title: Concurrent 5-fluorouracil, mitomycin C and radiation, with or without brachytherapy, in recurrent endometrial cancer: a scoring system to predict clinical response and outcome.
abstract: OBJECTIVE
  This prospective, phase II study aimed to test the efficacy of concurrent 5-fluorouracil, mitomycin C and radiation, with or without brachytherapy, on the clinical outcome of a series of recurrent endometrial cancer patients and to determine the prognostic impact of a subset of factors.
  
  
  METHODS
  Thirty patients with locally recurrent, nonmetastatic endometrial cancer received external beam radiation (4-week split course: 23.4 + 23.4 Gy) plus two courses of concomitant chemotherapy (5-fluorouracil, 96-h continous infusion, days 1-4; 1 g/m2/day; mitomycin C, 10 mg/m2, bolus iv, day 1). Nineteen patients (63.3%) underwent endocavitary, low-dose brachytherapy boost (20-25 Gy); eight patients (26.7%) received external beam radiation boost (14-20 Gy).
  
  
  RESULTS
  Eleven complete responses (36.7%), 11 partial responses (36.7%), 6 disease stabilizations (20.0%) and 2 progressions (6.6%) were observed. After a median follow-up of 27 months (range, 1-108), overall actuarial 3-year survival, progression-free survival and local progression-free survival were 46.8%, 35.2% and 41.2%, respectively. Two patients (6.7%) experienced hematological grade 3 toxicity. Two patients (6.7%) had grade 3 intestinal toxicity. Severe late toxicity was infrequent, only 3 patients showing severe vaginal stenosis (10.0%). A clinical score of 0 to 1 was assigned to each patient on the basis of the absence (score = 0) or presence (score = 1) of any of the following prognostic factors: time between surgery and recurrence shorter than 12 months, pelvic wall site of recurrence, positive lymph nodes, hemoglobin < 11 g/dL. With this device, it was clear that patients with a low score had a significantly better outcome (clinical remission: 77.2% of patients with a score < 2 vs 25.0% of patients with a score > or = 2, P = 0.009), better local control of the disease (50.2% vs. 0 at 3 years, P = 0.014,) and better overall survival (65.8% vs 0 at 3 years, P = 0.003).
  
  
  CONCLUSIONS
  Our data suggest that this combined modality therapy was relatively well tolerated and resulted in reasonable local control and survival. The scoring system proved to be helpful in identifying patients with the best chance of benefiting from the treatment.
authors.affiliation: Department of Radiation Oncology, Catholic University of the Sacred Heart, Rome, Italy. dsmaniotto@rm.unicatt.it
authors.forename: Daniela
authors.initials: D
authors.lastname: Smaniotto
authors.forename: Giuseppe
authors.initials: G
authors.lastname: D'Agostino
authors.forename: Stefano
authors.initials: S
authors.lastname: Luzi
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Valentini
authors.forename: Gabriella
authors.initials: G
authors.lastname: Macchia
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Mangiacotti
authors.forename: Pasquale Alessandro
authors.initials: PA
authors.lastname: Margariti
authors.forename: Gabriella
authors.initials: G
authors.lastname: Ferrandina
authors.forename: Giovanni
authors.initials: G
authors.lastname: Scambia
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001918:Brachytherapy; D004334:Drug Administration Schedule; D016889:Endometrial Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D023381:Endpoint Determination; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D011379:Prognosis; D011446:Prospective Studies; D012720:Severity of Illness Index; D016019:Survival Analysis
chemical_list: D005472:Fluorouracil