A phase II study of capecitabine plus gemcitabine in patients with locally advanced or metastatic pancreatic cancer

Hong Suk Song, Young Rok Do, Heung Moon Chang, Min Hee Ryu, Kyung Hee Lee, Yeul Hong Kim, Dae Sik Hong, Jae Yong Cho, Kyoung Eun Lee, Si Young Kim

Research output: Contribution to journalArticle

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Abstract

Purpose: This open-label, multicenter phase II study was conducted to investigate the efficacy and safety of capecitabine plus gemcitabine combination chemotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer. Patients and methods: We enrolled 63 patients who received capecitabine 830 mg/m2 orally twice daily on days 1-21 plus gemcitabine 1000 mg/m2 as a 30-min infusion on days 1, 8 and 15 every 4 weeks for up to six cycles. Results: A total of 14 patients had partial responses giving an overall response rate of 22% (95% confidence interval [CI] 13-34%) in the intent-to-treat population. The median time to progression and overall survival were 3.9 months (95% CI 3.5-5.7) and 7.5 months (95% CI 5.0-10.0), respectively, and 1-year survival rate was 27.1% in the intent-to-treat population. Capecitabine plus gemcitabine was well tolerated. Grade 3 hematological adverse events were neutropenia (21%) and thrombocytopenia (2%); the only grade 4 hematological events were anemia (2%) and neutropenia (6%). Non-hematological adverse events were mainly gastrointestinal events and hand-foot syndrome, which affected 16% of patients. Grade 3/4 non-hematological events were infrequent. Conclusion: The combination of capecitabine plus gemcitabine appears to be active and well tolerated as first-line treatment in patients with advanced/metastatic pancreatic cancer.

Original languageEnglish
Pages (from-to)763-768
Number of pages6
JournalCancer Chemotherapy and Pharmacology
Volume62
Issue number5
DOIs
Publication statusPublished - 2008 Oct 1

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gemcitabine
Pancreatic Neoplasms
Confidence Intervals
Neutropenia
Chemotherapy
Hand-Foot Syndrome
Labels
Combination Drug Therapy
Population
Capecitabine
Anemia
Survival Rate
Safety

Keywords

  • Capecitabine
  • Chemotherapy
  • Gemcitabine
  • Pancreatic cancer

ASJC Scopus subject areas

  • Cancer Research
  • Pharmacology
  • Oncology

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A phase II study of capecitabine plus gemcitabine in patients with locally advanced or metastatic pancreatic cancer. / Song, Hong Suk; Do, Young Rok; Chang, Heung Moon; Ryu, Min Hee; Lee, Kyung Hee; Kim, Yeul Hong; Hong, Dae Sik; Cho, Jae Yong; Lee, Kyoung Eun; Kim, Si Young.

In: Cancer Chemotherapy and Pharmacology, Vol. 62, No. 5, 01.10.2008, p. 763-768.

Research output: Contribution to journalArticle

Song, Hong Suk ; Do, Young Rok ; Chang, Heung Moon ; Ryu, Min Hee ; Lee, Kyung Hee ; Kim, Yeul Hong ; Hong, Dae Sik ; Cho, Jae Yong ; Lee, Kyoung Eun ; Kim, Si Young. / A phase II study of capecitabine plus gemcitabine in patients with locally advanced or metastatic pancreatic cancer. In: Cancer Chemotherapy and Pharmacology. 2008 ; Vol. 62, No. 5. pp. 763-768.
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AU - Chang, Heung Moon

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AU - Lee, Kyung Hee

AU - Kim, Yeul Hong

AU - Hong, Dae Sik

AU - Cho, Jae Yong

AU - Lee, Kyoung Eun

AU - Kim, Si Young

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N2 - Purpose: This open-label, multicenter phase II study was conducted to investigate the efficacy and safety of capecitabine plus gemcitabine combination chemotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer. Patients and methods: We enrolled 63 patients who received capecitabine 830 mg/m2 orally twice daily on days 1-21 plus gemcitabine 1000 mg/m2 as a 30-min infusion on days 1, 8 and 15 every 4 weeks for up to six cycles. Results: A total of 14 patients had partial responses giving an overall response rate of 22% (95% confidence interval [CI] 13-34%) in the intent-to-treat population. The median time to progression and overall survival were 3.9 months (95% CI 3.5-5.7) and 7.5 months (95% CI 5.0-10.0), respectively, and 1-year survival rate was 27.1% in the intent-to-treat population. Capecitabine plus gemcitabine was well tolerated. Grade 3 hematological adverse events were neutropenia (21%) and thrombocytopenia (2%); the only grade 4 hematological events were anemia (2%) and neutropenia (6%). Non-hematological adverse events were mainly gastrointestinal events and hand-foot syndrome, which affected 16% of patients. Grade 3/4 non-hematological events were infrequent. Conclusion: The combination of capecitabine plus gemcitabine appears to be active and well tolerated as first-line treatment in patients with advanced/metastatic pancreatic cancer.

AB - Purpose: This open-label, multicenter phase II study was conducted to investigate the efficacy and safety of capecitabine plus gemcitabine combination chemotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer. Patients and methods: We enrolled 63 patients who received capecitabine 830 mg/m2 orally twice daily on days 1-21 plus gemcitabine 1000 mg/m2 as a 30-min infusion on days 1, 8 and 15 every 4 weeks for up to six cycles. Results: A total of 14 patients had partial responses giving an overall response rate of 22% (95% confidence interval [CI] 13-34%) in the intent-to-treat population. The median time to progression and overall survival were 3.9 months (95% CI 3.5-5.7) and 7.5 months (95% CI 5.0-10.0), respectively, and 1-year survival rate was 27.1% in the intent-to-treat population. Capecitabine plus gemcitabine was well tolerated. Grade 3 hematological adverse events were neutropenia (21%) and thrombocytopenia (2%); the only grade 4 hematological events were anemia (2%) and neutropenia (6%). Non-hematological adverse events were mainly gastrointestinal events and hand-foot syndrome, which affected 16% of patients. Grade 3/4 non-hematological events were infrequent. Conclusion: The combination of capecitabine plus gemcitabine appears to be active and well tolerated as first-line treatment in patients with advanced/metastatic pancreatic cancer.

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KW - Gemcitabine

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