Phase II study of radiochemotherapy with UFT and low-dose oral leucovorin in patients with unresectable rectal cancer.
OBJECTIVE
To determine the activity and evaluate the toxicity of uracil and tegafur in a 4:1 molar concentration (UFT) plus low-dose leucovorin administered concomitantly with pelvic irradiation in patients with unresectable or recurrent rectal cancer.


METHODS
Thirty-five patients (22 with primary unresectable tumors and 13 with locally recurrent tumors) were enrolled in the trial. Thirty-five patients were evaluable for toxicity and 32 of these were evaluable for clinical response. Patients received 300 mg/m2/day UFT and 30 mg/day leucovorin on days 8-35 concomitantly with pelvic radiotherapy, to a total dose of 45 Gy.


RESULTS
Eight of the 35 (23%) patients developed Grade 3 diarrhea and were treated with radiotherapy alone after this event. Of the 22 patients with unresectable primary tumors, 17 underwent surgery, and resection was feasible in 15 cases (88%). Of the 32 patients evaluable for clinical response, 4 (13%) had a complete clinical response (CR) and 22 (69%) a partial response (PR). A complete pathologic response was observed in 3 cases (18%) and, a PR in 11 cases (65%).


CONCLUSIONS
The response rates achieved with this schedule seem comparable to those obtained with 5-FU and radiotherapy. These results warrant further evaluation of this combination in patients with unresectable or locally advanced tumors.
de la Torre
A
A
Department of Radiation Oncology, Clínica Puerta de Hierro, Madrid, Spain.
Ramos
S
S
Valcárcel
F J
FJ
Candal
A
A
Regueiro
C A
CA
Romero
J
J
Magallón
R
R
Salinas
J
J
de las Heras
M
M
Veiras
C
C
Tisaire
J L
JL
Aragón
G
G
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000931:Antidotes / Q000008:administration & dosage*; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D003967:Diarrhea / Q000139:chemically induced; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects; D014498:Uracil / Q000008:administration & dosage / Q000009:adverse effects
D000931:Antidotes; D000964:Antimetabolites, Antineoplastic; D005641:Tegafur; D014498:Uracil; D002955:Leucovorin