title: A randomized, multicenter, phase III study of gemcitabine combined with capecitabine versus gemcitabine alone as first-line chemotherapy for advanced pancreatic cancer in South Korea.
abstract: BACKGROUND
  This phase III trial compared the efficacy and safety of gemcitabine plus capecitabine (GemCap) versus single-agent gemcitabine (Gem) in advanced pancreatic cancer as first-line chemotherapy.
  
  
  METHODS
  A total of 214 advanced pancreatic cancer patients were enrolled from 16 hospitals in South Korea between 2007 and 2011. Patients were randomly assigned to receive GemCap (oral capecitabine 1660 mg/m plus Gem 1000 mg/m by 30-minute intravenous infusion weekly for 3 weeks followed by a 1-week break every 4 weeks) or Gem (by 30-minute intravenous infusion weekly for 3 weeks every 4 weeks).
  
  
  RESULTS
  Median overall survival (OS) time, the primary end point, was 10.3 and 7.5 months in the GemCap and Gem arms, respectively (P = 0.06). Progression-free survival was 6.2 and 5.3 months in the GemCap and Gem arms, respectively (P = 0.08). GemCap significantly improved overall response rate compared with Gem alone (43.7% vs 17.6%; P = 0.001). Overall frequency of grade 3 or 4 toxicities was similar in each group. Neutropenia was the most frequent grade 3 or 4 toxicity in both groups.
  
  
  CONCLUSIONS
  GemCap failed to improve OS at a statistically significant level compared to Gem treatment. This study showed a trend toward improved OS compared to Gem alone. GemCap and Gem both exhibited similar safety profiles.
authors.affiliation: Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu Department of Internal Medicine, Dong-A University College of Medicine, Busan Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine Department of Internal Medicine, Korea University College of Medicine Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul Department of Internal Medicine, Keimyung University School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu Digestive Disease Center and Research Institute, Department of Internal Medicine, Soon Chun Hyang University School of Medicine, Bucheon and Seoul Department of Internal Medicine, Pusan National University Hospital, Busan. Departments of Internal Medicine, Pusan National University Hospital, Yangsan Department of Internal Medicine, Digestive Disease Centre, Konkuk University School of Medicine, Seoul Departments of Internal Medicine, Hanyang University College of Medicine, Seoul Department of Internal Medicine, School of Medicine, Wonkwang University, Iksan Department of Internal Medicine, The Catholic University of Korea College of Medicine, St. Mary's Hospital Biostatistics Collaboration Unit, Medical Research Center, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Hee Seung
authors.initials: HS
authors.lastname: Lee
authors.forename: Moon Jae
authors.initials: MJ
authors.lastname: Chung
authors.forename: Jeong Youp
authors.initials: JY
authors.lastname: Park
authors.forename: Seungmin
authors.initials: S
authors.lastname: Bang
authors.forename: Seung Woo
authors.initials: SW
authors.lastname: Park
authors.forename: Ho Gak
authors.initials: HG
authors.lastname: Kim
authors.forename: Myung Hwan
authors.initials: MH
authors.lastname: Noh
authors.forename: Sang Hyub
authors.initials: SH
authors.lastname: Lee
authors.forename: Yong-Tae
authors.initials: YT
authors.lastname: Kim
authors.forename: Hyo Jung
authors.initials: HJ
authors.lastname: Kim
authors.forename: Chang Duck
authors.initials: CD
authors.lastname: Kim
authors.forename: Dong Ki
authors.initials: DK
authors.lastname: Lee
authors.forename: Kwang Bum
authors.initials: KB
authors.lastname: Cho
authors.forename: Chang Min
authors.initials: CM
authors.lastname: Cho
authors.forename: Jong Ho
authors.initials: JH
authors.lastname: Moon
authors.forename: Dong Uk
authors.initials: DU
authors.lastname: Kim
authors.forename: Dae Hwan
authors.initials: DH
authors.lastname: Kang
authors.forename: Young Koog
authors.initials: YK
authors.lastname: Cheon
authors.forename: Ho Soon
authors.initials: HS
authors.lastname: Choi
authors.forename: Tae Hyeon
authors.initials: TH
authors.lastname: Kim
authors.forename: Jae Kwang
authors.initials: JK
authors.lastname: Kim
authors.forename: Jieun
authors.initials: J
authors.lastname: Moon
authors.forename: Hye Jung
authors.initials: HJ
authors.lastname: Shin
authors.forename: Si Young
authors.initials: SY
authors.lastname: Song
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D056910:Republic of Korea; D066066:Response Evaluation Criteria in Solid Tumors; D015996:Survival Rate; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D000093542:Gemcitabine