Abstract:ObjectiveTo investigate the therapeutic effect, safety and its prognostic factors of capecitabine as maintenance treatment agent for prolonging the PFS of patients with recurrent and metastatic breast cancer after they received combination chemotherapy. MethodsFrom January 2011 to June 2013, 38 cases with recurrent and metastatic breast cancer were collected in the department of medical oncology of the First Hospital of Lanzhou University. All the 38 patients received NX scheme (vinorelbine combined capecitabine chemotherapy), and some patients among of them had stabile disease after chemotherapy and were administered X scheme (capecitabine, twice a day, 2 000 mg/m2 daily, withdrawal for 7 days after a consecutive intake of 14 days, 21 days as a cycle, at least 2 cycles) until disease progressed or toxicity could not be tolerated. Adverse reactions and PFS were observed and recorded. Single factor chi square test and multivariate COX proportion hazard model were used to evaluate the relationships between clinic features and RR, PFS. ResultsThe overall response rate (CR+PR) was 55.26% (21/38), clinical benefit patients rate (CR+PR+SD) was 84.2% (32/38), with 4 patients of CR (4/32), 17 patients of PR, 11 patients of SD, 6 patients of PD. Thirtytwo no progressived patients were administered capecitabine until PD. The median PFS was 10.0 months. Stratification analysis showed that patients whose Karnofsky (KPS)≥80 had an average PFS of 14.1 months, while an average PFS of 6.8 months for patients whose KPS<80, with a statistical significance (χ2 =6.251, P=0.000). Cox proportion hazard model also showed that age (RR=3.561, 95%CI：1.3725.216, χ2=4.025, P=0.031), menopausal status (RR=1.895, 95%CI：1.1244.452, χ2=5.725, P=0.048), KPS score (RR=4.553, 95%CI：1.1317.703, χ2=11.205, P=0.005), the number of metastasis (RR=5.781, 95%CI：2.321～11.243, χ2=3.925, P=0.011) were important prognostic factors for the patients with breast cancer. Major treatmentrelated adverse reaction was grade ⅠⅡ handfoot syndrome. One patient discontinued treatment because of grade Ⅲ handfoot syndrome. ConclusionCapecitabine as maintenance treatment can significantly prolong the PFS of patients with recurrent and metastatic breast cancers at remission or stable stage after combination chemotherapy with a better tolerance. Age of patients, menopausal status, KPS score, the number of metastasis are the prognostic factors for the efficacy of NXX regimen.