title: UFT as maintenance therapy in patients with advanced colorectal cancer responsive to the FOLFOX4 regimen.
abstract: BACKGROUND
  In advanced colorectal cancer (ACC), FOLFOX4 has been accepted as a standard chemotherapeutic regimen. Due to the neurotoxicity induced by oxaliplatin, which occurs in about 50% of patients during the 6-month FOLFOX4 regimen, and the frequent need for hospitalization, alternative regimens may be required. We aimed to determine whether a 'maintenance' therapy with oral UFT (uracil-tegafur) in patients responding to FOLFOX4 is able to maintain the response and improve the quality of life (QoL) as a result of the outpatient regimen and lower psychological distress.
  
  
  METHODS
  Untreated patients with ACC who did not progress after 6 months of FOLFOX4 received oral UFT until disease progression or unacceptable toxicity. The aim of the study was to maintain the response obtained with the FOLFOX4 regimen for at least 6 months. The secondary objective was to evaluate QoL during the two different treatment regimens utilizing the 36-item Short Form Health Survey (SF-36).
  
  
  RESULTS
  From January 2003 to August 2004, out of the enrolled 30 patients [22 males and 8 females; 2 patients with a complete response (CR), 14 patients with a partial response (PR) and 6 patients in stable disease (SD) after 6 months of FOLFOX4] 22 continued therapy with UFT until progression without significant toxicity; the remaining 8 patients (27%) had progressive disease (PD) during or at the end of FOLFOX4 and were treated with other regimen. After 6 months of UFT, 4 patients (13%) had CR, 6 patients (20%) PR and 4 patients (13%) SD; 16 patients (53%) progressed. Median follow-up was 31 months [interquartile range (IQR): 20-31 months]; 14 patients died of PD. The median time to progression was 13.9 (IQR: 7.7-20.1) months and the median survival time was 31 months (IQR: 20-31 months). Evaluation of QoL demonstrated a trend towards better QoL during UFT treatment.
  
  
  CONCLUSIONS
  These results support the feasibility of maintaining good response and improving QoL (measured by SF-36) with an oral fluoropyrimidine after combination chemotherapy in ACC patients; moreover, since UFT can be used orally, patient compliance is increased and the duration of hospitalization can be decreased.
authors.affiliation: Dipartimento di Medicina Interna, Oncologia e Gastroenterologia, Università degli Studi di Pavia, Policlinico San Matteo, Pavia, Italia.
authors.forename: R
authors.initials: R
authors.lastname: Scalamogna
authors.forename: S
authors.initials: S
authors.lastname: Brugnatelli
authors.forename: C
authors.initials: C
authors.lastname: Tinelli
authors.forename: P
authors.initials: P
authors.lastname: Sagrada
authors.forename: E
authors.initials: E
authors.lastname: Gattoni
authors.forename: M C
authors.initials: MC
authors.lastname: Tronconi
authors.forename: A
authors.initials: A
authors.lastname: Riccardi
authors.forename: G
authors.initials: G
authors.lastname: Luchena
authors.forename: G R
authors.initials: GR
authors.lastname: Corazza
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D011788:Quality of Life; D012074:Remission Induction; D005641:Tegafur / Q000008:administration & dosage; D014498:Uracil / Q000008:administration & dosage
chemical_list: D009944:Organoplatinum Compounds; D005641:Tegafur; D014498:Uracil; D002955:Leucovorin; D005472:Fluorouracil