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.
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