title: Preoperative uracil, tegafur, and concomitant radiotherapy in operable rectal cancer: a phase II multicenter study with 3 years' follow-Up.
abstract: OBJECTIVE
  To assess tolerance and efficacy of preoperative treatment with uracil/tegafur and radiotherapy (RT) followed by surgery and postoperative flurouracil (FU)/leucovorin (LV) in patients with rectal cancer.
  
  
  METHODS
  Patients (n = 94) with potentially resectable tumors, ultrasound at stages T2N+ (n = 4), T3 (n = 77), T4 (n = 13) were treated with UFT (400 mg/m2/d, 5 days a week for 5 weeks) and concomitant RT to the pelvis (45 Gy; 1.8 Gy/d over 5 weeks). Patients underwent surgery 5 to 6 weeks later followed by four cycles of FU/LV. Primary end points included downstaging, pathologic responses, and sphincter-preserving surgery. Secondary end points were recurrence-free survival and overall survival.
  
  
  RESULTS
  All patients received the full RT dose. Fifteen patients (16%) needed UFT dose reduction. Preoperative G3+ toxicities included diarrhea (14%), leukopenia (1%), thrombocytopenia (1%), and nausea (4%). The downstaging rate was 54%, pathologic complete response (pCR) was 9% and, in an additional 23%, there were only residual microscopic foci. When cellular viability criteria were taken into account, the pCR was 15%. From 43 patients with abdominoperineal resection indication, 11 (25%) had sphincter-preserving surgery performed. Postoperative scheduled chemotherapy dose was not administered to 24% of patients because of G3+ toxicity (diarrhea, 8%; mucositis, 9%; and leukopenia, 7%). Patients with downstaging had significantly higher survival and recurrence-free survival rates than those without. At 3 years, actuarial patterns of failure were pelvic, 5% and distant, 11%. OS was 75%.
  
  
  CONCLUSIONS
  UFT combined with RT is safe and effective. In resectable rectal cancer, if preoperative treatment is considered, this approach can be an option.
authors.affiliation: Department of Medical Oncology, Fundación Instituto Valenciano de Oncología, c/o Professor Beltrán Báguena 8 y 19, 46009 Valencia, Spain. carlosfmartos@mx2.redestb.es
authors.forename: Carlos
authors.initials: C
authors.lastname: Fernández-Martos
authors.forename: Jorge
authors.initials: J
authors.lastname: Aparicio
authors.forename: Carles
authors.initials: C
authors.lastname: Bosch
authors.forename: Marilo
authors.initials: M
authors.lastname: Torregrosa
authors.forename: Juan Manuel
authors.initials: JM
authors.lastname: Campos
authors.forename: Salvador
authors.initials: S
authors.lastname: Garcera
authors.forename: Jose Maria
authors.initials: JM
authors.lastname: Vicent
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Maestu
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Climent
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Mengual
authors.forename: Alejandro
authors.initials: A
authors.lastname: Tormo
authors.forename: Ana
authors.initials: A
authors.lastname: Hernandez
authors.forename: Rafael
authors.initials: R
authors.lastname: Estevan
authors.forename: Jose Maria
authors.initials: JM
authors.lastname: Richart
authors.forename: Vicente
authors.initials: V
authors.lastname: Viciano
authors.forename: Natalia
authors.initials: N
authors.lastname: Uribe
authors.forename: Jorge
authors.initials: J
authors.lastname: Campos
authors.forename: Ramon
authors.initials: R
authors.lastname: Puchades
authors.forename: Francisco
authors.initials: F
authors.lastname: Arlandis
authors.forename: Daniel
authors.initials: D
authors.lastname: Almenar
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D011184:Postoperative Period; D011300:Preoperative Care; D012004:Rectal Neoplasms / Q000401:mortality / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D005641:Tegafur / Q000008:administration & dosage*; D014498:Uracil / Q000008:administration & dosage*
chemical_list: D005641:Tegafur; D014498:Uracil; D002955:Leucovorin