title: A prospective randomized study of gemcitabine with doxifluridine versus paclitaxel with doxifluridine in concurrent chemoradiotherapy for locally advanced pancreatic cancer.
abstract: OBJECTIVE
  The objective of this study was to compare the efficacy and toxicity of gemcitabine-based concurrent chemoradiotherapy (CCRT) with paclitaxel-based CCRT in patients with locally advanced pancreatic cancer.
  
  
  METHODS
  A total of 48 patients who had received no prior therapy were enrolled. The patients were treated with 4500 cGy radiation in 25 fractions over 5 weeks concomitant with gemcitabine 1000 mg/m(2)/week/intravenously (IV) and doxifluridine 600 mg/m(2)/day/by mouth (PO), or paclitaxel 50 mg/m(2)/week/IV and doxifluridine 600 mg/m(2)/day/PO. After a 4-week rest, the responses were evaluated and maintenance therapies (operation or chemotherapy) (gemcitabine 1000 mg/m(2)/week/IV and doxifluridine 600 mg/m(2)/day/PO) were conducted.
  
  
  RESULTS
  The median survival was 12 months in the gemcitabine group vs. 14 months in the paclitaxel group. The response rate was 13.6% vs. 25%, and the median time to progression was 12 months vs. 12.5 months, respectively. The positive rate of the clinical benefit response was 59.1% vs. 41.7%, respectively. Toxicities were acceptable in both groups.
  
  
  CONCLUSIONS
  In this trial, we demonstrated that the gemcitabine-based CCRT and the paclitaxel-based CCRT in combination of doxifluridine are clearly acceptable treatment strategy, and appear more effective than the 5 fluorouracil-based CCRT for locally advanced pancreatic cancer with comparable tolerability. Furthermore, the paclitaxel-based CCRT showed similar efficacy and toxicities to the gemcitabine-based treatment when it was combined with 5-fluorouracil.
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.
authors.forename: Hye Won
authors.initials: HW
authors.lastname: Chung
authors.forename: Seung Min
authors.initials: SM
authors.lastname: Bang
authors.forename: Seung Woo
authors.initials: SW
authors.lastname: Park
authors.forename: Jae Bock
authors.initials: JB
authors.lastname: Chung
authors.forename: Jin Kyung
authors.initials: JK
authors.lastname: Kang
authors.forename: Ju Won
authors.initials: JW
authors.lastname: Kim
authors.forename: Jin Sil
authors.initials: JS
authors.lastname: Seong
authors.forename: Woo Jung
authors.initials: WJ
authors.lastname: Lee
authors.forename: Si Young
authors.initials: SY
authors.lastname: Song
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D005467:Floxuridine / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D011879:Radiotherapy Dosage; D000093542:Gemcitabine
chemical_list: D005467:Floxuridine; D003841:Deoxycytidine; D017239:Paclitaxel; C025034:doxifluridine; D000093542:Gemcitabine