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
- 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
- Issue Date
- LIPPINCOTT WILLIAMS & WILKINS
- capecitabine; gemcitabine; overall survival; pancreatic cancer; progression-free survival
- MEDICINE, v.96, no.1
- Journal Title
- 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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- 2. Clinical Science > Department of Gastroenterology and Hepatology > 1. Journal Articles
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