Gemcitabine chemotherapy and single-fraction stereotactic body radiotherapy for locally advanced pancreatic cancer.
OBJECTIVE
Fractionated radiotherapy and chemotherapy for locally advanced pancreatic cancer achieves only modest local control. This prospective trial evaluated the efficacy of a single fraction of 25 Gy stereotactic body radiotherapy (SBRT) delivered between Cycle 1 and 2 of gemcitabine chemotherapy.


METHODS
A total of 16 patients with locally advanced, nonmetastatic, pancreatic adenocarcinoma received gemcitabine with SBRT delivered 2 weeks after completion of the first cycle. Gemcitabine was resumed 2 weeks after SBRT and was continued until progression or dose-limiting toxicity. The gross tumor volume, with a 2-3-mm margin, was treated in a single 25-Gy fraction by Cyberknife. Patients were evaluated at 4-6 weeks, 10-12 weeks, and every 3 months after SBRT.


RESULTS
All 16 patients completed SBRT. A median of four cycles (range one to nine) of chemotherapy was delivered. Three patients (19%) developed local disease progression at 14, 16, and 21 months after SBRT. The median survival was 11.4 months, with 50% of patients alive at 1 year. Patients with normal carbohydrate antigen (CA)19-9 levels either at diagnosis or after Cyberknife SBRT had longer survival (p <0.01). Acute gastrointestinal toxicity was mild, with 2 cases of Grade 2 (13%) and 1 of Grade 3 (6%) toxicity. Late gastrointestinal toxicity was more common, with five ulcers (Grade 2), one duodenal stenosis (Grade 3), and one duodenal perforation (Grade 4). A trend toward increased duodenal volumes radiated was observed in those experiencing late effects (p = 0.13).


CONCLUSIONS
SBRT with gemcitabine resulted in comparable survival to conventional chemoradiotherapy and good local control. However, the rate of duodenal ulcer development was significant.
Schellenberg
Devin
D
Department of Radiation Oncology, Stanford University School of Medicine, Stanford, CA, USA.
Goodman
Karyn A
KA
Lee
Florence
F
Chang
Stephanie
S
Kuo
Timothy
T
Ford
James M
JM
Fisher
George A
GA
Quon
Andrew
A
Desser
Terry S
TS
Norton
Jeffrey
J
Greco
Ralph
R
Yang
George P
GP
Koong
Albert C
AC
D000230:Adenocarcinoma / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy / Q000601:surgery; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use* / Q000633:toxicity; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use / Q000633:toxicity; D018450:Disease Progression; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy / Q000601:surgery; D011859:Radiography; D016634:Radiosurgery; D011879:Radiotherapy Dosage; D016019:Survival Analysis; D017741:Survivors; D000093542:Gemcitabine
D000970:Antineoplastic Agents; D003841:Deoxycytidine; D000093542:Gemcitabine