Objective： In the present study, we have examined the safety and efficacy of recombinant adenovirus encoding human p53 tumor suppressor gene （rAd-p53） injection in patients with advanced non-small-cell lung cancer ...Objective： In the present study, we have examined the safety and efficacy of recombinant adenovirus encoding human p53 tumor suppressor gene （rAd-p53） injection in patients with advanced non-small-cell lung cancer （NSCLC） in the combination with the therapy of bronchial arterial infusion （BAI）. Methods： A total of 58 patients with advanced NSCLC were enrolled in a non-randomized, two-armed clinical trial. Of which, 19 received a combination treatment of BAI and rAd-p53 （the combo group）, while the remaining 39 were treated with only BAI （the control group）. Patients were followed up for 12 months, with safety and local response evaluated by the National Cancer lnstitute＇s Common Toxicity Criteria and response evaluation criteria in solid tumor （RECIST）, respectively. Time to progression （TTP） and survival rates were also analyzed by Kaplan-Meier method. Results In the combo group, 19 patients received a total of 49 injections ofrAd-p53 and 46 times of BAI, respectively, while 39 patients in the control group received a total of 113 times of BAI. The combination treatment was found to have less adverse events such as anorexia, nausea and emesis, pain, and leucopenia （P〈0.05） but more arthralgia, fever, influenza-like symptom, and myalgia （P〈0.05）, compared with the control group. The overall response rates （complete response （CR）＋partial response （PR）） were 47.3% and 38.4% for the combo group and the control group, respectively （P〉0.05）. Patients in the combo group had a longer TTP than those in the control group （a median 7.75 vs 5.5 months, P-0.018）. However, the combination treatment did not lead to better survival, with survival rates at 3, 6, and 12 months in the combo group being 94.74%, 89.47%, and 52.63%, respectively, com- pared with 92.31%, 69.23%, and 38.83% in the control group （P=0.224）. Conclusion： Our results show that the combination of rAd-p53 and BAI was well tolerated in patients with NSCLC and may have improved the quality of life and delayed the disease progression. A further study to better determine the efficacy of this combination therapy is warranted.展开更多
Objective： To study the efficiency, safety and feasibility of preoperative bronchial artery infusion （BAI） chemotherapy on operation in patients with locally advanced （stage Ⅲ） non-small cell lung cancer （NSCLC...Objective： To study the efficiency, safety and feasibility of preoperative bronchial artery infusion （BAI） chemotherapy on operation in patients with locally advanced （stage Ⅲ） non-small cell lung cancer （NSCLC）. Methods： 92 cases with locally advanced NSCLC patients were randomly divided into two groups： （1） BAI chemotherapy group： 39 cases were received BAI chemotherapy for 2 courses and followed surgery; （2） surgery alone group： 51 cases were treated by operation alone. The complete resection rate and preoperative complications were compared between these two groups. Results： In BAI chemotherapy group, the rate of clinical efficiency was 68.3% with slight toxicity. In BAI chemotherapy group the surgery complete resection rate was 89.7%, which was significantly higher than that in surgery alone group （72.5%, P 〈 0.05）. No significant differences of blood loss, operative complications and mortality were observed between these two groups. Conclusion： BAI neoadjuvant chemotherapy was safe and effective, which can increase the complete resection rate of the tumor and did not increase the operative complications and mortality.展开更多
文摘Objective： In the present study, we have examined the safety and efficacy of recombinant adenovirus encoding human p53 tumor suppressor gene （rAd-p53） injection in patients with advanced non-small-cell lung cancer （NSCLC） in the combination with the therapy of bronchial arterial infusion （BAI）. Methods： A total of 58 patients with advanced NSCLC were enrolled in a non-randomized, two-armed clinical trial. Of which, 19 received a combination treatment of BAI and rAd-p53 （the combo group）, while the remaining 39 were treated with only BAI （the control group）. Patients were followed up for 12 months, with safety and local response evaluated by the National Cancer lnstitute＇s Common Toxicity Criteria and response evaluation criteria in solid tumor （RECIST）, respectively. Time to progression （TTP） and survival rates were also analyzed by Kaplan-Meier method. Results In the combo group, 19 patients received a total of 49 injections ofrAd-p53 and 46 times of BAI, respectively, while 39 patients in the control group received a total of 113 times of BAI. The combination treatment was found to have less adverse events such as anorexia, nausea and emesis, pain, and leucopenia （P〈0.05） but more arthralgia, fever, influenza-like symptom, and myalgia （P〈0.05）, compared with the control group. The overall response rates （complete response （CR）＋partial response （PR）） were 47.3% and 38.4% for the combo group and the control group, respectively （P〉0.05）. Patients in the combo group had a longer TTP than those in the control group （a median 7.75 vs 5.5 months, P-0.018）. However, the combination treatment did not lead to better survival, with survival rates at 3, 6, and 12 months in the combo group being 94.74%, 89.47%, and 52.63%, respectively, com- pared with 92.31%, 69.23%, and 38.83% in the control group （P=0.224）. Conclusion： Our results show that the combination of rAd-p53 and BAI was well tolerated in patients with NSCLC and may have improved the quality of life and delayed the disease progression. A further study to better determine the efficacy of this combination therapy is warranted.
基金a grant from the Foundation of Science and Technology of Dalian (No. 20039907)
文摘Objective： To study the efficiency, safety and feasibility of preoperative bronchial artery infusion （BAI） chemotherapy on operation in patients with locally advanced （stage Ⅲ） non-small cell lung cancer （NSCLC）. Methods： 92 cases with locally advanced NSCLC patients were randomly divided into two groups： （1） BAI chemotherapy group： 39 cases were received BAI chemotherapy for 2 courses and followed surgery; （2） surgery alone group： 51 cases were treated by operation alone. The complete resection rate and preoperative complications were compared between these two groups. Results： In BAI chemotherapy group, the rate of clinical efficiency was 68.3% with slight toxicity. In BAI chemotherapy group the surgery complete resection rate was 89.7%, which was significantly higher than that in surgery alone group （72.5%, P 〈 0.05）. No significant differences of blood loss, operative complications and mortality were observed between these two groups. Conclusion： BAI neoadjuvant chemotherapy was safe and effective, which can increase the complete resection rate of the tumor and did not increase the operative complications and mortality.
