TY - JOUR
T1 - Low-Dose Radiotherapy as a Chemopotentiator of Gemcitabine in Tumors of the Pancreas or Small Bowel
T2 - A Phase I Study Exploring a New Treatment Paradigm
AU - Regine, William F.
AU - Hanna, Nader
AU - Garofalo, Michael C.
AU - Doyle, Austin
AU - Arnold, Susanne
AU - Kataria, Ritesh
AU - Sims, Jacqueline
AU - Tan, Ming
AU - Mohiuddin, Mohammed
N1 - Funding Information:
Supported in part by a grant from Eli-Lilly and Company.
PY - 2007/5/1
Y1 - 2007/5/1
N2 - 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/m2 at 10 mg/m2/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.
AB - 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/m2 at 10 mg/m2/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.
KW - Chemopotentiator
KW - Gemcitabine
KW - Pancreas
KW - Radiotherapy
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U2 - 10.1016/j.ijrobp.2006.11.045
DO - 10.1016/j.ijrobp.2006.11.045
M3 - Article
C2 - 17276612
AN - SCOPUS:34247096490
SN - 0360-3016
VL - 68
SP - 172
EP - 177
JO - International Journal of Radiation Oncology Biology Physics
JF - International Journal of Radiation Oncology Biology Physics
IS - 1
ER -
