Phase II Trial of Gemcitabine, UFT-E, Leucovorin Combination Chemotherapy in Advanced Pancreatic Adenocarcinoma

Yoon, So Young; Park, Kyong Hwa; Oh, Sang Chul; Seo, Jae Hong; Choi, Chul Won; Kim, Byung Soo; Kim, Jae Seon; Kim, Chang Duck; Shin, Sang Won; Kim, Yeul Hong; Kim, Jun Suk

doi:2002.34.2.111

Cancer Research and Treatment > Volume 34(2); 2002 > Article

Original Article

Cancer Research and Treatment 2002;34(2): 111-116. doi: https://doi.org/10.4143/crt.2002.34.2.111

Phase II Trial of Gemcitabine, UFT-E, Leucovorin Combination Chemotherapy in Advanced Pancreatic Adenocarcinoma

So Young Yoon, Kyong Hwa Park, Sang Chul Oh, Jae Hong Seo, Chul Won Choi, Byung Soo Kim, Jae Seon Kim, Chang Duck Kim, Sang Won Shin, Yeul Hong Kim, Jun Suk Kim

¹Section of Hemato-Oncology, Department of Internal Medicine,College of Medicine, Korea University Hospital, Seoul,Korea. kjs6651@kumc.or.kr
²Section of Gastro-enterology, Department of InternalMedicine, College of Medicine, Korea University Hospital,Seoul, Korea.

Published online: April 30, 2002.

ABSTRACT

PURPOSE:
To evaluate the efficacy and toxicity of a Gemcitabine, UFT-E, Leucovorin combination chemotherapy in the treatment of advanced pancreatic adenocarcinoma. PATIENTS AND
METHODS:
Patients <=70 years, with no prior chemotherapy and with bidimensionally measurable advanced pancreatic adenocarcinoma, ECOG performance status <=2, and adequate bone marrow, kidney, and liver function were eligible for this trial. Eligibility criteria for clinical benefit assessment were pain with at least a daily analgesic consumption of two nonsteroidal anti-inflammatory drugs or a Karnofsky performance status between 50 and 70. Treatment consisted of 1,000 mg/m2 of Gemcitabine on days 1, 8 and 15, repeated every 4 weeks, with UFT-E administered orally 500 mg-700 mg by body surface area (BSA). Leucovorin was administered 45 mg/day orally. Dosages of UFT-E and Leucovorin were divided and administered three times per day from day 1 to day 21. After 7 days of rest, UFT-E and Leucovorin were administered repeatedly.
RESULTS:
Twenty-three patients were enrolled between April 1999 to April 2000. Eighty two cycles (median, four cycles) were delivered to all patients. The objective response rate was 15.8% in 19 assessable patients and 13.0% in the intent-to-treat population. Twelve patients (57.9%) displayed stable disease. Grade 3 or 4 neutropenia occurred in 30.4% of patients, nausea/vomiting in 8.3%, diarrhea in 4.3%, and mucositis in 4.3%. The median time to progression was 8 months. The median survival was 8 months in the assessable population and 6 months in the intent-to-treat population Clinical benefit was achieved in 11 (57.9%) of 19 assessable patients.
CONCLUSION:
Gemcitabine, UFT-E, Leucovorin combination chemotherapy is a well-tolerated and safe regimen in cases of advanced pancreatic adenocarcinoma. Although the response rate is low, it shows a survival benefit and clinical benefit and deserves further evaluation in a phase III trial.

Key words: Pancreas neoplasm;Combination chemotherapy;Gemcitabine;UFT-E;Leucovorin