OBJECTIVE: To evaluate the efficacy of Endosteal(TM) (rh-endostatin, YH-16) combined with docetaxel and carboplatin (TP) regimen for the adjuvant treatment of non-small lung cancer (NSCLC) and its impact on circulating blood markers. METHODS:36 patients with stage Ib-IIIa postoperative NSCLC, were randomly divided into the treatment group, Endosteal(TM) plus TP regimen, and the control group, TP regimen only, respectively. DFS and toxicities of patients were observed. The numbers of CEC and the levels of tumor marker CEA, NSE and CYFR21-1 were measured. RESULTS: The numbers of CEC and the levels of CEA, NSE and CYFR21-1 decreased after treatment. There were significant differences in CEC and NSE between treatment group and control group after four cycles of treatment, respectively (P = 0.016 and 0.013). Disease-free survival time (DFS) was longer in treatment group than control group but without significant difference. CEC was significantly increased in recurrent and metastasis cases and decreased after effective treatment. CONCLUSION:Endosteal(TM) combined with TP regimen seem to be superior to TP alone in some short term index for the treatment of postoperative NSCLC even though long-term survival is still anticipated. CEC, as a biomarker, may be useful in predicting the efficacy of the such synergistic treatment.
RCT Entities:
OBJECTIVE: To evaluate the efficacy of Endosteal(TM) (rh-endostatin, YH-16) combined with docetaxel and carboplatin (TP) regimen for the adjuvant treatment of non-small lung cancer (NSCLC) and its impact on circulating blood markers. METHODS: 36 patients with stage Ib-IIIa postoperative NSCLC, were randomly divided into the treatment group, Endosteal(TM) plus TP regimen, and the control group, TP regimen only, respectively. DFS and toxicities of patients were observed. The numbers of CEC and the levels of tumor marker CEA, NSE and CYFR21-1 were measured. RESULTS: The numbers of CEC and the levels of CEA, NSE and CYFR21-1 decreased after treatment. There were significant differences in CEC and NSE between treatment group and control group after four cycles of treatment, respectively (P = 0.016 and 0.013). Disease-free survival time (DFS) was longer in treatment group than control group but without significant difference. CEC was significantly increased in recurrent and metastasis cases and decreased after effective treatment. CONCLUSION: Endosteal(TM) combined with TP regimen seem to be superior to TP alone in some short term index for the treatment of postoperative NSCLC even though long-term survival is still anticipated. CEC, as a biomarker, may be useful in predicting the efficacy of the such synergistic treatment.