| Background:At present,there is no uniform standard for the treatment of previously treated with anthracycline and paclitaxel drugs of recurrent metastatic breast cancer.The impact of treatment on overall survival of these patients is also very limited.The purpose of follow-up treatment is to extend the patient's life,while alleviating the patient's pain.For patients with advanced breast cancer who have a rapid tumor progression or a high tumor burden,the combination of chemotherapy is more considered to quickly control tumor progression and reduce tumor burden,after stabilization,single drug is used to maintain treatment.Single agent vinorelbine and S-1 monotherapy in the treatment of advanced breast cancer has been proved effective and well tolerated,while there is relatively little clinical research on the combination of the two drugs.Objective: To evaluate the efficacy and safety of vinorelbine combined with sequented S-1 in the treatment of recurrence of metastatic breast cancer with short-term tumor progression or visceral high tumor burden in the treatment of anthracycline and paclitaxel.Methods: A total of 41 patients with recurrent metastatic breast cancer treated with vinorelbine combined with sequented S-1 regimen were enrolled from September 2009 to May 2016 in the Affiliated Tumor Hospital of Guangxi Medical University.Vinorelbine was administered at a dose of 25 mg/?,intravenous on days 1 and 8 of a 21-day treatment cycle;combined with sequented S-1 oral dose was calculated based on body surface area(BSA)80–120 mg each day,Patients with BSA <1.25 m2 received 80 mg each day,patients with BSA between 1.25 m2 and 1.5 m2 received 100 mg each day,and patients with BSA ?1.5 m2 received 120 mg each day;twice daily for 14 days,followed by 7 days of rest,21 days for a treatment cycle.Two drugs combination treatment for a time course at least 2 cycles,single agent S-1 treatment until the toxicity intolerance or tumor progression or death in patients after the completion of 6 cycles of chemotherapy.If the patients Her-2 receptor overexpression,trastuzumab was also permitted concurrently.The secondary endpoint of the study was the efficacy and side effects of patients,with the primary endpoint being the patient's PFS.The follow-up time was initiated from the patient's treatment after enrollment to disease progression or to the end of the study.Results: 41 patients were evaluated,4 cases of treatment reached CR(4/41,9.8%),18 cases of PR(18/41,43.9%),14 cases of SD(14/41,34.1%),5 cases of PD(5/41,12.2%),over response rate(ORR)was 56.1%,the disease control rate(DCR)was 87.8%;Followed up to February 2017,during the follow-up period,34 patients had progressive disease,of which,there were 4 cases of death in the treatment of the disease.Median progression free time(PFS)was 9.4 months(95% confidence interval,5.2-13.6 month).The common hematological toxicity of chemotherapy,24 cases of white blood cell reduction(58.5%),and the reduction of neutrophil in 26 cases(63.4%),III?IV degree of white blood cell reduction was found in 12 patients(29.3%),III?IV degree of neutrophil reduction in 13 patients(31.7%);Non hematologic toxicity include ALT / AST elevation(16 cases 39.1%),Malignant,vomiting(14 cases,34.1%),Bilirubin increased(8 cases,19.5%),Abdominal pain,diarrhea(6 cases,14.6%).Conclusion: Vinorelbine combined with sequented S-1 have a significant efficacy in patients with recurrent metastatic breast cancer treated with anthracycline and paclitaxel,the side effects can be controlled and the patients are well tolerated,which is an effective treatment for advanced breast cancer. |
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