Phase II Trial of Gemcitabine, UFT-E, Leucovorin Combination Chemotherapy in Advanced Pancreatic Adenocarcinoma.
- Author:
So Young YOON
1
;
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
Author Information
1. Section of Hemato-Oncology, Department of Internal Medicine, College of Medicine, Korea University Hospital, Seoul, Korea. kjs6651@kumc.or.kr
- Publication Type:Original Article
- Keywords:
Pancreas neoplasm;
Combination chemotherapy;
Gemcitabine;
UFT-E;
Leucovorin
- MeSH:
Adenocarcinoma*;
Body Surface Area;
Bone Marrow;
Diarrhea;
Drug Therapy;
Drug Therapy, Combination*;
Humans;
Karnofsky Performance Status;
Kidney;
Leucovorin*;
Liver;
Mucositis;
Neutropenia;
Pancreatic Neoplasms
- From:Cancer Research and Treatment
2002;34(2):111-116
- CountryRepublic of Korea
- Language:Korean
-
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.
