OBJECTIVE: To evaluate the efficacy and safety of Pseudomonas aeruginosa MSHA (PA-MSHA) vaccine combined with TAC scheme in the treatment of breast carcinoma. METHODS: A non-blinded, randomized, controlled trial was conducted between January 2008 and June 2008 among 60 patients with breast carcinoma. The patients were randomized into control group (30 cases) with neoadjuvant chemotherapy and PA-MSHA group (30 cases) with PA-MSHA treatment in addition to neoadjuvant chemotherapy. The therapeutic effect, adverse effects, surgical approaches, postoperative complications and cost-effectiveness in both groups were analyzed before and after the treatment. RESULTS: The response rate in PA-MSHA group were significantly higher than that in the control group at 2, 3, and 4 weeks after neoadjuvant chemotherapy (P<0.05). The Karnofsky scores underwent no significant changes in PA-MSHA group after the chemotherapy, but significantly reduced in the control group (P<0.05). The incidence and severity of the toxic reactions and the rates of subcutaneous fluid, skin flap necrosis and infection in PA-MSHA group were significantly lower than those in the control group. The rate of operation following two neoadjuvant chemotherapy sessions was significantly higher in PA-MSHA group than in the control group. The cost of neoadjuvant chemotherapy for a 1% increment of the response rate was also significantly lower in PA-MSHA than in the control group. CONCLUSION:PA-MSHA vaccine combined with TAC scheme can significantly enhance the therapeutic effect of breast carcinoma, lowers the rate of postoperative complications, and improve the efficacy of chemotherapy.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of Pseudomonas aeruginosa MSHA (PA-MSHA) vaccine combined with TAC scheme in the treatment of breast carcinoma. METHODS: A non-blinded, randomized, controlled trial was conducted between January 2008 and June 2008 among 60 patients with breast carcinoma. The patients were randomized into control group (30 cases) with neoadjuvant chemotherapy and PA-MSHA group (30 cases) with PA-MSHA treatment in addition to neoadjuvant chemotherapy. The therapeutic effect, adverse effects, surgical approaches, postoperative complications and cost-effectiveness in both groups were analyzed before and after the treatment. RESULTS: The response rate in PA-MSHA group were significantly higher than that in the control group at 2, 3, and 4 weeks after neoadjuvant chemotherapy (P<0.05). The Karnofsky scores underwent no significant changes in PA-MSHA group after the chemotherapy, but significantly reduced in the control group (P<0.05). The incidence and severity of the toxic reactions and the rates of subcutaneous fluid, skin flap necrosis and infection in PA-MSHA group were significantly lower than those in the control group. The rate of operation following two neoadjuvant chemotherapy sessions was significantly higher in PA-MSHA group than in the control group. The cost of neoadjuvant chemotherapy for a 1% increment of the response rate was also significantly lower in PA-MSHA than in the control group. CONCLUSION:PA-MSHA vaccine combined with TAC scheme can significantly enhance the therapeutic effect of breast carcinoma, lowers the rate of postoperative complications, and improve the efficacy of chemotherapy.