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

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 KimJae Kwang Kim, Jieun Moon, Hye Jung Shin, Si Young Song

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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/m2 plus Gem 1000mg/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. Abbreviations: BSA = body surface area, CA 19-9 = carbohydrate antigen 19-9, Cap = capecitabine, CEA = chorioembryonic antigen, CR = complete responses, CT = computed tomography, ECOG = Eastern Cooperative Oncology Group, FOLFIRINOX = fluorouracil, irinotecan, oxaliplatin, and leucovorin, FU = fluorouracil, Gem = gemcitabine, GemCap = gemcitabine plus capecitabine, HR = hazard ratio, MRI = magnetic resonance imaging, ORR = objective response rate, OS = overall survival, PET = positron emission tomography, PFS = progression-free survival, PR = partial responses, RECIST = response evaluation criteria in solid tumors.

Original languageEnglish
Article number5702
JournalMedicine (United States)
Volume96
Issue number1
DOIs
Publication statusPublished - 2017 Jan 1

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gemcitabine
Republic of Korea
Pancreatic Neoplasms
Drug Therapy
Capecitabine
irinotecan
oxaliplatin

Keywords

  • Capecitabine
  • Gemcitabine
  • Overall survival
  • Pancreatic cancer
  • Progression-free survival

ASJC Scopus subject areas

  • Medicine(all)

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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. / 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.

In: Medicine (United States), Vol. 96, No. 1, 5702, 01.01.2017.

Research output: Contribution to journalArticle

Lee, HS, Chung, MJ, Park, JY, Bang, S, Park, SW, Kim, HG, Noh, MH, Lee, SH, Kim, YT, Kim, HJ, Kim, CD, Lee, DK, Cho, KB, Cho, CM, Moon, JH, Kim, DU, Kang, DH, Cheon, YK, Choi, HS, Kim, TH, Kim, JK, Moon, J, Shin, HJ & Song, SY 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 (United States), vol. 96, no. 1, 5702. https://doi.org/10.1097/MD.0000000000005702
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. / 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. In: Medicine (United States). 2017 ; Vol. 96, No. 1.
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T1 - 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

AU - Lee, Hee Seung

AU - Chung, Moon Jae

AU - Park, Jeong Youp

AU - Bang, Seungmin

AU - Park, Seung Woo

AU - Kim, Ho Gak

AU - Noh, Myung Hwan

AU - Lee, Sang Hyub

AU - Kim, Yong Tae

AU - Kim, Hyo Jung

AU - Kim, Chang Duck

AU - Lee, Dong Ki

AU - Cho, Kwang Bum

AU - Cho, Chang Min

AU - Moon, Jong Ho

AU - Kim, Dong Uk

AU - Kang, Dae Hwan

AU - Cheon, Young Koog

AU - Choi, Ho Soon

AU - Kim, Tae Hyeon

AU - Kim, Jae Kwang

AU - Moon, Jieun

AU - Shin, Hye Jung

AU - Song, Si Young

PY - 2017/1/1

Y1 - 2017/1/1

N2 - 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/m2 plus Gem 1000mg/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. Abbreviations: BSA = body surface area, CA 19-9 = carbohydrate antigen 19-9, Cap = capecitabine, CEA = chorioembryonic antigen, CR = complete responses, CT = computed tomography, ECOG = Eastern Cooperative Oncology Group, FOLFIRINOX = fluorouracil, irinotecan, oxaliplatin, and leucovorin, FU = fluorouracil, Gem = gemcitabine, GemCap = gemcitabine plus capecitabine, HR = hazard ratio, MRI = magnetic resonance imaging, ORR = objective response rate, OS = overall survival, PET = positron emission tomography, PFS = progression-free survival, PR = partial responses, RECIST = response evaluation criteria in solid tumors.

AB - 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/m2 plus Gem 1000mg/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. Abbreviations: BSA = body surface area, CA 19-9 = carbohydrate antigen 19-9, Cap = capecitabine, CEA = chorioembryonic antigen, CR = complete responses, CT = computed tomography, ECOG = Eastern Cooperative Oncology Group, FOLFIRINOX = fluorouracil, irinotecan, oxaliplatin, and leucovorin, FU = fluorouracil, Gem = gemcitabine, GemCap = gemcitabine plus capecitabine, HR = hazard ratio, MRI = magnetic resonance imaging, ORR = objective response rate, OS = overall survival, PET = positron emission tomography, PFS = progression-free survival, PR = partial responses, RECIST = response evaluation criteria in solid tumors.

KW - Capecitabine

KW - Gemcitabine

KW - Overall survival

KW - Pancreatic cancer

KW - Progression-free survival

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