title: Uracil and tegafur modulated with leucovorin: an effective regimen with low toxicity for the treatment of colorectal carcinoma in the elderly. Oncopaz Cooperative Group.
abstract: BACKGROUND
  In spite of the high prevalence of cancer in the elderly, little information is available about the efficacy and toxicity of chemotherapy in elderly patients. In a previous study, the authors demonstrated that the combination of uracil and tegafur (UFT) with leucovorin (LV) was active and well tolerated in patients with advanced colorectal carcinoma (ACC). The objective of the current study was to determine the efficacy and toxicity of this regimen in elderly patients with ACC.
  
  
  METHODS
  Thirty-eight unselected patients older than 70 years (median age, 74 years) with measurable ACC were included. All patients were evaluable for toxicity and response. The regimen consisted of intravenous LV 500 mg/m2 on Day 1, oral LV 15 mg every 12 hours on Days 2-14, and oral UFT 390 mg/m2 on Days 1-14. Treatment was repeated every 28 days for a minimum of 4 courses per patient.
  
  
  RESULTS
  Two hundred eighty-eight cycles of chemotherapy were delivered (median, 7 per patient). Two patients (5%) achieved a complete response and 9 (24%) a partial response, for an overall response rate of 29%. Toxicity was mild, without dose-limiting myelosuppression. Four patients (10%) experienced Grade 3-4 diarrhea, 1 patient had Grade 3-4 nausea/vomiting, and 1 had Grade 3-4 mucositis. Grade 3-4 toxicity was more frequent among women than men (38% vs. 4%, P < 0.05).
  
  
  CONCLUSIONS
  Treatment with oral UFT modulated with LV is effective, well tolerated, and feasible on an outpatient basis for elderly patients with ACC. However, elderly women should be followed closely for the early detection of toxicity.
authors.affiliation: Servicio de Oncología Médica, Hospital La Paz, Madrid, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Feliu
authors.forename: M
authors.initials: M
authors.lastname: González Barón
authors.forename: E
authors.initials: E
authors.lastname: Espinosa
authors.forename: C
authors.initials: C
authors.lastname: García Girón
authors.forename: I
authors.initials: I
authors.lastname: de la Gándara
authors.forename: J
authors.initials: J
authors.lastname: Espinosa
authors.forename: A
authors.initials: A
authors.lastname: Colmenarejo
authors.forename: J I
authors.initials: JI
authors.lastname: Jalón
authors.forename: Y
authors.initials: Y
authors.lastname: Fernández
authors.forename: J
authors.initials: J
authors.lastname: de Castro
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care; D000931:Antidotes / Q000008:administration & dosage* / Q000009:adverse effects; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001853:Bone Marrow / Q000187:drug effects; D002277:Carcinoma / Q000188:drug therapy*; D002985:Clinical Protocols; D003110:Colonic Neoplasms / Q000188:drug therapy*; D003967:Diarrhea / Q000139:chemically induced; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D002955:Leucovorin / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D009325:Nausea / Q000139:chemically induced; D012004:Rectal Neoplasms / Q000188:drug therapy*; D012074:Remission Induction; D012737:Sex Factors; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects; D014498:Uracil / Q000008:administration & dosage* / Q000009:adverse effects; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000931:Antidotes; D000964:Antimetabolites, Antineoplastic; D005641:Tegafur; D014498:Uracil; D002955:Leucovorin