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: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*
来源:Medicine, 2017, 96(1): e5702.
DOI:10.1097/MD.0000000000005702

摘要

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 1660mg/m(2) plus Gem 1000mg/m(2) 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.

  • 出版日期2017-1