title: Epidemiology and natural history of central venous access device use and infusion pump function in the NO16966 trial.
abstract: BACKGROUND
  Central venous access devices in fluoropyrimidine therapy are associated with complications; however, reliable data are lacking regarding their natural history, associated complications and infusion pump performance in patients with metastatic colorectal cancer.
  
  
  METHODS
  We assessed device placement, use during treatment, associated clinical outcomes and infusion pump performance in the NO16966 trial.
  
  
  RESULTS
  Device replacement was more common with FOLFOX-4 (5-fluorouracil (5-FU)+oxaliplatin) than XELOX (capecitabine+oxaliplatin) (14.1% vs 5.1%). Baseline device-associated events and post-baseline removal-/placement-related events occurred more frequently with FOLFOX-4 than XELOX (11.5% vs 2.4% and 8.5% vs 2.1%). Pump malfunctions, primarily infusion accelerations in 16% of patients, occurred within 1.6-4.3% of cycles. Fluoropyrimidine-associated grade 3/4 toxicity was increased in FOLFOX-4-treated patients experiencing a malfunction compared with those who did not (97 out of 155 vs 452 out of 825 patients), predominantly with increased grade 3/4 neutropenia (53.5% vs 39.8%). Febrile neutropenia rates were comparable between patient cohorts±malfunction. Efficacy outcomes were similar in patient cohorts±malfunction.
  
  
  CONCLUSIONS
  Central venous access device removal or replacement was common and more frequent in patients receiving FOLFOX-4. Pump malfunctions were also common and were associated with increased rates of grade 3/4 haematological adverse events. Oral fluoropyrimidine-based regimens may be preferable to infusional 5-FU based on these findings.
authors.affiliation: University of Pittsburgh Cancer Institute, University of Pittsburgh School of Medicine, 5150 Centre Avenue, Pittsburgh, PA 15232, USA.
authors.forename: E
authors.initials: E
authors.lastname: Chu
authors.affiliation: University of Pennsylvania, 16 Penn Tower, 3400 Spruce Street, Philadelphia, PA 19104, USA.
authors.forename: D
authors.initials: D
authors.lastname: Haller
authors.affiliation: Florida Cancer Affiliates, 433 SW 10th Street, Ocala, FL 34471, USA.
authors.forename: T
authors.initials: T
authors.lastname: Cartwright
authors.affiliation: Leeds Institute of Cancer and Pathology, University of Leeds and St James's University Hospital, Level 4, Bexley Wing, St James's University Hospital, Beckett Street, Leeds LS9 7TF, UK.
authors.forename: C
authors.initials: C
authors.lastname: Twelves
authors.affiliation: University of Glasgow/Beatson West of Scotland Cancer Centre, 1053 Great Western Road, Glasgow G12 0YH, UK.
authors.forename: J
authors.initials: J
authors.lastname: Cassidy
authors.affiliation: University of Pittsburgh Cancer Institute, University of Pittsburgh School of Medicine, 5150 Centre Avenue, Pittsburgh, PA 15232, USA.
authors.forename: W
authors.initials: W
authors.lastname: Sun
authors.affiliation: Tufts University School of Medicine, 800 Washington Street, Boston, MA 02111, USA.
authors.forename: M W
authors.initials: MW
authors.lastname: Saif
authors.affiliation: Genentech Inc., 1 DNA Way, South San Francisco, CA 94080, USA.
authors.forename: E
authors.initials: E
authors.lastname: McKenna
authors.affiliation: Genentech Inc., 1 DNA Way, South San Francisco, CA 94080, USA.
authors.forename: S
authors.initials: S
authors.lastname: Lee
authors.affiliation: University Clinic Halle (Saale), Ernst-Grube-Str. 40, Halle 06120, Germany.
authors.forename: H-J
authors.initials: HJ
authors.lastname: Schmoll
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D000069287:Capecitabine; D002405:Catheterization, Central Venous / Q000295:instrumentation / Q000379:methods / Q000706:statistics & numerical data*; D015331:Cohort Studies; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D010071:Oxaloacetates; D062666:Vascular Access Devices / Q000706:statistics & numerical data*
chemical_list: D009944:Organoplatinum Compounds; D010071:Oxaloacetates; D003841:Deoxycytidine; D000069287:Capecitabine; D002955:Leucovorin; D005472:Fluorouracil