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
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2017 |
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| Erschienen: |
2017 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:96 |
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| Enthalten in: |
Medicine - 96(2017), 1 vom: 15. Jan., Seite e5702 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Lee, Hee Seung [VerfasserIn] |
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| Links: |
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| Themen: |
0W860991D6 |
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| Anmerkungen: |
Date Completed 21.02.2017 Date Revised 07.12.2022 published: Print Citation Status MEDLINE |
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| doi: |
10.1097/MD.0000000000005702 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM267859201 |
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| 041 | |a eng | ||
| 100 | 1 | |a Lee, Hee Seung |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a 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 |
| 264 | 1 | |c 2017 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 21.02.2017 | ||
| 500 | |a Date Revised 07.12.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 7 | |a Deoxycytidine |2 NLM | |
| 650 | 7 | |a 0W860991D6 |2 NLM | |
| 650 | 7 | |a Capecitabine |2 NLM | |
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| 650 | 7 | |a Gemcitabine |2 NLM | |
| 700 | 1 | |a Chung, Moon Jae |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Jeong Youp |e verfasserin |4 aut | |
| 700 | 1 | |a Bang, Seungmin |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Seung Woo |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Ho Gak |e verfasserin |4 aut | |
| 700 | 1 | |a Noh, Myung Hwan |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Sang Hyub |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Yong-Tae |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Hyo Jung |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Chang Duck |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Dong Ki |e verfasserin |4 aut | |
| 700 | 1 | |a Cho, Kwang Bum |e verfasserin |4 aut | |
| 700 | 1 | |a Cho, Chang Min |e verfasserin |4 aut | |
| 700 | 1 | |a Moon, Jong Ho |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Dong Uk |e verfasserin |4 aut | |
| 700 | 1 | |a Kang, Dae Hwan |e verfasserin |4 aut | |
| 700 | 1 | |a Cheon, Young Koog |e verfasserin |4 aut | |
| 700 | 1 | |a Choi, Ho Soon |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Tae Hyeon |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Jae Kwang |e verfasserin |4 aut | |
| 700 | 1 | |a Moon, Jieun |e verfasserin |4 aut | |
| 700 | 1 | |a Shin, Hye Jung |e verfasserin |4 aut | |
| 700 | 1 | |a Song, Si Young |e verfasserin |4 aut | |
| 700 | 0 | |a Korean Society of Gastrointestinal Cancer |e verfasserin |4 aut | |
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