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Cited 15 time in webofscience Cited 18 time in scopus
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A randomized, multicenter, phase III study of gemcitabine combined with capecitabine versus gemcitabine alone as first-line chemotherapy for advanced pancreatic cancer in South Koreaopen access

Authors
Lee, Hee SeungChung, Moon JaePark, Jeong YoupBang, SeungminPark, Seung WooKim, Ho GakNoh, Myung HwanLee, Sang HyubKim, Yong-TaeKim, Hyo JungKim, Chang DuckLee, Dong KiCho, Kwang BumCho, Chang MinMoon, Jong HoKim, Dong UkKang, Dae HwanCheon, Young KoogChoi, Ho SoonKim, Tae HyeonKim, Jae KwangMoon, JieunShin, Hye JungSong, Si Young
Issue Date
Jan-2017
Publisher
LIPPINCOTT WILLIAMS & WILKINS
Keywords
capecitabine; gemcitabine; overall survival; pancreatic cancer; progression-free survival
Citation
MEDICINE, v.96, no.1
Indexed
SCIE
SCOPUS
Journal Title
MEDICINE
Volume
96
Number
1
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/5378
DOI
10.1097/MD.0000000000005702
ISSN
0025-7974
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 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.
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Kim, Hyo Jung
Guro Hospital (Department of Gastroenterology and Hepatology, Guro Hospital)
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