FLUOROURACIL AND HIGH-DOSE LEUCOVORIN WITH RADIOTHERAPY AS ADJUVANT THERAPY FOR RECTAL-CANCER - RESULTS OF A PHASE-II STUDY

The purpose of this phase II study was to evaluate the efficacy and to xicity of fluorouracil and high-dose leucovorin (5-FU/LV) with pelvic irradiation as adjuvant therapy for patients with macroscopical resect ed rectal or recto-sigmoid cancer. Following surgery for stages II-III primary (52) or recurrent rectal cancer (4), 56 patients received 8 c ycles of 5-FU/LV and pelvic irradiation. 5-FU doses were 200 mgr/m(2) for cycles 2-3 and 300 mgr/m(2) for cycles 1 and 4-8. LV doses remaine d fixed at 200 mgr/m(2). Pelvic radiation was started in the third wee k, between the first and second cycle. The total dose was 50.4 Gy. No severe complications had been recorded. The incidence of grade 3 diarr hea was 19%. Three patients presented leukopenia grade 3 (5%). In 44 p atients (78%) the planned treatment could be administered. The median follow-up was 40 months (range 22-66). Seven patients had a local rela pse (13%) and 6 developed distant metastasis (10%). The 3-year disease -free survival was 72% and the overall survival was 76%. These prelimi nary results show that combined post-operative 5-FU/LV and pelvic radi otherapy are well tolerated and present a reasonable local control and survival rates. This adjuvant treatment should be evaluated in random ized trials.