94 43

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

Title
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
Author
최호순
Keywords
capecitabine; gemcitabine; overall survival; pancreatic cancer; progression-free survival
Issue Date
2017-01
Publisher
LIPPINCOTT WILLIAMS & WILKINS
Citation
MEDICINE, v. 96, no. 1, Article no. e5702
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.
URI
https://insights.ovid.com/article/00005792-201701060-00026https://repository.hanyang.ac.kr/handle/20.500.11754/112294
ISSN
0025-7974; 1536-5964
DOI
10.1097/MD.0000000000005702
Appears in Collections:
COLLEGE OF MEDICINE[S](의과대학) > MEDICINE(의학과) > Articles
Files in This Item:
A randomized, multicenter, phase III study of gemcitabine combined with capecitabine versus gemcitabine alone as first-line.pdfDownload
Export
RIS (EndNote)
XLS (Excel)
XML


qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

BROWSE