title: Irinotecan in combination with fluorouracil in a 48-hour continuous infusion as first-line chemotherapy for elderly patients with metastatic colorectal cancer: a Spanish Cooperative Group for the Treatment of Digestive Tumors study.
abstract: OBJECTIVE
  Elderly patients constitute a subpopulation with special characteristics that differ from those of the nonelderly and have been underrepresented in clinical trials. This study was performed to determine the efficacy and safety of irinotecan (CPT-11) in combination with fluorouracil (FU) administered as a 48-hour continuous infusion twice a month in elderly patients.
  
  
  METHODS
  Patients > or = 72 years old with metastatic colorectal cancer, Eastern Cooperative Oncology Group performance status of 0 to 1, no geriatric syndromes, and no prior treatment were treated every 2 weeks with CPT-11 180 mg/m2 plus FU 3,000 mg/m2 in a 48-hour continuous infusion.
  
  
  RESULTS
  By intent-to-treat analysis, in 85 assessable patients, the objective response rate was 35% (95% CI, 25% to 46%), and stable disease was 33% (95% CI, 23% to 44%). Median time to progression was 8.0 months (95% CI, 6.0 to 10.0 months), and median overall survival time was 15.3 months (95% CI, 13.8 to 16.9 months). Toxicity was moderate. Grade 3 and 4 neutropenia, diarrhea, and asthenia were observed in 21%, 17%, and 13% of patients, respectively. Only one case of neutropenic fever occurred. There were two toxic deaths, one was a result of grade 4 diarrhea and acute kidney failure, and the other was a result of massive intestinal hemorrhage in the first cycle. The study of prognostic factors did not reveal any predictive factor of response. Response to treatment and baseline lactate dehydrogenase were the main factors conditioning progression-free and overall survival.
  
  
  CONCLUSIONS
  Twice a month continuous-infusion CPT-11 combined with FU is a valid therapeutic alternative for elderly patients in good general condition.
authors.affiliation: Servicio de Oncología Médica, Hospital Clínico San Carlos, C/Profesor Martín Lagos, s/n, 28040 Madrid, Spain. jsastre.hcsc@salud.madrid.org
authors.forename: Javier
authors.initials: J
authors.lastname: Sastre
authors.forename: Eugenio
authors.initials: E
authors.lastname: Marcuello
authors.forename: Bartomeu
authors.initials: B
authors.lastname: Masutti
authors.forename: Matilde
authors.initials: M
authors.lastname: Navarro
authors.forename: Silvia
authors.initials: S
authors.lastname: Gil
authors.forename: Antonio
authors.initials: A
authors.lastname: Antón
authors.forename: Albert
authors.initials: A
authors.lastname: Abad
authors.forename: Enrique
authors.initials: E
authors.lastname: Aranda
authors.forename: Joan
authors.initials: J
authors.lastname: Maurel
authors.forename: Manuel
authors.initials: M
authors.lastname: Valladares
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Maestu
authors.forename: Alfredo
authors.initials: A
authors.lastname: Carrato
authors.forename: José María
authors.initials: JM
authors.lastname: Vicent
authors.forename: Eduardo
authors.initials: E
authors.lastname: Díaz-Rubio
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002166:Camptothecin / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D005500:Follow-Up Studies; D015577:Geriatric Assessment; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008297:Male; D009361:Neoplasm Invasiveness / Q000473:pathology*; D009367:Neoplasm Staging; D011336:Probability; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin