一项在韩国进行的随机、多中心、III期研究，比较吉西他滨联合卡培他滨与单用吉西他滨作为晚期胰腺癌一线化疗的疗效。
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.
作者信息
Lee Hee Seung, Chung Moon Jae, Park Jeong Youp, Bang Seungmin, Park Seung Woo, Kim Ho Gak, Noh Myung Hwan, Lee Sang Hyub, Kim Yong-Tae, Kim Hyo Jung, Kim Chang Duck, Lee Dong Ki, Cho Kwang Bum, Cho Chang Min, Moon Jong Ho, Kim Dong Uk, Kang Dae Hwan, Cheon Young Koog, Choi Ho Soon, Kim Tae Hyeon, Kim Jae Kwang, Moon Jieun, Shin Hye Jung, Song Si Young
机构信息
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.
出版信息
Medicine (Baltimore). 2017 Jan;96(1):e5702. doi: 10.1097/MD.0000000000005702.
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.
CONCLUSION
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.
背景
本III期试验比较了吉西他滨联合卡培他滨（GemCap）与单药吉西他滨（Gem）作为晚期胰腺癌一线化疗的疗效和安全性。
方法
2007年至2011年间，从韩国16家医院招募了总共214例晚期胰腺癌患者。患者被随机分配接受GemCap（口服卡培他滨1660mg/m²加吉西他滨1000mg/m²，通过30分钟静脉输注，每周一次，共3周，然后每4周休息1周）或Gem（每4周通过30分钟静脉输注，每周一次，共3周）。
结果
主要终点中位总生存期（OS）在GemCap组和Gem组分别为10.3个月和7.5个月（P = 0.06）。无进展生存期在GemCap组和Gem组分别为6.2个月和5.3个月（P = 0.08）。与单独使用Gem相比，GemCap显著提高了总缓解率（43.7%对17.6%；P = 0.001）。每组3级或4级毒性的总体发生率相似。中性粒细胞减少是两组中最常见的3级或4级毒性。
结论
与Gem治疗相比，GemCap未能在统计学上显著提高OS。本研究显示与单独使用Gem相比有OS改善的趋势。GemCap和Gem均表现出相似的安全性。
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