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Objective To evaluate the efficacy and safety of recombinant adenovirus-p53(rAdp53) injection combined with radiotherapy and hyperthermia in the treatment of unresectable advanced soft tissue sarcoma.Methods In this retrospective study, we evaluated 76 patients with unresectable advanced primary or recurrent soft tissue sarcoma treated in our hospital from November 2005 to November 2012.These patients received radiotherapy and hyperthermia with rAdp53(p53 group, n=41) or without rAdp53(control group, n=35).rAdp53((1-2)×1012viral particles each time, once a week, 8 times on average) was injected into the tumor or infused into the pelvic cavity.Radiotherapy (2 Gy each time, 5 times a week) was performed for the planning target volume at 56.3±5.3 Gy in the p53 group and 58.1±4.2 Gy in the control group, with no significant difference between the two groups (P>0.05).Superficial or deep thermotherapy was employed 8 times on average (twice a week).Clinical features, response rate, time to progression (TTP), overall survival (OS), and adverse events were compared between the two groups (P>0.05).The Kaplan-Meier method was used to calculate OS;the log-rank test was used for survival difference analysis and univariate prognostic analysis;the chi-square test was used for comparison of categorical data.Results At 2 months after treatment, the p53 group had significantly increased response rate (partial response+ complete response+ stable disease)(85% vs.54%, P=0.003) and local control rate (49% vs.23%, P=0.020) as well as prolonged TTP (12 months vs.5 months, P=0.010) and OS (48 months vs.31 months, P=0.049), as compared with the control group.No adverse events caused by radiotherapy and hyperthermia except transient fever were seen in the two groups.Conclusions Concurrent radiotherapy and hyperthermia combined with rAdp53 injection is effective and safe for patients with advanced soft tissue sarcoma.
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Objective To evaluate the efficacy and safety of recombinant adenovirus-p53 (rhAd-p53) combined with neoadjuvant chemotherapy in treatment of locally advanced cervical cancer.Methods Forty patients with stage Ⅰ R2-Ⅲ A locally advanced cervical cancer were randomly divided into 2 groups,gene therapy + neoadjuvant chemotherapy group (rhAd-p53+PVB group,n =20.They received one course of chemotherapy consisting of PVB.rhAd-p53 solution 1 ×1012 VP was injected intratumorally every three days for three circles since the 3rd day of PVB chemotherapy) and chemotherapy group (PVB group,n=20,the above course of chemotherapy was conducted).The volums of tumors was observed.Patients were monitored for adverse event.The expression of VEGF,p53 pertein and MVD in tumor tissue was detected by immunohistochemistry.Results The evaluation was performed three weeks after the completion of chemotherapy.The PVB group response rate (CR+PR) was 75 ％,while the effective rate was 95 ％ of the PVB combined with gene group.After using of the PVB chemotherapy,the tumor was shrunk by (11.42±2.78) cm2.However,the volums of tumor were significantly shrunk by (15.25±4.00) cm2 using the PVB combined with gene therapy,and P ＜ 0.05.The positive expression rate of VEGF,p53 protein and MVD were reduced respectively in PVB group and rhAd-p53 + PVB group with statistic significance.There were no additional adverse events by recombinant adenovirus-p53 combined with neoadjuvant chemotherapy.Conclusion A potentially gene therapeutic agent for cervical cancer treatment,intratumoral injection of rhAd-p53 is effective.