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Title: Low-Dose Radiotherapy as a Chemopotentiator of Gemcitabine in Tumors of the Pancreas or Small Bowel: A Phase I Study Exploring a New Treatment Paradigm

Abstract

Purpose: To determine the maximum tolerated dose of upper abdominal low-dose fractionated radiotherapy (<1.0 Gy per fraction) given in combination with, and as a chemopotentiator for, gemcitabine. Methods and Materials: Gemcitabine was given at 1,250 mg/m{sup 2} at 10 mg/m{sup 2}/min on Days 1 and 8 of a 3-week cycle. Low-dose fractionated radiotherapy was tested at two dose levels: 60 cGy per fraction and 70 cGy per fraction. Radiotherapy was given b.i.d. on Days 1, 2, 8, and 9. Four cycles were planned. Results: Twenty-seven patients have been put on study. Ten patients have been entered in Phase I: 6 with metastatic/recurrent pancreatic carcinoma and 4 with unresectable pancreatic/small bowel carcinoma. Two of four patients at Dose Level 2 experienced dose-limiting toxicity. The overall radiographic response was 30%, and median survival was 11 months (range, 4-37 months). Conclusion: Low-dose fractionated radiotherapy to the upper abdomen is well tolerated at 60 cGy per fraction when combined with gemcitabine. Phase II evaluation is ongoing.

Authors:
 [1];  [2];  [3];  [4];  [5];  [3];  [6];  [7];  [8]
  1. Department of Radiation Oncology, University of Maryland, Baltimore, MD (United States). E-mail: wregine@umm.edu
  2. Department of Surgery, University of Maryland, Baltimore, MD (United States)
  3. Department of Radiation Oncology, University of Maryland, Baltimore, MD (United States)
  4. Department of Medicine, University of Maryland, Baltimore, MD (United States)
  5. Division of Hematology-Oncology, University of Kentucky, Lexington, KY (United States)
  6. Department of Radiation Medicine, University of Kentucky, Lexington, KY (United States)
  7. Department of Biostatistics, University of Maryland, Baltimore, MD (United States)
  8. Geisinger-Fox Chase Cancer Center, Wilkes-Barre, PA (United States)
Publication Date:
OSTI Identifier:
20951629
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 68; Journal Issue: 1; Other Information: DOI: 10.1016/j.ijrobp.2006.11.045; PII: S0360-3016(06)03533-4; Copyright (c) 2007 Elsevier Science B.V., Amsterdam, Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; ABDOMEN; CARCINOMAS; EVALUATION; METASTASES; PANCREAS; PATIENTS; RADIATION DOSES; RADIOTHERAPY; TOXICITY

Citation Formats

Regine, William F., Hanna, Nader, Garofalo, Michael C., Doyle, Austin, Arnold, Susanne, Kataria, Ritesh, Sims, Jacqueline, Tan Ming, and Mohiuddin, Mohammed. Low-Dose Radiotherapy as a Chemopotentiator of Gemcitabine in Tumors of the Pancreas or Small Bowel: A Phase I Study Exploring a New Treatment Paradigm. United States: N. p., 2007. Web. doi:10.1016/j.ijrobp.2006.11.045.
Regine, William F., Hanna, Nader, Garofalo, Michael C., Doyle, Austin, Arnold, Susanne, Kataria, Ritesh, Sims, Jacqueline, Tan Ming, & Mohiuddin, Mohammed. Low-Dose Radiotherapy as a Chemopotentiator of Gemcitabine in Tumors of the Pancreas or Small Bowel: A Phase I Study Exploring a New Treatment Paradigm. United States. doi:10.1016/j.ijrobp.2006.11.045.
Regine, William F., Hanna, Nader, Garofalo, Michael C., Doyle, Austin, Arnold, Susanne, Kataria, Ritesh, Sims, Jacqueline, Tan Ming, and Mohiuddin, Mohammed. Tue . "Low-Dose Radiotherapy as a Chemopotentiator of Gemcitabine in Tumors of the Pancreas or Small Bowel: A Phase I Study Exploring a New Treatment Paradigm". United States. doi:10.1016/j.ijrobp.2006.11.045.
@article{osti_20951629,
title = {Low-Dose Radiotherapy as a Chemopotentiator of Gemcitabine in Tumors of the Pancreas or Small Bowel: A Phase I Study Exploring a New Treatment Paradigm},
author = {Regine, William F. and Hanna, Nader and Garofalo, Michael C. and Doyle, Austin and Arnold, Susanne and Kataria, Ritesh and Sims, Jacqueline and Tan Ming and Mohiuddin, Mohammed},
abstractNote = {Purpose: To determine the maximum tolerated dose of upper abdominal low-dose fractionated radiotherapy (<1.0 Gy per fraction) given in combination with, and as a chemopotentiator for, gemcitabine. Methods and Materials: Gemcitabine was given at 1,250 mg/m{sup 2} at 10 mg/m{sup 2}/min on Days 1 and 8 of a 3-week cycle. Low-dose fractionated radiotherapy was tested at two dose levels: 60 cGy per fraction and 70 cGy per fraction. Radiotherapy was given b.i.d. on Days 1, 2, 8, and 9. Four cycles were planned. Results: Twenty-seven patients have been put on study. Ten patients have been entered in Phase I: 6 with metastatic/recurrent pancreatic carcinoma and 4 with unresectable pancreatic/small bowel carcinoma. Two of four patients at Dose Level 2 experienced dose-limiting toxicity. The overall radiographic response was 30%, and median survival was 11 months (range, 4-37 months). Conclusion: Low-dose fractionated radiotherapy to the upper abdomen is well tolerated at 60 cGy per fraction when combined with gemcitabine. Phase II evaluation is ongoing.},
doi = {10.1016/j.ijrobp.2006.11.045},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 1,
volume = 68,
place = {United States},
year = {Tue May 01 00:00:00 EDT 2007},
month = {Tue May 01 00:00:00 EDT 2007}
}