title: Elderly patients with advanced colorectal cancer derive similar benefit without excessive toxicity after first-line chemotherapy with oxaliplatin-based combinations: comparative outcomes from the 03-TTD-01 phase III study.
abstract: OBJECTIVE
  Healthy elderly patients with metastatic colorectal cancer may benefit from chemotherapy as much as the younger population. This analysis compares the outcomes of first-line oxaliplatin plus fluoropyrimidines in elderly versus young patients.
  
  
  METHODS
  348 patients were randomized to capecitabine 1000 mg/(m2 12 h), days 1-14 plus oxaliplatin 130 mg/m2 day 1, every 3 weeks or weekly infusional 5-FU 2250 mg/m2 over 48 h plus bimonthly oxaliplatin 85 mg/m2. We evaluated response rate, time to progression, overall survival and toxicity according to age.
  
  
  RESULTS
  ORR for elderly and young patients were 34.9% and 44.7%, respectively (p=0.081). Median TTP did not differ between the two groups: 8.3 months for patients > or =70 years and 9.6 months for those <70 years (p=0.114). Median OS was 16.8 months and 20.5 months for the > or =70 and <70 years groups, respectively (p=0.74). With XELOX, mild paresthesia and an increase in transaminase levels were more frequent for young patients, whereas grade 3/4 diarrhea was higher in those > or =70 years (25% vs. 8%, p=0.005). For FUOX, only paresthesia was significantly lower in patients > or =70 years (53% vs. 71%, p=0.032).
  
  
  CONCLUSIONS
  Elderly patients with MCRC benefit from first-line oxaliplatin-fluoropyrimidine combinations as much as younger patients, without increased toxicity.
authors.affiliation: Servicio de Oncologia Medica, Hospital Clínico San Carlos, 28040 Madrid, Spain. jsastre.hcsc@salud.madrid.org
authors.forename: Javier
authors.initials: J
authors.lastname: Sastre
authors.forename: Enrique
authors.initials: E
authors.lastname: Aranda
authors.forename: Bartomeu
authors.initials: B
authors.lastname: Massutí
authors.forename: Jose
authors.initials: J
authors.lastname: Tabernero
authors.forename: Manuel
authors.initials: M
authors.lastname: Chaves
authors.forename: Albert
authors.initials: A
authors.lastname: Abad
authors.forename: Alfredo
authors.initials: A
authors.lastname: Carrato
authors.forename: Juan José
authors.initials: JJ
authors.lastname: Reina
authors.forename: Bernardo
authors.initials: B
authors.lastname: Queralt
authors.forename: Auxiliadora
authors.initials: A
authors.lastname: Gómez-España
authors.forename: Encarnación
authors.initials: E
authors.lastname: González-Flores
authors.forename: Fernando
authors.initials: F
authors.lastname: Rivera
authors.forename: Ferrán
authors.initials: F
authors.lastname: Losa
authors.forename: Teresa
authors.initials: T
authors.lastname: García
authors.forename: Pedro
authors.initials: P
authors.lastname: Sanchez-Rovira
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Maestu
authors.forename: Eduardo
authors.initials: E
authors.lastname: Díaz-Rubio
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000077150:Oxaliplatin
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil