title: Combination of Recombinant Adenovirus-p53 with Radiochemotherapy in Unresectable Pancreatic Carcinoma.
abstract: 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/m(2), 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.
  
  
  CONCLUSIONS
  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.
authors: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Radiotherapy, Peking University School of Oncology, Beijing Cancer Hospital & Institute, Beijing 100142, China.
authors: Jin-Luan
authors: JL
authors: Li
authors: Yong
authors: Y
authors: Cai
authors: Shan-Wen
authors: SW
authors: Zhang
authors: Shao-Wen
authors: SW
authors: Xiao
authors: Xiao-Fan
authors: XF
authors: Li
authors: You-Jia
authors: YJ
authors: Duan
authors: Yong-Heng
authors: YH
authors: Li
authors: Bo
authors: B
authors: Xu
authors: Kun
authors: K
authors: Yan
keywords: Pancreatic carcinoma; Radiochemotherapy; Recombinant adenovirus-p53