Cancer Chemotherapy and Pharmacology

, Volume 60, Issue 4, pp 489–494 | Cite as

A phase II trial of gemcitabine plus capecitabine for patients with advanced pancreatic adenocarcinoma

  • Byeong-Bae Park
  • Joon Oh Park
  • Hyo Rak Lee
  • Jeeyun Lee
  • Dong Wook Choi
  • Seong-Ho Choi
  • Jin Seok Heo
  • Jong Kyun Lee
  • Kyu Taek Lee
  • Do Hoon Lim
  • Young Suk Park
  • Ho-Yeong Lim
  • Won Ki Kang
  • Keunchil Park
Original Article

Abstract

Purpose

While gemcitabine (GEM) is widely accepted for the treatment of advanced pancreatic cancer, capecitabine (CAP) has shown single agent activity and promising efficacy in combination with GEM. This phase II study was conducted to evaluate the efficacy and toxicity of GEM combined with dose escalated 14-day CAP as first-line chemotherapy for advanced pancreatic cancer. In addition, we also analyzed the correlation between CA19-9 response and clinical outcomes.

Methods

Patients had advanced pancreatic adenocarcinoma, no prior systemic chemotherapy other than that given concurrently with radiation therapy, at lease one measurable disease, and adequate organ functions. The patients were treated with GEM 1,000 mg/m2 IV on days 1, 8 and CAP 1,000 mg/m2 twice a day PO on days 1–14, in 21-day cycles.

Results

The objective RR among 45 patients was 40.0% (95% CI; 25.1–54.9), including 1CR (2.2%). The median TTP and OS were 5.4 months (95% CI; 1.8–9.0) and 10.4 months (95% CI; 6.2–14.5), respectively. Patients with ≥25% decline of serum CA19-9 had significantly better outcomes in terms of TTP and OS than those who did not (P < 0.03). The most frequent, grade 3–4, non-hematologic toxicity was hand–foot syndrome (6.7%).

Conclusions

The combination of GEM with dose escalated 14-day CAP is well tolerated and offers encouraging activity in the treatment of advanced pancreatic cancer. In addition, CA19-9 response correlates well with clinical outcomes in this population.

Keywords

Gemcitabine Capecitabine Pancreatic cancer CA19-9 

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Copyright information

© Springer-Verlag 2007

Authors and Affiliations

  • Byeong-Bae Park
    • 1
  • Joon Oh Park
    • 1
  • Hyo Rak Lee
    • 1
  • Jeeyun Lee
    • 1
  • Dong Wook Choi
    • 2
  • Seong-Ho Choi
    • 2
  • Jin Seok Heo
    • 2
  • Jong Kyun Lee
    • 3
  • Kyu Taek Lee
    • 3
  • Do Hoon Lim
    • 4
  • Young Suk Park
    • 1
  • Ho-Yeong Lim
    • 1
  • Won Ki Kang
    • 1
  • Keunchil Park
    • 1
  1. 1.Division of Hematology-Oncology, Department of Medicine, Samsung Medical CenterSungkyunkwan University School of MedicineSeoulSouth Korea
  2. 2.Department of Surgery, Samsung Medical CenterSungkyunkwan University School of MedicineSeoulSouth Korea
  3. 3.Division of Gastroenterology, Department of Medicine, Samsung Medical CenterSungkyunkwan University School of MedicineSeoulSouth Korea
  4. 4.Department of Radiation Oncology, Samsung Medical CenterSungkyunkwan University School of MedicineSeoulSouth Korea

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