title: Phase II trial of oxaliplatin and tegafur/uracil and oral folinic acid for advanced or metastatic colorectal cancer in elderly patients.
abstract: OBJECTIVE
  Colorectal cancer is usually diagnosed in elderly patients. Since there is clear evidence that such patients are under-treated and under-represented or even excluded from clinical studies and there are no reliable and prospective data on the feasibility and efficacy of an oxaliplatin (L-OHP)-based chemotherapy in this setting, we have tested the L-OHP plus oral uracil/tegafur (UFT) and oral folinic acid (FA) combination as first-line therapy in patients with advanced or metastatic colorectal cancer (MCRC) aged 70 or older.
  
  
  METHODS
  Forty-seven patients with advanced or MCRC, aged over 70, were treated with L-OHP 65 mg/m(2) as an intravenous 3-hour infusion on day 1 and 8 plus UFT 300 mg/m(2) and FA 90 mg in 3 divided doses given orally on days 1-14 for each 3-week cycle. Patients were followed by a geriatric and a quality of life (QoL) assessment with specific scales and EORTC-QLQ-C30 questionnaire.
  
  
  RESULTS
  All patients were assessable for toxicity and 45 for response to treatment. Complete response was achieved in 2 patients (4%) and partial response in 22 (47%) [overall response rate, 51%; 95% confidence interval (CI): 40.7-61.2%]; 18 patients (38%) had stable disease, and 5 (11%) had disease progression. The median duration of response was 8 months (range, 3-19+ months). After a minimum follow-up of 17 months, the median time to disease progression and the median overall survival were 8.0 (95% CI: 6.7-9.3%) and 14.1 (95% CI: 11.0-17.1%) months, respectively. Regimen safety was manageable. Most adverse events were mild to moderate, and this did not result in QoL impairment. The most common grade 3-4 treatment-related adverse events were diarrhea (17%), neutro- and thrombocytopenia (2%), laryngeal spasm (2%), and peripheral neuropathy (12.7%). No treatment-related deaths occurred.
  
  
  CONCLUSIONS
  These results confirmed that this tested chemotherapy combination is active with acceptable tolerability and QoL maintenance in elderly patients with advanced or MCRC.
authors.affiliation: Medical Oncology Unit, 'S. Carlo' Hospital of Potenza, Italy. rosatiger@yahoo.com
authors.forename: Gerardo
authors.initials: G
authors.lastname: Rosati
authors.forename: Stefano
authors.initials: S
authors.lastname: Cordio
authors.forename: Aniello
authors.initials: A
authors.lastname: Tucci
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Blanco
authors.forename: Roberto
authors.initials: R
authors.lastname: Bordonaro
authors.forename: Giorgio
authors.initials: G
authors.lastname: Reggiardo
authors.forename: Luigi
authors.initials: L
authors.lastname: Manzione
mesh_terms: D000284:Administration, Oral; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome; D014498:Uracil / Q000008:administration & dosage
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D005641:Tegafur; D014498:Uracil; D002955:Leucovorin