determine the efficacy and safety of the two regimens. |