| Breast cancer is the most common malignant turmor in the felmale, the incidence rate has increased recently. Anthracycline was used by many physicians as fist-line chemotherapy. So overall survival of patients with breast cancer have increased. But approximately 50% of all women diagnosed with breast carcinoma develop metastatic breast cancer (MBC). The treatment of MBC is a considerable challenge for physicians. The shift in use of anthracydines and taxanes to earlier in the course of disease has increased the likehood of patients presenting with MBC that has recurred after treatment with these agents. For patients in whom anthracydines have failed, combination chemotherapy of vinorelbine and cisplatine is a common regimen. Docetaxel and capecitabine are the new drugs for metastatic breast cancer (MBC). Docetaxel is a type of cytotoxic drug, an agent with antimicrotubule activity, has been found to be efficacious in breast cancer. The capecitabine was rationally designed to generate 5-Fu preferentially in tumor tissue. This tumor selectivity is achieved though exploitation of the significantly higher activity of thymidine phosphorylase in many human tumor issues compared with healthy tissue. In this trial, we investigated the efficacy and toxicity of docetaxel combined with capecitabine and compared with combination chemotherapy of vinorelbine (NVB) and cisplatine (DDP) in MBC. Patients were required to have histologicallg proved MBC and failed prior treatment with anthracycline. Patients were randomized into two groups A and B. In group A, 32 patients received docetaxel 75mg/m2 iv d1, capecitabine 950mg/ m2 po bid, d1-14, once every 3 weeks. Docetaxel was administered by 1 hour infusion. Prior to every cycle patients were premedicated with dexamethasome 10mg qd orally, 1day before the docetaxel infusion, for 3 days. To reduce capecitabine-induced hand-food syndrome (HFS) patients received Vit-B6 100mg po tid at the same time. In group B, 36 patients received NVB 25mg/m2 civ d1,8, DDP 80 mg/m2 iv in first 3 days, cycles were repeated every 21 days. Patients were evaluable for the response after two cycle. 68 patients were evaluated for response and toxicity. The response rate of group A and group B was 71.9 % and 44.4% respectively. The differency between the two group was significant (P<0.05). In group A and group B, the median time to disease progression (TTP) was 5.7 months and 3.8 months respectively. The differency between the two group was significant (P<0.01). In group A, the efficentcy was not significantly different between piror anthracydine chemotherapy and taxol chemotherapy. Grade III-â…£neutropenia was observed in group A and group B was 53.1% and 44.4%. The differency between the two groupwasnot significant (P>0.05). The incidence of HFS was 43.7% in group A. Clinical studies have shown that single-agent capecitabine was an active and tolerable treatment in metastatic breast cancer that has progressed during or after anthracydine and taxane therapy. Preclinical stdies in human cancer xenograft models demonstrated that administration of docetaxel results in further upregulation of thymidine phosphorylase in tumor tissue. Co-administration of capecitabine and docetaxel in xenograft models resulted in synergistic antitumor activity. In this trial, capecitabine/docetaxel (group A) resulted in significantly superior efficacy in time to disease progression (median TTP5.7 v 3.8 months p<0.01) and response with (71.9 % v 44.4% P<0.05) compared with vinorelbine/ cisplatine (group B). Prior chemotherapy with taxel may be did not influence the efficency. Grade III-â…£neutropenia was observed in group A and group B was 53.1% and 44.4%. The differency between the two group wasnot significant (P>0.05). The incidence of HFS was more common with group A. The combination of docetaxel and capecitabine is an effective regimen for the patients who failed prior treament with anthracyclin. Overall toxicity was acceptable. Prior chemotherapy with taxel may be did not influence the efficency. Docetaxel and capecitabine combination regimen had a higher response rate than NVB and DDP... |
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