• Hee Seung Lee, Moon Jae Chung, Jeong Youp Park, Seungmin Bang, Seung Woo Park, Ho Gak Kim, Myung Hwan Noh, Sang Hyub Lee, Yong-Tae Kim, Hyo Jung Kim, Chang Duck Kim, Dong Ki Lee, Kwang Bum Cho, Chang Min Cho, Jong Ho Moon, Dong Uk Kim, Dae Hwan Kang, Young Koog Cheon, Ho Soon Choi, Tae Hyeon Kim, Jae Kwang Kim, Jieun Moon, Hye Jung Shin, Si Young Song, and Korean Society of Gastrointestinal Cancer.
• 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.
• Medicine (Baltimore). 2017 Jan 1; 96 (1): e5702e5702.

BackgroundThis 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.MethodsA 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).ResultsMedian 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.ConclusionGemCap 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.

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