High-dose radiotherapy and concurrent UFT plus l-leucovorin in locally advanced rectal cancer: a phase I trial.
A phase I trial of preoperative high dose pelvic radiotherapy and oral UFT/l-leucovorin in patients with locally advanced and unresectable rectal cancer patients to evaluate toxicity and efficacy was performed. Eighteen patients (14 with primary unresectable tumours and four with locally recurrent tumours) were treated. All patients were evaluable for acute toxicity and efficacy. Patients received increasing doses of UFT (150 to 300 mg/m2/day UFT and a fixed dose of 22.5 mg/day l-leucovorin) with each fraction, five days a week for 30 days, concomitantly with pelvic radiotherapy (60 Gy in 30 fractions using concomitant boost technique). All patients received the planned dose of radiotherapy. No hematological toxicity was observed. Only one patient developed grade 3 toxicity (diarrhea). Fourteen patients (78%) had surgery (11 R0 and 3 R1) after median 40 days. Two patients (11%) had a complete pathological response. Ten patients are alive after median follow-up of 49 months. Toxicity, resection rate and survival are very encouraging and the study continues as a phase II trial.
Pfeiffer
Per
P
Department of Oncology, Odense University Hospital, DK-5000, Odense C, Denmark. Per.Pfeiffer@ouh.fyns-amt.dk
D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy* / Q000601:surgery; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D003967:Diarrhea / Q000139:chemically induced; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D002955:Leucovorin / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000532:radiotherapy; D009367:Neoplasm Staging; D011879:Radiotherapy Dosage; D012004:Rectal Neoplasms / Q000188:drug therapy / Q000532:radiotherapy* / Q000601:surgery; D012074:Remission Induction; D015996:Survival Rate; D005641:Tegafur / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014498:Uracil / Q000009:adverse effects / Q000627:therapeutic use
D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D005641:Tegafur; D014498:Uracil; D002955:Leucovorin