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Phase II study of biweekly gemcitabine followed by oxaliplatin and simplified 48-h infusion of 5-fluorouracil/leucovorin (GOFL) in advanced pancreatic cancer

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Abstract

Purpose

To evaluate the efficacy and safety profile of a triplet regimen consisting of gemcitabine, oxaliplatin, and infusional fluorouracil and leucovorin (LV) in advanced pancreatic carcinoma (APC).

Patients and methods

Chemotherapy-naïve patients with histo-/cytologically proven unresectable APC, and bi-dimensionally measurable diseases were eligible. Treatment consisted of fixed-dose rate (10 mg/m2/min) infusion of 800 mg/m2 gemcitabine followed by 2-h infusion of 85 mg/m2 oxaliplatin and then 48-h infusion of fluorouracil and LV (3,000 and 300 mg/m2, respectively) every 2 weeks (the GOFL regimen). The primary end-point was objective response rate.

Results

Forty-five patients were enrolled and received a median of seven [95% confidence interval (CI) 6.4–8.8] cycles of treatment. On intent-to-treat analysis, the overall response and disease-control rates were 33.3% (95% CI 21.4–48.0%) and 68.9% (95% CI 54.8–83.0%), respectively. Clinical benefit response was observed in 46.2% of initially symptomatic patients. The median time-to-tumor progression and overall survival were 5.1 (95% CI 4.0–6.3) months and 8.7 (95% CI, 6.1–11.3) months, respectively. Major grade 3–4 toxicities were neutropenia (28.9%, with 4.4% complicated with fever), peripheral sensory neuropathy (15.6%), nausea/vomiting (13.3%), and diarrhea (6.7%).

Conclusions

The triplet regimen is feasible and exhibits promising activity against APC, deserving further exploration.

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Acknowledgment

Supported by grants (CA094-PP-04 and CA095-CP-06) from the National Health Research Institutes, Zhunan, Taiwan.

Author information

Authors and Affiliations

  1. National Institute of Cancer Research, National Health Research Institutes, 2F, No. 367, Sheng-Li Road, Tainan, 70456, Taiwan

    Hui-Ju Ch’ang, Her-Shyong Shiah, Jacqueline Whang-Peng & Li-Tzong Chen

  2. Department of Radiation Oncology, National Cheng-Kung University Hospital, Tainan, Taiwan

    Hui-Ju Ch’ang

  3. Department of Internal Medicine, National Cheng-Kung University Hospital, Tainan, Taiwan

    Her-Shyong Shiah & Li-Tzong Chen

  4. Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan

    Chin-Lun Huang & Ann-Lii Cheng

  5. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan

    Hsiu-Po Wang, Ming-Chu Chang, Jaw-Town Lin & Ann-Lii Cheng

  6. Department of Surgery, National Taiwan University Hospital, Taipei, Taiwan

    Yu-Wen Tien

  7. Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan

    Chang-Ming Jan & Li-Tzong Chen

  8. Department of Oncology, Chang Gung Memorial Hospital, Taoyuan, Taiwan

    Jen-Shi Chen

  9. Department of Surgery, Chang Gung Memorial Hospital, Taoyuan, Taiwan

    Tsann-Long Hwang

Authors
  1. Hui-Ju Ch’ang
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  2. Chin-Lun Huang
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  3. Hsiu-Po Wang
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  4. Her-Shyong Shiah
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  6. Chang-Ming Jan
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  7. Jen-Shi Chen
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  9. Tsann-Long Hwang
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  10. Jaw-Town Lin
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  11. Ann-Lii Cheng
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  12. Jacqueline Whang-Peng
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  13. Li-Tzong Chen
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Corresponding author

Correspondence to Li-Tzong Chen.

Additional information

This article describes the triplet regimen, GOFL (Gemcitabine, Oxaliplatin, Fluorouracil, Leucovorin), being feasible and exhibiting promising activity against advanced pancreatic cancer. This phase II study revealed that GOFL might have better therapeutic efficacy and toxicity profile compared to the current standard gemcitabine monotherapy.

Employment/leadership position: None; Intellectual property rights/inventor/patent holder: None; Consultant/advisory role: None; Ownership interest: None; Expert testimony: None; Other: None.

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Ch’ang, HJ., Huang, CL., Wang, HP. et al. Phase II study of biweekly gemcitabine followed by oxaliplatin and simplified 48-h infusion of 5-fluorouracil/leucovorin (GOFL) in advanced pancreatic cancer. Cancer Chemother Pharmacol 64, 1173–1179 (2009). https://doi.org/10.1007/s00280-009-0980-2

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  • DOI: https://doi.org/10.1007/s00280-009-0980-2

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