title: Capecitabine plus oxaliplatin (xelox) versus protracted 5-fluorouracil venous infusion plus oxaliplatin (pvifox) as first-line treatment in advanced colorectal cancer: a GOAM phase II randomised study (FOCA trial).
abstract: This phase II randomised trial compares oxaliplatin plus protracted infusion of 5-fluorouracil (pviFOX) or oxaliplatin plus capecitabine (XELOX) in the first-line treatment of advanced colorectal cancer (ACRC).
  
  
  METHODS
  From December 2001 to March 2005, 118 patients were randomised to arm A (pviFOX: pvi5-FU by a central venous catheter 250 mg/m2/daily d1-21+oxaliplatin 130 mg/m2 d1 q3w) (56 pts) or arm B (XELOX: capecitabine 1000 mg/m2 po bid d1-14+oxaliplatin at the same schedule) (62 pts).
  
  
  RESULTS
  Patient characteristics were well-balanced between the two arms. Median number of complete cycles was six. The objective responses were: CR 1 (1.7%) and 3 (4.8%), PR 26 (46.4 %) and 24 (38.7%), SD 13 (23.2%) and 20 (32.3%), P 13(23.2%) and 10 (16.1%), not evaluable 3 (5.4%) and 5 (8.1 %) in arms A and B, respectively; the CR+PR rate was 48.2% (95% confidence limits 34.6%-61.9%) versus 43.5 % (31.0%-56.7%). Median TTP was 7 versus 9 months, respectively. About 50% of the patients with symptoms or low performance status at baseline experienced improvement without major differences between the two arms. G3-4 diarrhoea was observed in 14.0% versus 8.2%, G3 stomatitis in 3.7% versus 0, and G3 neurotoxicity in 18.5% versus 24.6% in arms A and B, respectively. Eight patients in arm A (14.8%) had venous line problems that obliged the temporary suspension (six cases) or stopping (two cases) of the 5-FU infusion.
  
  
  CONCLUSIONS
  Both pviFOX and XELOX are effective and safe first-line treatments for patients with ACRC. By avoiding intravenous (i.v.) administration by a central catheter, XELOX is favoured in clinical practice.
authors.affiliation: Medical Oncology Unit, S.Orsola-Malpighi Hospital, via Albertoni 15, 40138 Bologna, Italy. martoni@aosp.bo.it
authors.forename: Andrea Angelo
authors.initials: AA
authors.lastname: Martoni
authors.forename: Carmine
authors.initials: C
authors.lastname: Pinto
authors.forename: Francesca
authors.initials: F
authors.lastname: Di Fabio
authors.forename: Giorgio
authors.initials: G
authors.lastname: Lelli
authors.forename: Fabiola Lorena
authors.initials: FL
authors.lastname: Rojas Llimpe
authors.forename: Anna Lisa
authors.initials: AL
authors.lastname: Gentile
authors.forename: Vita
authors.initials: V
authors.lastname: Mutri
authors.forename: PierLuigi
authors.initials: P
authors.lastname: Ballardini
authors.forename: Stefania
authors.initials: S
authors.lastname: Giaquinta
authors.forename: Edera
authors.initials: E
authors.lastname: Piana
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018450:Disease Progression; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil