Toxicity of recombinant adenovirus p53 agent injection combince with radiotherapy in treatment of local recurrent nasopharyngeal carcinoma ( NPC )

Abstract

Objective To evaluate the toxicity of recombinant adenovirus p53 agent injection (rAdp53 ) combince with radiotherapy in treatment of local recurrent nasopharyngeal carcinoma( NPC ). Methods Between June 2005 and December 2005,20 cases patients that had non-keratinizing( WHO classification) local recurrent nasopharyngeal carcinoma were enrolled in the study, randomly divided into two groups:gene therapy +radiotherapy group( GIRT group) 10 cases, radiotherapy group( RT group), l0 cases. The GIRT group was injected rAd-p53 once a week for 8 weeks, and received radiotherapy 3 days after injection. Two groups received same dose of radiation. All patients were assessed by intent-to-treat analysis. The toxicity of rAd-p53 were evaluted.(The efficacy of rAd-p53 will be reported on another paper). Results The two groups were well balanced in the distribution of all prognostic factors and RT parameters, such as sex, age, performance status, staging method and clinical stage. 10 cases of GIRT group received 80 person-times rAd-p53 injections, o fever 41 person-times,the incidence is 51.3% ,o fever 24 person-times,the incidence is 30% ,o fever 15 person-times,the incidence is 18.7%. One cases was noted needle track implantation, the incidence is 1.3%. No others adverse events were noted. Conclusion Toxicity of recombinant adenovirus p53 agent injection combince with radiotherapy in treatment of local recurrent nasopharyngeal carcinoma is tolerable. Key words: Local recurrent nasopharyngeal carcinoma; Rene therapy; Radiotherapy