A COX-2 inhibitor combined with chemoradiation of locally advanced rectal cancer: a phase II trial.
OBJECTIVE
The aim of this study was to investigate the possible effect of a COX-2 inhibitor in addition to chemoradiation of locally advanced rectal cancer.


METHODS
The study included 35 patients with rectal adenocarcinoma. All patients had a tumor localised <or=10 cm from the anal verge and a circumferential margin <or=5 mm on a magnetic resonance scan. The patients were scheduled to receive external radiation with a tumor dose of 60 Gy supplemented with an endorectal boost of 5 Gy. Concurrent with radiation, the patients received uracil-tegafur 300 mg/m(2) daily. Celexocib was scheduled throughout the radiation period in a dose of 400 mg x 2 daily.


RESULTS
A macular papular rash was seen in 17 (49%) of the patients leading to stop of medication with celecoxib. Thirty-three patients were operated, and all patients responded to treatment. Complete pathological remission was found in 21% of the patients and further 24% had only microscopic residual tumor cells. The results did not suggest any difference according to the accomplishment of the COX-2 medication.


CONCLUSIONS
The addition of a COX-2 inhibitor to chemotherapy-enhanced radiation treatment of rectal cancer was not feasible due to a high incidence of rash in the present study.
Jakobsen
Anders
A
Department of Oncology, Danish Colorectal Cancer Group South, Vejle Hospital, University of Southern Denmark, Vejle, Denmark. anders.jakobsen@vgs.regionsyddanmark.dk
Mortensen
John Pløen
JP
Bisgaard
Claus
C
Lindebjerg
Jan
J
Rafaelsen
Søren Rafael
SR
Bendtsen
Vagn Ove
VO
D000230:Adenocarcinoma / Q000175:diagnosis / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001706:Biopsy; D002318:Cardiovascular Diseases; D000068579:Celecoxib; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004307:Dose-Response Relationship, Radiation; D019160:Endosonography; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011720:Pyrazoles / Q000627:therapeutic use*; D012004:Rectal Neoplasms / Q000175:diagnosis / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D013449:Sulfonamides / Q000627:therapeutic use*; D005641:Tegafur / Q000627:therapeutic use; D016896:Treatment Outcome; D014498:Uracil / Q000627:therapeutic use
D016861:Cyclooxygenase Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D005641:Tegafur; D014498:Uracil; D000068579:Celecoxib