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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.

Authors
 Hee Seung Lee  ;  Moon Jae Chung  ;  Jeong Youp Park  ;  Seungmin Bang  ;  Seung Woo Park  ;  Ho Gak Kim  ;  Myung Hwan Noh  ;  Sang Hyub Lee  ;  Yong-Tae Kim  ;  Hyo Jung Kim  ;  Chang Duck Kim  ;  Dong Ki Lee  ;  Kwang Bum Cho  ;  Chang Min Cho  ;  Jong Ho Moon  ;  Dong Uk Kim  ;  Dae Hwan Kang  ;  Young Koog Cheon  ;  Ho Soon Choi  ;  Tae Hyeon Kim  ;  Jae Kwang Kim  ;  Jieun Moon  ;  Hye Jung Shin  ;  Si Young Song 
Citation
 MEDICINE, Vol.96(1) : 5702, 2017 
Journal Title
 MEDICINE 
ISSN
 0025-7974 
Issue Date
2017
MeSH
Adenocarcinoma/drug therapy* ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Capecitabine/administration & dosage ; Deoxycytidine/administration & dosage ; Deoxycytidine/adverse effects ; Deoxycytidine/analogs & derivatives* ; Deoxycytidine/therapeutic use ; Disease-Free Survival ; Female Humans ; Male ; Middle Aged ; Neutropenia/chemically induced ; Pancreatic Neoplasms/drug therapy* ; Republic of Korea ; Response Evaluation Criteria in Solid Tumors ; Survival Rate
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/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.
Files in This Item:
T201700302.pdf Download
DOI
10.1097/MD.0000000000005702
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Seung Woo(박승우) ORCID logo https://orcid.org/0000-0001-8230-964X
Park, Jeong Youp(박정엽) ORCID logo https://orcid.org/0000-0003-0110-8606
Bang, Seungmin(방승민) ORCID logo https://orcid.org/0000-0001-5209-8351
Song, Si Young(송시영) ORCID logo https://orcid.org/0000-0002-1417-4314
Lee, Hee Seung(이희승) ORCID logo https://orcid.org/0000-0002-2825-3160
Chung, Moon Jae(정문재) ORCID logo https://orcid.org/0000-0002-5920-8549
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/154182
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