title: Oxaliplatin in combination with infusional 5-fluorouracil as first-line chemotherapy for elderly patients with metastatic colorectal cancer: a phase II study of the Spanish Cooperative Group for the Treatment of Digestive Tumors.
abstract: BACKGROUND
  We previously reported a 35% overall response rate (ORR) with biweekly 5-fluorouracil (5-FU) continuous infusion (TTD [Spanish Cooperative Group for Digestive Tumour Therapy] schedule) plus irinotecan as first-line therapy in elderly patients with metastatic colorectal cancer (mCRC). The present study also was carried out in elderly patients to determine the efficacy and safety of the same 5-FU schedule plus oxaliplatin.
  
  
  METHODS
  Patients (aged ≥72 years old) with mCRC, measurable disease, ECOG (Eastern Cooperative Oncology Group) ≤2, and no prior treatment were treated with oxaliplatin 85 mg/m(2) plus 5-FU 3000 mg/m(2) as a 48-hour infusion every 2 weeks.
  
  
  RESULTS
  The study included 134 patients, of whom, 129 were eligible. The main comorbidities were hypertension (44%), diabetes (17%), and chronic obstructive pulmonary disease (11%). The ORR and disease control rate (ORR plus stable disease) were 52% and 80%, respectively. With a median follow-up of 14 months, the median progression-free survival and overall survival were 9.1 and 16.3 months, respectively. The most frequent grade 3/4 adverse events included neutropenia (16%), diarrhea (11%), and grade 3 neurotoxicity (18%). No correlation was found between efficacy or safety and comorbidities.
  
  
  CONCLUSIONS
  To our knowledge, this is the largest phase II prospective study in elderly patients with mCRC. The observed efficacy and safety of this schedule compared favorably with those reported in this population, including regimens with monoclonal antibodies.
authors.affiliation: Medical Oncology, Hospital Regional Universitario Carlos Haya, Málaga, Spain. manuel.benavides.sspa@juntadeandalucia.es
authors.forename: Manuel
authors.initials: M
authors.lastname: Benavides
authors.forename: Carles
authors.initials: C
authors.lastname: Pericay
authors.forename: Manuel
authors.initials: M
authors.lastname: Valladares-Ayerbes
authors.forename: Silvia
authors.initials: S
authors.lastname: Gil-Calle
authors.forename: Bartomeu
authors.initials: B
authors.lastname: Massutí
authors.forename: Jorge
authors.initials: J
authors.lastname: Aparicio
authors.forename: Rosario
authors.initials: R
authors.lastname: Dueñas
authors.forename: Encarna
authors.initials: E
authors.lastname: González-Flores
authors.forename: Alfredo
authors.initials: A
authors.lastname: Carrato
authors.forename: Eugenio
authors.initials: E
authors.lastname: Marcuello
authors.forename: Auxiliadora
authors.initials: A
authors.lastname: Gómez
authors.forename: Enrique
authors.initials: E
authors.lastname: Cabrera
authors.forename: Bernardo
authors.initials: B
authors.lastname: Queralt
authors.forename: Ma José
authors.initials: MJ
authors.lastname: Gómez
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Guasch
authors.forename: Arantxa
authors.initials: A
authors.lastname: Etxeberría
authors.forename: Jordi
authors.initials: J
authors.lastname: Alfaro
authors.forename: Juan Manuel
authors.initials: JM
authors.lastname: Campos
authors.forename: Juan José
authors.initials: JJ
authors.lastname: Reina
authors.forename: Enrique
authors.initials: E
authors.lastname: Aranda
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D015179:Colorectal Neoplasms / Q000150:complications / Q000473:pathology*; D048909:Diabetes Complications / Q000150:complications; D003967:Diarrhea / Q000139:chemically induced; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D006973:Hypertension / Q000150:complications; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008207:Lymphatic Metastasis; D008297:Male; D020258:Neurotoxicity Syndromes / Q000209:etiology; D009503:Neutropenia / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D005472:Fluorouracil