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

Hui Ju Ch'ang, Chin Lun Huang, Hsiu Po Wang, Her Shyong Shiah, Ming Chu Chang, Chang Ming Jan, Jen Shi Chen, Yu Wen Tien, Tsann Long Hwang, Jaw Town Lin, Ann Lii Cheng, Jacqueline Whang-Peng, Li Tzong Chen

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1173-1179
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Volume64
Issue number6
DOIs
Publication statusPublished - Nov 2009
Externally publishedYes

Fingerprint

oxaliplatin
gemcitabine
Leucovorin
Pancreatic Neoplasms
Fluorouracil
Confidence Intervals
Disease control
Chemotherapy
Toxicity
Tumors
Peripheral Nervous System Diseases
Neutropenia
Nausea
Vomiting
Diarrhea
Fever
Safety
Drug Therapy

Keywords

  • Fluorouracil
  • Gemcitabine
  • Oxaliplatin
  • Pancreatic cancer
  • Phase II

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pharmacology
  • Pharmacology (medical)
  • Toxicology

Cite this

Phase II study of biweekly gemcitabine followed by oxaliplatin and simplified 48-h infusion of 5-fluorouracil/leucovorin (GOFL) in advanced pancreatic cancer. / Ch'ang, Hui Ju; Huang, Chin Lun; Wang, Hsiu Po; Shiah, Her Shyong; Chang, Ming Chu; Jan, Chang Ming; Chen, Jen Shi; Tien, Yu Wen; Hwang, Tsann Long; Lin, Jaw Town; Cheng, Ann Lii; Whang-Peng, Jacqueline; Chen, Li Tzong.

In: Cancer Chemotherapy and Pharmacology, Vol. 64, No. 6, 11.2009, p. 1173-1179.

Research output: Contribution to journalArticle

Ch'ang, Hui Ju ; Huang, Chin Lun ; Wang, Hsiu Po ; Shiah, Her Shyong ; Chang, Ming Chu ; Jan, Chang Ming ; Chen, Jen Shi ; Tien, Yu Wen ; Hwang, Tsann Long ; Lin, Jaw Town ; Cheng, Ann Lii ; Whang-Peng, Jacqueline ; Chen, Li Tzong. / Phase II study of biweekly gemcitabine followed by oxaliplatin and simplified 48-h infusion of 5-fluorouracil/leucovorin (GOFL) in advanced pancreatic cancer. In: Cancer Chemotherapy and Pharmacology. 2009 ; Vol. 64, No. 6. pp. 1173-1179.
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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-na{\"i}ve 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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author = "Ch'ang, {Hui Ju} and Huang, {Chin Lun} and Wang, {Hsiu Po} and Shiah, {Her Shyong} and Chang, {Ming Chu} and Jan, {Chang Ming} and Chen, {Jen Shi} and Tien, {Yu Wen} and Hwang, {Tsann Long} and Lin, {Jaw Town} and Cheng, {Ann Lii} and Jacqueline Whang-Peng and Chen, {Li Tzong}",
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T1 - Phase II study of biweekly gemcitabine followed by oxaliplatin and simplified 48-h infusion of 5-fluorouracil/leucovorin (GOFL) in advanced pancreatic cancer

AU - Ch'ang, Hui Ju

AU - Huang, Chin Lun

AU - Wang, Hsiu Po

AU - Shiah, Her Shyong

AU - Chang, Ming Chu

AU - Jan, Chang Ming

AU - Chen, Jen Shi

AU - Tien, Yu Wen

AU - Hwang, Tsann Long

AU - Lin, Jaw Town

AU - Cheng, Ann Lii

AU - Whang-Peng, Jacqueline

AU - Chen, Li Tzong

PY - 2009/11

Y1 - 2009/11

N2 - 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.

AB - 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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KW - Gemcitabine

KW - Oxaliplatin

KW - Pancreatic cancer

KW - Phase II

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