Clinical effectiveness of recombinant adenovirus-p53 combined with radiotherapy in advanced soft tissue sarcoma: A report of 37 cases.

Abstract

e21514 Background: To evaluate the efficacy and safety for the treatment of advanced soft tissue sarcoma with recombinant human adenovirus p53 (rAd-p53, Gendicine) injection and radiotherapy. Methods: From October 1, 2001, to May 1, 2013, 37 advanced soft tissue sarcoma patients have been treated with rAd-p53 plus radiotherapy. Gene therapy: multipoint injection of rAd-p53 within the neoplasm was given to head and neck as well as abdominal and pelvic tumor by ultrasound guided and to pulmonary metastatic lesion by CT guided. rAd-p53 was injected or perfused 1 × 1012 VP / 2 ml once a week for 3-16 weeks, and the average was 7 ± 2 weeks. Radiotherapy: radiotherapy was delivered 48-72 hours after the first rAd-p53 perfusion to a cumulative dose of 16-70 Gy / 8-35 fractioins / 2-7 weeks (average dose, 52.0 ± 5.0 Gy). Results: The rates of CR, PR, SD accounted for 8.1% (3/37), 43.2% (16/37) and 48.6% (18/37), respectively. All 18 patients of SD achieved the purpose of relieving pain and reducing local symptoms. The median follow-up time was 21 months (range, 6 to 116 months). The median overall survival (OS) and time to progression (TTP) times were 18.0 months and 13.6 months, respectively. The 1-,2-, 3- and 5-year OS rates were 56.8% (21/37), 21.6% (8/37), 16.2% (6/37) and 10.8% (4/37), respectively. Among all 39 patients who accepted rAd-p53 injection for several times, there were no significant adverse events except temporary fever. Conclusions: It is effective and safe for soft tissue sarcoma patients using the treatment of rAd-p53 weekly injection with concurrent radiotherapy. The rAd-p53 is a potential gene therapy drug for the treatment of soft tissue sarcoma.