title: Oxaliplatin/5-fluorouracil-based adjuvant chemotherapy as a standard of care for colon cancer in clinical practice: Outcomes of the ACCElox registry.
abstract: OBJECTIVE
  The ACCElox registry was set up to assess therapeutic management of early-stage colon cancer with oxaliplatin/5-fluorouracil (5-FU)-based regimen and the duration of adjuvant chemotherapy in current clinical practice.
  
  
  METHODS
  This prospective observational study was conducted between 2006 and 2008 in 19 countries on 1548 newly diagnosed patients with stage II/III colon cancer, who had complete resection of the primary tumor and treated with at least one dose of oxaliplatin. The patient/disease characteristics, dose intensity, toxicity management, treatment delay and duration of disease-free survival (DFS)/relapse were assessed.
  
  
  RESULTS
  About 73 and 27% of the patients were diagnosed with stage III (Dukes C) and stage II (Dukes B2) colon cancer, respectively. Overall, 74.4% patients completed the prescribed chemotherapy (FOLFOX 88%) and 97.6% patients received at least two cycles of oxaliplatin chemotherapy. The median actual dose intensity of oxaliplatin per cycle was 85 mg/m(2) . Relapse within 3 years occurred in 18.4% of patients with similar rate in all three groups (FOLFOX - 18.1%, FLOX - 19%, XELOX - 18.6%). At 3 years follow-up only 72 deaths were reported. The most common adverse events (AEs) at any cycle were neutropenia (63.9%), thrombocytopenia (23.3%), diarrhea (9.7%), sensory neuropathy (4.5%) and infection (2.6%). Disorders of central and peripheral nervous systems were frequently reported AEs at 6 months (54.3%, grade ≥1) and 12 months (36.4%, grade ≥1) of follow-up.
  
  
  CONCLUSIONS
  Majority of the patients completed the prescribed oxaliplatin/5-FU regimen. There was no significant difference in the DFS among these regimens. Our results confirm the favorable benefit/risk profile of oxaliplatin/5-FU-based regimens in this setting in clinical practice.
authors.affiliation: Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, South Korea.
authors.forename: Young Suk
authors.initials: YS
authors.lastname: Park
authors.affiliation: Beijing Cancer Hospital, Beijing, China.
authors.forename: Jiafu
authors.initials: J
authors.lastname: Ji
authors.affiliation: Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: John Raymond
authors.initials: JR
authors.lastname: Zalcberg
authors.affiliation: National Cancer Institute, University of Cairo, Giza, Egypt.
authors.forename: Mostafa
authors.initials: M
authors.lastname: El-Serafi
authors.affiliation: Hospital Sirio Libanes, São Paulo, Brazil.
authors.forename: Antonio
authors.initials: A
authors.lastname: Buzaid
authors.affiliation: Hotel-Dieu de France Hospital, Beirut, Lebanon.
authors.forename: Marwan
authors.initials: M
authors.lastname: Ghosn
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010818:Practice Patterns, Physicians'; D011379:Prognosis; D011446:Prospective Studies; D059039:Standard of Care; D015996:Survival Rate; D055815:Young Adult
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D005472:Fluorouracil
keywords: adjuvant chemotherapy; neutropenia; oxaliplatin; sensory neuropathy; thrombocytopenia