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Title: Phase II Study of Oral S-1 and Concurrent Radiotherapy in Patients With Unresectable Locally Advanced Pancreatic Cancer

Purpose: S-1 is an oral fluoropyrimidine derivative that has demonstrated favorable antitumor activity in patients with metastatic pancreatic cancer. The aim of this study was to evaluate safety and efficacy of S-1 and concurrent radiotherapy in patients with unresectable locally advanced pancreatic cancer. Methods and Materials: Patients with histopathologically proven, unresectable, locally advanced pancreatic cancer were eligible. Radiotherapy was delivered in 1.8 Gy daily fractions to a total dose of 50.4 Gy over 5.5 weeks. S-1 was administered orally twice a day at a dose of 80 mg/m{sup 2}/day from day 1 to 14 and 22 to 35. Two weeks after the completion of chemoradiotherapy, maintenance chemotherapy with S-1 was administered for 28 days every 6 weeks until progression. Results: Thirty-four patients were enrolled in this study. The most common Grade 3 toxicities during chemoradiotherapy were anorexia (24%) and nausea (12%). The overall response rate was 41% (95% confidence interval, 25%-58%) and overall disease control rate (partial response plus stable disease) was 97%. More than 50% decrease in serum CA 19-9 was seen in 27 of 29 evaluable patients (93%). The median progression-free survival was 8.7 months. The median overall survival and 1-year survival rate were 16.8 months and 70.6%,more » respectively. Conclusions: Oral S-1 and concurrent radiotherapy exerted a promising antitumor activity with acceptable toxicity in patients with locally advanced pancreatic cancer. This combination therapy seems to be an attractive alternative to conventional chemoradiotherapy using 5-fluorouracil infusion.« less
Authors:
 [1] ;  [1] ;  [2] ; ; ; ;  [1] ; ; ; ;  [3] ; ; ;  [4] ;  [2]
  1. Department of Gastroenterology, Chiba Cancer Center, Chiba (Japan)
  2. Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, Chiba (Japan)
  3. Department of Radiation Oncology, Chiba Cancer Center, Chiba (Japan)
  4. Department of Radiation Oncology, Graduate School of Medicine, Chiba University, Chiba (Japan)
Publication Date:
OSTI Identifier:
21491738
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 80; Journal Issue: 1; Other Information: DOI: 10.1016/j.ijrobp.2010.01.027; PII: S0360-3016(10)00126-4; Copyright (c) 2011 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; ANOREXIA; ANTINEOPLASTIC DRUGS; CHEMOTHERAPY; COMBINED THERAPY; NAUSEA; NEOPLASMS; PANCREAS; RADIOTHERAPY; SURVIVAL CURVES; TOXICITY BODY; DIGESTIVE SYSTEM; DISEASES; DRUGS; ENDOCRINE GLANDS; GLANDS; MEDICINE; NUCLEAR MEDICINE; ORGANS; RADIOLOGY; SYMPTOMS; THERAPY