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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 Korea

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Author(s)
Hee Seung LeeMoon Jae ChungJeong Youp ParkSeungmin BangSeung Woo ParkHo Gak KimMyung Hwan NohSang Hyub LeeYong-Tae KimHyo Jung KimChang Duck KimDong Ki LeeKwang Bum ChoChang Min ChoJong Ho MoonDong Uk KimDae Hwan KangYoung Koog CheonHo Soon ChoiTae Hyeon KimJae Kwang KimJieun MoonHye Jung ShinSi Young Song
Keimyung Author(s)
Cho, Kwang Bum
Department
Dept. of Internal Medicine (내과학)
Journal Title
Medicine
Issued Date
2017
Volume
96
Issue
1
Keyword
capecitabinegemcitabineoverall survivalpancreatic cancerprogression-free survival
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/m2 plus Gem 1000 mg/m2 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.
Keimyung Author(s)(Kor)
조광범
Publisher
School of Medicine
Citation
Hee Seung Lee et al. (2017). 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. Medicine, 96(1), e5702–e5702. doi: 10.1097/MD.0000000000005702
Type
Article
ISSN
0025-7974
DOI
10.1097/MD.0000000000005702
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/32523
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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