Treatment of Uterine Sarcoma with rAd-p53 (Gendicine) Followed by Chemotherapy: Clinical Study of TP53 Gene Therapy.

This study evaluated the efficacy of rAd-p53 (Gendicine®) followed by chemotherapy for the treatment of uterine sarcoma. Twelve cases of uterine sarcoma treated at Shengjing Hospital were retrospectively analyzed. Among the 12 patients, one had primary cancer, and 11 had recurrent cancer. For the recurrent cases, the interval between the first operation and diagnosis of recurrence, or progression-free survival time 1 (PFS1), was 1-18 months (median 3 months). All patients were treated with local application of rAd-p53 followed by chemotherapy (local injection of bleomycin and i.v. infusion of cisplatin, epirubicin, and isocyclophosphamide). Efficacy was evaluated, and the rates of complete remission (CR) and partial remission (PR) were calculated. During follow-up, PFS time 2 (PFS2) after the baseline period and overall survival (OS) time after the baseline period of rAd-p53 treatment data were obtained. The treatment resulted in one CR, seven PR, three with stable disease (SD), and one with progressive disease (PD). The remission rate (CR + PR) was 66.7%, and the responsive (CR + PR + SD) rate was 91.7%. PFS2 ranged from 2 to 62 months, with a median of 13 months, which is 10 months longer than that of PFS1; this difference was statistically significant (p = 0.0038). The OS time ranged from 6 to 62 months, with a median of 24 months. Following the combined treatment, four of the patients underwent a second debulking surgery. Of the two patients with liver metastases, one had CR of liver foci, and one had PR. Up to the follow-up date of the two patients who survived, one was tumor-free for 60 months. The PFS2 for the other patient was 39 months. This patient survived with tumor for 53 months with slow disease progression. The remaining 10 patients died. Local application of rAd-p53 combined with local injection of bleomycin and intravenous infusion of cisplatin, epirubicin and isocyclophosphamide was effective for treatment of uterine sarcoma, especially for patients with liver metastases. For patients with uterine sarcoma who do not have the opportunity for surgery, this regimen can be used as a new adjuvant therapy to obtain a surgical opportunity that allows further debulking of the tumor mass.