Early results from a phase I/II radiation dose-escalation study with concurrent amifostine and infusional 5-fluorouracil chemotherapy for preoperative treatment of unresectable or locally recurrent rectal carcinoma.
To improve the resectability and long-term local control of locally advanced rectal cancer, we have initiated a radiation dose-escalation trial. It is hoped that the radioprotector amifostine will sufficiently reduce rectal morbidity (without also reducing tumor response) to permit increasing radiation doses. Only 6 patients have been treated at the first dose level (45 Gy with a 9-Gy boost and concurrent continuous infusion of 5-fluorouracil). During treatment, daily stool frequency improved or was stable. There was one case of transitory severe proctitis/enteritis. Four of the six patients achieved objective responses to preoperative treatment. These very early results suggest that the use of amifostine does not interfere with tumor response and that it may facilitate the delivery of higher boost doses to the rectum.
Myerson
Robert
R
Department of Radiation Oncology, and the Divisions of Colorectal Surgery and Medical Oncology, Washington University School of Medicine, St Louis, MO 63110-1001, USA.
Zobeiri
Imran
I
Birnbaum
Elisa
E
Dietz
David
D
Fleshman
James
J
Kodner
Ira
I
Picus
Joel
J
Ratkin
Gary
G
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D004999:Amifostine / Q000627:therapeutic use*; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D019610:Cytoprotection; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery; D011832:Radiation Injuries / Q000517:prevention & control*; D011837:Radiation-Protective Agents / Q000627:therapeutic use*; D011879:Radiotherapy Dosage; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery
D000964:Antimetabolites, Antineoplastic; D011837:Radiation-Protective Agents; D004999:Amifostine; D005472:Fluorouracil