Cancer Chemotherapy and Pharmacology

, Volume 62, Issue 5, pp 763–768

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
Original Article

DOI: 10.1007/s00280-007-0661-y

Cite this article as:
Song, H.S., Do, Y.R., Chang, H.M. et al. Cancer Chemother Pharmacol (2008) 62: 763. doi:10.1007/s00280-007-0661-y

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.

Keywords

Pancreatic cancerCapecitabineGemcitabineChemotherapy

Copyright information

© Springer-Verlag 2007

Authors and Affiliations

  • Hong Suk Song
    • 1
  • Young Rok Do
    • 1
  • Heung Moon Chang
    • 2
  • Min Hee Ryu
    • 2
  • Kyung Hee Lee
    • 3
  • Yeul Hong Kim
    • 4
  • Dae Sik Hong
    • 5
  • Jae Yong Cho
    • 6
  • Kyoung Eun Lee
    • 7
  • Si Young Kim
    • 8
  1. 1.Division of Hematooncology, Department of Internal Medicine, Dongsan Medical CenterKeimyung University School of MedicineDaeguSouth Korea
  2. 2.Department of Internal Medicine, Asan Medical CenterUniversity of UlsanSeoulSouth Korea
  3. 3.Department of Internal MedicineYeungNam University Medical CenterDaeguSouth Korea
  4. 4.Department of Internal MedicineKorea University Anam HospitalSeoulSouth Korea
  5. 5.Department of Internal MedicineSoonChunHyang University HospitalSeoulSouth Korea
  6. 6.Department of Internal MedicineYongDong Severance HospitalSeoulSouth Korea
  7. 7.Department of Internal MedicineEwha Womans University Mokdong HospitalSeoulSouth Korea
  8. 8.Department of Internal MedicineKyungHee University HospitalSeoulSouth Korea