Breast cancer is one of the most common tumors in women. In recent years, the incidence and death rate have been increasing year by year in China, and chemotherapy is a common treatment for advanced breast cancer. Norviben (NVB) is a new semi-synthetic periwinkle alkaloid antitumor drug commonly used in the treatment of non-small cell lung cancer and breast cancer. Combination chemotherapy regimens containing anthracyclines are one of the common treatments for advanced breast cancer. We treated 68 cases of advanced breast cancer from January 2002 to December 2005 with Noviben combined with epi-anthracycline (EPI) regimen (NE) and achieved good efficacy. 1 , Data and Methods (1-1) Clinical Data All 68 cases were female patients with pathologically confirmed breast cancer, aged 39-65 years, median age 43 years, with TNM stage (AJCC 6th edition) of IIIC and VI, and KPS score >60. Pathological staging: 49 cases of invasive ductal carcinoma, 6 cases of simple carcinoma, 3 cases of adenocarcinoma, 2 cases of mucinous adenocarcinoma, and 8 cases of medullary carcinoma. All patients in the group had measurable metastatic lesions, with 38 cases of solitary metastases and 30 cases of multiple metastases in the whole group. Metastatic organs: 54 cases of lymph node metastases, 20 cases of skin metastases, 12 cases of bone metastases, 10 cases of lung and pleural metastases, 7 cases of liver metastases, 3 cases of brain metastases, and 1 case of ovarian metastases. 42 cases were treated initially. 26 cases were retreated (12 of them had received combined treatment with CMF or CEF). By the time of this treatment. All had stopped the above treatment for more than 3 months, and the liver and kidney function and blood routine were normal before treatment, and the expected survival period was longer than 3 months. (1-2) Treatment regimen All patients were treated with NVB 30mg/m2, IV on days 1 and 8, and EPI 60mg/m2, IV on day 1, for 21 days. Chemotherapy was administered for at least 3 cycles, and treatment reached more than 4 cycles in 52 cases. Endanserone 8mg was administered intravenously 15min before chemotherapy to prevent vomiting. Cardiac monitoring was given during chemotherapy, and if the white blood cell count was <3.5×109/L, symptomatic supportive treatment such as leukocyte-raising drugs was given. (1-3) Efficacy evaluation Observation indexes Comprehensive physical examination before and after treatment, careful measurement and recording of measurable lesions, detailed recording of lesion changes during treatment, weekly rechecking of blood routine, liver and kidney function, and electrocardiogram. 3 cycles later, the efficacy was evaluated and classified according to WHO criteria for recent efficacy evaluation of solid tumors: complete remission (CR), partial remission (PR), no change (NC), and progression (PD). Adverse reactions were evaluated according to the WHO anticancer drug toxicity classification (0-IV). 2, Results (2-1) Efficacy There were 9 cases of CR, 33 cases of PR, 16 cases of SD and 8 cases of PD in the whole group. The total effective rate (CR+PR) was 61.8%. The effective rate of primary treatment was 66.7%. The effective rate of retreatment was 53.8% (see Table 1). The effective rate for 3 cycles of treatment was 50.0%, and the effective rate for more than 3 cycles was 65.4% (see Table 2). The relationship between different sites of metastasis and efficacy (see Table 3), lymph node, skin and lung metastasis had better efficacy (effective rate > 60%); bone metastasis had poor efficacy, liver, brain and ovarian metastasis needed further observation because of the small number of cases. (2-2) Toxic side effects The main toxic side effects of NE chemotherapy regimen are myelosuppression, leukopenia incidence of 80.9%, III-IV incidence of 32.4%, anemia incidence of 42.6%, III-IV incidence of 8.8%, and thrombocytopenia in 66.2% of patients; gastrointestinal reactions were significantly reduced after the use of Endanserone before chemotherapy, and III-IV incidence of 4.4%. Other toxic side effects such as alopecia, phlebitis and peripheral neuritis were not serious, and the incidence of III-IV reactions were low. Liver and kidney function and electrocardiogram changes were less common. No chemotherapy-related deaths occurred during the course of chemotherapy. (2-3) Intermediate efficacy The remission period of patients ranged from 4 to 20 months, with a median remission period of 7.5 months. The median survival was 14 months (1-40 months). There were 12 deaths in the whole group from the follow-up to December 2005. There were no lost cases. The longest survivor was 48 months. 3 , Discussion There is no uniform regimen for chemotherapy of breast cancer, and there is a preference for combination regimens. In this study, the NE regimen was used, in which the main action of EPI is to directly embed between DNA base pairs, interfere with the transcription process, prevent the formation of mRNA and act as a cell cycle non-specific drug by inhibiting both DNA and RNA synthesis [1]. NVB is a semi-synthetic vincristine compound with broad-spectrum antitumor activity that inhibits the polymerization of microtubule proteins and causes the disintegration of dividing microtubules, leading to the death of cells entering interphase or late division by blocking mitosis in G2 and M-phase cells, and is a cell cycle specific drug. nVB has the least affinity for axonal microtubules and thus has relatively low neurotoxicity [2]. Studies have shown that NVB is an effective drug in the treatment of breast cancer. Jiang Zefei et al [3] achieved an efficiency of more than 40% with NVB alone in the treatment of metastatic breast cancer. spilmann [4] et al used a combination regimen of NVB + ADM to treat metastatic breast cancer with an efficiency of 74% (66/89), a CR of 21%, a median remission of l2 months, and a median survival of 27.5 months. Wang Tianfeng et al [5] clinically reported 59 cases of breast cancer treated with NE regimen, with an overall effective rate of 59.5%, 76.7% for primary treatment and 62.1% for recurrent treatment. Gu Xiaoman et al [6] treated 15 cases of breast cancer with NE regimen, and the effective rate was 66.7%. In this study, 68 cases of breast cancer were treated with NE regimen, and the total effective rate (CR+PR) was 61.8%. The effective rate of primary treatment was 66.7%. The patients’ remission period ranged from 4 to 20 months, with a median remission period of 7.5 months. The median survival period was 14 months (1-40 months). This is comparable to the results of current domestic and international studies, and also indicates that the NE regimen has good efficacy in treating advanced breast cancer. In our group, the effective rate was 50.0% for 3 cycles of treatment and 65.4% for more than 3 cycles, suggesting that chemotherapy with 4 or more cycles may be more effective. The results of the efficacy of metastases at different sites suggest that this regimen is more effective for lymph node, skin and lung metastases, and the efficacy for metastatic tumors at other sites is uncertain at this time. The main toxic side effects in this group were bone marrow suppression, leukopenia (80.9%), III-IV (32.4%), anemia (42.6%) and III-IV (8.8%). Gastrointestinal reactions were significantly reduced after the use of Endanserone before chemotherapy, and the incidence of III-IV was 4.4%, and all of them recovered through symptomatic treatment without affecting the treatment. Other toxic side effects such as alopecia, phlebitis, peripheral neuritis, etc. were not serious. The above indicates that with effective preventive measures and timely symptomatic treatment for patients treated with NE regimen, the toxic side effects of this regimen are still low and the regimen is safe and feasible. In conclusion, we believe that the NE combination chemotherapy regimen has good clinical efficacy for patients with advanced breast cancer, while its adverse effects are tolerable and can be used for the treatment of advanced breast cancer.