Combination of Recombinant Adenovirus-p53 with Radiochemotherapy in Unresectable Pancreatic Carcinoma

Objective：To assess the safety and efficacy of the combination of recombinant adenovirus-p53 （rAd-p53） with radiochemotherapy for treating unresectable pancreatic carcinoma.Methods：The eligible patients received concurrent rAd-p53 intratumoral injection and radiochemotherapy.Intratumoral injection of rAd-p53 was guided by B ultrasound.Radiochemotherapy consisted of intensity-modulated radiotherapy （IMRT） at two dose levels and intravenous gemcitabine （Gem）.For radiotherapy,gross target volume （GTV） and clinical target volume （CTV） were 55-60 Gy and 45-55 Gy in 25-30 fractions,respectively.Concurrent intravenous gemcitabine was administered at 350 mg/m2,weekly,for 6 weeks.The primary end points included toxicity,clinical benefit response （CBR） and disease control rate （DCR）.The secondary end points included progression-free survival （PFS） and overall survival （OS）.Results：Fifteen eligible patients were enrolled.Eight patients （53.3%） were evaluated as CBR and 12 （80%） achieved DCR.The median PFS and OS were 6.7 and 13.8 months,respectively.One-year PFS and OS were 40.0% and 51.1%,respectively.There were 8 （53.3%） patients reported grade 3 toxicities including neutropenia （6 patients,40%）,fever （1 patient,6.7%） and fatigue （1 patient,6.7%）.There was no grade 4 toxicity reported.Conclusion：Combination of rAd-p53 in unresectable pancreatic carcinoma showed encouraging efficacious benefit and was well tolerated.Long-term follow-up is needed to confirm the improvement of PFS and OS.