Efficacy And Safety Analysis Of Raltitrexed-based Regime For Advanced Breast Cancer Of Failed With Anthracyclines Taxanes

Purpose:Evaluate the efficacy and the safety of raltitrexed-based chemotherapy in patients with advanced breast cancer(ABC)failed with anthracyclines or(and)taxanes.Methods:A total of 72 advanced breast cancer patients who failed with anthracyclines or taxanes were enrolled in Affiliated Cancer Hospital of Guangxi Medical University from June 2012 to June 2018.All patients were treated with raltitrexed-based chemotherapy,21 days as a cycle.Raltitrexed at dose of 3 mg/m2,intravenous on days 1,vinorelbine at dose of 25 mg/m2,intravenous on days 1 and days 8,docetaxel at dose of 75 mg/m2,intravenous on days 1.The first goal were ORR,PFS,secondary goal were DCR,OS and safty.Using ratios and percentages to describe baseline characteristics of patients and chemotherapy efficacy of patients.Chi-square or Fisher’s for univariate analysis of ORR and DCR.Using Kaplan-Meier and Log-rank to analyze the efficacy of age,menopause status,ECOG PS,molecular classification,Line of treatment,the number of metastatic sites and HER-2 Positive patients on PFS.Results:1.All patients were treated with raltitrexed-based chemotherapy,1 patient(1.4%)achieved complete tumor response,25 patients(34.7%)had a partial tumor response,25 patients(34.7%)had stable disease and 21 patients(29.2%)had progressive disease.ORR and DCR were 36.1%and 70.8%,respectively.Median PFS and OS were 4.1 months(95%confidence interval,3.5 to 4.7 months)and 16.3 months(95%confidence interval,11.2 to 21.3 months),respectively.2.Univariate analysis showed that:Patients’age,menopause status,ECOG PS,molecular classification,Line of treatment,the number of metastatic sites and HER-2 Positive patients whether to use Herceptin had no strong correlations with ORR,DCR and mPFS(P>0.05).3.Patients who treated with raltitrexed-based chemotherapy achieved disease stabilization or response in combination chemotherapy continued receiving maintenance therapy,got mPFS of 10.5 months,and the patients who do not continue to receiving maintenance therapy,got mPFS of 4.7 months,the difference was statistically significant(P<0.001).4.The major toxicities of raltitrexed-based chemotherapy included anemia(77.7%),transaminase elevation(73.6%),leukopenia(55.6%),neutropenia(41.6%)and vomit(9.8%),most AEs were of grade I or II severity,grade III or IV severity were not more common.5.The ORR was 38.3%and the DCR was 72.3%in raltitrexed combination with vinorelbine.The adverse events of combination chemotherapy were anemia(89.4%),transaminase elevation(76.6%),leukopenia(61.7%)and neutropenia(48.9%).Most AEs were of grade Ⅰ or Ⅱ severity,grade Ⅲ or Ⅳseverity were not more common.Conclusion:1.Raltitrexed-based chemotherapy were certain effective and toleration in advanced breast cancer patients who failed with anthracyclines or taxanes.2.Patients received raltitrexed-based chemotherapy and achieved disease stabilization or response continued receiving maintenance therapy,can obviously prolong the patient’s progression free survival.3.The combination of raltitrexed and vinorelbine got certain effect,most patients have no serious adverse reactions,It is one of the alternative option for advanced breast cancer.